Existing law, the Sherman Food, Drug, and Cosmetic Law, under the administration and enforcement of the State Department of Public Health, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics. A violation of the Sherman Food, Drug, and Cosmetic Law is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require, commencing January 1, 2027, a manufacturer of a bulk prenatal multivitamin product or packaged prenatal multivitamin product, as defined, that is sold, manufactured, delivered, held, or offered for sale in this state to test a representative sample of each lot of the manufacturers bulk prenatal multivitamin product or packaged prenatal multivitamin product for heavy metals, as specified. The bill would define heavy metals to mean arsenic, cadmium, lead, and mercury. The bill would require both a manufacturer and brand owner to provide test results to an authorized agent of the department upon their request, as specified. The bill would, commencing January 1, 2027, require a brand owner of a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state, as specified, to disclose specified product information to the public, including, among other things, the heavy metal testing information. Commencing on or after January 1, 2027, for products shipped to retailers or consumers, the bill would require the outermost package of a packaged prenatal vitamin product and the product details page on an internet website where the product is sold to include a statement regarding heavy metal testing. The bill would prohibit a person from selling in the state or manufacturing, delivering, holding, or offering for sale in the state a prenatal multivitamin that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, under the administration and enforcement of the State Department of Public Health, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics. A violation of the Sherman Food, Drug, and Cosmetic Law is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require, commencing January 1, 2027, a manufacturer of a bulk prenatal multivitamin product or packaged prenatal multivitamin product, as defined, that is sold, manufactured, delivered, held, or offered for sale in this state to test a representative sample of each lot of the manufacturers bulk prenatal multivitamin product or packaged prenatal multivitamin product for heavy metals, as specified. The bill would define heavy metals to mean arsenic, cadmium, lead, and mercury. The bill would require both a manufacturer and brand owner to provide test results to an authorized agent of the department upon their request, as specified. The bill would, commencing January 1, 2027, require a brand owner of a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state, as specified, to disclose specified product information to the public, including, among other things, the heavy metal testing information. Commencing on or after January 1, 2027, for products shipped to retailers or consumers, the bill would require the outermost package of a packaged prenatal vitamin product and the product details page on an internet website where the product is sold to include a statement regarding heavy metal testing. The bill would prohibit a person from selling in the state or manufacturing, delivering, holding, or offering for sale in the state a prenatal multivitamin that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, under the administration and enforcement of the State Department of Public Health, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics. A violation of the Sherman Food, Drug, and Cosmetic Law is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require, commencing January 1, 2027, a manufacturer of a bulk prenatal multivitamin product or packaged prenatal multivitamin product, as defined, that is sold, manufactured, delivered, held, or offered for sale in this state to test a representative sample of each lot of the manufacturers bulk prenatal multivitamin product or packaged prenatal multivitamin product for heavy metals, as specified. The bill would define heavy metals to mean arsenic, cadmium, lead, and mercury. The bill would require both a manufacturer and brand owner to provide test results to an authorized agent of the department upon their request, as specified. The bill would, commencing January 1, 2027, require a brand owner of a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state, as specified, to disclose specified product information to the public, including, among other things, the heavy metal testing information. Commencing on or after January 1, 2027, for products shipped to retailers or consumers, the bill would require the outermost package of a packaged prenatal vitamin product and the product details page on an internet website where the product is sold to include a statement regarding heavy metal testing. The bill would prohibit a person from selling in the state or manufacturing, delivering, holding, or offering for sale in the state a prenatal multivitamin that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law Law, under the administration and enforcement of the State Department of Public Health, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. cosmetics. A violation of these provisions the Sherman Food, Drug, and Cosmetic Law is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require require, commencing January 1, 2027, a manufacturer of a bulk prenatal multivitamin products product or packaged prenatal multivitamin products, product, as defined, that are is sold, manufactured, delivered, held, or offered for sale in this state to test a representative sample of each lot of the manufacturers bulk prenatal multivitamin product or packaged prenatal multivitamin product for toxic elements, heavy metals, as specified. The bill would define heavy metals to mean arsenic, cadmium, lead, and mercury. The bill would require both a manufacturer and brand owner to provide test results to any an authorized agent of the department upon their request, as specified. The bill would, commencing January 1, 2027, require a brand owner of a packaged prenatal multivitamin products product that are is sold, manufactured, delivered, held, or offered for sale in the state, as specified, to disclose specified product information to the public, including, among other things, the toxic element heavy metal testing information. Commencing on or after January 1, 2027, for products shipped to retailers or consumers, the bill would require the outermost package of a packaged prenatal vitamin product and the product details page on an internet website where the product is sold to include a statement regarding heavy metal testing. The bill would prohibit a person from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any a prenatal multivitamin that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require a manufacturer and brand owner of of bulk prenatal multivitamin products or packaged prenatal multivitamin products products, as defined, that are sold, manufactured, delivered, held, or offered for sale in this state to test a representative sample of each lot of the manufacturers bulk prenatal multivitamin product or packaged prenatal multivitamin product, as defined, product for toxic elements, as specified. The bill would require both a manufacturer and brand owner to provide test results to any authorized agent of the department upon their request, as specified. The bill would, commencing January 1, 2027, require a manufacturer and brand owner of packaged prenatal multivitamin products that are sold, manufactured, delivered, held, or offered for sale in the state state, as specified, to disclose specified product information to the public, including, among other things, the toxic element testing information. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal multivitamin that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require a manufacturer of prenatal multivitamins for sale or distribution and brand owner of prenatal multivitamin products that are sold, manufactured, delivered, held, or offered for sale in this state to test a representative sample of each lot of the manufacturers bulk prenatal multivitamin product or packaged prenatal multivitamin product, as defined, for toxic elements, as specified. The bill would require a manufacturer and brand owner to provide test results to any authorized agent of the department upon their request, as specified. The bill would, commencing January 1, 2027, require a manufacturer and brand owner of packaged prenatal multivitamin products that are sold, manufactured, delivered, held, or offered for sale in the state to disclose specified product information to the public, including, among other things, the toxic element testing information. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal multivitamin that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, product for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, as specified, except for the prerequisite that the FDA establish an action level, regulatory limit, or tolerance. a manufacturer of prenatal multivitamins for sale or distribution in this state to test a representative sample of each lot of the manufacturers bulk prenatal multivitamin product or packaged prenatal multivitamin product, as defined, for toxic elements, as specified. The bill would require a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. The bill would, commencing January 1, 2027, require a manufacturer of packaged prenatal multivitamin products that are sold, manufactured, delivered, held, or offered for sale in the state to disclose specified product information to the public, including, among other things, the toxic element testing information. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamins multivitamin that do does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, as specified, except for the prerequisite that the FDA establish an action level, regulatory limit, or tolerance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamins that do not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, except for the prerequisite that the FDA establish an action level, regulatory limit, or tolerance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamins that do not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.

This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, except for the prerequisite that the FDA establish an action level, regulatory limit, or tolerance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamins that do not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

 UNFINISHED BUSINESS 

Bill No: SB 646

Author: Weber Pierson (D)

Amended: 10/11/25

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 4/2/25

AYES: Menjivar, Valladares, Durazo, Gonzalez, Grove, Limón, Padilla, Richardson, Rubio, Weber Pierson, Wiener

SENATE ENVIRONMENTAL QUALITY COMMITTEE: 8-0, 4/30/25

AYES: Blakespear, Valladares, Dahle, Gonzalez, Hurtado, Menjivar, Padilla, Pérez

SENATE APPROPRIATIONS COMMITTEE: 6-0, 5/23/25

AYES: Caballero, Seyarto, Cabaldon, Grayson, Richardson, Wahab

NO VOTE RECORDED: Dahle

SENATE FLOOR: 38-0, 5/28/25

AYES: Allen, Alvarado-Gil, Archuleta, Arreguín, Ashby, Becker, Blakespear, Cabaldon, Caballero, Cervantes, Choi, Cortese, Dahle, Durazo, Gonzalez, Grayson, Grove, Hurtado, Jones, Laird, McGuire, McNerney, Menjivar, Niello, Ochoa Bogh, Padilla, Pérez, Richardson, Rubio, Seyarto, Smallwood-Cuevas, Stern, Strickland, Umberg, Valladares, Wahab, Weber Pierson, Wiener

NO VOTE RECORDED: Limón, Reyes

ASSEMBLY FLOOR: 77-0, 9/13/25 - See last page for vote

SUBJECT: Prenatal multivitamins

SOURCE: American College of Obstetricians & Gynecologists

Environmental Working Group

Unleaded Kids

DIGEST:

This bill requires manufacturers of prenatal vitamins to test samples of the vitamins for arsenic, cadmium, lead, and mercury, and requires the brand owner of a multivitamin product to disclose the testing results and other information to the public.

Assembly Amendments of 9/9/25

distinguish between the testing responsibilities of the manufacturer and the disclosure responsibilities of brand owners, add additional information that is required to be disclosed on the brand owner’s website, including a statement regarding the presence of heavy metals in multivitamins and foods, delay implementation to January 1, 2027, specify that multivitamins sold in the state after January 1, 2030 are required to comply with the labeling requirements, and make other changes to clarify and make more specific various provisions.

ANALYSIS:

Existing federal law:

1. Establishes, through the federal Food and Drug Administration (FDA), various requirements for food labels under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which includes the Nutritional Labeling and Education Act and the Food Allergen Labeling and Consumer Protection Act. These include requiring specified nutrition information, a listing of all ingredients, and whether a produce contains any of eight major food allergens, such as milk, eggs, shellfish, tree nuts, etc. [21 United States Code (USC) §301, et seq. and 21 Code of Federal Regulations §101, et seq.]
2. Defines “dietary supplement” as a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance to supplement the diet by increasing the total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any of these ingredients. Excludes from this definition something that is represented for use as a conventional food or as a sole item of a meal or the diet. [21 USC §322(ff)]

Existing state law:

1. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by the California Department of Public Health (CDPH), which provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted, by regulation, to adopt additional food labeling regulations. [Health & Safety Code (HSC) §109875 et seq. and §110380]
2. Requires a manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturer’s final baby food product, at least once per month, at a proficient laboratory, for arsenic, cadmium, lead, and mercury. Requires the laboratory to be able to quantify each toxic element to at least six micrograms to kilogram of food. [HSC §110962(b)(1)]
3. Requires a manufacturer of baby food for sale or distribution in this state to disclose product information for baby food sold on an after January 1, 2025, including making publicly available on the manufacturer’s website the name and level of each toxic element present in a final baby food product. [HSC §110962(b)(2)]
4. Requires, if a baby food product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by FDA, to include a Quick Response (QR) code that links to a page on the manufacturer’s website that contains test results for the toxic element and a link to an FDA website where consumers can find the most recent FDA guidance and information about the health effects of the toxic element on children. [HSC §110962(b)(B)]
5. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. [HSC §25249.6]
6. Permits, under Proposition 65, a warning to be provided by general methods, such as labels on consumer products, posting of notices, placing notices in public news media, and the like, provided that the warning is clear and reasonable; requires regulations implementing Proposition 65, to the extent practicable, to place the obligation to provide any warning materials on the producer or packager rather than on the retail seller, except where the retail seller itself is responsible for introducing a chemical known to the state to cause cancer or reproductive toxicity. [HSC §25249.11(f)]

This bill:

1. Requires a manufacturer of a bulk prenatal multivitamin product or a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state to test a representative sample of each lot of the manufacturer’s bulk prenatal multivitamin product or packaged prenatal multivitamin product, beginning January 1, 2027, at a proficient laboratory for heavy metals.
2. Requires the laboratory, including a manufacturer’s in-house laboratory, to meet all of the following criteria:
   1. Be accredited under the standards of the International Organization for Standardization’s and the International Electrotechnical Commission’s international standard regarding the general requirements for the competence of testing and calibration laboratories as they pertain to the testing of heavy metals, unless they contradict federal regulations, which shall control;
   2. Use an analytical method that is at least as sensitive and specific as described in the FDA’s Elemental Analysis Manual for Food and Related Products: Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion; and,
   3. Demonstrate proficiency in quantifying each heavy metal to 10 micrograms or less of the heavy metal to kilogram of supplement through an independent proficiency test, and defines proficiency as achieving a z-score that is less than or equal to plus or minus two.
3. Requires both manufacturers and brand owners to provide test results to an authorized agent of CDPH upon their request. Permits a brand owner, if it does not manufacture the multivitamin product, to comply by providing the test results of the manufacturer they use to produce the multivitamin product.
4. Requires the brand owner of a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state, including prenatal multivitamins that are sold by a retailer or that are sold directly to consumers, beginning January 1, 2027, to disclose product information to the public consistent with all of the following:
   1. Make publicly available on the brand owner’s website, for the duration of the product shelf life plus one month, all of the following: the name and level of each heavy metal present in each lot of a packaged prenatal multivitamin product; information from the product’s supplement facts panel, including the amount per serving of each ingredient; and, the following statement:
      
      “Prenatal multivitamins containing certain minerals critical to support an expectant person’s health and proper development of their fetus may contain trace levels of heavy metals that occur in the environment naturally or from human activities. The levels of heavy metals in prenatal multivitamin ingredients may vary depending on whether and at what levels the prenatal multivitamin contains these ingredients, as well as the location from which the ingredients are sourced. Certain foods containing minerals critical to support an expectant person’s health and proper development of their fetus may also contain heavy metals. For more information, speak with your physician about choosing a prenatal multivitamin that meets your specific nutrient needs.”
   2. Provide descriptive information on its website to enable accurate identification of the prepackaged prenatal multivitamin product by the public, including information that makes the levels of heavy metals available to the public by lot;
   3. An internet website hyperlink to the FDA where the public can find the most recent FDA website relating to heavy metals in food’; and,
   4. On the brand owner’s website describing a packaged prenatal multivitamin product, on the outermost package for products sold in retail stores, and on the product details page for a product sold online or directly to consumers, requires a statement that reads: “For information about heavy metal testing on this product” followed by a hyperlink to the website that contains the publicly available test results, or a website address, as appropriate.
5. Prohibits a person from selling, manufacturing, delivering, holding, or offering for sale, on or after January 1, 2030, a prenatal multivitamin that does not include the packaging or online statements specified by this bill..
6. Defines “heavy metals” as arsenic, cadmium, lead, and mercury, and defines various other terms for purposes of this bill, including “brand owner,” “bulk” and “prepackaged” prenatal multivitamin products, and others.

Comments

According to the author of this bill:

Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. While a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. Prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. Recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. A U.S. Government Accountability Office (GAO) study found lead, a heavy metal with no safe level of exposure, in half of the sampled prenatal vitamins, with some independent studies finding contamination, exceeding California’s Proposition 65 limits. Given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.

Background

FDA regulation of dietary supplements. Under the FD&C Act, as amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), the FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public. Instead, dietary supplements are regulated by the FDA in much the same manner as food, which means they are subject to requirements relating to good manufacturing practices, and must meet certain labeling standards, among other requirements. According to the FDA, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law. Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). The FD&C Act requires that manufacturers and distributors who wish to market dietary supplements that contain a “new dietary ingredient” (NDI) to notify the FDA about these ingredients. An NDI is an ingredient that was not marketed in a dietary supplement in the U.S. prior to October 15, 1994. When notifying the FDA about an NDI, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing the NDI will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. While the FDA is not required to formally approve an NDI, it will consider a dietary supplement “adulterated” unless the NDI has been present in the food supply in the same chemical form that you plan to use in the dietary supplement, or the manufacturer has shown evidence of safety at least 75 days before being introduced or delivered for introduction into interstate commerce, including any citation to published articles.

Importance of prenatal vitamins. According to a study published in the journal Maternal Health, Neonatology and Perinatology in July of 2022, entitled, “Evidence Based Recommendations for an Optimal Prenatal Supplement for Women in the US: Vitamins and Related Nutrients,” sub-optimal intake of vitamins from preconception through pregnancy increases the risk of many pregnancy complications and infant health problems. According to this study, in the U.S., dietary intake of vitamins is often below recommended intakes, especially for vitamin D, choline, and DHA, and that many studies suggest that insufficient vitamin intake is associated with a wide range of pregnancy complications (anemia, Cesarean section, depression, gestational diabetes, hypertension, infertility, preeclampsia, and premature rupture of membranes) and infant health problems (asthma/wheeze, autism, low birth weight, congenital heart defects, intellectual development, intrauterine growth restriction, miscarriage, neural tube defects, orofacial defects, and preterm birth). The study found that prenatal supplements vary widely in content, often contained only a subset of essential vitamins and the levels were often below recommendations. The study suggested that increasing prenatal vitamin supplementation to the levels recommended in the study may reduce the incidence of many pregnancy complications and infant health problems. A related study by the same authors focusing on minerals, including calcium, iron, magnesium, selenium, and zinc, made similar findings and recommendations regarding the need for supplementation, especially for iodine, magnesium, and iron. Numerous organizations, including the FDA, the Centers for Disease Control and Prevention, and the American College of Obstetricians and Gynecologists, emphasize the importance of taking a prenatal vitamin that contains at least 400 micrograms of folic acid each day at least one month before pregnancy and during the first 12 weeks of pregnancy, and to consult with an obstetric care provider to see if additional supplementation is recommended based on a person’s health history. Folic acid can help prevent neural tube defects.

GAO report on prenatal supplements. The GAO published a report in December 2023 entitled “Prenatal Supplements: Amounts of Some Key Nutrients Different from Product Labels.” The overall thrust of this report was that of the 12 supplement products tested; most of them had levels of nutrients that did not correspond to the value on the label. The GAO report noted that FDA lacks authority to regulate dietary supplements with the same rigor as drugs, with oversight primarily occurring once the supplements are already on the market. The GAO recommended that Congress consider measures providing the FDA with sufficient authority to carry out oversight of dietary supplements. However, as part of the testing for this report, the supplement products were tested for heavy metal contamination, and six of the 12 products were found to have trace amounts of heavy metals, though not in amounts likely to cause a health concern based on metrics used by the FDA. Of the six products with trace amounts of heavy metals, all six had trace amounts of lead, and two had trace amounts of cadmium. Arsenic and mercury were below the detection limits in all of the samples. The highest average lead content found was 0.31 micrograms per daily serving, which is well below FDA’s threshold of 8.8 micrograms of lead per day for individuals of a childbearing age. The report noted that while the FDA recognizes that a safe level of lead exposure has not been identified for fetal brain and cognitive development, based on existing data and other information, the FDA concluded that the levels found it its study were unlikely to pose a health concern. Regarding the two supplement products that contained cadmium, one was contained 0.52 micrograms per daily serving, and the other contained 0.32 micrograms per daily serving. The FDA uses a daily exposure limit of 0.21 – 0.36 micrograms of cadmium per kilogram of body weight per day for any individual, which corresponds to a limit of 14.3 – 24.5 micrograms per day for a 150-pound individual. Based on daily exposure limits used by the FDA, neither of the findings of cadmium in the tested supplements is likely to pose a health concern.

Why are these toxic elements in supplements and other food products? The FDA’s “Closer to Zero” initiative is working to reduce childhood exposure to toxic elements in food. According to the FDA, arsenic, lead, cadmium and mercury may occur in the environment naturally (as elements in the earth’s crust) and from human activities. Levels in the air, water, and soil used to grow crops, process foods, and raise animals can vary depending on natural geographical proximity to past or current pollution. The amount of arsenic, lead, cadmium, or mercury in certain foods depends on the amount in the environment and how much the plant or animal ‘takes up’ from the environment. The GAO report on prenatal supplements noted that the presence of heavy metals may not be from the manufacturing process, but rather the ingredients chosen for the vitamins or minerals they contain. For example, bioaccumulation (a build-up of environmental substances in an organism) can result in an increased presence of arsenic in rice (a source of iron and calcium) and mercury in fish (a source of omega-3 fatty acids). Additionally, research shows a correlation between calcium and lead in naturally occurring sources of calcium such as shells, bone, and rock.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Assembly Committee on Appropriations:

1. The California Department of Public Health estimates ongoing, annual costs of $169,000 starting in fiscal year 2026-27 to cover one full-time employee position to perform inspections and field audits, including remote inspections and desk audits, re-inspections, new license inspections, label review, and field visits to California firms holding out-of-state products (General Fund).
2. The Department of Justice (DOJ) anticipates increased workload for the Environmental Justice and Protection Section (EJPS) within DOJ's Public Rights Division to enforce this bill. The work anticipated by EJPS could require a significant increase in attorney hours. DOJ is unable to estimate at this time the additional number of Deputy Attorneys General, along with their legal complement, that might need to be hired. If DOJ does not pursue enforcement as authorized by this bill, DOJ would likely not incur any costs, but if DOJ hires staff to handle enforcement actions, costs could be in the low hundreds of thousands of dollars annually, at a minimum (Unfair Competition Law Fund).

SUPPORT: (Verified 9/10/25)

American College of Obstetricians & Gynecologists (co-sponsor)

Environmental Working Group (co-sponsor)

Unleaded Kids (co-sponsor)

A Voice for Choice Advocacy

American College of Obstetricians & Gynecologists – District IX

American Nurses Association\California

Black Women for Wellness Action Project

California Environmental Voters

California Medical Association

California Nurses for Environmental Health & Justice

California Nurse Midwives Association

California WIC Association

Center for Community Action and Environmental Justice

Center for Environmental Health

Center for Science in the Public Interest

Children Now

Cleanearth4kids.org

Consumer Federation of California

Consumer Reports Advocacy

Families Advocating for Chemical Toxics Safety

Friends Committee on Legislation of California

GMO Science

Healthy Babies Bright Futures

Indivisible Marin

Long Beach Alliance for Clean Energy

Mamavation

Maternal and Child Health Access

National Health Law Program

Non-Toxic Neighborhoods

Planned Parenthood Affiliates of California

Recolte Energy

Ritual

Unleaded Kids

www.GMOScience.org

OPPOSITION: (Verified 9/10/25)

Consumer Healthcare Products Association

Council for Responsible Nutrition

Natural Products Association

ARGUMENTS IN SUPPORT: This bill is co-sponsored by the American College of Obstetricians and Gynecologists District IX, the Environmental Working Group, and Unleaded Kids. The sponsors state that prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help lower the risk of birth defects, low birth weight, and other complications. However, recent studies have raised concerns about contamination of these supplements with toxic elements known to pose serious health risks, especially to pregnant individuals and developing fetuses. The sponsors state that this bill addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury, and permits consumers to access this information via a QR code on product labels, linking to a webpage with FDA guidance on the health risks associated with these heavy metals. Sponsors state that California has long led the nation in protecting public health through transparency and accountability measures, and this bill builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants.

ARGUMENTS IN OPPOSITION: The Natural Produces Association (NPA) opposes this bill state that it would lead to significant consumer confusion for a variety of reasons. First, NPA states that it could lead to a misinterpretation of risk, where consumers may mistakenly believe that prenatal vitamins are intentionally contaminated with substances even though these elements are naturally occurring and present in many foods, and that this warning could cause fear and hesitation that will lead some pregnant individuals to avoid essential prenatal vitamins. Second, NPA states that there will be a lack of context about natural occurrence, making consumers believe prenatal vitamins pose a unique health risk even thoug the levels are well below established safety thresholds. NPA points out that the FDA already regulates heavy metal limits in food and supplements based on scientific risk assessments and if enacted, this bill will conflict with federal law and cause confusion over whether prenatal vitamins sold in California are somehow different from those sold elsewhere. Finally, NPA states that this bill has the potential for unnecessary alarm and product avoidance, where women will stop taking prenatal vitamins altogether out of fear of toxicity, leading to greater health risks for both mother and baby.

Oppose unless amended. The Council for Responsible Nutrition and the Consumer Healthcare Products Association submitted a joint letter opposing this bill unless amended. The opponents argue that manufacturers do not intentionally add these elements to their products, but they may occur in certain raw materials, that federal regulations already require Good Manufacturing Practices, and that manufacturers already test these products for the presence of heavy metals. Opponents state that notifying consumers of the presence of these elements at any level will send mixed messages when those consumers are also encouraged by their doctor to take prenatal vitamins while pregnant. Opponents point out that the specified toxic elements are already regulated and enforced under California’s Proposition 65, which requires a warning if the product might expose consumers to carcinogens or reproductive toxicants at protective levels set by the Office of Environmental Health Hazard Assessment. The opponents request that the provisions requiring public disclosure of laboratory test results on manufacturer websites, and the provisions mandating QR codes on product labels, be removed from the bill.

ASSEMBLY FLOOR: 77-0, 9/13/25

AYES: Addis, Aguiar-Curry, Ahrens, Alanis, Alvarez, Arambula, Ávila Farías, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Caloza, Carrillo, Chen, Connolly, Davies, DeMaio, Dixon, Elhawary, Fong, Gabriel, Gallagher, Garcia, Gipson, Jeff Gonzalez, Mark González, Hadwick, Haney, Harabedian, Hart, Hoover, Irwin, Jackson, Johnson, Kalra, Krell, Lackey, Lee, Lowenthal, Macedo, McKinnor, Muratsuchi, Nguyen, Ortega, Pacheco, Papan, Patel, Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Ransom, Celeste Rodriguez, Michelle Rodriguez, Rogers, Blanca Rubio, Sanchez, Schiavo, Schultz, Sharp-Collins, Solache, Soria, Stefani, Ta, Tangipa, Valencia, Wallis, Ward, Wicks, Wilson, Zbur, Rivas

NO VOTE RECORDED: Castillo, Ellis, Flora

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

7/16/26 14:04:32

**** END ****

 UNFINISHED BUSINESS  

Bill No: SB 646

Author: Weber Pierson (D)

Amended: 9/9/25 in Assembly

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 4/2/25

AYES: Menjivar, Valladares, Durazo, Gonzalez, Grove, Limón, Padilla, Richardson, Rubio, Weber Pierson, Wiener

SENATE ENVIRONMENTAL QUALITY COMMITTEE: 8-0, 4/30/25

AYES: Blakespear, Valladares, Dahle, Gonzalez, Hurtado, Menjivar, Padilla, Pérez

SENATE APPROPRIATIONS COMMITTEE: 6-0, 5/23/25

AYES: Caballero, Seyarto, Cabaldon, Grayson, Richardson, Wahab

NO VOTE RECORDED: Dahle

SENATE FLOOR: 38-0, 5/28/25

AYES: Allen, Alvarado-Gil, Archuleta, Arreguín, Ashby, Becker, Blakespear, Cabaldon, Caballero, Cervantes, Choi, Cortese, Dahle, Durazo, Gonzalez, Grayson, Grove, Hurtado, Jones, Laird, McGuire, McNerney, Menjivar, Niello, Ochoa Bogh, Padilla, Pérez, Richardson, Rubio, Seyarto, Smallwood-Cuevas, Stern, Strickland, Umberg, Valladares, Wahab, Weber Pierson, Wiener

NO VOTE RECORDED: Limón, Reyes

ASSEMBLY FLOOR: 58-0, 9/13/25 – Roll call not available.

SUBJECT: Prenatal multivitamins

SOURCE: American College of Obstetricians & Gynecologists

Environmental Working Group

Unleaded Kids

DIGEST:

This bill requires manufacturers of prenatal vitamins to test samples of the vitamins for arsenic, cadmium, lead, and mercury, and requires the brand owner of a multivitamin product to disclose the testing results and other information to the public.

Assembly Amendments of 9/9/25

distinguish between the testing responsibilities of the manufacturer and the disclosure responsibilities of brand owners, add additional information that is required to be disclosed on the brand owner’s website, including a statement regarding the presence of heavy metals in multivitamins and foods, delay implementation to January 1, 2027, specify that multivitamins sold in the state after January 1, 2030 are required to comply with the labeling requirements, and make other changes to clarify and make more specific various provisions.

ANALYSIS:

Existing federal law:

1. Establishes, through the federal Food and Drug Administration (FDA), various requirements for food labels under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which includes the Nutritional Labeling and Education Act and the Food Allergen Labeling and Consumer Protection Act. These include requiring specified nutrition information, a listing of all ingredients, and whether a produce contains any of eight major food allergens, such as milk, eggs, shellfish, tree nuts, etc. [21 United States Code (USC) §301, et seq. and 21 Code of Federal Regulations §101, et seq.]
2. Defines “dietary supplement” as a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance to supplement the diet by increasing the total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any of these ingredients. Excludes from this definition something that is represented for use as a conventional food or as a sole item of a meal or the diet. [21 USC §322(ff)]

Existing state law:

1. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by the California Department of Public Health (CDPH), which provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted, by regulation, to adopt additional food labeling regulations. [Health & Safety Code (HSC) §109875 et seq. and §110380]
2. Requires a manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturer’s final baby food product, at least once per month, at a proficient laboratory, for arsenic, cadmium, lead, and mercury. Requires the laboratory to be able to quantify each toxic element to at least six micrograms to kilogram of food. [HSC §110962(b)(1)]
3. Requires a manufacturer of baby food for sale or distribution in this state to disclose product information for baby food sold on an after January 1, 2025, including making publicly available on the manufacturer’s website the name and level of each toxic element present in a final baby food product. [HSC §110962(b)(2)]
4. Requires, if a baby food product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by FDA, to include a Quick Response (QR) code that links to a page on the manufacturer’s website that contains test results for the toxic element and a link to an FDA website where consumers can find the most recent FDA guidance and information about the health effects of the toxic element on children. [HSC §110962(b)(B)]
5. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. [HSC §25249.6]
6. Permits, under Proposition 65, a warning to be provided by general methods, such as labels on consumer products, posting of notices, placing notices in public news media, and the like, provided that the warning is clear and reasonable; requires regulations implementing Proposition 65, to the extent practicable, to place the obligation to provide any warning materials on the producer or packager rather than on the retail seller, except where the retail seller itself is responsible for introducing a chemical known to the state to cause cancer or reproductive toxicity. [HSC §25249.11(f)]

This bill:

1. Requires a manufacturer of a bulk prenatal multivitamin product or a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state to test a representative sample of each lot of the manufacturer’s bulk prenatal multivitamin product or packaged prenatal multivitamin product, beginning January 1, 2027, at a proficient laboratory for heavy metals.
2. Requires the laboratory, including a manufacturer’s in-house laboratory, to meet all of the following criteria:
   1. Be accredited under the standards of the International Organization for Standardization’s and the International Electrotechnical Commission’s international standard regarding the general requirements for the competence of testing and calibration laboratories as they pertain to the testing of heavy metals, unless they contradict federal regulations, which shall control;
   2. Use an analytical method that is at least as sensitive and specific as described in the FDA’s Elemental Analysis Manual for Food and Related Products: Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion; and,
   3. Demonstrate proficiency in quantifying each heavy metal to 10 micrograms or less of the heavy metal to kilogram of supplement through an independent proficiency test, and defines proficiency as achieving a z-score that is less than or equal to plus or minus two.
3. Requires both manufacturers and brand owners to provide test results to an authorized agent of CDPH upon their request. Permits a brand owner, if it does not manufacture the multivitamin product, to comply by providing the test results of the manufacturer they use to produce the multivitamin product.
4. Requires the brand owner of a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state, including prenatal multivitamins that are sold by a retailer or that are sold directly to consumers, beginning January 1, 2027, to disclose product information to the public consistent with all of the following:
   1. Make publicly available on the brand owner’s website, for the duration of the product shelf life plus one month, all of the following: the name and level of each heavy metal present in each lot of a packaged prenatal multivitamin product; information from the product’s supplement facts panel, including the amount per serving of each ingredient; and, the following statement:
      
      “Prenatal multivitamins containing certain minerals critical to support an expectant person’s health and proper development of their fetus may contain trace levels of heavy metals that occur in the environment naturally or from human activities. The levels of heavy metals in prenatal multivitamin ingredients may vary depending on whether and at what levels the prenatal multivitamin contains these ingredients, as well as the location from which the ingredients are sourced. Certain foods containing minerals critical to support an expectant person’s health and proper development of their fetus may also contain heavy metals. For more information, speak with your physician about choosing a prenatal multivitamin that meets your specific nutrient needs.”
   2. Provide descriptive information on its website to enable accurate identification of the prepackaged prenatal multivitamin product by the public, including information that makes the levels of heavy metals available to the public by lot;
   3. An internet website hyperlink to the FDA where the public can find the most recent FDA website relating to heavy metals in food’; and,
   4. On the brand owner’s website describing a packaged prenatal multivitamin product, on the outermost package for products sold in retail stores, and on the product details page for a product sold online or directly to consumers, requires a statement that reads: “For information about heavy metal testing on this product” followed by a hyperlink to the website that contains the publicly available test results, or a website address, as appropriate.
5. Prohibits a person from selling, manufacturing, delivering, holding, or offering for sale, on or after January 1, 2030, a prenatal multivitamin that does not include the packaging or online statements specified by this bill..
6. Defines “heavy metals” as arsenic, cadmium, lead, and mercury, and defines various other terms for purposes of this bill, including “brand owner,” “bulk” and “prepackaged” prenatal multivitamin products, and others.

Comments

According to the author of this bill:

Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. While a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. Prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. Recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. A U.S. Government Accountability Office (GAO) study found lead, a heavy metal with no safe level of exposure, in half of the sampled prenatal vitamins, with some independent studies finding contamination, exceeding California’s Proposition 65 limits. Given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.

Background

FDA regulation of dietary supplements. Under the FD&C Act, as amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), the FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public. Instead, dietary supplements are regulated by the FDA in much the same manner as food, which means they are subject to requirements relating to good manufacturing practices, and must meet certain labeling standards, among other requirements. According to the FDA, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law. Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). The FD&C Act requires that manufacturers and distributors who wish to market dietary supplements that contain a “new dietary ingredient” (NDI) to notify the FDA about these ingredients. An NDI is an ingredient that was not marketed in a dietary supplement in the U.S. prior to October 15, 1994. When notifying the FDA about an NDI, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing the NDI will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. While the FDA is not required to formally approve an NDI, it will consider a dietary supplement “adulterated” unless the NDI has been present in the food supply in the same chemical form that you plan to use in the dietary supplement, or the manufacturer has shown evidence of safety at least 75 days before being introduced or delivered for introduction into interstate commerce, including any citation to published articles.

Importance of prenatal vitamins. According to a study published in the journal Maternal Health, Neonatology and Perinatology in July of 2022, entitled, “Evidence Based Recommendations for an Optimal Prenatal Supplement for Women in the US: Vitamins and Related Nutrients,” sub-optimal intake of vitamins from preconception through pregnancy increases the risk of many pregnancy complications and infant health problems. According to this study, in the U.S., dietary intake of vitamins is often below recommended intakes, especially for vitamin D, choline, and DHA, and that many studies suggest that insufficient vitamin intake is associated with a wide range of pregnancy complications (anemia, Cesarean section, depression, gestational diabetes, hypertension, infertility, preeclampsia, and premature rupture of membranes) and infant health problems (asthma/wheeze, autism, low birth weight, congenital heart defects, intellectual development, intrauterine growth restriction, miscarriage, neural tube defects, orofacial defects, and preterm birth). The study found that prenatal supplements vary widely in content, often contained only a subset of essential vitamins and the levels were often below recommendations. The study suggested that increasing prenatal vitamin supplementation to the levels recommended in the study may reduce the incidence of many pregnancy complications and infant health problems. A related study by the same authors focusing on minerals, including calcium, iron, magnesium, selenium, and zinc, made similar findings and recommendations regarding the need for supplementation, especially for iodine, magnesium, and iron. Numerous organizations, including the FDA, the Centers for Disease Control and Prevention, and the American College of Obstetricians and Gynecologists, emphasize the importance of taking a prenatal vitamin that contains at least 400 micrograms of folic acid each day at least one month before pregnancy and during the first 12 weeks of pregnancy, and to consult with an obstetric care provider to see if additional supplementation is recommended based on a person’s health history. Folic acid can help prevent neural tube defects.

GAO report on prenatal supplements. The GAO published a report in December 2023 entitled “Prenatal Supplements: Amounts of Some Key Nutrients Different from Product Labels.” The overall thrust of this report was that of the 12 supplement products tested; most of them had levels of nutrients that did not correspond to the value on the label. The GAO report noted that FDA lacks authority to regulate dietary supplements with the same rigor as drugs, with oversight primarily occurring once the supplements are already on the market. The GAO recommended that Congress consider measures providing the FDA with sufficient authority to carry out oversight of dietary supplements. However, as part of the testing for this report, the supplement products were tested for heavy metal contamination, and six of the 12 products were found to have trace amounts of heavy metals, though not in amounts likely to cause a health concern based on metrics used by the FDA. Of the six products with trace amounts of heavy metals, all six had trace amounts of lead, and two had trace amounts of cadmium. Arsenic and mercury were below the detection limits in all of the samples. The highest average lead content found was 0.31 micrograms per daily serving, which is well below FDA’s threshold of 8.8 micrograms of lead per day for individuals of a childbearing age. The report noted that while the FDA recognizes that a safe level of lead exposure has not been identified for fetal brain and cognitive development, based on existing data and other information, the FDA concluded that the levels found it its study were unlikely to pose a health concern. Regarding the two supplement products that contained cadmium, one was contained 0.52 micrograms per daily serving, and the other contained 0.32 micrograms per daily serving. The FDA uses a daily exposure limit of 0.21 – 0.36 micrograms of cadmium per kilogram of body weight per day for any individual, which corresponds to a limit of 14.3 – 24.5 micrograms per day for a 150-pound individual. Based on daily exposure limits used by the FDA, neither of the findings of cadmium in the tested supplements is likely to pose a health concern.

Why are these toxic elements in supplements and other food products? The FDA’s “Closer to Zero” initiative is working to reduce childhood exposure to toxic elements in food. According to the FDA, arsenic, lead, cadmium and mercury may occur in the environment naturally (as elements in the earth’s crust) and from human activities. Levels in the air, water, and soil used to grow crops, process foods, and raise animals can vary depending on natural geographical proximity to past or current pollution. The amount of arsenic, lead, cadmium, or mercury in certain foods depends on the amount in the environment and how much the plant or animal ‘takes up’ from the environment. The GAO report on prenatal supplements noted that the presence of heavy metals may not be from the manufacturing process, but rather the ingredients chosen for the vitamins or minerals they contain. For example, bioaccumulation (a build-up of environmental substances in an organism) can result in an increased presence of arsenic in rice (a source of iron and calcium) and mercury in fish (a source of omega-3 fatty acids). Additionally, research shows a correlation between calcium and lead in naturally occurring sources of calcium such as shells, bone, and rock.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Assembly Committee on Appropriations:

1. The California Department of Public Health estimates ongoing, annual costs of $169,000 starting in fiscal year 2026-27 to cover one full-time employee position to perform inspections and field audits, including remote inspections and desk audits, re-inspections, new license inspections, label review, and field visits to California firms holding out-of-state products (General Fund).
2. The Department of Justice (DOJ) anticipates increased workload for the Environmental Justice and Protection Section (EJPS) within DOJ's Public Rights Division to enforce this bill. The work anticipated by EJPS could require a significant increase in attorney hours. DOJ is unable to estimate at this time the additional number of Deputy Attorneys General, along with their legal complement, that might need to be hired. If DOJ does not pursue enforcement as authorized by this bill, DOJ would likely not incur any costs, but if DOJ hires staff to handle enforcement actions, costs could be in the low hundreds of thousands of dollars annually, at a minimum (Unfair Competition Law Fund).

SUPPORT: (Verified 9/10/25)

American College of Obstetricians & Gynecologists (co-sponsor)

Environmental Working Group (co-sponsor)

Unleaded Kids (co-sponsor)

A Voice for Choice Advocacy

American College of Obstetricians & Gynecologists – District IX

American Nurses Association\California

Black Women for Wellness Action Project

California Environmental Voters

California Medical Association

California Nurses for Environmental Health & Justice

California Nurse Midwives Association

California WIC Association

Center for Community Action and Environmental Justice

Center for Environmental Health

Center for Science in the Public Interest

Children Now

Cleanearth4kids.org

Consumer Federation of California

Consumer Reports Advocacy

Families Advocating for Chemical Toxics Safety

Friends Committee on Legislation of California

GMO Science

Healthy Babies Bright Futures

Indivisible Marin

Long Beach Alliance for Clean Energy

Mamavation

Maternal and Child Health Access

National Health Law Program

Non-Toxic Neighborhoods

Planned Parenthood Affiliates of California

Recolte Energy

Ritual

Unleaded Kids

www.GMOScience.org

OPPOSITION: (Verified 9/10/25)

Consumer Healthcare Products Association

Council for Responsible Nutrition

Natural Products Association

ARGUMENTS IN SUPPORT: This bill is co-sponsored by the American College of Obstetricians and Gynecologists District IX, the Environmental Working Group, and Unleaded Kids. The sponsors state that prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help lower the risk of birth defects, low birth weight, and other complications. However, recent studies have raised concerns about contamination of these supplements with toxic elements known to pose serious health risks, especially to pregnant individuals and developing fetuses. The sponsors state that this bill addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury, and permits consumers to access this information via a QR code on product labels, linking to a webpage with FDA guidance on the health risks associated with these heavy metals. Sponsors state that California has long led the nation in protecting public health through transparency and accountability measures, and this bill builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants.

ARGUMENTS IN OPPOSITION: The Natural Produces Association (NPA) opposes this bill state that it would lead to significant consumer confusion for a variety of reasons. First, NPA states that it could lead to a misinterpretation of risk, where consumers may mistakenly believe that prenatal vitamins are intentionally contaminated with substances even though these elements are naturally occurring and present in many foods, and that this warning could cause fear and hesitation that will lead some pregnant individuals to avoid essential prenatal vitamins. Second, NPA states that there will be a lack of context about natural occurrence, making consumers believe prenatal vitamins pose a unique health risk even thoug the levels are well below established safety thresholds. NPA points out that the FDA already regulates heavy metal limits in food and supplements based on scientific risk assessments and if enacted, this bill will conflict with federal law and cause confusion over whether prenatal vitamins sold in California are somehow different from those sold elsewhere. Finally, NPA states that this bill has the potential for unnecessary alarm and product avoidance, where women will stop taking prenatal vitamins altogether out of fear of toxicity, leading to greater health risks for both mother and baby.

Oppose unless amended. The Council for Responsible Nutrition and the Consumer Healthcare Products Association submitted a joint letter opposing this bill unless amended. The opponents argue that manufacturers do not intentionally add these elements to their products, but they may occur in certain raw materials, that federal regulations already require Good Manufacturing Practices, and that manufacturers already test these products for the presence of heavy metals. Opponents state that notifying consumers of the presence of these elements at any level will send mixed messages when those consumers are also encouraged by their doctor to take prenatal vitamins while pregnant. Opponents point out that the specified toxic elements are already regulated and enforced under California’s Proposition 65, which requires a warning if the product might expose consumers to carcinogens or reproductive toxicants at protective levels set by the Office of Environmental Health Hazard Assessment. The opponents request that the provisions requiring public disclosure of laboratory test results on manufacturer websites, and the provisions mandating QR codes on product labels, be removed from the bill.

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

9/13/25 0:55:46

**** END ****

SENATE THIRD READING

STR Bill Id:SB 646

Author:(Weber Pierson)

As Amended Ver:September 9, 2025

Majority vote

SUMMARY

Commencing January 1, 2027, under the state's Sherman Food, Drug, and Cosmetic Law (Sherman Law), requires manufacturers of prenatal multivitamins to test their products for arsenic, cadmium, lead, and mercury (heavy metals). Commencing January 1, 2027, requires brand owners to disclose specified information to the public on their websites, including the levels of heavy metals in their prenatal multivitamins, nutrient information, and a statement about the varying levels of heavy metals. Requires, for a product sold in a retailer store that is shipped to retailers on or after January 1, 2027, the outermost package of packaged prenatal vitamin products sold in a retail store to include a statement regarding arsenic, cadmium, lead, and mercury testing. Requires, for a product sold online or directly to consumers on or after January, 1, 2027, the product details page on an internet website where the product is sold, to include a statement regarding heavy metals and link to the website where information required to be disclosed by brand owners pursuant to this bill can be found. Prohibits a person from selling in the state or manufacturing, delivering, holding, or offering for the sale in the state a prenatal multivitamin that does not comply with these provisions. Prohibits, on or after January 1, 2030, a person from selling in the state or manufacturing, delivering, holding, or offering for the sale in the state a prenatal multivitamin that does not include the packaging or online statements specified by this bill.

Major Provisions

COMMENTS

Why are prenatal vitamins important? Prenatal supplements can help pregnant individuals obtain sufficient nutrients to support a healthy pregnancy. During pregnancy, the fetus and placenta divert nutrients from the parent's blood. To account for this, the recommended dietary allowance of certain nutrients for pregnant individuals is higher than for non-pregnant individuals. For example, the recommended dietary allowance of 18 milligrams per day of iron increases to 27 milligrams per day during pregnancy. Prenatal supplements can help individuals who may not have the ability to obtain the appropriate nutrients from diet alone. Factors including the pregnant individual’s current diet, medical history, and food access can contribute to their ability to obtain appropriate amounts of some nutrients, according to experts.

A 2025 study titled, "Heavy metals and phthalate contamination in prenatal vitamins and folic acid supplements," explores prenatal vitamins as a source of heavy metal exposure, specifically looking at the elements lead and cadmium, and found that lead and Cadmium were detected in the majority of prenatal vitamins, including prescription prenatal vitamins. Among the commercially available prenatal vitamins, 15% exceeded the California Proposition 65 threshold for daily lead consumption of 0.5 micrograms, as did a third of the prescription-based samples.

The United States (US) Government Accountability Office (GAO) published a report in 2023 titled, "Prenatal Supplements: Amounts of Some Key Nutrients Differed from Product Labels" assessing the accuracy of over-the-counter prenatal supplement labels for amounts of certain nutrients—vitamins and minerals—and determining whether the supplements also contain harmful substances, such as heavy metals. The GAO contracted with the accredited laboratory to test prenatal supplement products for lead, arsenic, cadmium and mercury because these elements have been associated with harmful effects on the fetal brain, cognitive development, and growth. The GAO's testing identified heavy metal contaminants in six of the 12 prenatal supplement products tested. The GAO concluded that all concentrations were low and unlikely to pose a health concern based on daily exposure limits used by the US Food and Drug Administration.

This bill requires testing of prenatal multivitamins for arsenic, cadmium, lead, and mercury, and further requires companies to post the levels of these elements present in each lot of a packaged prenatal vitamin product, information from the product's supplement facts panel including the level of each nutrient ingredient and an explanatory statement regarding the varying levels of arsenic, cadmium, lead and mercury in prenatal vitamins to provide the consumer with context.

Please see the Assembly Health Committee analysis and the Environmental Safety and Toxic Materials Committee analysis for additional background.

According to the Author

Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. The author continues that while a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. The author notes that prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. The author continues that recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. The author concludes that given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.

Arguments in Support

The Environmental Working Group (EWG), Unleaded Kids, and the American College of Obstetricians and Gynecologists District IX (ACOG) are the co-sponsors of this bill and state that this bill will protect maternal and fetal health by requiring the testing and public reporting of heavy metals in prenatal vitamins sold or manufactured in California. The co-sponsors continue that prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help the lower the risk of birth defects, low birth weight, and other complications. The co-sponsors state that recent studies have raised significant concerns about contamination of these supplements with toxic elements, including lead, arsenic, cadmium, and mercury—substances known to pose serious health risks, especially to pregnant individuals and developing fetuses. The co-sponsors continue that additional independent studies have documented contamination levels exceeding California's Proposition 65 thresholds. The co-sponsors note that despite these alarming findings, there are currently no federal or state regulations requiring the testing and disclosure of heavy metals in prenatal vitamins. The co-sponsors state that this bill addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury. The co-sponsors conclude that this bill builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants.

Arguments in Opposition

The Natural Products Association (NPA) opposes this bill and states that if this bill were enacted, it would lead to significant consumer confusion for a variety of reasons, including: misinterpretation of risk, lack of context about natural occurrence, inconsistency with federal standards, potential for unnecessary alarm and product avoidance. NPA notes that elements like lead, arsenic, cadmium, and mercury are found naturally in soil, water, and plants, meaning they can inadvertently be present in trace amounts of foods and supplements. NPA concludes that without clear context, a warning label will make consumers believe prenatal vitamins pose a unique health risk even though the levels are well below established safety thresholds. The Council for Responsible Nutrition and the Consumer Healthcare Products Association oppose this bill unless it is amended, stating appreciation for the author's willingness to ensure the consumer receives a disclosure that will provide important context, and requesting further amendments to apply this bill to prenatal multivitamins manufactured on or after January 1, 2027; narrow applicability to products sold or offered for sale in the state of California; ensure consistent terminology required on product labels versus what must be disclosed on manufacturer websites; and other clarifying changes.

FISCAL COMMENTS

According to the Assembly Committee on Appropriations:

1. The California Department of Public Health estimates ongoing, annual costs of $169,000 starting in fiscal year 2026-27 to cover one full-time employee position to perform inspections and field audits, including remote inspections and desk audits, re-inspections, new license inspections, label review, and field visits to California firms holding out-of-state products (General Fund).
2. The Department of Justice (DOJ) anticipates increased workload for the Environmental Justice and Protection Section (EJPS) within DOJ's Public Rights Division to enforce this bill. The work anticipated by EJPS could require a significant increase in attorney hours. DOJ is unable to estimate at this time the additional number of Deputy Attorneys General, along with their legal complement, that might need to be hired. If DOJ does not pursue enforcement as authorized by this bill, DOJ would likely not incur any costs, but if DOJ hires staff to handle enforcement actions, costs could be in the low hundreds of thousands of dollars annually, at a minimum (Unfair Competition Law Fund).

VOTES

SENATE FLOOR: 38-0-2

YES: Allen, Alvarado-Gil, Archuleta, Arreguín, Ashby, Becker, Blakespear, Cabaldon, Caballero, Cervantes, Choi, Cortese, Dahle, Durazo, Gonzalez, Grayson, Grove, Hurtado, Jones, Laird, McGuire, McNerney, Menjivar, Niello, Ochoa Bogh, Padilla, Pérez, Richardson, Rubio, Seyarto, Smallwood-Cuevas, Stern, Strickland, Umberg, Valladares, Wahab, Weber Pierson, Wiener

ABS, ABST OR NV: Limón, Reyes

ASM HEALTH: 15-0-1

YES: Bonta, Chen, Addis, Aguiar-Curry, Caloza, Carrillo, Flora, Mark González, Krell, Patel, Celeste Rodriguez, Sanchez, Schiavo, Sharp-Collins, Stefani

ABS, ABST OR NV: Patterson

ASM ENVIRONMENTAL SAFETY AND TOXIC MATERIALS: 5-0-2

YES: Connolly, Bauer-Kahan, Lee, McKinnor, Papan

ABS, ABST OR NV: Ellis, Castillo

ASM APPROPRIATIONS: 15-0-0

YES: Wicks, Sanchez, Arambula, Calderon, Caloza, Dixon, Elhawary, Fong, Mark González, Ahrens, Pacheco, Pellerin, Solache, Ta, Tangipa

UPDATED

VERSION: September 9, 2025

CONSULTANT: Eliza Brooks / HEALTH / (916) 319-2097 FN: 0001922

SENATE THIRD READING

STR Bill Id:SB 646

Author:(Weber Pierson)

As Amended Ver:September 5, 2025

Majority vote

SUMMARY

Commencing January 1, 2027, under the state's Sherman Food, Drug, and Cosmetic Law (Sherman Law), requires manufacturers of prenatal multivitamins to test their products for arsenic, cadmium, lead, and mercury (heavy metals). Commencing January 1, 2027, requires brand owners to disclose specified information to the public on their websites, including the levels of heavy metals in their prenatal multivitamins, nutrient information, and a statement about the varying levels of heavy metals. Requires, for a product sold in a retailer store that is shipped to retailers on or after January 1, 2027, the outermost package of packaged prenatal vitamin products sold in a retail store to include a statement regarding arsenic, cadmium, lead, and mercury testing. Requires, for a product sold online or directly to consumers on or after January, 1, 2027, the product details page on an internet website where the product is sold, to include a statement regarding heavy metals and link to the website where information required to be disclosed by brand owners pursuant to this bill can be found. Prohibits a person from selling in the state or manufacturing, delivering, holding, or offering for the sale in the state a prenatal multivitamin that does not comply with these provisions.

Major Provisions

COMMENTS

Why are prenatal vitamins important? Prenatal supplements can help pregnant individuals obtain sufficient nutrients to support a healthy pregnancy. During pregnancy, the fetus and placenta divert nutrients from the parent's blood. To account for this, the recommended dietary allowance of certain nutrients for pregnant individuals is higher than for non-pregnant individuals. For example, the recommended dietary allowance of 18 milligrams per day of iron increases to 27 milligrams per day during pregnancy. Prenatal supplements can help individuals who may not have the ability to obtain the appropriate nutrients from diet alone. Factors including the pregnant individual's current diet, medical history, and food access can contribute to their ability to obtain appropriate amounts of some nutrients, according to experts.

A 2025 study titled, "Heavy metals and phthalate contamination in prenatal vitamins and folic acid supplements," explores prenatal vitamins as a source of heavy metal exposure, specifically looking at the elements lead and cadmium, and found that lead and Cadmium were detected in the majority of prenatal vitamins, including prescription prenatal vitamins. Among the commercially available prenatal vitamins, 15% exceeded the California Proposition 65 threshold for daily lead consumption of 0.5 micrograms, as did a third of the prescription-based samples.

The United States (US) Government Accountability Office (GAO) published a report in 2023 titled, "Prenatal Supplements: Amounts of Some Key Nutrients Differed from Product Labels" assessing the accuracy of over-the-counter prenatal supplement labels for amounts of certain nutrients—vitamins and minerals—and determining whether the supplements also contain harmful substances, such as heavy metals. The GAO contracted with the accredited laboratory to test prenatal supplement products for lead, arsenic, cadmium and mercury because these elements have been associated with harmful effects on the fetal brain, cognitive development, and growth. The GAO's testing identified heavy metal contaminants in 6 of the 12 prenatal supplement products tested. The GAO concluded that all concentrations were low and unlikely to pose a health concern based on daily exposure limits used by the US Food and Drug Administration.

This bill requires testing of prenatal multivitamins for arsenic, cadmium, lead, and mercury, and further requires companies to post the levels of these elements present in each lot of a packaged prenatal vitamin product, information from the product's supplement facts panel including the level of each nutrient ingredient and an explanatory statement regarding the varying levels of arsenic, cadmium, lead and mercury in prenatal vitamins to provide the consumer with context.

Please see the Assembly Health Committee analysis and the Environmental Safety and Toxic Materials Committee analysis for additional background.

According to the Author

Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. The author continues that while a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. The author notes that prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. The author continues that recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. The author concludes that given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.

Arguments in Support

The Environmental Working Group (EWG), Unleaded Kids, and the American College of Obstetricians and Gynecologists District IX (ACOG) are the co-sponsors of this bill and state that this bill will protect maternal and fetal health by requiring the testing and public reporting of heavy metals in prenatal vitamins sold or manufactured in California. The co-sponsors continue that prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help the lower the risk of birth defects, low birth weight, and other complications. The co-sponsors state that recent studies have raised significant concerns about contamination of these supplements with toxic elements, including lead, arsenic, cadmium, and mercury—substances known to pose serious health risks, especially to pregnant individuals and developing fetuses. The co-sponsors continue that additional independent studies have documented contamination levels exceeding California's Proposition 65 thresholds. The co-sponsors note that despite these alarming findings, there are currently no federal or state regulations requiring the testing and disclosure of heavy metals in prenatal vitamins. The co-sponsors state that this bill addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury. The co-sponsors conclude that this bill builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants.

Arguments in Opposition

The Natural Products Association (NPA) opposes this bill and states that if this bill were enacted, it would lead to significant consumer confusion for a variety of reasons, including: misinterpretation of risk, lack of context about natural occurrence, inconsistency with federal standards, potential for unnecessary alarm and product avoidance. NPA notes that elements like lead, arsenic, cadmium, and mercury are found naturally in soil, water, and plants, meaning they can inadvertently be present in trace amounts of foods and supplements. NPA concludes that without clear context, a warning label will make consumers believe prenatal vitamins pose a unique health risk even though the levels are well below established safety thresholds. The Council for Responsible Nutrition and the Consumer Healthcare Products Association oppose this bill unless it is amended, stating appreciation for the author's willingness to ensure the consumer receives a disclosure that will provide important context, and requesting further amendments to apply this bill to prenatal multivitamins manufactured on or after January 1, 2027; narrow applicability to products sold or offered for sale in the state of California; ensure consistent terminology required on product labels versus what must be disclosed on manufacturer websites; and other clarifying changes.

FISCAL COMMENTS

According to the Assembly Committee on Appropriations:

1. The California Department of Public Health estimates ongoing, annual costs of $169,000 starting in fiscal year 2026-27 to cover one full-time employee position to perform inspections and field audits, including remote inspections and desk audits, re-inspections, new license inspections, label review, and field visits to California firms holding out-of-state products (General Fund).
2. The Department of Justice (DOJ) anticipates increased workload for the Environmental Justice and Protection Section (EJPS) within DOJ's Public Rights Division to enforce this bill. The work anticipated by EJPS could require a significant increase in attorney hours. DOJ is unable to estimate at this time the additional number of Deputy Attorneys General, along with their legal complement, that might need to be hired. If DOJ does not pursue enforcement as authorized by this bill, DOJ would likely not incur any costs, but if DOJ hires staff to handle enforcement actions, costs could be in the low hundreds of thousands of dollars annually, at a minimum (Unfair Competition Law Fund).

VOTES

SENATE FLOOR: 38-0-2

YES: Allen, Alvarado-Gil, Archuleta, Arreguín, Ashby, Becker, Blakespear, Cabaldon, Caballero, Cervantes, Choi, Cortese, Dahle, Durazo, Gonzalez, Grayson, Grove, Hurtado, Jones, Laird, McGuire, McNerney, Menjivar, Niello, Ochoa Bogh, Padilla, Pérez, Richardson, Rubio, Seyarto, Smallwood-Cuevas, Stern, Strickland, Umberg, Valladares, Wahab, Weber Pierson, Wiener

ABS, ABST OR NV: Limón, Reyes

ASM HEALTH: 15-0-1

YES: Bonta, Chen, Addis, Aguiar-Curry, Caloza, Carrillo, Flora, Mark González, Krell, Patel, Celeste Rodriguez, Sanchez, Schiavo, Sharp-Collins, Stefani

ABS, ABST OR NV: Patterson

ASM ENVIRONMENTAL SAFETY AND TOXIC MATERIALS: 5-0-2

YES: Connolly, Bauer-Kahan, Lee, McKinnor, Papan

ABS, ABST OR NV: Ellis, Castillo

ASM APPROPRIATIONS: 15-0-0

YES: Wicks, Sanchez, Arambula, Calderon, Caloza, Dixon, Elhawary, Fong, Mark González, Ahrens, Pacheco, Pellerin, Solache, Ta, Tangipa

UPDATED

VERSION: September 5, 2025

CONSULTANT: Eliza Brooks / HEALTH / (916) 319-2097 FN: 0001790

SENATE THIRD READING

STR Bill Id:SB 646

Author:(Weber Pierson)

As Amended Ver:July 10, 2025

Majority vote

SUMMARY

Requires, under the state's Sherman Food, Drug, and Cosmetic Law (Sherman Law), manufacturers of prenatal multivitamins to test their products for toxic elements (arsenic, cadmium, lead, and mercury); requires brand owners to disclose specified information to the public on their websites, including the levels of toxic elements in their prenatal multivitamins; requires brand owners to include, on the same webpage showing toxic element levels, nutrient information and a statement about toxic elements and ingredients in prenatal vitamins, as specified.

Major Provisions

COMMENTS

Why are prenatal vitamins important? Prenatal supplements can help pregnant individuals obtain sufficient nutrients to support a healthy pregnancy. During pregnancy, the fetus and placenta divert nutrients from the parent's blood. To account for this, the recommended dietary allowance of certain nutrients for pregnant individuals is higher than for non-pregnant individuals. For example, the recommended dietary allowance of 18 milligrams per day of iron increases to 27 milligrams per day during pregnancy. Prenatal supplements can help individuals who may not have the ability to obtain the appropriate nutrients from diet alone. Factors including the pregnant individual’s current diet, medical history, and food access can contribute to their ability to obtain appropriate amounts of some nutrients, according to experts.

A 2025 study titled, "Heavy metals and phthalate contamination in prenatal vitamins and folic acid supplements," explores prenatal vitamins as a source of heavy metal exposure, specifically looking at the elements lead and cadmium, and found that lead and Cadmium were detected in the majority of prenatal vitamins, including prescription prenatal vitamins. Among the commercially available prenatal vitamins, 15% exceeded the California Proposition 65 threshold for daily lead consumption of 0.5 micrograms, as did a third of the prescription-based samples.

The United States (US) Government Accountability Office (GAO) published a report in 2023 titled, "Prenatal Supplements: Amounts of Some Key Nutrients Differed from Product Labels" assessing the accuracy of over-the-counter prenatal supplement labels for amounts of certain nutrients—vitamins and minerals—and determining whether the supplements also contain harmful substances, such as heavy metals. The GAO contracted with the accredited laboratory to test prenatal supplement products for lead, arsenic, cadmium and mercury because these elements have been associated with harmful effects on the fetal brain, cognitive development, and growth. The GAO's testing identified heavy metal contaminants in 6 of the 12 prenatal supplement products tested. The GAO concluded that all concentrations were low and unlikely to pose a health concern based on daily exposure limits used by the US Food and Drug Administration.

This bill requires testing of prenatal multivitamins for arsenic, cadmium, lead, and mercury, and further requires companies to post the levels of toxic elements present in each lot of a packaged prenatal vitamin product, information from the product's supplement facts panel including the level of each nutrient ingredient and an explanatory statement regarding the varying levels of toxic elements in prenatal vitamins to provide the consumer with context.

Please see the Assembly Environmental Safety and Toxic Materials analysis for the most updated major provisions and additional background, as well as the Assembly Health Committee analysis for additional background.

According to the Author

Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. The author continues that while a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. The author notes that prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. The author continues that recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. The author concludes that given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.

Arguments in Support

The Environmental Working Group (EWG), Unleaded Kids, and the American College of Obstetricians and Gynecologists District IX (ACOG) are the co-sponsors of this bill and state that this bill will protect maternal and fetal health by requiring the testing and public reporting of heavy metals in prenatal vitamins sold or manufactured in California. The co-sponsors continue that prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help the lower the risk of birth defects, low birth weight, and other complications. The co-sponsors state that recent studies have raised significant concerns about contamination of these supplements with toxic elements, including lead, arsenic, cadmium, and mercury—substances known to pose serious health risks, especially to pregnant individuals and developing fetuses. The co-sponsors continue that additional independent studies have documented contamination levels exceeding California's Proposition 65 thresholds. The co-sponsors note that despite these alarming findings, there are currently no federal or state regulations requiring the testing and disclosure of heavy metals in prenatal vitamins. The co-sponsors state that this bill addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury. The co-sponsors conclude that this bill builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants.

Arguments in Opposition

The Natural Products Association (NPA) opposes this bill and states that if this bill were enacted, it would lead to significant consumer confusion for a variety of reasons, including: misinterpretation of risk, lack of context about natural occurrence, inconsistency with federal standards, potential for unnecessary alarm and product avoidance. NPA notes that elements like lead, arsenic, cadmium, and mercury are found naturally in soil, water, and plants, meaning they can inadvertently be present in trace amounts of foods and supplements. NPA concludes that without clear context, a warning label will make consumers believe prenatal vitamins pose a unique health risk even though the levels are well below established safety thresholds. The Council for Responsible Nutrition and the Consumer Healthcare Products Association oppose this bill unless it is amended, stating appreciation for the author's willingness to ensure the consumer receives a disclosure that will provide important context, and requesting further amendments to apply this bill to prenatal multivitamins manufactured on or after January 1, 2027; narrow applicability to products sold or offered for sale in the state of California; ensure consistent terminology required on product labels versus what must be disclosed on manufacturer websites; and other clarifying changes.

FISCAL COMMENTS

According to the Assembly Committee on Appropriations:

1. The California Department of Public Health estimates ongoing, annual costs of $169,000 starting in fiscal year 2026-27 to cover one full-time employee position to perform inspections and field audits, including remote inspections and desk audits, re-inspections, new license inspections, label review, and field visits to California firms holding out-of-state products (General Fund).
2. The Department of Justice (DOJ) anticipates increased workload for the Environmental Justice and Protection Section (EJPS) within DOJ’s Public Rights Division to enforce this bill. The work anticipated by EJPS could require a significant increase in attorney hours. DOJ is unable to estimate at this time the additional number of Deputy Attorneys General, along with their legal complement, that might need to be hired. If DOJ does not pursue enforcement as authorized by this bill, DOJ would likely not incur any costs, but if DOJ hires staff to handle enforcement actions, costs could be in the low hundreds of thousands of dollars annually, at a minimum (Unfair Competition Law Fund).

VOTES

SENATE FLOOR: 38-0-2

YES: Allen, Alvarado-Gil, Archuleta, Arreguín, Ashby, Becker, Blakespear, Cabaldon, Caballero, Cervantes, Choi, Cortese, Dahle, Durazo, Gonzalez, Grayson, Grove, Hurtado, Jones, Laird, McGuire, McNerney, Menjivar, Niello, Ochoa Bogh, Padilla, Pérez, Richardson, Rubio, Seyarto, Smallwood-Cuevas, Stern, Strickland, Umberg, Valladares, Wahab, Weber Pierson, Wiener

ABS, ABST OR NV: Limón, Reyes

ASM HEALTH: 15-0-1

YES: Bonta, Chen, Addis, Aguiar-Curry, Caloza, Carrillo, Flora, Mark González, Krell, Patel, Celeste Rodriguez, Sanchez, Schiavo, Sharp-Collins, Stefani

ABS, ABST OR NV: Patterson

ASM ENVIRONMENTAL SAFETY AND TOXIC MATERIALS: 5-0-2

YES: Connolly, Bauer-Kahan, Lee, McKinnor, Papan

ABS, ABST OR NV: Ellis, Castillo

ASM APPROPRIATIONS: 15-0-0

YES: Wicks, Sanchez, Arambula, Calderon, Caloza, Dixon, Elhawary, Fong, Mark González, Ahrens, Pacheco, Pellerin, Solache, Ta, Tangipa

UPDATED

VERSION: July 10, 2025

CONSULTANT: Eliza Brooks / HEALTH / (916) 319-2097 FN: 0001437

Date of Hearing: August 20, 2025

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Buffy Wicks, Chair

SBPCA Bill Id:SB 646

Author:(Weber Pierson) – As Amended Ver:July 10, 2025

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill requires a manufacturer of prenatal multivitamins to test a sample of each lot for toxic elements and disclose specified information to the public, including the toxic element testing information. This bill also bans the manufacture, delivery, and sale of a prenatal multivitamin that does not comply with these provisions.

Please refer to the Assembly Committee on Environmental Safety and Toxic Materials analysis for definitions and further detail.

Specifically, this bill:

1. Defines "toxic elements" to mean arsenic, cadmium, lead, and mercury.
2. Requires a manufacturer of a bulk prenatal multivitamin product or a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state to test a representative sample of each lot of the manufacturer’s prenatal multivitamin product at a proficient laboratory for toxic elements.
3. Requires a proficient laboratory, as defined, including a manufacturer’s in-house laboratory that analyzes the bulk prenatal multivitamin product or packaged prenatal multivitamin product for toxic elements, meet specified criteria relating to competence of testing and calibration laboratories, testing of toxic elements, analytical methods, and quantifying toxic elements.
4. Requires manufacturers and brand owners to provide test results to any authorized agent of the California Department of Public Health (CDPH) upon request. Authorizes a brand owner to comply with this requirement by providing the test results of the manufacturer used to produce the bulk prenatal multivitamin product or packaged prenatal multivitamin product.
5. Requires, commencing January 1, 2027, a brand owner of packaged prenatal multivitamin products sold, manufactured, delivered, held, or offered for sale in the state disclose product information to the public consistent with all of the following:
6. Make publicly available on the brand owner's website, for the duration of the product shelf life for a packaged prenatal multivitamin product plus one month, the name and level of each toxic element present in each lot of a packaged prenatal multivitamin product. Requires the brand owner include, on the same webpage, information from the product's supplement facts panel, including the level per serving of each nutrient ingredient, and the following statement:

Prenatal multivitamins may contain varying levels of toxic elements. Unless the ingredients come from sources with low levels of toxic elements, the prenatal multivitamins may also contain higher levels of toxic elements. The levels of toxic elements can also vary with the types of ingredients included in a prenatal multivitamin. For more information, speak with your physician about choosing a prenatal multivitamin that meets your specific nutrient needs.

1. Make the toxic element testing information available to the public user, without the user having to provide a UPC number, lot number, or proof of purchase.
2. Provide descriptive information on the brand owner’s internet website to enable accurate identification of the packaged prenatal multivitamin product by the public, including information that makes the levels of toxic elements available to the public by lot.
3. Provide a website link to the FDA's most recent webpage where the public can find information relating to toxic elements in food.
4. On the brand owner’s webpage describing a packaged prenatal multivitamin product, include a prominent statement that reads, "For information about toxic element testing on this product," followed by a link to the webpage containing the testing results. For products sold in retail stores, on the outermost package of any packaged prenatal multivitamin product sold, include a statement that reads: "For information about toxic element testing on this product, visit" followed by the webpage specified in this provision.
5. Prohibits a person from selling, manufacturing, delivering, holding, or offering for sale in the state any prenatal multivitamin that does not comply with the requirements of this bill.

FISCAL EFFECT:

The California Department of Public Health (CDPH) estimates ongoing, annual costs of $169,000 starting in fiscal year 2026-27 to cover one full-time employee position to perform inspections and field audits, including remote inspections and desk audits, re-inspections, new license inspections, label review, and field visits to California firms holding out-of-state products (General Fund).

The Department of Justice (DOJ) anticipates increased workload for the Environmental Justice and Protection Section (EJPS) within DOJ’s Public Rights Division to enforce this bill. The work anticipated by EJPS could require a significant increase in attorney hours. DOJ is unable to estimate at this time the additional number of Deputy Attorneys General, along with their legal complement, that might need to be hired. If DOJ does not pursue enforcement as authorized by this bill, DOJ would likely not incur any costs, but if DOJ hires staff to handle enforcement actions, costs could be in the low hundreds of thousands of dollars annually, at a minimum (Unfair Competition Law Fund).

COMMENTS:

1. Purpose. This bill is sponsored by Environmental Working Group, American College of OB/GYNs District IX (ACOG), and Unleaded Kids. According to the author:
   

Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. While a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. Prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual.

Recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. A GAO study found lead, a heavy metal with no safe level of exposure, in half of the sampled prenatal vitamins, with some independent studies finding contamination, exceeding California’s Proposition 65 limits.

Given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.

1. Background. Under the federal Food, Drug, and Cosmetic Act, as amended in 1994 by the Dietary Supplement Health and Education Act, the federal Food and Drug Administration (FDA) regulates dietary supplements—including prenatal supplements—as a special category of food. Therefore, unlike drugs, dietary supplements are subject to a limited pre-market approval process and it is the responsibility of dietary supplement companies to ensure their products meet safety standards for dietary supplements and are not otherwise in violation of the law. Dietary supplement labels must have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. The label also must have a statement on the front of the product identifying it as a "dietary supplement" or similar descriptive term, such as "herbal supplement" or "calcium supplement." No federal statutory definition exists for a "prenatal supplement" and what it must contain. According to a 2023 report from the U.S. Government Accountability Office, there is a large and highly variable market in terms of nutrient content across prenatal supplement products.

Studies have documented the presence of heavy metals in prenatal supplements. For example, a 2025 study of a sample of 156 commercially available, over-the-counter prenatal vitamins detected lead in 83% of samples and cadmium was detected in 73% of samples. The authors of this study note that the presence of heavy metals in prenatal supplements is especially problematic because lead and cadmium have chemical similarities to calcium, allowing them to replace calcium in biological processes, which can lead to health problems such as reduced calcium and iron absorption.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: July 15, 2025

ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS

Damon Connolly, Chair

SBPCA Bill Id:SB 646

Author:(Weber Pierson) – As Amended Ver:July 10, 2025

SENATE VOTE: 38-0

SUBJECT: Prenatal multivitamins

SUMMARY: Requires, under the state's Sherman Food, Drug, and Cosmetic Law (Sherman Law), manufacturers of prenatal multivitamins to test their products for toxic elements (arsenic, cadmium, lead, and mercury); requires brand owners to disclose specified information to the public on their websites, including the levels of toxic elements in their prenatal multivitamins; requires brand owners to include, on the same webpage showing toxic element levels, nutrient information and a statement about toxic elements and ingredients in prenatal vitamins, as specified. Specifically, this bill:

1. Establishes the following definitions:
2. "Brand owner" means the person who owns or licenses the trademark that is the most prominent trademark on the principal display panel of the prenatal multivitamin product label; provides that the manufacturer of a prenatal multivitamin for another person who owns the trademark is not the brand owner.
3. "Bulk prenatal multivitamin product" means the bulk prenatal multivitamin product in finished dosage form before it is packaged and labeled; provides that "bulk prenatal multivitamin product" does not mean the constituent ingredients of prenatal multivitamins.
4. "Lot" means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition, or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.
5. "Manufacturer" means a person who is either of the following:
6. A brand owner that manufactures, as defined under Sherman Law, a prenatal multivitamin; or,
7. A person who manufactures, as defined under Sherman Law, but is not the brand owner of a prenatal multivitamin.
8. "Packaged prenatal multivitamin product" means the bulk prenatal multivitamin product that has been packaged for sale or distribution to the public or health care professionals and whose product label bears a universal product code (UPC).
9. "Prenatal multivitamin" means a dietary supplement that contains one or more vitamins or minerals and is represented or purported to be specifically used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or lactating; specifies that "prenatal multivitamins" also use Reference Daily Intakes and Daily Reference Values that are specified for this intended group when calculating percent Daily Values, as required under the federal Food, Drug, and Cosmetic Act (FD&C Act).
10. "Product label" means a display of written, printed, or graphic material that is affixed to a product’s immediate container.
11. "Product shelf life" means the time, measured in the number of months, as printed on the product label, between the date of manufacture and the expiration date for a packaged prenatal multivitamin product.
12. "Proficient laboratory" means a laboratory that meets the criteria specified in SB 646.
13. "Representative sample" means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.
14. "Toxic elements" means arsenic, cadmium, lead, and mercury.
15. Requires a manufacturer of a bulk prenatal multivitamin product or a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state to test a representative sample of each lot of the manufacturer’s prenatal multivitamin product at a proficient laboratory for toxic elements.
16. Requires a proficient laboratory, including a manufacturer’s in-house laboratory, that analyzes the bulk prenatal multivitamin product or packaged prenatal multivitamin product for toxic elements to meet all of the following criteria:
    1. Be accredited under the standards of the International Organization for Standardization/ International Electrotechnical Commission 17025:2017 regarding the general requirements for the competence of testing and calibration laboratories, as they pertain to the testing of toxic elements; provides that, to the extent such standards contradict the requirements of any federal regulations under the FD&C Act pertaining to supplements, the federal regulations shall control;
    2. Use an analytical method that is at least as sensitive as that described in the United States Food and Drug Administration's (FDA) Elemental Analysis Manual 4.7; and,
    3. Demonstrate proficiency in quantifying each toxic element to at least 10 micrograms (μg) of the toxic element to kilogram (kg) of supplement (μg/kg) through an independent proficiency test; provides that "proficiency" means that laboratories achieve a z-score that is less than, or equal to, plus or minus two (≤ ±2).
17. Requires both manufacturers and brand owners to provide test results to any authorized agent of the California Department of Public Health (CDPH) upon request; authorizes a brand owner to comply with this requirement by providing the test results of the manufacturer used to produce the bulk prenatal multivitamin product or packaged prenatal multivitamin product, if the brand owner does not manufacture the prenatal multivitamin product.
18. Requires, commencing January 1, 2027, a brand owner of packaged prenatal multivitamin products sold, manufactured, delivered, held, or offered for sale in the state—including, without limitation, prenatal multivitamins that are sold by a retailer or prenatal multivitamins that are sold directly to consumers—to disclose product information to the public consistent with all of the following:
19. Make publicly available on the brand owner's website, for the duration of the product shelf life for a packaged prenatal multivitamin product plus one month, the name and level of each toxic element present in each lot of a packaged prenatal multivitamin product; requires the brand owner to include, on the same webpage containing this information, information from the product's supplement facts panel, including the level per serving of each nutrient ingredient, and the following statement:

"Prenatal multivitamins may contain varying levels of toxic elements. Unless the ingredients come from sources with low levels of toxic elements, the prenatal multivitamins may also contain higher levels of toxic elements. The levels of toxic elements can also vary with the types of ingredients included in a prenatal multivitamin. For more information, speak with your physician about choosing a prenatal multivitamin that meets your specific nutrient needs."

1. Make the toxic element testing information available to the public user, without the user having to provide a UPC number, lot number, or proof of purchase;
2. Provide descriptive information on its internet website to enable accurate identification of the packaged prenatal multivitamin product by the public, including information that makes the levels of toxic elements available to the public by lot; provides that descriptive information can include, but is not limited to, product name, UPC, size, or lot numbers;
3. Provide a website link to the FDA's most recent webpage, where the public can find information relating to toxic elements in food; and,
4. On the brand owner’s webpage describing a packaged prenatal multivitamin product, include a prominent statement that reads, "For information about toxic element testing on this product," followed by a link to the webpage containing the testing results; for products sold in retail stores, on the outermost package of any packaged prenatal multivitamin product sold, include a statement that reads: "For information about toxic element testing on this product, visit," followed by the webpage specified in this provision.
5. Prohibits a person from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal multivitamin—including, without limitation, prenatal multivitamins that are sold by a retailer or prenatal multivitamins that are sold directly to consumers—that does not comply with the requirements of SB 646.

EXISTING LAW:

1. Defines, for the purposes of the FD&C Act, "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any of the prior ingredients described. (21 United States Code (USC) § 321(ff))
2. Prohibits, under the FD&C Act, the introduction or delivery for introduction into interstate commerce any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded. (21 USC § 331(a))
3. Provides that a food, including a dietary supplement, shall be deemed adulterated under specified circumstances, including if it is a dietary supplement or contains a dietary ingredient that presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if it bears or contains any poisonous or deleterious substance which may render it injurious to health. (21 USC § 342(f))
4. Prohibits the FDA from establishing, as specified, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food, as provided; prohibits the FDA from classifying any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the FDA has determined is nutritionally rational or useful; prohibits the FDA from limiting, as specified, the combination or number of any synthetic or natural vitamin, mineral, or other ingredient of food, within a food for special dietary use. (21 USC § 350)
5. Establishes the state's Sherman Law, administered by CDPH, which regulates the manufacture, packaging, labeling, and advertising of food, drugs, and cosmetics. (Health and Safety Code (HSC) § 109875-111929.4)
6. Establishes the following definitions under Sherman Law:
   1. "Person" means any individual, firm, partnership, trust, corporation, limited liability company, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within the state, and any representative, agent, or agency of any of the foregoing. (HSC § 109995)
   2. "Label" means a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container. (HSC § 109955)
   3. "Manufacture" means the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic; provides that the term "manufacture" includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic; provides that the term "manufacture" does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer. (HSC § 109970)
7. Requires all labels of foods, drugs, devices, or cosmetics to conform to federal requirements, as specified. (HSC § 110340)
8. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. (HSC § 25249.6)
9. Requires, under Sherman Law, manufacturers of baby food for sale or distribution in this state to, among other things, test a representative sample of each production aggregate of the manufacturer's final baby food product for toxic elements (arsenic, cadmium, lead, and mercury); disclose, on and after January 1, 2025, specified information to consumers on the manufacturer's website, including the levels of toxic elements present in each production aggregate; and, include a QR code on the product label that links to the manufacturer's website containing test results for toxic elements, for those toxic elements for which the FDA has established an action level, regulatory limit, or tolerance. (HSC § 110962(b))

FISCAL EFFECT: Unknown.

COMMENTS:

Need for the bill: According to the author:

"Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. While a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. Prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. Recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. A [United States Government Accountability Office (GAO)] study found lead, a heavy metal with no safe level of exposure, in half of the sampled prenatal vitamins, with some independent studies finding contamination, exceeding California’s Proposition 65 limits. Given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards."

Health consequences of heavy metal exposure: This bill requires testing of prenatal multivitamins for arsenic, cadmium, lead, and mercury, as well as disclosure of the results to the public. Below are descriptions of these heavy metals, including common sources of exposure and their human health implications.

• Arsenic: According to the federal Agency for Toxic Substances and Disease Registry (ATSDR), arsenic can be found in soil, water, food, and air. As a result, people may take in arsenic in the air they breathe, the water they drink, and the food they eat. Some of the effects of arsenic exposure can include irritation of the stomach and intestines, blood vessel damage, skin changes, and reduced nerve function. There is also some evidence that long-term exposure to inorganic arsenic in children may result in lower IQ scores, and that exposure in early life (including gestation and early childhood) may increase mortality later in life, in young adulthood.
• Cadmium: According to the ATSDR, in the United States, the primary source of cadmium exposure for nonsmokers is from the food supply. In general, potatoes, grains, peanuts, soybeans, sunflower seeds, and leafy vegetables such as lettuce and spinach can contain high levels of cadmium. Because cadmium binds strongly to organic matter, it can enter the food supply by accumulating in aquatic organisms and agricultural crops.

According to a literature review by Flannery et al. (2022) in Regulatory Toxicology and Pharmacology, 90% of cadmium exposure is dietary in those who are not exposed through smoking or occupation. In adults, cadmium is known to accumulate in organs over time, leading to kidney dysfunction and decreased bone density, among other adverse effects. More studies are needed to better understand the adverse effects of cadmium exposure in infants and children, although the ATSDR states that the health effects seen in children from exposure to toxic levels of cadmium are expected to be similar to the effects seen in adults (kidney and lung damage). A few studies in animals suggest that younger animals absorb more cadmium than adults, and that young animals are more susceptible to bone loss and decreased bone strength resulting from cadmium exposure.

• Lead: According to the Centers for Disease Control and Prevention (CDC), research shows that there is no safe level of lead and even very low levels can have negative and irreversible health effects, especially in children. Childhood lead exposure can seriously harm a child's health and cause well-documented adverse effects, including brain and nervous system damage, slowed growth and development, learning and behavior problems, and hearing and speech problems.

Children and developing fetuses are particularly susceptible to the harmful effects of lead. However, lead in blood can also result in an increased risk of cardiovascular disease, high blood pressure, and kidney and nervous system problems for adults. Because the human body can store lead in bone, even temporary environmental exposures in childhood can result in many years to decades of recurring or ongoing elevations in blood lead levels. One study by Nie et al. (2009), published in the Journal of Occupational and Environmental Medicine, reports that lead stored in bone can release back into the blood, resulting in elevated blood lead levels during periods of illness (e.g., with skeletal or dental disease) and during multiple life stages, including childhood, pregnancy, lactation, and menopause.

• Mercury: According to the ATSDR, food is the most common route of exposure to mercury. Most people are exposed to organic mercury compounds (typically methylmercury) in foods such as fish, seafood, and rice. The health effects of mercury exposure depend on a number of factors, including the amount and form of mercury, route and length of exposure, and age. All forms of mercury can affect the nervous system and the kidneys. People who eat foods with high levels of methylmercury may experience tremors, coordination problems, impaired vision, impaired learning and memory, and mood changes. Some children born in communities that ate food with high levels of organic mercury had learning, sensory, and movement problems. In people exposed to high levels of methylmercury in their diets, birth defects have occurred. In addition, research shows that some humans and animals that ate mercury compounds had high blood pressure and alterations in their immune systems, and animals that ate high levels of mercury compounds showed decreased fertility and/or birth defects.

The importance of prenatal nutrition: Proper nutrition before and during pregnancy is critical for both maternal and fetal health. One 2022 study, "Evidence based recommendations for an optimal prenatal supplement for women in the US: Vitamins and related nutrients," published in Maternal health, neonatology and perinatology, reviewed the literature to examine associations between vitamin levels and adverse health outcomes. The study's authors found significant evidence for associations between low vitamin levels and numerous potential issues for both maternal health (e.g., anemia, premature membrane rupture, preeclampsia, and gestational diabetes) and infant health (e.g., bleeding resulting from Vitamin K deficiency, neural tube and other serious birth defects, and preterm birth). Similarly, the same authors found—reporting in the paper "Evidence-based recommendations for an optimal prenatal supplement for women in the U.S., Part Two: Minerals," published in Nutrients—significant evidence for associations between low mineral levels and adverse outcomes for both maternal health (e.g., anemia, gestational diabetes, miscarriage, and preeclampsia) and infant health (e.g., anemia, cerebral palsy, neural tube defects, and preterm birth).

Given the critical role that nutrients play in maternal and fetal health, medical experts recommend that persons who are pregnant or trying to become pregnant eat a nutritious, well-balanced diet, as well as take prenatal supplements, to help make up for any nutrients that a person may not be able to get enough of through diet alone. Pregnant persons may need higher amounts of certain nutrients—for example, folic acid and iron—to support a healthy pregnancy. Several factors, including the pregnant individual’s current diet, medical history, and food access can also contribute to their ability to obtain appropriate amounts of some nutrients.

FDA regulation of dietary supplements. Under the FD&C Act, as amended in 1994 by the Dietary Supplement Health and Education Act, the FDA regulates dietary supplements—including prenatal supplements—as a special category of food. Therefore, unlike drugs, dietary supplements are subject to a limited pre-market approval process. As a result, the FDA may not discover mislabeling and contamination until after the products are on the market. According to the FDA, it is the responsibility of dietary supplement companies to ensure their products meet safety standards for dietary supplements and are not otherwise in violation of the law. Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a "dietary supplement" or similar descriptive term (e.g., "herbal supplement" or "calcium supplement"). 

Regarding prenatal supplements, specifically, no federal statutory definition exists for what a "prenatal supplement" is and what these products should contain. According to the GAO—in its 2023 report, "Prenatal supplements: Amounts of some key nutrients differed from product labels" (GAO Report)—this has resulted in a large and highly variable market in terms of nutrient content across products.

California's Proposition 65: In 1986, California voters approved a ballot initiative, the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly referred to as Proposition 65, to address concerns that "hazardous chemicals pose a serious potential threat to their health and well-being, [and] that state government agencies have failed to provide them with adequate protection…" Proposition 65 requires the state to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list, which must be updated at least once a year, currently includes approximately 900 chemicals. Proposition 65 also prohibits businesses from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity, without first giving clear and reasonable warning, which can take the form of product labels or notices. The Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program, including an evaluation of all currently available scientific information on substances considered for placement on the Proposition 65 list.

OEHHA has established No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs), collectively referred to as "Safe Harbor Levels," for many of the chemicals on the Proposition 65 list. NSRLs are used for cancer-causing chemicals and MADLs are used for chemicals causing reproductive toxicity. Exposure levels that are below these safe harbor levels are exempt from the requirements of Proposition 65. The safe harbor levels for the heavy metals specified in SB 646 are 10 μg/day (NSRL) for arsenic; 4.1 μg/day (MADL) for cadmium; and 15 μg/day (NSRL) and 0.5 μg/day (MADL) for lead. No safe harbor level has been specified for mercury; businesses that expose individuals to mercury are required to provide a Proposition 65 warning, unless they can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm.

Heavy metals in prenatal supplements: Several studies and investigations have documented the presence of heavy metals in prenatal supplements. For example, in the 2025 study, "Heavy metals and phthalate contamination in prenatal vitamins and folic acid supplements," published in Environmental Research, the authors found after sampling 156 commercially available, over-the-counter prenatal vitamins that lead and cadmium were detected in 83% and 73% of samples, respectively. The authors also found that among the commercially available prenatal vitamins, 15% exceeded the Proposition 65 MADL threshold for daily lead consumption, and that calcium and iron doses were associated with increased lead and cadmium contamination. The authors note that the presence of heavy metals in prenatal supplements is especially problematic because lead and cadmium have chemical similarities to calcium, allowing them to replace calcium in biological processes, which can lead to health problems such as reduced calcium and iron absorption.

Similarly, the GAO Report—which assessed the accuracy of over-the-counter prenatal supplement labels for vitamin and mineral levels, and also investigated whether the supplements contained harmful substances—documented heavy metals in prenatal supplements. Specifically, the GAO Report identified heavy metal contaminants in six of the 12 prenatal supplement products tested, although the GAO concluded that all concentrations were low and unlikely to pose a health concern based on daily exposure limits used by FDA. All six products had trace amounts of lead, and two of these six products also contained trace amounts of cadmium. Arsenic and mercury were below the detection limits in all samples. The GAO Report also notes that its findings are similar to a study conducted by the FDA. The FDA found that lead was the most commonly detected heavy metal in prenatal supplements and occurred at levels not likely to pose a health concern, although the FDA recognizes that no safe level of lead exposure has been identified for fetal brain and cognitive development.

On the question of how heavy metals might end up in prenatal supplements, the GAO Report states:

"The presence of heavy metals may not be from the manufacturing process, but rather the ingredients chosen for the vitamins or minerals they contain. For example, bioaccumulation—a build-up of environmental substances in an organism—can result in an increased presence of arsenic in rice (e.g., a source of iron and calcium) and mercury in fish (e.g., a source of omega-3 fatty acids). Additionally, research shows a correlation between calcium and lead in naturally occurring sources of calcium such as shells, bone, and rock."

Similarities and differences relative to prior legislation: This bill is substantially similar to AB 899 (Muratsuchi, Chapter 668, Statutes of 2023), which requires, under the state's Sherman Law, manufacturers of baby food for sale or distribution in California to test a representative sample of the final product, and to disclose information to consumers about the levels of arsenic, cadmium, lead, and mercury present in each final product. Also similar to SB 646, AB 899 prohibits the sale, manufacture, or distribution of products in the state that do not comply with its requirements.

Unlike AB 899, SB 646 requires companies to ensure that test results are made available to the public, without requiring consumers to provide a UPC number, lot number, or proof of purchase. Also, SB 646 defines "manufacturer" and "brand owner," and specifies that the manufacturer—that is, the company that makes the product—must test it for heavy metals, and the brand owner—that is, the consumer-facing company—must disclose the test results to the public. In combination, these provisions in SB 646 stand to improve the public's access to critical information that can help them make informed consumer choices.

This bill: SB 646 requires manufacturers to test their prenatal vitamins for heavy metal levels, and then requires brand owners to post this information so that it is publicly available. In doing so, this bill would help provide a level of transparency about heavy metals in prenatal supplements that is not currently available to consumers, and allow pregnant persons to make informed decisions when they examine their options for prenatal supplements.

Policy considerations: As noted below, industry stakeholders have raised concerns that some companies might eliminate or reduce nutrients in their products, in an effort to reduce heavy metal levels (since some nutrients can co-occur with certain heavy metals in source materials, like produce used to manufacture prenatal supplements). Without context, these differences in nutrient levels might not be immediately apparent to consumers as they seek out prenatal supplements with the lowest heavy metal levels. To address this concern, SB 646 was recently amended to require companies to post nutrient levels on the same webpage as heavy metal levels, along with an explanatory statement, so that consumers can put the information they are seeing into context. As this bill moves forward, modifications to fine tune the explanatory statement, in furtherance of this goal, might be worth considering.

Arguments in support: According to the American College of Obstetricians and Gynecologists (District IX), Environmental Working Group, and Unleaded Kids:

"Prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help lower the risk of birth defects, low birth weight, and other complications. However, recent studies have raised significant concerns about contamination of these supplements with toxic elements, including lead, arsenic, cadmium, and mercury—substances known to pose serious health risks, especially to pregnant individuals and developing fetuses.

A Government Accountability Office (GAO) study found that lead, a toxic metal with no known safe level of exposure, was present in half of the prenatal vitamin samples tested. Additional independent studies have documented contamination levels exceeding California’s Proposition 65 thresholds. Despite these alarming findings, there are currently no federal or state regulations requiring the testing and disclosure of heavy metal levels in prenatal vitamins.

SB 646 addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury. The bill further mandates public reporting of test results to the California Department of Public Health and requires manufacturers to disclose toxic element levels on their websites starting in 2027. Consumers may access this information on the manufacturer’s website, which should also include linking to a webpage with FDA guidance on the health risks associated with these heavy metals.

California has long led the nation in protecting public health through transparency and accountability measures, including AB 899 (2023), which requires toxic element testing in baby food. SB 646 builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants."

Arguments in opposition: Writing in an opposed-unless-amended position, the Council for Responsible Nutrition (CRN, a trade association for the dietary supplement industry) and Consumer Healthcare Products Association (CHPA, a trade association for the consumer healthcare products industry) state the following:

"While CRN and CHPA appreciate the overall intent of SB 646 and are appreciative of the amendments thus far, we remain concerned that as written SB 646 would incentivize prenatal vitamin manufacturers to reduce essential nutrients in their vitamins so that they can make 'low heavy metal' claims.

To better understand why SB 646 would create this incentive, it is critical to note that many ingredients in prenatal vitamins are derived from natural sources and thus may contain trace levels of heavy metals. For example, calcium, which is essential for developing babies’ bones, teeth, and other vital organs, is naturally derived and may contain very small amounts of lead. That fact notwithstanding, it is undisputed that taking adequate amounts of calcium during pregnancy is critical, as inadequate amounts may compromise expectant mothers’ bone health and increase the risk of pregnancy complications like preeclampsia…CRN and CHPA have serious concerns that SB 646, by requiring prenatal vitamin manufacturers to publicly disclose levels of heavy metals, will significantly exacerbate this issue by incentivizing manufactures to reduce or eliminate the levels of critical nutrients.

Even worse, assuming expectant mothers are aware that their prenatal vitamins contain insufficient nutrients, they would need to get those nutrients from food sources, which could actually expose them to higher levels of heavy metals…prenatal vitamins and the specified elements are already regulated and heavily enforced under Prop. 65, the most health protective warning law in the country…This is why our organizations have offered a revised proposal that focuses on requiring manufacturers to publicly disclose the presence and levels of these elements if they are contained in the product at or above levels that would require a warning under Prop. 65…Our organizations remain committed to this approach but have also expressed a willingness to work with Senator Weber Pierson and her sponsors to address the issues outlined in this letter."

Related legislation:

1. SB 236 (Weber Pierson). Requires the Department of Toxic Substances Control (DTSC) to identify accepted testing methods in hair relaxer products, for specified chemicals that are prohibited under existing law; requires manufacturers to register their hair relaxer products with DTSC; requires DTSC to enforce the prohibitions for the specified chemicals, as provided; establishes the C.U.R.L. Act Fund for the deposit of penalties and fees, as provided, to support DTSC's implementation costs. This bill is pending before the Assembly Judiciary Committee.
2. SB 754 (Durazo). Requires a manufacturer of disposable tampons or menstrual pads to maintain information regarding the concentrations of lead, arsenic, cadmium, and zinc in their products and to provide that information to DTSC upon request. This bill is pending before the Assembly Appropriations Committee.
3. AB 899 (Muratsuchi, Chapter 668, Statutes of 2023). Requires, under the state's Sherman Law, manufacturers of baby food for sale or distribution in California to test a representative sample of the final product, as specified, and to disclose information, as specified, to consumers about the levels of arsenic, cadmium, lead, and mercury present in each final product; prohibits the sale, manufacture, or distribution of products in the state that do not comply with AB 899's requirements.
4. AB 1200 (Ting, Chapter 503, Statutes of 2021). Prohibits, commencing January 1, 2023, the sale of food packaging that contains PFAS; requires, commencing January 1, 2024, cookware manufacturers to label their product if it contains an intentionally added chemical on specified lists; and prohibits, commencing January 1, 2023, for the internet and January 1, 2024, for cookware packaging, a cookware manufacturer from making a claim that cookware is free of a chemical, unless no chemical from that chemical class is intentionally added to the cookware.
5. AB 1316 (Quirk, Chapter 507, Statutes of 2017). Requires CDPH to revise its regulations for the Childhood Lead Poisoning Prevention Program to redefine the assessment of risks for the purposes of evaluating a child's risk for lead exposure.
6. SB 258 (Lara, Chapter 830, Statutes of 2017). Creates the Cleaning Product Right to Know Act of 2017, which requires manufacturers of cleaning products to disclose specified chemical ingredients on a product label and on the manufacturers’ website.
7. SB 1019 (Leno, Chapter 862, Statutes of 2014). Requires manufacturers of upholstered furniture to indicate, on a label currently required by law, whether or not the product contains added flame retardant chemicals.

REGISTERED SUPPORT / OPPOSITION:

Support

A Voice for Choice Advocacy
American College of Obstetricians & Gynecologists District IX
American Nurses Association California
California Environmental Voters
California Medical Association
California Nurse Midwives Association
California Nurses for Environmental Health and Justice
California WIC Association
Center for Community Action and Environmental Justice
Center for Environmental Health
Center for Science in the Public Interest
Children Now
CleanEarth4Kids.org
Consumer Federation of California
Consumer Reports
Consumer Reports Advocacy
Environmental Working Group
Families Advocating for Chemical and Toxics Safety
Friends Committee on Legislation of California
Green Policy Initiative

GMOScience
Healthy Babies Bright Futures
Indivisible Marin
Long Beach Alliance for Clean Energy
Mamavation - Non-toxic Products for Healthy Families
Maternal and Child Health Access
National Health Law Program
Non-toxic Neighborhoods
Planned Parenthood Affiliates of California
Recolte Energy
Ritual
Unleaded Kids

Opposition

Consumer Healthcare Products Association
Council for Responsible Nutrition

Natural Products Association

Analysis Prepared by: Naomi Ondrasek / E.S. & T.M. / (916) 319-3965

Date of Hearing: July 1, 2025

ASSEMBLY COMMITTEE ON HEALTH

Mia Bonta, Chair

SBPCA Bill Id:SB 646

Author:(Weber Pierson) – As Amended Ver:June 16, 2025

SENATE VOTE: 38-0

SUBJECT: Prenatal multivitamins.

SUMMARY: Requires manufacturers of prenatal vitamins to test samples of the vitamins for arsenic, cadmium, lead, and mercury, to disclose the results of this testing on their websites and to provide a link on their websites where consumers can find the federal Food and Drug Administration’s (FDA) most recent guidance on the health effects of the toxic elements. Specifically, this bill:

1. Requires a manufacturer of prenatal vitamins for sale or distribution in this state to test a sample of each lot, manufacturer’s bulk prenatal multivitamin product, or packaged prenatal multivitamin product at a proficient laboratory for toxic elements.
2. Requires a proficient laboratory, including a manufacturer’s in-house laboratory, that analyzes the prenatal multivitamin product for toxic elements to meet all of the following criteria:
   1. Be accredited under the standards of the International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) 17025:2017 regarding the general requirements for the competence of testing and calibration laboratories;
   2. Use an analytical method that is at least as sensitive as that described in the FDA Elemental Analysis Manual 4.7; and,
   3. Demonstrate proficiency in quantifying each toxic element to at least 10 micrograms of the toxic element to kilogram of supplement (μg/kg) through an independent proficiency test. Proficiency means that laboratories achieve a z-score that is less than, or equal to, plus or minus two (≤ ±2).
3. Requires a manufacturer to provide test results to any authorized agent of the State Department of Public Health (DPH) upon their request.
4. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to disclose product information to the public consistent with all of the following:
   1. Make publicly available on their website, for the duration of the product shelf life for a packaged prenatal multivitamin product plus one month, the name and level of each toxic element present in each lot of a final prenatal vitamin product;
   2. Make the toxic element testing information available to the public user without the user having to provide a Universal Product Code (UPC) number, a lot number, or a proof of purchase;
   3. Provide descriptive information on the internet website to enable accurate identification of the packaged prenatal multivitamin product by the public. Permits descriptive information to include, but not be limited to, product name, UPC, size, or lot numbers;
   4. Include an internet website link to where the public can find the most recent FDA guidance and information about the health effects of the toxic elements on fetuses, infants, children, and individuals who are pregnant, planning to become pregnant, or lactating; and,
   5. On the manufacturer’s internet webpage describing a product, include a prominent statement that reads “For information about toxic element testing on this product” followed by a link to the webpage that contains the publicly available testing results.
5. Prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state, any prenatal vitamin that does not comply with the requirements in this bill.
6. Defines the following terms for purposes of this bill:
   1. “Bulk prenatal multivitamin product” to mean the bulk prenatal multivitamin product in finished dosage form before it is packaged and labeled. Bulk prenatal multivitamin product does not mean the constituent ingredients of prenatal multivitamins.
   2. “Packaged prenatal multivitamin product” to mean the bulk prenatal multivitamin product that has been packaged for sale or distribution to the public or health care professionals and whose product label bears a UPC.
   3. “Lot” to mean a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition, or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.
   4. “Prenatal multivitamin” to mean a dietary supplement that contains one or more vitamins or minerals and is represented or purported to be specifically used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or lactating.
   5. “Product label” to mean a display of written, printed, or graphic material that is affixed to a product’s immediate container.
   6. “Product shelf life” to mean the time, measured in the number of months, as printed on the product label, between the date of manufacture and the expiration date for a packaged prenatal multivitamin product.
   7. “Proficient laboratory” to mean a laboratory that meets the criteria listed in 2) above.
   8. “Representative sample” to mean a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.
   9. “Toxic elements” to mean arsenic, cadmium, lead, and mercury.

EXISTING LAW:

State Law:

1. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by DPH, which provides broad authority for DPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but DPH is permitted, by regulation, to adopt additional food labeling regulations. [Health and Safety Code (HSC) § 109875 et seq. and § 110380]
2. Requires a manufacturer of baby food for sale or distribution in the state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturer’s final baby food product, at least once per month, at a proficient laboratory, for arsenic, cadmium, lead, and mercury. Requires the laboratory to be able to quantify each toxic element to at least six micrograms of the toxic element to kilogram of food. [HSC § 110962(b)(1)]
3. Requires a manufacturer of baby food for sale or distribution in the state to disclose product information for baby food sold on an after January 1, 2025, including making publicly available on the manufacturer’s website the name and level of each toxic element present in a final baby food product. [HSC § 110962(b)(2)]
4. Requires, if a baby food product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA, to include a Quick Response (QR) code that links to a page on the manufacturer’s website that contains test results for the toxic element and a link to an FDA website where consumers can find the most recent FDA guidance and information about the health effects of the toxic element on children. [HSC § 110962(b)(B)]
5. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. [HSC § 25249.6]
6. Permits, under Proposition 65, a warning to be provided by general methods, such as labels on consumer products, posting of notices, placing notices in public news media, and the like, provided that the warning is clear and reasonable; requires regulations implementing Proposition 65, to the extent practicable, to place the obligation to provide any warning materials on the producer or packager rather than on the retail seller, except where the retail seller itself is responsible for introducing a chemical known to the state to cause cancer or reproductive toxicity. [HSC § 25249.11(f)]

Federal Law:

1. Establishes, through the FDA, various requirements for food labels under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which includes the Nutritional Labeling and Education Act and the Food Allergen Labeling and Consumer Protection Act. These include requiring specified nutrition information, a listing of all ingredients, and whether a produce contains any of eight major food allergens, such as milk, eggs, shellfish, tree nuts, etc. [21 United States Code (USC) § 301, et seq. and 21 Code of Federal Regulations (CFR) § 101, et seq.]
2. Defines “dietary supplement” as a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance to supplement the diet by increasing the total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any of these ingredients. Excludes from this definition something that is represented for use as a conventional food or as a sole item of a meal or the diet. [21 USC § 322(ff)]

FISCAL EFFECT: According to the Senate Appropriations Committee analysis, unknown ongoing General Fund costs, likely hundreds of thousands, for DPH for state administration.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. The author continues that while a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. The author notes that prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. The author continues that recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. The author highlights that a United States Government Accountability Office (GAO) study found lead, a heavy metal with no safe level of exposure, in half of the sampled prenatal vitamins, with some independent studies finding contamination, exceeding California’s Proposition 65 limits. The author concludes that given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.
2. BACKGROUND.
   1. Why are prenatal vitamins important? Prenatal supplements can help pregnant individuals obtain sufficient nutrients to support a healthy pregnancy. During pregnancy, the fetus and placenta divert nutrients from the parent’s blood. To account for this, the recommended dietary allowance of certain nutrients for pregnant individuals is higher than for non-pregnant individuals. For example, the recommended dietary allowance of 18 milligrams per day of iron increases to 27 milligrams per day during pregnancy. Prenatal supplements can help individuals who may not have the ability to obtain the appropriate nutrients from diet alone. Factors including the pregnant individual’s current diet, medical history, and food access can contribute to their ability to obtain appropriate amounts of some nutrients, according to experts.
   2. Regulatory Environment for Prenatal Vitamins. The oversight of prenatal supplements, a subset of dietary supplements, falls under the FDA’s responsibility for overseeing dietary supplements. Dietary supplements are regulated by the FDA in much the same manner as food, which means they are subject to requirements relating to good manufacturing practices, and must meet certain labeling standards, among other requirements. According to the FDA, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law. Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). The FD&C Act requires that manufacturers and distributors who wish to market dietary supplements that contain a “new dietary ingredient” (NDI) to notify the FDA about these ingredients. An NDI is an ingredient that was not marketed in a dietary supplement in the United States prior to October 15, 1994. When notifying the FDA about an NDI, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing the NDI will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. While the FDA is not required to formally approve an NDI, it will consider a dietary supplement “adulterated” unless the NDI has been present in the food supply in the same chemical form is planned to be used in the dietary supplement, or the manufacturer has shown evidence of safety at least 75 days before being introduced or delivered for introduction into interstate commerce, including any citation to published articles.
   3. Prenatal Vitamins and Heavy Metals. According to the GAO, heavy metals including arsenic, lead, mercury, and cadmium occur naturally in the environment and therefore may be present in supplement ingredients. The FDA notes that such metals can be present in foods because they are in the soil, water, or air where foods are grown, raised, or processed. The FDA is prioritizing looking at these contaminants due to their potential to cause harm during times of active brain development—in the womb through early childhood. In 2021, the FDA began its Closer to Zero initiative to outline the agency’s actions for reducing lead, arsenic, cadmium, and mercury in foods intended for babies and young children.

A 2025 study titled, “Heavy metals and phthalate contamination in prenatal vitamins and folic acid supplements,” explores prenatal vitamins as a source of heavy metal exposure, specifically looking at the elements lead and cadmium, and found that lead and Cadmium were detected in the majority of prenatal vitamins, including prescription prenatal vitamins. Among the commercially available prenatal vitamins, 15% exceeded the California Proposition 65 threshold for daily lead consumption of 0.5 micrograms, as did a third of the prescription-based samples. In contrast, less than half of the folate/folic acid supplements had detectable levels of lead and cadmium, and only one of these products had lead contamination that exceeded the California Proposition 65 threshold. The study’s author notes that the study did not investigate the impact of these metals quantities on neonatal outcomes, but highlights that people often take prenatal vitamins daily for many years, from pre-conception, through pregnancy and lactation, representing frequent and long-term exposure.

The GAO published a report in 2023 titled, “Prenatal Supplements: Amounts of Some Key Nutrients Differed from Product Labels” assessing the accuracy of over-the-counter prenatal supplement labels for amounts of certain nutrients—vitamins and minerals—and determining whether the supplements also contain harmful substances, such as heavy metals. The GAO contracted with the accredited laboratory to test prenatal supplement products for lead, arsenic, cadmium and mercury because these elements have been associated with harmful effects on the fetal brain, cognitive development, and growth. The GAO’s testing identified heavy metal contaminants in 6 of the 12 prenatal supplement products tested.

Arsenic and mercury were below the detection limits in all of the samples. The highest average lead content found was 0.31 micrograms per daily serving, which is well below FDA’s threshold of 8.8 micrograms of lead per day for individuals of a childbearing age. The report noted that while the FDA recognizes that a safe level of lead exposure has not been identified for fetal brain and cognitive development, based on existing data and other information, the FDA concluded that the levels found it its study were unlikely to pose a health concern. Regarding the two supplement products that contained cadmium, one was contained 0.52 micrograms per daily serving, and the other contained 0.32 micrograms per daily serving. The FDA uses a daily exposure limit of 0.21 – 0.36 micrograms of cadmium per kilogram of body weight per day for any individual, which corresponds to a limit of 14.3 – 24.5 micrograms per day for a 150-pound individual. Based on daily exposure limits used by the FDA, neither of the findings of cadmium in the tested supplements is likely to pose a health concern.

• 1. Prop 65. According to the Office of Environmental Health Hazard Assessment, Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. These chemicals can be in the products that Californians purchase, in their homes or workplaces, or that are released into the environment. By requiring that this information be provided, Proposition 65 enables Californians to make informed decisions about their exposures to these chemicals. Proposition 65 also prohibits California businesses from knowingly discharging significant amounts of listed chemicals into sources of drinking water. Proposition 65 requires California to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 900 chemicals since it was first published in 1987. Lead, cadmium, arsenic and mercury are on the Prop 65 list.
  2. Similarities and differences to AB 899 (Muratsuchi). AB 899 (Muratsuchi), Chapter 668, Statutes of 2023, requires a manufacturer of baby food sold or distributed in this state to test a representative sample of each production aggregate of baby food product, at a proficient laboratory meeting specified criteria (including being accredited, using an analytical method, and, demonstrating proficiency), for toxic elements (meaning arsenic, cadmium, lead, and mercury). AB 899 further requires for final baby food products sold, manufactured, delivered, held, or offered for sale in the state, to disclose specified information to consumers, including making publicly available on its internet website the name and level of each toxic element present in each product aggregate of the final baby food product. AB 899 further requires manufacturers to include on the product label a quick response code that links to a page on the manufacturer's internet website containing testing results for the toxic element and a link to related FDA guidance, if a product tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. This bill requires a manufacturer to test each batch of prenatal vitamins for lead, arsenic, cadmium and mercury and disclose the results of the testing on the manufacturer’s website.

1. SUPPORT. The Environmental Working Group (EWG), Unleaded Kids, and the American College of Obstetricians and Gynecologists District IX (ACOG) are the co-sponsors of this bill and state that this bill will protect maternal and fetal health by requiring the testing and public reporting of heavy metals in prenatal vitamins sold or manufactured in California. The co-sponsors continue that prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help the lower the risk of birth defects, low birth weight, and other complications. The co-sponsors state that recent studies have raised significant concerns about contamination of these supplements with toxic elements, including lead, arsenic, cadmium, and mercury—substances known to pose serious health risks, especially to pregnant individuals and developing fetuses. The co-sponsors highlight that a GAO study found that lead, a toxic metal with no known safe level of exposure, was present in half of the prenatal vitamin samples tested. The co-sponsors continue that additional independent studies have documented contamination levels exceeding California’s Proposition 65 thresholds. The co-sponsors note that despite these alarming findings, there are currently no federal or state regulations requiring the testing and disclosure of heavy metals in prenatal vitamins. The co-sponsors state that this bill addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury. The co-sponsors continue that this bill further mandates public reporting of test results to DPH and requires manufacturers to disclose toxic element levels on their websites starting in 2027. The co-sponsors continue that California has long led the nation in protecting public health through transparency and accountability measures, including AB 899, which requires toxic element testing in baby food. The co-sponsors conclude that this bill builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants.
2. OPPOSITION. The Natural Products Association (NPA) opposes this bill and states that if this bill were enacted, it would lead to significant consumer confusion for a variety of reasons, including: misinterpretation of risk, lack of context about natural occurrence, inconsistency with federal standards, potential for unnecessary alarm and product avoidance. NPA notes that consumers may mistakenly believe that prenatal vitamins are intentionally contaminated with substances even though these elements are naturally occurring and present in many foods. NPA believes this warning could cause fear and hesitation, leading some pregnant individuals to avoid essential prenatal vitamins, which are crucial for fetal development. NPA notes that elements like lead, arsenic, cadmium, and mercury are found naturally in soil, water, and plants, meaning they can inadvertently be present in trace amounts of foods and supplements. NPA concludes that without clear context, a warning label will make consumers believe prenatal vitamins pose a unique health risk even though the levels are well below established safety thresholds.
3. OPPOSE UNLESS AMENDED. The Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) oppose this bill unless it is amended, arguing that this bill would incentivize prenatal vitamin manufacturers to reduce essential nutrients in their vitamins so that they can make “low heavy metal” claims. CRN and CHPHA note that many ingredients in prenatal vitamins are derived from natural sources and thus may contain trace levels of heavy metals. CRN and CHPHA argue several prenatal vitamins on the market claim to have “low heavy metals,” but an evaluation of those products shows that those prenatal vitamins also contain no or insufficient levels of several critical nutrients. CRN and CHPA have serious concerns that this bill, by requiring prenatal vitamin manufacturers to publicly disclose levels of heavy metals, will significantly exacerbate this issue by incentivizing manufactures to reduce or eliminate the levels of critical nutrients. CRN and CHPA argues that assuming expectant mothers are aware that their prenatal vitamins contain insufficient nutrients, they would instead need to instead get their essential nutrients from foods like leafy greens, milk, nuts, and legumes, which also contain the very heavy metals that this bill seeks to regulate. CRN and CHPA’s proposed amendments focus on requiring manufacturers to publicly disclose the presence and levels of these elements if they are contained in the product at or above levels that would require a warning under Prop. 65, which CRN and CHPA argue invite public scrutiny, draw the attention of the active Prop. 65 plaintiff’s bar and the California Attorney General, who would have a clear view of noncompliant actors that they do not have today. CRN and CHPA conclude their proposed amendments ensures robust regulatory and public oversight while preventing both potential consumer confusion and unnecessary concern from exposure to raw laboratory data that requires specialized knowledge to meaningfully interpret.
4. PREVIOUS LEGISLATION.
   1. AB 899 (Muratsuchi), Chapter 668, Statutes of 2023 requires a manufacturer of baby food sold or distributed in this state to test a representative sample of each production aggregate of baby food product, at a proficient laboratory meeting specified criteria (including being accredited; using an analytical method; demonstrating proficiency), for toxic elements (meaning arsenic, cadmium, lead, and mercury). Requires, for the final baby food products sold, manufactured, delivered, held, or offered for sale in the state or and after January 1, 2025, to disclose specified information to consumers, including making publicly available on its internet website the name and level of each toxic element present in each product aggregate of the final baby food product. Requires manufacturers to include on the product label a QR code that links to a page on the manufacturer's internet website containing testing results for the toxic element and a link to related FDA guidance, if a product tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA.
   2. AB 82 (Weber) of 2024 would have prohibited a retail establishment from selling dietary supplements for weight loss or over-the-counter (OTC) diet bills to any person under 18 years of age without a prescription. AB 82 would have required DPH to determine which dietary supplements and OTC diet pills were subject to the bill, and develop a notice for distribution to retail establishments for posting that stated that certain dietary supplements for weight loss and OTC diet pills may contribute to specified medical conditions or other serious injury, or death. AB 82 was held on the Senate Appropriations Committee suspense file.
   3. AB 1178 (Quirk) of 2019 would have required a manufacturer or distributor of dietary supplements that contain live microorganisms, to include the genus, species, and strain of each live microorganism in the dietary supplement on the label of the dietary supplement. AB 1178 was held on the Senate Appropriations Committee suspense file.
   4. AB 1316 (Quirk and Cristina Garcia), Chapter 507, Statutes of 2017 requires DPH to revise its regulations for the Childhood Lead Poisoning Prevention Program to redefine the assessment of risks for the purposes of evaluating a child's risk for lead exposure.
   5. AB 688 (Pan), Chapter 681, Statutes of 2011, among other things, prohibits a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law.
   6. AB 455 (Chu), Chapter 679, Statutes of 2003 enacted the “Toxics in Packaging Prevention Act,” which prohibits a manufacturer, importer, agent, or supplier, as defined, from offering for sale or for promotional purposes in this state a package or packaging component that includes a regulated metal, defined as lead, cadmium, mercury, or hexavalent chromium, if that regulated metal has been intentionally introduced into the package or packaging component during manufacturing or distribution.
5. DOUBLE REFERRAL. This bill is double referred. Should it pass out of this Committee, it will be referred to the Assembly Committee on Environmental Safety and Toxic Materials.
6. AMENDMENTS. To address the opposition’s technical concerns, the author wishes to amend this bill as follows:
7. To include Omega-3 in the definition of prenatal multivitamin, and specify that prenatal multivitamins use Reference Daily Intake Values and Daily Reference Values specific to this group when calculating percent Daily Values for the Supplement Facts, as required by federal regulations.
8. To address concerns regarding clarity of the definition of “manufacturer” and “brand owner,” the author wishes to amend this bill to add a definition of “brand owner” meaning “the person or entity who owns or licenses the trademark that is the most prominent trademark on the principal display panel of the prenatal vitamin product label and offers for sale or sells the prenatal vitamin in the state,” and require both the brand owner and manufacturer to “comply with the provisions of this bill.
9. The author also proposes to amend the bill to update a cross-reference within the definition of manufacturer, making the person or entity who the prenatal vitamins are manufactured for or distributed by, identified by the product label pursuant to to Section 500.5(a) of Title 16, of the Code of Federal Regulations rather than the federal Fair Packaging and Labeling Act.
10. The author also wishes to amend the bill to require products sold in retail stores (as defined in federal law) on the outermost package to include a statement, “For information about toxic element testing on this product, visit” followed by the internet webpage where information required by 4) of this bill is posted.
11. To address concerns regarding the availability of an FDA webpage with guidance and information regarding the effects of toxic elements on infants, children, individuals who are pregnant, planning to become pregnant, or lactating, the author wishes to amend the bill to more generally require a link to the most recent FDA page relating to toxic elements in food. The author also wishes to specify to the extent the standards for laboratories in the bill contradict federal regulations, that the federal regulations shall control.

REGISTERED SUPPORT / OPPOSITION:

Support

American College of Obstetricians & Gynecologists - District IX (co-sponsor)

Environmental Working Group (co-sponsor)
Unleaded Kids (co-sponsor)

A Voice for Choice Advocacy
California Medical Association (CMA)
California Nurse Midwives Association (CNMA)
California Nurses for Environmental Health & Justice
California Wic Association
Center for Environmental Health
Children Now
Cleanearth4kids.org
Consumer Federation of California
Consumer Reports Advocacy
Facts Families Advocating for Chemical and Toxics Safety
Friends Committee on Legislation of California
Healthy Babies Bright Futures
Indivisible Marin
National Health Law Program
Planned Parenthood Affiliates of California
Ritual

Opposition

Natural Products Association

Consumer Healthcare Products Association (unless amended)
Council for Responsible Nutrition (unless amended)

Analysis Prepared by: Eliza Brooks / HEALTH / (916) 319-2097

 THIRD READING  

Bill No: SB 646

Author: Weber Pierson (D)

Amended: 4/10/25

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 4/2/25

AYES: Menjivar, Valladares, Durazo, Gonzalez, Grove, Limón, Padilla, Richardson, Rubio, Weber Pierson, Wiener

SENATE ENVIRONMENTAL QUALITY COMMITTEE: 8-0, 4/30/25

AYES: Blakespear, Valladares, Dahle, Gonzalez, Hurtado, Menjivar, Padilla, Pérez

SENATE APPROPRIATIONS COMMITTEE: 6-0, 5/23/25

AYES: Caballero, Seyarto, Cabaldon, Grayson, Richardson, Wahab

NO VOTE RECORDED: Dahle

SUBJECT: Prenatal vitamins

SOURCE: American College of Obstetricians & Gynecologists (co-sponsor)

Environmental Working Group (co-sponsor)

Unleaded Kids (co-sponsor)

DIGEST:

This bill requires manufacturers of prenatal vitamins to test samples of the vitamins for arsenic, cadmium, lead, and mercury, to disclose the results of this testing on their websites, and to include a Quick Response code on the product label that links to the test results and that provides a link to where consumers can find the federal Food and Drug Administration’s most recent guidance on the health effects of the toxic elements.

ANALYSIS:

Existing federal law:

1. Establishes, through the FDA, various requirements for food labels under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which includes the Nutritional Labeling and Education Act and the Food Allergen Labeling and Consumer Protection Act. These include requiring specified nutrition information, a listing of all ingredients, and whether a produce contains any of eight major food allergens, such as milk, eggs, shellfish, tree nuts, etc. [21 United States Code (USC) §301, et seq. and 21 Code of Federal Regulations §101, et seq.]
2. Defines “dietary supplement” as a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance to supplement the diet by increasing the total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any of these ingredients. Excludes from this definition something that is represented for use as a conventional food or as a sole item of a meal or the diet. [21 USC §322(ff)]

Existing state law:

1. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by the California Department of Public Health (CDPH), which provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted, by regulation, to adopt additional food labeling regulations. [Health & Safety Code (HSC) §109875 et seq. and §110380]
2. Requires a manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturer’s final baby food product, at least once per month, at a proficient laboratory, for arsenic, cadmium, lead, and mercury. Requires the laboratory to be able to quantify each toxic element to at least six micrograms to kilogram of food. [HSC §110962(b)(1)]
3. Requires a manufacturer of baby food for sale or distribution in this state to disclose product information for baby food sold on an after January 1, 2025, including making publicly available on the manufacturer’s website the name and level of each toxic element present in a final baby food product. [HSC §110962(b)(2)]
4. Requires, if a baby food product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the federal Food and Drug Administration (FDA), to include a Quick Response (QR) code that links to a page on the manufacturer’s website that contains test results for the toxic element and a link to an FDA website where consumers can find the most recent FDA guidance and information about the health effects of the toxic element on children. [HSC §110962(b)(B)]
5. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. [HSC §25249.6]
6. Permits, under Proposition 65, a warning to be provided by general methods, such as labels on consumer products, posting of notices, placing notices in public news media, and the like, provided that the warning is clear and reasonable; requires regulations implementing Proposition 65, to the extent practicable, to place the obligation to provide any warning materials on the producer or packager rather than on the retail seller, except where the retail seller itself is responsible for introducing a chemical known to the state to cause cancer or reproductive toxicity. [HSC §25249.11(f)]

This bill:

1. Requires a manufacturer of prenatal vitamins for sale or distribution in this state to test a sample of each lot, as defined, of the manufacturer’s final prenatal vitamin product, at a proficient laboratory, for arsenic, cadmium, lead, and mercury (toxic elements). Permits a manufacturer to test the final prenatal vitamin product before packaging individual units of vitamins for sale or distribution.
2. Requires a manufacturer to provide test results to any authorized agent of CDPH upon their request.
3. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to make publicly available on their website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each lot of a final prenatal vitamin product.
4. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to provide descriptive information on their website to enable accurate identification of the final prenatal vitamin product by consumers. Permits descriptive information to include product name, unique universal product code (UPC), size, lot numbers, or batch numbers.
5. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to include on the product label both of the following:
   1. A QR code or other machine-readable code that links to a page on their website containing test results for the toxic element, and an internet website link to a website of the FDA where consumers can find the most recent FDA guidance and information about the health effects of the toxic elements on fetuses, infants, children, and individuals who are pregnant, planning to become pregnant, or breastfeeding; and,
   2. A statement that reads: “For information about toxic element testing on this product, scan the QR code.”
6. Requires the proficient laboratory that analyzes the final prenatal vitamin product for toxic elements to meet all of the following criteria:
   1. Be accredited under the standards of the International Organization for Standardization/International Electrotechnical Commission regarding the general requirements for the competence of testing and calibration laboratories, as specified;
   2. Use an analytical method that is at least as sensitive as that described in an FDA Elemental Analysis Manual, as specified; and,
   3. Demonstrate proficiency in quantifying each toxic element to at least 10 micrograms of the toxic element to kilograms of supplement through an independent proficiency test. Specifies that proficiency means that laboratories achieve a z-score that is less than, or equal to, plus or minus two.
7. Prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state, any prenatal vitamin that does not comply with the requirements in this bill.
8. Defines the following terms for purposes of this bill:
   1. “Final prenatal vitamin product” means the finished product of prenatal vitamins with a UPC. Excludes from this definition the constituent ingredients of prenatal vitamins;
   2. “Lot” means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition, or, in the cast of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.
   3. “Prenatal vitamins” means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding;
   4. “Product label” means a display of written, printed, or graphic material that is affixed to the product or its immediate container;
   5. “Product shelf life” means the time, measure in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product;
   6. “QR Code” means a machine-readable code, consisting of an array of squares, used for storing an internet an internet website in order to access a web page;
   7. “Representative sample” means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled; and,
   8. “Toxic elements” means arsenic, cadmium, lead, and mercury.

Comments

According to the author of this bill:

Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. While a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. Prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. Recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. A U.S. Government Accountability Office (GAO) study found lead, a heavy metal with no safe level of exposure, in half of the sampled prenatal vitamins, with some independent studies finding contamination, exceeding California’s Proposition 65 limits. Given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.

Background

FDA regulation of dietary supplements. Under the FD&C Act, as amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), the FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public. Instead, dietary supplements are regulated by the FDA in much the same manner as food, which means they are subject to requirements relating to good manufacturing practices, and must meet certain labeling standards, among other requirements. According to the FDA, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law. Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). The FD&C Act requires that manufacturers and distributors who wish to market dietary supplements that contain a “new dietary ingredient” (NDI) to notify the FDA about these ingredients. An NDI is an ingredient that was not marketed in a dietary supplement in the U.S. prior to October 15, 1994. When notifying the FDA about an NDI, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing the NDI will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. While the FDA is not required to formally approve an NDI, it will consider a dietary supplement “adulterated” unless the NDI has been present in the food supply in the same chemical form that you plan to use in the dietary supplement, or the manufacturer has shown evidence of safety at least 75 days before being introduced or delivered for introduction into interstate commerce, including any citation to published articles.

Importance of prenatal vitamins. According to a study published in the journal Maternal Health, Neonatology and Perinatology in July of 2022, entitled, “Evidence Based Recommendations for an Optimal Prenatal Supplement for Women in the US: Vitamins and Related Nutrients,” sub-optimal intake of vitamins from preconception through pregnancy increases the risk of many pregnancy complications and infant health problems. According to this study, in the U.S., dietary intake of vitamins is often below recommended intakes, especially for vitamin D, choline, and DHA, and that many studies suggest that insufficient vitamin intake is associated with a wide range of pregnancy complications (anemia, Cesarean section, depression, gestational diabetes, hypertension, infertility, preeclampsia, and premature rupture of membranes) and infant health problems (asthma/wheeze, autism, low birth weight, congenital heart defects, intellectual development, intrauterine growth restriction, miscarriage, neural tube defects, orofacial defects, and preterm birth). The study found that prenatal supplements vary widely in content, often contained only a subset of essential vitamins and the levels were often below recommendations. The study suggested that increasing prenatal vitamin supplementation to the levels recommended in the study may reduce the incidence of many pregnancy complications and infant health problems. A related study by the same authors focusing on minerals, including calcium, iron, magnesium, selenium, and zinc, made similar findings and recommendations regarding the need for supplementation, especially for iodine, magnesium, and iron. Numerous organizations, including the FDA, the Centers for Disease Control and Prevention, and the American College of Obstetricians and Gynecologists, emphasize the importance of taking a prenatal vitamin that contains at least 400 micrograms of folic acid each day at least one month before pregnancy and during the first 12 weeks of pregnancy, and to consult with an obstetric care provider to see if additional supplementation is recommended based on a person’s health history. Folic acid can help prevent neural tube defects.

GAO report on prenatal supplements. The GAO published a report in December 2023 entitled “Prenatal Supplements: Amounts of Some Key Nutrients Different from Product Labels.” The overall thrust of this report was that of the 12 supplement products tested; most of them had levels of nutrients that did not correspond to the value on the label. The GAO report noted that FDA lacks authority to regulate dietary supplements with the same rigor as drugs, with oversight primarily occurring once the supplements are already on the market. The GAO recommended that Congress consider measures providing the FDA with sufficient authority to carry out oversight of dietary supplements. However, as part of the testing for this report, the supplement products were tested for heavy metal contamination, and six of the 12 products were found to have trace amounts of heavy metals, though not in amounts likely to cause a health concern based on metrics used by the FDA. Of the six products with trace amounts of heavy metals, all six had trace amounts of lead, and two had trace amounts of cadmium. Arsenic and mercury were below the detection limits in all of the samples. The highest average lead content found was 0.31 micrograms per daily serving, which is well below FDA’s threshold of 8.8 micrograms of lead per day for individuals of a childbearing age. The report noted that while the FDA recognizes that a safe level of lead exposure has not been identified for fetal brain and cognitive development, based on existing data and other information, the FDA concluded that the levels found it its study were unlikely to pose a health concern. Regarding the two supplement products that contained cadmium, one was contained 0.52 micrograms per daily serving, and the other contained 0.32 micrograms per daily serving. The FDA uses a daily exposure limit of 0.21 – 0.36 micrograms of cadmium per kilogram of body weight per day for any individual, which corresponds to a limit of 14.3 – 24.5 micrograms per day for a 150-pound individual. Based on daily exposure limits used by the FDA, neither of the findings of cadmium in the tested supplements is likely to pose a health concern.

Why are these toxic elements in supplements and other food products? The FDA’s “Closer to Zero” initiative is working to reduce childhood exposure to toxic elements in food. According to the FDA, arsenic, lead, cadmium and mercury may occur in the environment naturally (as elements in the earth’s crust) and from human activities. Levels in the air, water, and soil used to grow crops, process foods, and raise animals can vary depending on natural geographical proximity to past or current pollution. The amount of arsenic, lead, cadmium, or mercury in certain foods depends on the amount in the environment and how much the plant or animal ‘takes up’ from the environment. The GAO report on prenatal supplements noted that the presence of heavy metals may not be from the manufacturing process, but rather the ingredients chosen for the vitamins or minerals they contain. For example, bioaccumulation (a build-up of environmental substances in an organism) can result in an increased presence of arsenic in rice (a source of iron and calcium) and mercury in fish (a source of omega-3 fatty acids). Additionally, research shows a correlation between calcium and lead in naturally occurring sources of calcium such as shells, bone, and rock.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee, unknown ongoing General Fund costs, likely hundreds of thousands, for CDPH for state administration.

SUPPORT: (Verified 5/8/25)

American College of Obstetricians & Gynecologists (co-sponsor)

Environmental Working Group (co-sponsor)

Unleaded Kids (co-sponsor)

A Voice for Choice Advocacy

American Nurses Association\California

Black Women for Wellness Action Project

California Nurses for Environmental Health & Justice

California Nurse Midwives Association

California WIC Association

Center for Environmental Health

Center for Science in the Public Interest (not signed)

Children Now

Cleanearth4kids.org

Consumer Federation of California

Consumer Reports Advocacy

Families Advocating for Chemical Toxics Safety

Friends Committee on Legislation of California

Healthy Babies Bright Futures

Indivisible Marin

National Health Law Program

Planned Parenthood Affiliates of California

Ritual

OPPOSITION: (Verified 5/8/25)

Consumer Healthcare Products Association (unless amended)

Council for Responsible Nutrition (unless amended)

Natural Products Association

ARGUMENTS IN SUPPORT: This bill is co-sponsored by the American College of Obstetricians and Gynecologists District IX, the Environmental Working Group, and Unleaded Kids. The sponsors state that prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help lower the risk of birth defects, low birth weight, and other complications. However, recent studies have raised concerns about contamination of these supplements with toxic elements known to pose serious health risks, especially to pregnant individuals and developing fetuses. The sponsors state that this bill addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury, and permits consumers to access this information via a QR code on product labels, linking to a webpage with FDA guidance on the health risks associated with these heavy metals. Sponsors state that California has long led the nation in protecting public health through transparency and accountability measures, and this bill builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants.

ARGUMENTS IN OPPOSITION: The Natural Produces Association (NPA) opposes this bill state that it would lead to significant consumer confusion for a variety of reasons. First, NPA states that it could lead to a misinterpretation of risk, where consumers may mistakenly believe that prenatal vitamins are intentionally contaminated with substances even though these elements are naturally occurring and present in many foods, and that this warning could cause fear and hesitation that will lead some pregnant individuals to avoid essential prenatal vitamins. Second, NPA states that there will be a lack of context about natural occurrence, making consumers believe prenatal vitamins pose a unique health risk even thoug the levels are well below established safety thresholds. NPA points out that the FDA already regulates heavy metal limits in food and supplements based on scientific risk assessments and if enacted, this bill will conflict with federal law and cause confusion over whether prenatal vitamins sold in California are somehow different from those sold elsewhere. Finally, NPA states that this bill has the potential for unnecessary alarm and product avoidance, where women will stop taking prenatal vitamins altogether out of fear of toxicity, leading to greater health risks for both mother and baby.

Oppose unless amended. The Council for Responsible Nutrition and the Consumer Healthcare Products Association submitted a joint letter opposing this bill unless amended. The opponents argue that manufacturers do not intentionally add these elements to their products, but they may occur in certain raw materials, that federal regulations already require Good Manufacturing Practices, and that manufacturers already test these products for the presence of heavy metals. Opponents state that notifying consumers of the presence of these elements at any level will send mixed messages when those consumers are also encouraged by their doctor to take prenatal vitamins while pregnant. Opponents point out that the specified toxic elements are already regulated and enforced under California’s Proposition 65, which requires a warning if the product might expose consumers to carcinogens or reproductive toxicants at protective levels set by the Office of Environmental Health Hazard Assessment. The opponents request that the provisions requiring public disclosure of laboratory test results on manufacturer websites, and the provisions mandating QR codes on product labels, be removed from the bill.

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

5/26/25 13:26:58

**** END ****

SENATE COMMITTEE ON

Senator Anna Caballero, Chair

2025 - 2026 Regular Session

SB 646 (Weber Pierson) - Prenatal vitamins

Bill Summary:

SB 646 would require manufacturers of prenatal vitamins to test samples of the vitamins for arsenic, cadmium, lead, and mercury, as specified.

Fiscal Impact:

Unknown ongoing General Fund costs, likely hundreds of thousands, for the California Department of Public Health (CDPH) for state administration.

Background:

California’s Sherman Food, Drug and Cosmetic Law (Sherman Law) provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted to adopt additional food labeling regulations.

State law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturer’s final baby food product for arsenic, cadmium, lead, and mercury. The manufacturer must disclose product information for baby food sold, including making publicly available on the manufacturer’s website the name and level of each toxic element present in a final baby food product. A baby food product tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the U.S. Food and Drug Administration (FDA) must include a Quick Response (QR) code that links to a page on the manufacturer’s website that contains test results for the toxic element and a link to an FDA website where consumers can find the most recent FDA guidance and information about the health effects of the toxic element on children.

Proposed Law:

Specific provisions of the bill would:

• Require a manufacturer of prenatal vitamins for sale or distribution in this state to test a representative sample of each lot of the manufacturer’s final prenatal vitamin product, at a proficient laboratory, for arsenic, cadmium, lead, and mercury.
• Require the manufacturer to make publicly available on the manufacturer’s internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each lot of a final prenatal vitamin product.
• Require the manufacturer to include on the product label a QR code or other machine-readable code that links to a page on the manufacturer’s internet website containing information on test results for the toxic element and an internet website link to a website of the FDA where consumers can find the most recent FDA guidance and information about the health effects of the toxic elements on fetuses, infants, children, and individuals who are pregnant, planning to become pregnant, or breastfeeding.
• Prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamin that does not comply with these provisions.

-- END --

SENATE COMMITTEE ON ENVIRONMENTAL QUALITY

Senator Blakespear, Chair

2025 - 2026 Regular

Bill No: SB 646

SUBJECT: Prenatal vitamins

DIGEST: This bill requires manufacturers of prenatal vitamins to test samples of the vitamins for toxic elements, disclose the results of this testing on their websites, and include a Quick Response code on the product label that links to information on the test results, federal guidance, and health effects of the toxic elements.

ANALYSIS:

Existing federal law:

1. Establishes, through the Federal Food and Drug Administration (FDA), various requirements for food labels under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which includes the Nutritional Labeling and Education Act and the Food Allergen Labeling and Consumer Protection Act. These include requiring specified nutrition information, a listing of all ingredients, and whether a produce contains any of eight major food allergens, such as milk, eggs, shellfish, tree nuts, etc. (21 United States Code (USC) §301, et seq. and 21 Code of Federal Regulations (CFR) § 101, et seq.)
2. Defines “dietary supplement” as a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance to supplement the diet by increasing the total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any of these ingredients. Excludes from this definition something that is represented for use as a conventional food or as a sole item of a meal or the diet. (21 USC § 322(ff))

Existing state law:

1. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by the California Department of Public Health (CDPH), which provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted, by regulation, to adopt additional food labeling regulations. (Health and Safety Code (HSC) § 109875 et seq. and § 110380)
2. Requires a manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturer’s final baby food product, at least once per month, at a proficient laboratory, for arsenic, cadmium, lead, and mercury. Requires the laboratory to be able to quantify each toxic element to at least six micrograms to kilogram of food. (HSC § 110962(b)(1))
3. Requires a manufacturer of baby food in this state for food sold on and after January 1, 2025, to:
   1. Disclose product information, including making publicly available on the manufacturer’s website the name and level of each toxic element present in a final baby food product; and,
   2. Include a Quick Response (QR) code that links to the manufacturer’s website that contains test results for the toxic element and a link where consumers can find the most recent FDA guidance and information about the health effects of the toxic element on children. (HSC § 110962)
4. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. (HSC § 25249.6)
5. Permits, under Proposition 65 (Prop 65), a warning to be provided by general methods, such as labels on consumer products, posting of notices, placing notices in public news media, and the like, provided that the warning is clear and reasonable; requires regulations implementing Proposition 65, to the extent practicable, to place the obligation to provide any warning materials on the producer or packager rather than on the retail seller, except where the retail seller itself is responsible for introducing a chemical known to the state to cause cancer or reproductive toxicity. (HSC § 25249.11(f))

This bill:

1. Requires a manufacturer of prenatal vitamins to test a sample of each lot of the manufacturer’s final prenatal vitamin product, at a proficient laboratory, for arsenic, cadmium, lead, and mercury (toxic elements). Permits a manufacturer to test the final prenatal vitamin product before packaging individual units of vitamins for sale or distribution.
2. Requires a manufacturer to provide test results to any authorized agent of CDPH upon their request.
3. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to:
   1. Make publicly available on their website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present.
   2. Provide descriptive information on their website to enable accurate identification of the final prenatal vitamin product by consumers. Allows descriptive information to include product name, unique universal product code (UPC), size, lot numbers, or batch numbers.
4. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to include on the product label both of the following:
   1. A QR code or other machine-readable code that links to a page on their website containing test results for the toxic element, and a link to a website of the FDA where consumers can find the most recent FDA guidance and information about the health effects of the toxic elements on fetuses, infants, children, and individuals who are pregnant, planning to become pregnant, or breastfeeding; and
   2. A statement that reads: “For information about toxic element testing on this product, scan the QR code.”
5. Requires the proficient laboratory that analyzes the final prenatal vitamin product for toxic elements to meet specified criteria.
6. Prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state, any prenatal vitamin that does not comply with the requirements in this bill.
7. Defines key terms for purposes of this bill, including:
   1. “Final prenatal vitamin product” means the finished product of prenatal vitamins with a UPC. Excludes from this definition the constituent ingredients of prenatal vitamins.
   2. “Lot” means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition, or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.
   3. “Prenatal vitamins” means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding.
   4. “Toxic elements” means arsenic, cadmium, lead, and mercury.

Background

1. FDA regulation of dietary supplements. Under the FD&C Act, as amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), the FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public. Instead, dietary supplements are regulated by the FDA in much the same manner as food, which means they are subject to requirements relating to good manufacturing practices, and must meet certain labeling standards, among other requirements. According to the FDA, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law.

Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). 

1. Importance of prenatal vitamins. According to research, sub-optimal intake of vitamins from preconception through pregnancy increases the risk of many pregnancy complications and infant health problems. In the United States, dietary intake of vitamins is often below recommended intakes, especially for vitamin D, choline, and DHA, and many studies suggest that insufficient vitamin intake is associated with a wide range of pregnancy complications (anemia, Cesarean section, depression, gestational diabetes, hypertension, infertility, preeclampsia, and premature rupture of membranes) and infant health problems (asthma/wheeze, autism, low birth weight, congenital heart defects, intellectual development, intrauterine growth restriction, miscarriage, neural tube defects, orofacial defects, and preterm birth). Furthermore, prenatal supplements vary widely in content, often containing only a subset of essential vitamins at levels below recommendations.^[1]

Increasing prenatal vitamin supplementation, especially for iodine, magnesium, and iron may reduce the risk of pregnancy complications and adverse infant health impacts.^[2] Numerous organizations, including the FDA, the Centers for Disease Control and Prevention, and the American College of Obstetricians and Gynecologists, emphasize the importance of taking a prenatal vitamin that contains at least 400 micrograms of folic acid each day at least one month before pregnancy and during the first 12 weeks of pregnancy, and to consult with an obstetric care provider to see if additional supplementation is recommended based on a person’s health history. Folic acid can help prevent neural tube defects.

1. GAO report on prenatal supplements. The U.S. Government Accountability Office (GAO) published a report in December 2023 testing the amounts of nutrients and heavy metals in prenatal vitamins.^[3] As part of the report, 12 prenatal supplement products were tested and most of them had levels of nutrients that did not correspond to the value on the label. The GAO report noted that FDA lacks authority to regulate dietary supplements with the same rigor as drugs, with oversight primarily occurring once the supplements are already on the market. The GAO recommended that Congress consider measures providing the FDA with sufficient authority to carry out oversight of dietary supplements.

Additionally, as part of the testing for this report, the supplement products were tested for heavy metal contamination, and six of the 12 products were found to have trace amounts of heavy metals, though not in amounts likely to cause a health concern based on metrics used by the FDA. Of the six products with trace amounts of heavy metals, all six had trace amounts of lead, and two had trace amounts of cadmium. Arsenic and mercury were below the detection limits in all of the samples. The highest average lead content found was 0.31 micrograms per daily serving, which is well below FDA’s threshold of 8.8 micrograms of lead per day for individuals of a childbearing age. The report noted that while the FDA recognizes that a safe level of lead exposure has not been identified for fetal brain and cognitive development, based on existing data and other information, the FDA concluded that the levels found it its study were unlikely to pose a health concern.

Regarding the two supplement products that contained cadmium, one contained 0.52 micrograms per daily serving, and the other contained 0.32 micrograms per daily serving. The FDA uses a daily exposure limit of 0.21 – 0.36 micrograms of cadmium per kilogram of body weight per day for any individual, which corresponds to a limit of 14.3 – 24.5 micrograms per day for a 150-pound individual. Based on daily exposure limits used by the FDA, neither of the findings of cadmium in the tested supplements is likely to pose a health concern.

1. How do toxic elements end up in supplements? The FDA’s “Closer to Zero” initiative is working to reduce childhood exposure to toxic elements in food. According to the FDA, arsenic, lead, cadmium and mercury may occur in the environment naturally (as elements in the earth’s crust) and from human activities. The amounts of these elements in the air, water, and soil can vary depending on natural geographical proximity to past or current pollution. The amount of arsenic, lead, cadmium, or mercury in certain foods depends on the amount in the environment and how much plants or animals ‘take up’ from the environment. The GAO report on prenatal supplements noted that the presence of heavy metals may not be from the manufacturing process, but rather the ingredients chosen for the vitamins or minerals they contain. For example, bioaccumulation (a build-up of environmental substances in an organism) can result in an increased presence of arsenic in rice (a source of iron and calcium) and mercury in fish (a source of omega-3 fatty acids). Additionally, research shows a correlation between calcium and lead in naturally occurring sources of calcium such as shells, bone, and rock.

Multiple studies have shown that some prenatal vitamins exceed the threshold for daily lead consumption set by Prop 65 and have detectable levels of cadmium, mercury, and arsenic.^[4],[5] One of these studies also indicated that some prenatal vitamins exceeded limits for lead that the FDA has established for candy, with the highest levels over 20 times the limit.⁴

Comments

1. Purpose of Bill. According to the author, “Prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. While a balanced ideal, many Americans, including Californians, do not consume adequate nutrients. Prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual.

Recent studies highlight concern over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. A March 2025 peer-reviewed study found that 80% of 164 prenatal vitamin products had measurable levels of lead, a heavy metal with no safe level of exposure, with some independent studies finding contamination, exceeding California’s Proposition 65 limits.

Given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce contamination, and, if needed, provide a basis for setting safety standards.”

1. A self-regulating mechanism. By making manufacturers of prenatal vitamins publicly display their test results, companies may self-regulate. The sponsors of this bill have noticed a similar trend with the manufacturers of baby food after AB 899 (Muratsuchi, Chapter 668, Statutes of 2023) came into effect. It seems that with transparency, manufacturers will have an incentive through competition and find ways to reduce heavy metal contamination.

Unlike baby food, there are no established action levels or limits for toxic elements in prenatal vitamins. AB 899 only requires manufacturers to publicly display their test results if the toxic element is subject to an action level, regulatory limit, or tolerance established by the FDA. Because transparency would create an incentive for manufacturers to reduce contamination, for this bill, an established action level may not be necessary.

1. Eliminating toxicity, creating deficiency. Members of organizations representing dietary supplement manufacturers and suppliers have indicated that eliminating toxic metals may lead to the elimination of certain ingredients. Some of these ingredients are the only ingredients that provide a certain nutritional value.

For example, spinach is high in calcium content. Calcium intake during pregnancy supports the prevention of hypertensive disorders, which is the second major cause of maternal deaths globally.^[6],[7] However, spinach tends to uptake cadmium at higher levels relative to other foods because of their ability to efficiently transfer the toxins from the soil to the leaves. Spinach also tends to collect higher levels of lead on its leaves relative to other foods.^[8] If a prenatal vitamin only includes an ingredient, such as spinach, for its calcium content, then the ingredient may be at risk of being removed completely to remove or reduce the contamination of cadmium or lead. This could lead to a calcium deficiency if consumers do not find other sources of calcium to intake.

In response to this bill, it is possible that manufacturers will remove key ingredients to lower levels of contamination, while also removing necessary nutrients if they are not available in other ingredients. Pregnant individuals would have to find other food sources to supplement their diets. A possible resolution to this issue could be additional labels that express the lack of particular nutrients. Opposition has also indicated other regulatory mechanisms to ensure the appropriate levels of nutrients are contained within prenatal vitamins while reducing contamination. More engagement surrounding this concern will be necessary to ensure that by protecting pregnant individuals, policies aren’t inadvertently harming them. The author may wish to consider engaging with relevant stakeholders to ensure that this bill will not result in nutrient-deficient prenatal vitamins or that appropriate guardrails will be put in place.

1. Public perception. There are arguments that increasing the transparency of contamination may lead to the discontinued use of prenatal vitamins by concerned consumers. It may also lead to confusion, as these products are recommended by their doctors and are considered necessary throughout pregnancy. While this is an important consideration, consumers will also be able to make a choice between products. The amount of contamination in one product may fall within 10 to 100 times the average of all products, so there is an incentive for manufacturers to ensure that their product has lower amounts of contamination. It could be argued that the outcomes of this bill would not be worse than the status quo, in which consumers may blindly purchase highly contaminated products, while manufacturers may continue to operate business as usual.

DOUBLE REFERRAL:

This measure was heard in Senate Committee on Health on April 2, 2025, and passed out of committee with a vote of 11-0.

Related/Prior Legislation

AB 899 (Muratsuchi, Chapter 668, Statutes of 2023) required manufacturers of baby food to test a representative sample of final products for arsenic, cadmium, lead, and mercury, as specified, and to disclose information to consumers about the levels of these toxic elements present in each final product.

AB 82 (Weber, 2024) prohibited a retail establishment from selling dietary supplements for weight loss or over-the-counter (OTC) diet bills to any person under 18 years of age without a prescription. AB 82 was held on the Senate Appropriations Committee suspense file.

AB 1178 (Quirk, 2019) required a manufacturer or distributor of dietary supplements that contain live microorganisms, to include the genus, species, and strain of each live microorganism in the dietary supplement on the label of the dietary supplement. AB 1178 was held on the Senate Appropriations Committee suspense file.

AB 1316 (Quirk, Chapter 507, Statutes of 2017) required CDPH to revise its regulations for the Childhood Lead Poisoning Prevention Program to redefine the assessment of risks for the purposes of evaluating a child's risk for lead exposure.

AB 688 (Pan, Chapter 681, Statutes of 2011) prohibited a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law.

AB 455 (Chu, Chapter 679, Statutes of 2003) enacted the “Toxics in Packaging Prevention Act,” which prohibits a manufacturer, importer, agent, or supplier from offering for sale or for promotional purposes a package or packaging component that includes a regulated metal, defined as lead, cadmium, mercury, or hexavalent chromium, if that regulated metal has been intentionally introduced into the package or packaging component during manufacturing or distribution.

SOURCE:

Environmental Working Group

SUPPORT:

A Voice for Choice Advocacy
American College of Obstetricians & Gynecologists - District Ix
American Nurses Association/california
California Medical Association (CMA)
California Nurse Midwives Association (CNMA)
California Nurses for Environmental Health & Justice
California School Nurse's Organization
California Wic Association
Center for Environmental Health
Center for Science in the Public Interest
Children Now
Cleanearth4kids.org
Consumer Federation of California
Consumer Reports Advocacy
Environmental Working Group
Facts Families Advocating for Chemical and Toxics Safety
Friends Committee on Legislation of California
Healthy Babies Bright Futures
Indivisible Marin
National Health Law Program
Ritual
Unleaded Kids

OPPOSITION:

Consumer Healthcare Products Association

Council for Responsible Nutrition

Natural Products Association

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1. Adams, J. B., et. al. (2022). Evidence based recommendations for an optimal prenatal supplement for women in the US: vitamins and related nutrients. ↑

2. Adams, J. B., et. al. (2021). Evidence-based recommendations for an optimal prenatal supplement for women in the US, part two: Minerals. ↑

3. U.S. Government Accountability Office. (2023). Prenatal Supplements: Amounts of Some Key

   Nutrients Differed from Product Labels. ↑

4. Gardener, H., et. al. (2025). Heavy metals and phthalate contamination in prenatal vitamins and folic acid supplements. ↑

5. Schwalfenberg, G., et. al. (2018). Heavy metal contamination of prenatal vitamins. ↑

6. Imdad, A., & Bhutta, Z. A. (2012). Effects of calcium supplementation during pregnancy on maternal, fetal and birth outcomes. ↑

7. Kumar, A., & Kaur, S. (2017). Calcium: a nutrient in pregnancy. ↑

8. Seyfferth, A. L., et. al. (2024). Mitigating toxic metal exposure through leafy greens: A comprehensive review contrasting cadmium and lead in spinach. ↑

SENATE COMMITTEE ON HEALTH

Senator Caroline Menjivar, Chair

BILL NO: SB 646

SUBJECT: Prenatal vitamins

SUMMARY:

Requires manufacturers of prenatal vitamins to test samples of the vitamins for arsenic, cadmium, lead, and mercury, to disclose the results of this testing on their websites, and to include a Quick Response code on the product label that links to the test results and that provides a link to where consumers can find the federal Food and Drug Administration’s most recent guidance on the health effects of the toxic elements.

Existing state law:

1. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by the California Department of Public Health (CDPH), which provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted, by regulation, to adopt additional food labeling regulations. [HSC §109875 et seq. and §110380]
2. Requires a manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturer’s final baby food product, at least once per month, at a proficient laboratory, for arsenic, cadmium, lead, and mercury. Requires the laboratory to be able to quantify each toxic element to at least six micrograms to kilogram of food. [HSC §110962(b)(1)]
3. Requires a manufacturer of baby food for sale or distribution in this state to disclose product information for baby food sold on an after January 1, 2025, including making publicly available on the manufacturer’s website the name and level of each toxic element present in a final baby food product. [HSC §110962(b)(2)]
4. Requires, if a baby food product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the federal Food and Drug Administration (FDA), to include a Quick Response (QR) code that links to a page on the manufacturer’s website that contains test results for the toxic element and a link to an FDA website where consumers can find the most recent FDA guidance and information about the health effects of the toxic element on children. [HSC §110962(b)(B)]
5. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. [HSC §25249.6]
6. Permits, under Proposition 65, a warning to be provided by general methods, such as labels on consumer products, posting of notices, placing notices in public news media, and the like, provided that the warning is clear and reasonable; requires regulations implementing Proposition 65, to the extent practicable, to place the obligation to provide any warning materials on the producer or packager rather than on the retail seller, except where the retail seller itself is responsible for introducing a chemical known to the state to cause cancer or reproductive toxicity. [HSC §25249.11(f)]

Existing federal law:

1. Establishes, through the FDA, various requirements for food labels under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which includes the Nutritional Labeling and Education Act and the Food Allergen Labeling and Consumer Protection Act. These include requiring specified nutrition information, a listing of all ingredients, and whether a produce contains any of eight major food allergens, such as milk, eggs, shellfish, tree nuts, etc. [21 USC §301, et seq. and 21 CFR §101, et seq.]
2. Defines “dietary supplement” as a product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance to supplement the diet by increasing the total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any of these ingredients. Excludes from this definition something that is represented for use as a conventional food or as a sole item of a meal or the diet. [21 USC §322(ff)]

This bill:

1. Requires a manufacturer of prenatal vitamins for sale or distribution in this state to test a sample of each production aggregate, as defined, of the manufacturer’s final prenatal vitamin product, at a proficient laboratory, for arsenic, cadmium, lead, and mercury (toxic elements). Permits a manufacturer to test the final prenatal vitamin product before packaging individual units of vitamins for sale or distribution.
2. Requires a manufacturer to provide test results to any authorized agent of CDPH upon their request.
3. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to make publicly available on their website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate of a final prenatal vitamin product.
4. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to provide descriptive information on their website to enable accurate identification of the final prenatal vitamin product by consumers. Permits descriptive information to include product name, unique universal product code (UPC), size, lot numbers, or batch numbers.
5. Requires a manufacturer, for final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, to include on the product label both of the following:
   1. A QR code or other machine-readable code that links to a page on their website containing test results for the toxic element, and an internet website link to a website of the FDA where consumers can find the most recent FDA guidance and information about the health effects of the toxic elements on fetuses, infants, children, and individuals who are pregnant, planning to become pregnant, or breastfeeding; and,
   2. A statement that reads: “For information about toxic element testing on this product, scan the QR code.”
6. Requires the proficient laboratory that analyzes the final prenatal vitamin product for toxic elements to meet all of the following criteria:
   1. Be accredited under the standards of the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) regarding the general requirements for the competence of testing and calibration laboratories, as specified;
   2. Use an analytical method that is at least as sensitive as that described in an FDA Elemental Analysis Manual, as specified; and,
   3. Demonstrate proficiency in quantifying each toxic element to at least 10 micrograms of the toxic element to kilograms of supplement through an independent proficiency test. Specifies that proficiency means that laboratories achieve a z-score that is less than, or equal to, plus or minus two.
7. Prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state, any prenatal vitamin that does not comply with the requirements in this bill.
8. Defines the following terms for purposes of this bill:
   1. “Final prenatal vitamin product” means the finished product of prenatal vitamins with a UPC. Excludes from this definition the constituent ingredients of prenatal vitamins;
   2. “Prenatal vitamins” means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding;
   3. “Product label” means a display of written, printed, or graphic material that is affixed to the product or its immediate container;
   4. “Product shelf life” means the time, measure in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product;
   5. “Production aggregate” means a quantity of product that is intended to have uniform composition, character, and quality, and is produced according to a master manufacturing order;
   6. “QR Code” means a machine-readable code, consisting of an array of squares, used for storing an internet an internet website in order to access a web page;
   7. “Representative sample” means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled; and,
   8. “Toxic elements” means arsenic, cadmium, lead, and mercury.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, prenatal vitamins are essential for supplementing the nutritional needs of pregnant individuals, helping to prevent birth defects, low birth weight, and pregnancy complications. While a balanced diet is ideal, many Americans, including Californians, do not consume adequate nutrients. Prenatal vitamins commonly contain folic acid, iodine, iron, and other essential nutrients for a pregnant individual. Recent studies highlight concerns over toxic element contamination of prenatal vitamins with lead, arsenic, cadmium, and mercury. A U.S. Government Accountability Office (GAO) study found lead, a heavy metal with no safe level of exposure, in half of the sampled prenatal vitamins, with some independent studies finding contamination, exceeding California’s Proposition 65 limits. Given the risks associated with heavy metal exposure and the absence of federal or state regulations specific to prenatal vitamins, legislative action is needed to enhance transparency, which allows consumers to make informed choices, incentivizes companies to reduce toxic element contamination, and, if needed, provide a basis for setting safety standards.
2. FDA regulation of dietary supplements. Under the FD&C Act, as amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), the FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public. Instead, dietary supplements are regulated by the FDA in much the same manner as food, which means they are subject to requirements relating to good manufacturing practices, and must meet certain labeling standards, among other requirements. According to the FDA, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law. Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label that includes the serving size, the number of servings per container, a listing of all dietary ingredients in the product, and the amount per serving of those ingredients. They also must have a statement on the front of the product identifying it as a “dietary supplement” or similar descriptive term (e.g., “herbal supplement” or “calcium supplement”). The FD&C Act requires that manufacturers and distributors who wish to market dietary supplements that contain a “new dietary ingredient” (NDI) to notify the FDA about these ingredients. An NDI is an ingredient that was not marketed in a dietary supplement in the U.S. prior to October 15, 1994. When notifying the FDA about an NDI, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing the NDI will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. While the FDA is not required to formally approve an NDI, it will consider a dietary supplement “adulterated” unless the NDI has been present in the food supply in the same chemical form that you plan to use in the dietary supplement, or the manufacturer has shown evidence of safety at least 75 days before being introduced or delivered for introduction into interstate commerce, including any citation to published articles.
3. Importance of prenatal vitamins. According to a study published in the journal Maternal Health, Neonatology and Perinatology in July of 2022, entitled, “Evidence Based Recommendations for an Optimal Prenatal Supplement for Women in the US: Vitamins and Related Nutrients,” sub-optimal intake of vitamins from preconception through pregnancy increases the risk of many pregnancy complications and infant health problems. According to this study, in the U.S., dietary intake of vitamins is often below recommended intakes, especially for vitamin D, choline, and DHA, and that many studies suggest that insufficient vitamin intake is associated with a wide range of pregnancy complications (anemia, Cesarean section, depression, gestational diabetes, hypertension, infertility, preeclampsia, and premature rupture of membranes) and infant health problems (asthma/wheeze, autism, low birth weight, congenital heart defects, intellectual development, intrauterine growth restriction, miscarriage, neural tube defects, orofacial defects, and preterm birth). The study found that prenatal supplements vary widely in content, often contained only a subset of essential vitamins and the levels were often below recommendations. The study suggested that increasing prenatal vitamin supplementation to the levels recommended in the study may reduce the incidence of many pregnancy complications and infant health problems. A related study by the same authors focusing on minerals, including calcium, iron, magnesium, selenium, and zinc, made similar findings and recommendations regarding the need for supplementation, especially for iodine, magnesium, and iron. Numerous organizations, including the FDA, the Centers for Disease Control and Prevention, and the American College of Obstetricians and Gynecologists, emphasize the importance of taking a prenatal vitamin that contains at least 400 micrograms of folic acid each day at least one month before pregnancy and during the first 12 weeks of pregnancy, and to consult with an obstetric care provider to see if additional supplementation is recommended based on a person’s health history. Folic acid can help prevent neural tube defects.
4. GAO report on prenatal supplements. The GAO published a report in December 2023 entitled “Prenatal Supplements: Amounts of Some Key Nutrients Different from Product Labels.” The overall thrust of this report was that of the 12 supplement products tested; most of them had levels of nutrients that did not correspond to the value on the label. The GAO report noted that FDA lacks authority to regulate dietary supplements with the same rigor as drugs, with oversight primarily occurring once the supplements are already on the market. The GAO recommended that Congress consider measures providing the FDA with sufficient authority to carry out oversight of dietary supplements. However, as part of the testing for this report, the supplement products were tested for heavy metal contamination, and six of the 12 products were found to have trace amounts of heavy metals, though not in amounts likely to cause a health concern based on metrics used by the FDA. Of the six products with trace amounts of heavy metals, all six had trace amounts of lead, and two had trace amounts of cadmium. Arsenic and mercury were below the detection limits in all of the samples. The highest average lead content found was 0.31 micrograms per daily serving, which is well below FDA’s threshold of 8.8 micrograms of lead per day for individuals of a childbearing age. The report noted that while the FDA recognizes that a safe level of lead exposure has not been identified for fetal brain and cognitive development, based on existing data and other information, the FDA concluded that the levels found it its study were unlikely to pose a health concern. Regarding the two supplement products that contained cadmium, one was contained 0.52 micrograms per daily serving, and the other contained 0.32 micrograms per daily serving. The FDA uses a daily exposure limit of 0.21 – 0.36 micrograms of cadmium per kilogram of body weight per day for any individual, which corresponds to a limit of 14.3 – 24.5 micrograms per day for a 150-pound individual. Based on daily exposure limits used by the FDA, neither of the findings of cadmium in the tested supplements is likely to pose a health concern.
5. Why are these toxic elements in supplements and other food products? The FDA’s “Closer to Zero” initiative is working to reduce childhood exposure to toxic elements in food. According to the FDA, arsenic, lead, cadmium and mercury may occur in the environment naturally (as elements in the earth’s crust) and from human activities. Levels in the air, water, and soil used to grow crops, process foods, and raise animals can vary depending on natural geographical proximity to past or current pollution. The amount of arsenic, lead, cadmium, or mercury in certain foods depends on the amount in the environment and how much the plant or animal ‘takes up’ from the environment. The GAO report on prenatal supplements noted that the presence of heavy metals may not be from the manufacturing process, but rather the ingredients chosen for the vitamins or minerals they contain. For example, bioaccumulation (a build-up of environmental substances in an organism) can result in an increased presence of arsenic in rice (a source of iron and calcium) and mercury in fish (a source of omega-3 fatty acids). Additionally, research shows a correlation between calcium and lead in naturally occurring sources of calcium such as shells, bone, and rock.
6. Double referral. This bill is double referred. Should it pass out of this Committee, it will be referred to the Senate Environmental Quality Committee.
7. Prior legislation. AB 899 (Muratsuchi, Chapter 668, Statutes of 2023) requires manufacturers of baby food to test a representative sample of final products for arsenic, cadmium, lead, and mercury, as specified, and to disclose information to consumers about the levels of these toxic elements present in each final product.
   
   AB 82 (Weber of 2024) would have prohibited a retail establishment from selling dietary supplements for weight loss or over-the-counter (OTC) diet bills to any person under 18 years of age without a prescription. AB 82 would have required CDPH to determine which dietary supplements and OTC diet pills were subject to the bill, and develop a notice for distribution to retail establishments for posting that stated that certain dietary supplements for weight loss and OTC diet pills may contribute to specified medical conditions or other serious injury, or death. AB 82 was held on the Senate Appropriations Committee suspense file.
   
   AB 1178 (Quirk of 2019) would have required a manufacturer or distributor of dietary supplements that contain live microorganisms, to include the genus, species, and strain of each live microorganism in the dietary supplement on the label of the dietary supplement. AB 1178 was held on the Senate Appropriations Committee suspense file.
   
   AB 1316 (Quirk and Cristina Garcia, Chapter 507, Statutes of 2017) requires CDPH to revise its regulations for the Childhood Lead Poisoning Prevention Program to redefine the assessment of risks for the purposes of evaluating a child's risk for lead exposure.
   
   AB 688 (Pan, Chapter 681, Statutes of 2011), among other things, prohibits a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law.
   
   AB 455 (Chu, Chapter 679, Statutes of 2003) enacted the “Toxics in Packaging Prevention Act,” which prohibits a manufacturer, importer, agent, or supplier, as defined, from offering for sale or for promotional purposes in this state a package or packaging component that includes a regulated metal, defined as lead, cadmium, mercury, or hexavalent chromium, if that regulated metal has been intentionally introduced into the package or packaging component during manufacturing or distribution.
   
8. Support. This bill is co-sponsored by the American College of Obstetricians and Gynecologists District IX, the Environmental Working Group, and Unleaded Kids. The sponsors state that prenatal vitamins play a critical role in supporting healthy pregnancies, providing essential nutrients that help lower the risk of birth defects, low birth weight, and other complications. However, recent studies have raised concerns about contamination of these supplements with toxic elements known to pose serious health risks, especially to pregnant individuals and developing fetuses. The sponsors state that this bill addresses this critical gap by requiring manufacturers to test a representative sample from each production lot for arsenic, cadmium, lead, and mercury, and permits consumers to access this information via a QR code on product labels, linking to a webpage with FDA guidance on the health risks associated with these heavy metals. Sponsors state that California has long led the nation in protecting public health through transparency and accountability measures, and this bill builds on that progress by empowering pregnant individuals with vital information to choose safe and reliable prenatal supplements, free from harmful contaminants.
9. Oppose unless amended. The Council for Responsible Nutrition and the Consumer Healthcare Products Association submitted a joint letter opposing this bill unless amended. The opponents argue that manufacturers do not intentionally add these elements to their products, but they may occur in certain raw materials, that federal regulations already require Good Manufacturing Practices, and that manufacturers already test these products for the presence of heavy metals. Opponents state that notifying consumers of the presence of these elements at any level will send mixed messages when those consumers are also encouraged by their doctor to take prenatal vitamins while pregnant. Opponents point out that the specified toxic elements are already regulated and enforced under California’s Proposition 65, which requires a warning if the product might expose consumers to carcinogens or reproductive toxicants at protective levels set by the Office of Environmental Health Hazard Assessment. The opponents request that the provisions requiring public disclosure of laboratory test results on manufacturer websites, and the provisions mandating QR codes on product labels, be removed from the bill. Additionally, opponents request that the testing schedule be aligned with federal regulations and production cycles (“lot testing”).
10. Policy comment. This bill is very similar to AB 899 (Muratsuchi) from 2023 that requires testing and labeling of toxic elements in baby food. There are three substantive differences between AB 899 and this bill. First, the laboratory testing for vitamin supplements only has to be able to test at least 10 micrograms of the toxic element per kilogram of supplement, compared to 6 micrograms per kilogram of food for baby food. Proponents say that this testing requirement was relaxed to account for different testing sensitivities for supplements compared to baby food. A second difference is that this bill eliminates the requirement under AB 899 to test the product at least once a month, with proponents saying that because supplements have a longer shelf life, testing once a month could unnecessarily require re-testing of an already tested batch. The third substantive difference is that while AB 899 required all final baby products to be tested for the four toxic elements and the results made available on the manufacturer’s website, it only required the products to be labeled with the QR code if the toxic element is subject to an action level, regulatory limit, or tolerance established by the FDA. As part of its Closer to Zero initiative, the FDA is working to establish action levels for these elements in foods consumed by babies and children. However, the FDA does not have any plans to set action levels or limits for supplements. According to proponents, this is why the labeling requirements in this bill are not conditioned on the adoption of an action level by the FDA, and instead require all prenatal supplement products to be labeled with the QR code that leads to testing results.

SUPPORT AND OPPOSITION:

Support: American College of Obstetricians & Gynecologists (co-sponsor)

Environmental Working Group (co-sponsor)

Unleaded Kids (co-sponsor)
A Voice for Choice Advocacy

California Nurses for Environmental Health & Justice

California Nurse Midwives Association

California WIC Association

Center for Environmental Health

Children Now

Cleanearth4kids.org

Consumer Reports Advocacy

Families Advocating for Chemical Toxics Safety

Friends Committee on Legislation of California

Healthy Babies Bright Futures

Planned Parenthood Affiliates of California

Ritual

Oppose: Consumer Healthcare Products Association (unless amended)

Council for Responsible Nutrition (unless amended)

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