Existing law, the Medicinal and Adult-Use Cannabis Regulation and Safety Act, which includes the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA), enacted by the voters at the November 8, 2016, statewide general election, regulates the cultivation, distribution, and use of marijuana cannabis for medical purposes and for nonmedical purposes by people 21 years of age and older. Under existing law, the Bureau of Marijuana Cannabis Control is responsible for licensing and regulating retail sales, distribution, and transportation, and the State Department of Public Health is responsible for licensing and regulating manufacturers. AUMA Existing law places restrictions on the packaging and labeling of marijuana cannabis and marijuana cannabis products, including requirements that the packaging be resealable, child resistant, and not made attractive to children.

This bill would require a manufacturer, prior to introducing an edible marijuana cannabis product into commerce in California, to submit the packaging and labeling to the State Department of Public Health for approval and would require the department to determine whether the packaging and labeling are in compliance with the requirements of prescribed provisions of AUMA, law, including the requirements that the packaging be child resistant and not attractive to children, as specified. The bill would authorize the department to charge a manufacturer a fee for the determination, in an amount no greater than the amount required to cover the actual and reasonable costs of administering the approval program.

AUMA authorizes the Legislature to amend, by a majority vote, certain provisions of the act to implement specified substantive provisions, provided that the amendments are consistent with and further the specified purposes and the intent of the act.

This bill would declare that its provisions implement specified substantive provisions of the Control, Regulate and Tax Adult Use of Marijuana Act. The bill would also declare that its provisions further specified purposes and the intent of the Control, Regulate and Tax Adult Use of Marijuana Act.

Existing law, the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA), enacted by the voters at the November 8, 2016, statewide general election, regulates the cultivation, distribution, and use of marijuana for nonmedical purposes by people 21 years of age and older. Under existing law, the Bureau of Marijuana Control is responsible for licensing and regulating retail sales, distribution, and transportation, and the State Department of Public Health is responsible for licensing and regulating manufacturers. AUMA places restrictions on the packaging and labeling of marijuana and marijuana products, including that the packaging be resealable, child resistant, and not made attractive to children.

This bill would require a manufacturer, prior to introducing an edible marijuana product into commerce in California, to submit the packaging and labeling to the bureau State Department of Public Health for approval and would require the bureau department to determine whether the packaging and labeling are in compliance with the requirements of prescribed provisions of AUMA, including the requirements that the packaging be child resistant and not attractive to children, as specified. The bill would authorize the bureau department to charge a manufacturer a fee for the determination, in an amount no greater than the amount required to cover the actual and reasonable costs of administering the approval program.

AUMA authorizes the Legislature to amend, by a majority vote, certain provisions of the act to implement specified substantive provisions, provided that the amendments are consistent with and further the purposes and intent of the act.

This bill would declare that its provisions implement specified substantive provisions of the Control, Regulate and Tax Adult Use of Marijuana Act. The bill would also declare that its provisions further specified purposes and the intent of the Control, Regulate and Tax Adult Use of Marijuana Act.

Existing law, the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA), enacted by the voters at the November 8, 2016, statewide general election, regulates the cultivation, distribution, and use of marijuana for nonmedical purposes by people 21 years of age and older. Under existing law, the Bureau of Marijuana Control is responsible for licensing and regulating retail sales, distribution, and transportation, and the State Department of Public Health is responsible for licensing and regulating manufacturers. AUMA places restrictions on the packaging and labeling of marijuana and marijuana products, including that the packaging be resealable, child resistant, and not made attractive to children.

This bill would require a manufacturer, prior to introducing an edible marijuana product into commerce in California, to submit the packaging and labeling to the bureau for approval and would require the bureau to determine whether the packaging and labeling are in compliance with the requirements of prescribed provisions of AUMA, including the requirements that the packaging be child resistant and not attractive to children, as specified. The bill would authorize the bureau to charge a manufacturer a fee for the determination, in an amount no greater than the amount required to cover the actual and reasonable costs of administering the approval program.

AUMA authorizes the Legislature to amend, by a majority vote, certain provisions of the act to implement specified substantive provisions, provided that the amendments are consistent with and further the purposes and intent of the act.

This bill would declare that its provisions implement specified substantive provisions of the Control, Regulate and Tax Adult Use of Marijuana Act. The bill would also declare that its provisions further specified purposes and the intent of the Control, Regulate and Tax Adult Use of Marijuana Act.

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2017 - 2018 Regular Session

AB 175 (Chau) - Cannabis marketing: packaging and labeling

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

AB 175 would require the Department of Public Health to grant prior approval for the labelling and packaging of edible cannabis products before those products could be offered for sale.

Fiscal Impact:

Ongoing costs of $1.2 million per year for the Department of Public Health to review proposed product labels and packaging for approval (Cannabis Control Fund). The costs identified by the Department include staff to review proposed labels and packaging for conformity with state law and regulation, communication with product manufacturers, review of appeals, and one-time IT costs. The Department assumes that ten to fifteen thousand different products will be submitted for review (in part, this reflects the very large number of small manufacturers and retailers that are anticipated to participate in the state’s legal cannabis market beginning in 2018). Over time, the number of reviews conducted by the Department is likely to decline as would the Department’s workload and staff costs.

Background:

The Medical Cannabis Regulation and Safety Act (MCRSA) was enacted by the legislature to regulate the production and sale of medical cannabis. The MCRSA created a regulatory structure and licensing requirements for a variety of entities involved in the production, distribution, and sale of medical cannabis.

The Control, Regulate, and Tax Adult Use of Marijuana Act (AUMA, Proposition 64 of 2016) legalized the sale, possession, and use of marijuana for individuals over the age of 21. The AUMA created a regulatory structure for the recreational marijuana industry, similar to that created under the MCRSA, but with some differences in licensing requirements.

SB 94 (Committee on Budget and Fiscal Review, Statutes of 2017) consolidated and harmonized the requirements of the two bodies of law relating to both medicinal and recreational cannabis (and changed the official terminology to cannabis).

Current law prohibits advertising and marketing in a manner intended to encourage persons under 21 years of age to consume marijuana.

Proposed Law:

AB 175 would require the Department of Public Health to grant prior approval for the labelling and packaging of edible cannabis products before those products could be offered for sale.

Specific provisions of the bill would:

• Require a manufacturer, prior to introduction an edible cannabis product into commerce, to submit the proposed packaging and labelling to the Department of Public Health for approval;
• Require the Department to determine whether the packaging and labelling are in compliance with the requirements of current law;
• Provide the Department with 60 days to make the determination, including the ability for a 30 day extension, with notification to the applicant;
• Require the Department to notify the applicant if the packaging or labelling are not in compliance with state law;
• Authorize an administrative appeal process for denials issued by the Department;
• Require any material change to a product’s packaging or labelling to be submitted to the Department for approval;
• Authorize the Department to charge a fee to applicants to cover its costs.

Related Legislation:

• SB 663 (Nielsen) would establish the criteria for packaging cannabis products that is to be considered “attractive to children”. That bill is pending in the Assembly.
• SB 794 (Stern) would require each single serving of an edible cannabis product to be stamped or otherwise marked with a universal symbol. That bill is pending in the Assembly.
• AB 350 (Salas) would specify that cannabis products with specified characteristics are deemed to be attractive to children. That bill is pending on the Senate Floor.
• In addition, there are a number of other bills generally relating to cannabis and its regulation that will be heard in this committee.

Staff Comments:

Prior to 2016, beer producers were required to submit their labels to the Department of Alcohol Beverage Control for approval. As the beer industry diversified over recent years, the number of labels grew significantly and backlog of approvals developed. AB 893 (Stone, Statutes of 2016) repealed the requirement for prior approval of beer labels and instead requires labels to meet federal standards and brands to be registered with the Department of Alcohol Beverage Control.

In addition to harmonizing the two bodies of law governing cannabis, the budget trailer bill (SB 94, Statutes of 2017) created new requirements on the cannabis industry. In particular, the trailer bill requires the use of a quality assurance compliance monitor by cannabis distributors. Under the law, a quality assurance compliance monitor is required to be an employee or contractor of the Bureau of Cannabis Control and may not be a licensee or have any ownership interest in a licensee. The quality assurance compliance monitor is require to conduct random quality assurance reviews at licensed distributors’ premises to ensure that the labelling and packaging of cannabis products conform to the requirements of the law.

Given that current law requires an independent review of manufacturers’ compliance with state labelling and packaging requirements, it is not clear what additional value a state prior approval process for labelling and packaging will provide.

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SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 175

SUBJECT: Adult-use marijuana: marketing: packaging and labeling

SUMMARY:

1. Requires the label and packaging of edible marijuana products to have prior approval from the Department of Public Health.

Existing law:

1. Pursuant to the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA), an initiative statute enacted by the approval of Proposition 64 on November 8, 2016, authorizes a person 21 years of age or older to possess and use specified amounts of cannabis.
2. Establishes the Medicinal and Adult-Use Cannabis Regulation and Safety Act (Cannabis Act) to control and regulate the cultivation, distribution, transport, storage, manufacturing, processing, and sale of both medical cannabis and adult-use cannabis. Licenses under the Cannabis Act are scheduled to begin being issued on January 1, 2018.
3. Establishes, in the Department of Consumer Affairs (DCA), the Bureau of Cannabis Control (Bureau), which has the sole authority to create, issue, deny, renew, discipline, suspend, or revoke licenses for microbusinesses, transportation, storage unrelated to manufacturing activities, distribution, testing, and sale of cannabis and cannabis products in California.
4. Requires the Department of Food and Agriculture to administer the provisions of the Cannabis Act related to and associated with the cultivation of cannabis, and to have the authority to create, issue, deny, and suspend or revoke cultivation licenses.
5. Requires the Department of Public Health (DPH) to administer the provisions of the Cannabis Act related to and associated with the manufacturing of cannabis products, and to have the authority to create, issue, deny, and suspend or revoke manufacturing licenses.
6. Requires, prior to delivery or sale at a retailer, cannabis and cannabis products to be labeled and placed in a resealable, tamper-evident, child-resistant package, and to include a unique identifier for the purposes of identifying and tracking cannabis and cannabis products.
7. Prohibits cannabis and cannabis product labels from being made to be attractive to children.
8. Requires cannabis and cannabis product labels to include specified information, including a specified warning statement, the source and date of cultivation, the type of cannabis product and the date of manufacture, among other types of information, as well as any other requirement set by the Bureau or DPH.

This bill:

1. Requires a manufacturer, prior to introducing an edible marijuana product into commerce in California, to submit the packaging and labeling to DPH for approval.
2. Requires DPH to determine whether the packaging and labeling of the edible marijuana product are in compliance with the requirements of the Cannabis Act, including the requirements that the packaging be child resistant and not attractive to children.
3. Requires DPH to have 60 days in which to determine whether the packaging and labeling of the edible marijuana product are in compliance, and to notify the manufacturer in writing. Requires DPH, if a determination has not been made within 60 days, to notify the manufacturer of the delay and at what date within the following 30 days the determination is expected to be made.
4. Requires DPH, if it determines that the edible marijuana product packaging and labeling are not in compliance with the Cannabis Act, to notify the manufacturer, in writing, of the reasons for non-compliance.
5. Requires the manufacturer to have 60 days after receiving the notice of noncompliance to redesign and submit the packaging and labeling for that product for reassessment by DPH. Requires DPH to make a determination on the new packaging within 30 days of resubmission and notify the manufacturer of that determination in writing. Requires DPH, if it again determines that the packaging and labeling are not in compliance, to notify the manufacturer, in writing, of the reasons for noncompliance, and permits the manufacturer to request an administrative hearing with DPH within 30 days after the date of DPH’s notice.
6. Requires a manufacturer, any time it proposes to make a material change to the packaging and labeling of an edible marijuana product, to submit that packaging and labeling to DPH for review in accordance with the provisions of this bill.
7. Permits DPH to charge a fee to a manufacturer for the packaging and labeling determination required under this bill, and limits this fee to an amount no greater than the amount required to cover the actual and reasonable costs of administering the approval program established by this bill.
8. Makes legislative findings and declarations that this bill implements a specified section of AUMA, and that it is consistent with and furthers the purposes of that act, as specified.

FISCAL EFFECT:

According to the Assembly Committee on Appropriations (which analyzed the prior version of this bill, before amendments that shifted approval of packaging and labels from the Bureau to DPH), this bill would include:

1. One-time, start-up administrative costs to the Bureau to develop regulations implementing the approval program are expected to be absorbable within existing resources.
2. Significant ongoing costs to implement a "prior approval" process, estimated in the range of $530,000 for the last half of fiscal year 2017-18, and $900,000 per year thereafter (funded through fee revenue). There could be a large workload over the first year or two as numerous products are introduced to market, with lower ongoing costs once the market more fully stabilizes. This estimate includes potential administrative hearing costs, which would depend on the volume of noncompliance and appeals of Bureau rulings.
3. Potential short-term reduced tax revenues to the General Fund and the California Marijuana Tax Fund. Given the timing of this bill, and given licenses are to be issued beginning January 1, 2018, if this bill significantly slows the availability of products to market, it could potentially reduce the number of edible marijuana products sold and reduce related tax revenue for the first year or until the program has reached a steady state. Revenues from existing state and local sales taxes, as well as a 15% retail excise tax to be collected on recreational marijuana purchases under current law, would likely be impacted by any process that slowed the availability of products to market.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, as it pertains to marijuana legalization in California, children must come first. In a recent newspaper article, Colorado Governor John Hickenlooper was adamant that his state “didn’t regulate edibles strongly enough at first.” As a result, Colorado experienced a spike in emergency room visits by children who had consumed marijuana products, and one instance of an underage individual dying after ingesting marijuana. In an attempt to curb the potential for unsafe packaging and marketing of edible marijuana products to children, Washington requires their State Liquor and Cannabis Board to approve the labeling and packaging for all marijuana infused products, prior to offering these items for sale in retail stores. With edibles growing in popularity as an alternative form for consuming marijuana, it is important that we establish a packaging and labeling approval process to ensure that these products are child resistant, and not made in a way that is specifically attractive to children.
2. Compliance monitor for packaging and labeling, and proposed regulations. Cannabis distributors are required, under existing law, to conduct a quality assurance review before distribution to ensure the labeling and packaging of the cannabis and cannabis products conform to requirements. Additionally, existing law provides for a quality assurance monitor, who is required to be an employee or contractor of the Bureau and cannot hold a license or any ownership interest in any category of cannabis licensure. The quality assurance monitor is required to conduct random quality assurance reviews at a distributor’s licensed premises before distribution to ensure the labeling and packaging conform to requirements.
   
   DPH released proposed regulations for manufactured cannabis products for public comment in April of 2017. These proposed regulations, among other things, prohibit content on labels that is attractive to individuals under the age of 21, including, but not limited to: cartoons; any likeness to images, characters, or phrases that are popularly used to advertise to children; or, any imitation of candy packaging or labeling. These proposed regulations also include provisions requiring tamper-evident packaging that is child-resistant, as specified, and prohibits the package from imitating any package used for products typically marketed to children. Additionally, if it is an edible product, the package is required to be opaque.
3. AUMA. As a result of the 2016 initiative, those who are aged 21 years or older are allowed to possess, cultivate, and use marijuana for recreational purposes, particularly in a private home or at a business licensed for onsite marijuana consumption. However, smoking marijuana remains illegal while driving a vehicle, anywhere smoking tobacco is prohibited, and in all public places. AUMA, in addition to allowing adult consumption of marijuana and marijuana products for recreational purposes, established numerous controls and safeguards to protect the public, specifically children under the age of 21, including: allowing local governments to enforce state laws and regulations for nonmedical marijuana businesses and enact additional local requirements for nonmedical marijuana businesses; requiring a rigid track and trace management process from cultivation to sale; comprehensive testing; strict environmental and product safety standards; prohibiting the sale of nonmedical marijuana by businesses that also sell alcohol or tobacco; and, prohibiting the marketing and advertising of nonmedical marijuana to persons younger than 21 years of age, or near schools or other places where children are present.
4. Journal of the American Medical Association (JAMA) Article. A JAMA Pediatrics article was published in 2016 entitled “Unintentional Pediatric Exposures to Marijuana in Colorado, 2009-2015.” The authors examined the effect of the legalization of recreational marijuana on unintentional pediatric exposures by evaluating data on hospital admissions at a tertiary children’s hospital and cases at a regional poison center (RPC) between 2009 and 2015. Study participants included children younger than 10 years who were evaluated at the hospital’s emergency department, urgent care centers, or an inpatient unit and RPC cases for marijuana exposure. The authors identified 81 children (62 included in the analysis), evaluated at the hospital and 163 marijuana exposure calls to a Colorado RPC. For 10 exposure scenarios, the product was not in a child-resistant container; for an additional 40 scenarios (34%), poor child supervision or product storage was reported. Edible products were responsible for 51 exposures (52%).
5. Budget trailer bill combined medical and adult use cannabis regulation. SB 94 (Committee on Budget and Fiscal Review, Chapter 27, Statutes of 2017), one of the trailer bills for the 2017 Budget Act, unified the regulatory framework for cannabis. Prior to AUMA, the Legislature established, through a series of bills, the Medical Cannabis Regulation and Safety Act, which included a Bureau of Medical Cannabis. The passage of AUMA in 2016 created inconsistencies between how medical cannabis was regulated and the provisions of AUMA. Among other things, SB 94 created agricultural cooperatives, a method for collecting and remitting taxes, a process for testing and packaging, and a process for collecting data related to driving under the influence.
6. Related legislation. AB 1090 (Cunningham) prohibits the possessing, smoking, or ingesting

of marijuana or marijuana products in or upon the grounds of a school, day care center, or youth center at all times, instead of only while children are present. AB 1090 passed out of the Senate Health Committee by a vote of 7-0 on June 28, 2017.

AB 350 (Salas) prohibits a marijuana product from being made in the shape of a person, animal, insect, or fruit. AB 350 passed out of the Senate Business, Professions, and Economic Development Committee by a vote of 9-0 on June 12, 2017.

SB 794 (Stern) requires each single serving of an edible marijuana product to be stamped, marked, or otherwise imprinted directly on the product with a universal symbol, as specified. Requires edible marijuana products to be sold in packaging that is tamper-proof, child resistant, and, if the product contains more than one serving, re-sealable. SB 794 is pending in the Assembly Health Committee.

1. Prior legislation. SB 94 (Committee on Budget and Fiscal Review) was the cannabis trailer bill for the Budget Act of 2017, and established a single system of administration for cannabis laws in California.

AB 243 (Wood, Chapter 688, Statutes of 2015) requires the Department of Food and Agriculture, Department of Pesticide Regulation, DPH, the Department of Fish and Wildlife, and the State Water Resources Control Board to promulgate regulations or standards relating to medical cannabis and its cultivation, as specified, and establishes licensing fees, fines, and penalties. 

AB 266 (Bonta et al., Chapter 689, Statutes of 2015) established the Medical Cannabis Regulation and Safety Act for the licensure and regulation of medical cannabis and established the Bureau of Medical Cannabis within DCA. 

SB 643 (McGuire, Chapter 719, Statutes of 2015) set standards for the licensed cultivation and physician prescription of medical cannabis; establishes a track and trace program for the transportation of medical cannabis; and authorizes counties to impose a tax on medical cannabis. 

1. Support. The bill is co-sponsored by the American Federation of State, County and Municipal Employees (AFSCME), and the Union of American Physicians and Dentists (UAPD). According to AFSCME, this bill would require a manufacturer to submit for approval the packaging and label of an edible marijuana product to DPH. AFSCME states this bill strikes an appropriate balance between protecting public health and the needs of the marijuana industry. UAPD states that by establishing a process by which manufacturers of marijuana-infused edibles would be required to submit their packaging and labeling for approval, this bill will ensure that every product that hits stores in California is in child resistant packaging and is not made in a way that is specifically attractive to children. According to UAPD, Colorado and Washington became the first states in the nation to fully legalize marijuana in 2012, and since that time, one of the main issues that both states have faced is the accidental ingestion and child exposure to marijuana-infused edibles.
   
   Numerous organizations support this bill. The California Teachers Association states that the physical health of children is a prerequisite to learning, and children are an especially vulnerable audience and must be protected from exploitation by advertisers. Numerous law enforcement organizations, including the California Statewide Law Enforcement Association, state that law enforcement agencies will largely be responsible for enforcement of cannabis regulations, and that these initial approval steps for packaging and labeling will help with enforcement efforts and ensure that cannabis remains out of the hands of minors. The American Academy of Pediatrics, California, states that to protect California’s consumers, and our children, we must institute a strict review process for marijuana product packaging, such as the one established by this bill.
2. Opposition. The California Cannabis Industry Association (CCIA) states in opposition that it fully supports the need to curb the potential for unsafe packaging and marketing of edible cannabis products to children, and that is why it has been proactively working with DPH, which is tasked with developing regulations for the labeling of all manufactured cannabis products. CCIA states that it is premature to be imposing additional requirements in advance of proposed regulations, that this bill will slow down the implementation of the new regulatory system for cannabis, and would create possible liability for the state in making the state be the deciding factor in determining what packaging is attractive to children and what is not. Quantum Management Company, a cannabis firm, states that the solution proposed by this bill is overly burdensome for DPH at a time when cannabis regulations are still in development, with a potentially devastating impact on edible manufacturers that will cause significant job losses and business closures, when a better solution was just approved by the Legislature. According to Quantum, with just under six months remaining until licenses are due to be issued, adding a new packaging and labeling pre-approval requirement would add significant workload and distract DPH from its core focus on finalizing regulations and licenses that will ensure product safety. Consortium Management Group states in opposition that this bill is redundant of existing requirements that provides DPH with authority to ensure packaging and labeling standards are met.

SUPPORT AND OPPOSITION:

Support: Union of American Physicians and Dentists AFSCME-Local 207 (sponsor)

American Federation of State, County and Municipal Employees, AFSCME, AFL-CIO (co-sponsor)

American Academy of Pediatrics

Association of Orange County Deputy Sheriffs

California Academy of Child & Adolescent Psychiatry

California Association of Highway Patrolmen

California Chapter of the American College of Emergency Physicians

California Children’s Hospital Association

CaliforniaHealth+ Advocates

California Police Chiefs Association

California State PTA

California Statewide Law Enforcement Association

California Teachers Association

City of San Marcos

Coalition for Drug Free Escondido

Common Sense Kids Action

Community Action, Service & Advocacy

Consumer Federation of California

County Health Executives Association of California

First 5 LA

Fraternal Order of Police

Gatekeeper Innovation

League of California Cities

Long Beach Police Officers Association

Los Angeles County Board of Supervisors

National Association of Social Workers

Nurse-Family Partnership

Sacramento County Deputy Sherrffs’ Association

Saving Lives Camarillo

Smart Approaches to Marijuana

Youth Forward

Oppose: California Cannabis Industry Association

Consortium Management Group

Quantum Management Company, LLC.

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SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2017 - 2018 Regular

Bill No: Hearing Date: June 26, 2017

Subject:

SUMMARY:

Requires a manufacturer to submit packaging and labeling of edible marijuana products to the State Department of Public Health prior to introducing the product into commerce, and after any material changes to the label or packaging.

Existing law:

1. Establishes the Bureau of Marijuana Control (Bureau) under the Department of Consumer Affairs to regulate the medical and recreational cannabis industry through the Medical Cannabis Regulation and Safety Act (Act) and the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA). (Business and Professions Code (BPC) §§ 19302 and 26010)
2. Prohibits marijuana and marijuana products, packages, and labels from being made to be attractive to children. (BPC § 26120(b))
3. Requires marijuana and marijuana products to be labeled and placed in child resistant package. (BPC § 26120 (a))
4. Prohibits marijuana products from being designed to be attractive to children or easily confused with commercially sold candy or foods that do not contain marijuana. (BPC § 26130 (a)(1))
5. Authorizes the Bureau or State Department of Public Health (DPH) to establish other requirements for marijuana and marijuana product labels. (BPC § 26120)

This bill:

1. Requires a manufacturer, before introducing an edible marijuana product into commerce in California, to submit the packaging and labeling to DPH for approval. DPH shall determine whether the packaging and labeling are in compliance with current law.
2. Gives DPH 60 days to determine whether the packaging and labeling of the edible marijuana product is in compliance with specified requirements, and to notify the manufacturer of its decision in writing. If a determination has not been made within 60 days, DPH shall notify the manufacturer of the delay and at what date within the following 30 days the determination is expected to be made.
3. Requires DPH to notify the manufacturer, in writing, of the reasons for noncompliance. A manufacturer shall have 60 days after receiving the notice of noncompliance to redesign and submit the packaging and labeling for that product for reassessment by DPH. DPH shall make a determination on the new packaging within 30 days of resubmission and notify the manufacturer of that determination in writing.
4. Requires DPH, in the case of a resubmission, to notify the manufacturer, in writing, of the reasons for noncompliance. The manufacturer may request an administrative hearing with DPH within 30 days after the date of the department’s notice.
5. Requires that packaging and labeling be submitted to DPH any time a manufacturer proposes to make a material change to the packaging or labeling of an edible marijuana product.
6. Authorizes DPH to charge a fee to the manufacturer to determine packaging and labeling compliance in an amount no greater than the amount required to cover the actual and reasonable costs of administering the approval program.

FISCAL EFFECT:

According to the Assembly Appropriations Committee analysis dated May 3, 2017, the following costs are associated with this bill:

1. One-time, start-up administrative costs to the Bureau to develop regulations implementing the approval program are expected to be absorbable within existing resources.
2. Significant ongoing costs to implement a “prior approval” process, estimated in the range of $530,000 for the last half of fiscal year 2017-18, and $900,000 per year thereafter (funded through fee revenue). There could be a large workload over the first year or two as numerous products are introduced to market, with lower ongoing costs once the market more fully stabilizes. This estimate includes potential administrative hearing costs, which would depend on the volume of noncompliance and appeals of Bureau rulings.
3. Potential short-term reduced tax revenues to the General Fund and the California Marijuana Tax Fund. Given the timing of this bill, and given licenses are to be issued beginning January 1, 2018, if this bill significantly slows the availability of products to market, it could potentially reduce the number of edible marijuana products sold and a reduce related tax revenue for the first year or until the program has reached a steady state. Revenues from existing state and local sales taxes, as well as a 15 percent retail excise tax to be collected on recreational marijuana purchases under current law, would likely be impacted by any process that slowed the availability of products to market.

COMMENTS:

1. Purpose. The Author is the sponsor of this bill. According to the Author, “In November of 2016, AUMA passed to make adult use of marijuana legal to cultivate and consume in the state of California. Prior to this, in 2012, Colorado and Washington became the first states in the nation to fully legalize marijuana for recreational purposes. Since that time, one of the main issues that both states have faced is accidental ingestion and child exposure to marijuana-infused edible products. In a recent LA Times article, Colorado Governor John Hickenlooper was adamant that his state “didn’t regulate edibles strongly enough at first.” As a result, Colorado experienced a spike in emergency room visits by children who had consumed marijuana products, and one instance of an underage individual dying after ingesting marijuana.

“The AUMA contains numerous provisions that are intended to protect children. These provisions include that all edibles must be in child resistant packaging, and may not be made in a way that is attractive to children. However, the AUMA is silent on a mechanism to ensure compliance with these provisions of the law.”

1. Background. California’s medical and non-medical cannabis market is governed by the Act, which delegates licensing duties at the state level to the Bureau, Department of Food and Agriculture (DFA), and DPH (collectively, “licensing authorities”). DPH is responsible for promulgating packaging and labeling standards, and the Bureau is responsible for enforcement.

Each licensing authority is authorized to promulgate regulations to further clarify statutory intent. The Bureau, DFA, and DPH have all current released proposed regulations based on the medical cannabis statutes, including labeling requirements, and are currently accepting public comments. Although the medical and non-medical statutes have been merged by SB 94 (Committee on Budget and Fiscal Review, pending the Governor’s signature), eliminating much of the statutory basis for the authorities’ work, it is anticipated that the content will be re-used as the basis for additional emergency regulations necessary to meet the January 1, 2018 deadline. These regulations are also subject to public notice and comment.

These emergency regulations will be informed by an advisory committee mandated by statute to advise the licensing authorities on the development of standards and regulations. The members of the committee must include representatives of the cannabis industry, labor organizations, appropriate state and local agencies, persons who work directly with racially, ethnically, and economically diverse populations,  public health experts, and other subject matter experts.

1. Related Legislation. AB 350 (Salas) would change references to marijuana instead to cannabis and would amend the AUMA to prohibit a cannabis product from being made in the shape of a person, animal, insect, or fruit. (Status: This bill is pending on the Senate floor.)

AB 389 (Salas) would require the bureau, by July 1, 2018, to establish and make available on its Internet Web site a consumer guide to educate the public on the regulation of medical and nonmedical marijuana. (Status: This bill is pending in the Senate Appropriations Committee.)

AB 823 (Cooper) would require each single serving of chocolate, soft confections, hard confections and lozenges, consolidated baked goods, and pressed pills and capsules that include marijuana or marijuana products to be stamped, marked, or otherwise imprinted directly on the product with a cannabis product symbol, to be designed by DPH. The bill would specify the required size and visibility of the cannabis product symbol. (Status: This bill is pending in the Senate Appropriations Committee.)

SB 663 (Nielsen) would specify that a package or label of marijuana or marijuana products is deemed to be attractive to children if the package or label has specific characteristics, including, among others, resembling any candy, snack food, baked good, or beverage commercially sold without marijuana. (Status: This bill is pending in the Assembly Health Committee.)

SB 94 (Committee on Budget and Fiscal Review) merges the Act and AUMA, and makes various regulatory and enforcement changes. (Status: This bill is pending the Governor’s signature.)

1. Prior Legislation. SB 837 (Budget, Chapter 32, Statutes of 2016) defined “misbranding” of a cannabis product to include false or misleading labeling, and makes it unlawful to manufacture, sell, deliver, hold, or offer for sale a misbranded medical cannabis product.

AB 243 (Wood, Chapter 688, Statutes of 2015) requires CDFA, DPR, the State Department of Public Health, the Department of Fish and Wildlife, and the State Water Resources Control Board to promulgate regulations or standards relating to medical cannabis and its cultivation, as specified. This bill also establishes licensing fees, fines, and penalties. 

AB 266 (Bonta et al., Chapter 689, Statutes of 2015) established the Act for the licensure and regulation of medical cannabis and establishes the Bureau of Medical Cannabis Regulation within the DCA. 

SB 643 (McGuire, Chapter 719, Statutes of 2015) sets standards for the licensed cultivation and physician prescription of medical cannabis; establishes a track and trace program for the transportation of medical cannabis; and authorizes counties to impose a tax on medical cannabis. 

1. Arguments in Support. The Co-Sponsor of this measure, American Federation of State, County and Municipal Employees (AFSCME) writes, “The measure strikes an appropriate balance between protecting public health and the needs of the marijuana industry. Its primary purpose is protecting California’s youth while not infringing upon the success of this emerging sector.” It is AFSCME’s prediction that public health savings that will result from the implementation of this regulation will substantially outweigh its costs.

The California State PTA cites the study, Marijuana Exposure Among Children Younger Than Six Years in the United States, published by the National Library of Medicine National Institutes of Health, to ground their argument. According to this study, which used data from the National Poison data System, children under the age of six experienced a 150 percent increased likelihood of being exposed to cannabis, during the years 2000 to 2013. 75 percent of the children exposed to cannabis were under the age of three, the majority of which ingested a cannabis product as opposed to inhaling cannabis smoke or vapor.

1. Arguments in Opposition. The California Department of Public Health has been assigned the duty to develop regulations concerning standards for manufacturing and labeling l cannabis products, including edibles. According to the California Cannabis Industry Association (CCIA), AB 175 is premature in that it attempts to undercut DPHs statutory duty, which it is performing in a timely manner. Furthermore, CCIA proposes that AB 175 will “slow down implantation of the new regulatory system for cannabis.” Given the fact that at this time state licensing entities are struggling to process an unprecedented workload in a timely manner, requiring the state to additionally approve each individual product packaging is unrealistic. Lastly, AB 175 raises possible issues regarding the State of California’s legal culpability for harm resulting from an improper packaging design if a state regulator is to be the deciding factor in the packaging approval.
   
2. Policy Considerations. There are currently packaging and labeling requirements in statute, and there will be regulations promulgated further interpreting the Code, the development of which will be open to the public to ensure clarity.

Additionally, SB 94 (Committee on Budget and Fiscal Review, pending the Governor’s signature), which combines the Act and AUMA, creates the position of a “quality assurance compliance monitor” whose responsibility will be to conduct random quality assurance reviews at a distributor’s licensed premises to ensure the labeling and packaging of cannabis and cannabis products conform to law.

It is unclear whether the Author’s office believes that noncompliance will be due to willful disobedience or confusion with acceptable parameters. If it is the latter, the regulatory process should satisfy technical uncertainty, and there is nothing prohibiting individual manufacturers from asking DPH if packages and labels are compliant. If it is this bill’s desire to ensure compliant packaging and labeling immediately prior to sale, it would seem that random checks would be the best way to ensure all licensees are following the law; the process of mailing and receiving approval from DPH for each individual product does not prohibit a manufacturer from getting approval for one product and then placing another in the commerce stream. It is a valid question as to whether both mechanisms are necessary.

NOTE:

Double-referral to the Health Committee, second.

SUPPORT AND OPPOSITION:

Support:

Union of American Physicians and Dentists (Sponsor)

American Federation of State, County, and Municipal Employees (Co-Sponsor)

American Academy of Pediatrics

Association of Orange County Deputy Sheriffs

California Academy of Child Adolescent Psychiatry

California ACEP

California Association of Highway Patrolmen

California Children’s Hospital Association

California Health Advocates

California Police Chiefs Association Inc.

California State PTA

California Statewide Law Enforcement Association

California Teachers Association

Coalition for Drug Free Escondido

Common Sense Kid Action

Community Action Service Advocacy

Consumer Federation of California

County Health Executives Association of California

Fraternal Order of Police

Gatekeeper Innovation

League of California Cities

Long Beach Police Officers Association

Los Angeles Board of Supervisors

National Association of Social Workers

Nurse Family Partnership

Sacramento County Deputy Sheriff’s Association

Saving Lives Camarillo

Smart Approaches to Marijuana

Youth Forward

Opposition:

California Cannabis Industry Association

Consortium Management Group

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 175

Author:(Chau)

As Amended Ver:May 30, 2017

Majority vote

SUMMARY: This bill requires manufacturers of edible cannabis products to submit packaging for each product intended for sale in California to the Bureau of Medical Cannabis Regulation (Bureau) within the Department of Consumer Affairs (DCA) for review; and provides a 60 day review period for the Bureau to ensure that packaging meets the standards established in the division for child resistant packaging. This bill requires the Bureau to notify the manufacturer in writing and the manufacturer may pursue a reassessment of the packaging and labeling; any time a manufacturer makes a material change to the packaging or labeling of a product, it must resubmit it to the Bureau for evaluation. To cover the cost of the evaluation, the bill permits the Bureau to charge a fee to manufacturers. Specifically, this bill:

1. Requires manufacturers, before introducing an edible marijuana product to market in California, to submit the packaging and labeling to the Bureau to be evaluated for whether the packaging and labeling comply with the requirements set in law.
2. Requires the Bureau to complete its initial determination within 60 days and if there is a delay, must notify the manufacturer at which date the determination is expected to be made. Determinations must be made in writing.
3. Requires that if the Bureau determines that the packaging and labeling are not in compliance, then the manufacturer shall have 60 days to redesign and submit the packaging for reassessment. The Bureau must then make the determination within 30 days and notify the manufacturer in writing.
4. Requires that, if, after resubmission, the Bureau still does not approve the design, the manufacturer may request an administrative hearing within 30 days of the Bureau's notice.
5. Requires that any time a manufacturer seeks to make a change to the packaging or labeling, the manufacturer must resubmit the packaging and labeling to the Bureau for reassessment.
6. Permits the Bureau may charge a fee to the manufacturer to cover the costs of administering the approval process.

FISCAL EFFECT: According to the Assembly Committee on Appropriations, this bill would include:

1. One-time, start-up administrative costs to the Bureau to develop regulations implementing the approval program are expected to be absorbable within existing resources.
2. Significant ongoing costs to implement a "prior approval" process, estimated in the range of $530,000 for the last half of fiscal year 2017-18, and $900,000 per year thereafter (funded through fee revenue). There could be a large workload over the first year or two as numerous products are introduced to market, with lower ongoing costs once the market more fully stabilizes. This estimate includes potential administrative hearing costs, which would depend on the volume of noncompliance and appeals of Bureau rulings.
3. Potential short-term reduced tax revenues to the GF and the California Marijuana Tax Fund. Given the timing of this bill, and given licenses are to be issued beginning January 1, 2018, if this bill significantly slows the availability of products to market, it could potentially reduce the number of edible marijuana products sold and a reduce related tax revenue for the first year or until the program has reached a steady state. Revenues from existing state and local sales taxes, as well as a 15% retail excise tax to be collected on recreational marijuana purchases under current law, would likely be impacted by any process that slowed the availability of products to market.

COMMENTS:

Purpose. This bill is sponsored by the National Union of American Physicians and Dentists as well as the American Federation of State, County and Municipal Employees (AFSCME) AFL-CIO.

Background. This bill seeks to protect minors from cannabis products by requiring cannabis product manufacturers to submit labeling and packaging for any new cannabis product to the Bureau for evaluation of conformance with statute.

The bill also places strict prohibitions on the collection and use of data from underage users, explicitly stating that personally identifiable information may not be collected in the course of advertising or seeking to advertise marijuana or related products and services.

Child-Resistant Marijuana Packaging – The regulation of cannabis has been subdivided between three state agencies: 1) the California Department of Food and Agriculture (CDFA) will regulate the cultivation of cannabis, 2) the Department of Public Health (DPH) will regulate cannabis products, including edibles, and 3) the Bureau under the direction of DCA will regulate commerce and handle the largest segment of enforcement. Agencies are in the process of creating regulations in accordance with MCRSA and are expected to release the initial regulations in April of 2017.

Current law requires marijuana products to be labeled and packaged in a resealable, child-resistant package and stipulates that packages and labels shall not be made attractive to children. The law does not state by which standards packaging would be determined to be child resistant or what constitutes labeling that is unattractive to children. There are a number of such vague prescriptions in current law that will be clarified by regulation when it is implemented. Most relevant to this bill will be the regulations issued by DPH regarding edibles and their manufacture and sale. These regulations have been broadly outlined, including the likely restriction on anything other than "shelf-stable" products and an emphasis on preventing the diversion and accidental consumption of cannabis products by minors, however it is not clear how these regulations would tackle the issues raised in this bill.

The cannabis industry, regulators, and lawmakers are concerned about the accidental consumption of cannabis and cannabis products by children. In response to these concerns, the California Cannabis Industry Association (CCIA) released a white paper on October 26, 2016 outlining its position on this issue. Specifically, the paper highlights concerns that child resistant packaging is only intended to prevent access by children five years of age or younger and that child resistant packaging fails to prevent teens from accessing cannabis. This issue is bolstered by data from the Washington Poison Center, which indicates that in 2015 it received 272 calls for exposure to cannabis products, of which, 46%, 126 calls, were regarding children. Of those 126 calls, most involved teens, nearly 25% of all cannabis related poison center calls statewide. (Washington Poison Center Toxic Trends Report: 2015 Annual Cannabis Report)

Pediatric Cannabis Exposure - In September 2016, the American Medical Association published a study comparing the incidence of exposure to cannabis before and after the legalization of recreational cannabis and found that Colorado saw more cases of unintentional pediatric exposure to cannabis that the rest of the United States. Specifically the study found that the mean rate of exposure increased from 1.2 per 100,000 population two years prior to legalization to 2.3 per 100,000 population two years after legalization. (Wang, Le Lait, Deakyne, et al. "Unintentional Pediatric Exposures to Marijuana in Colorado, 2009-2015" JAMA Pediatrics.) While Colorado's increase of 34% per year of exposure is higher than other states, it is notable that pediatric cannabis exposure is on the rise generally in the United States, increasing 19% over the same time period. The study found that when the source of the exposure was known, 48% included cannabis edibles and 40% of scenarios were attributed to poor-child supervision or product storage. For 9%t of cases, the product was not in a child resistant container.

Similar Statewide Labeling Approvals – As recently as 2015, beer makers in the state were required to submit labels to the California Department of Alcohol Beverage Control (ABC) in a similar effort to protect the health, safety and welfare of the people of the state. This practice was ceased by the passage of AB 893 (Stone, Chapter 410, Statutes of 2015) as the growth of the craft beer industry had led to a large backlog of label approvals at ABC, creating a bottleneck in the industry that prevented inventory from getting to shelves in a timely fashion and created economic harm to brewers. The bill placed the responsibility for compliance on brewers and granted full authorization to ABC to enforce noncompliance.

Analysis Prepared by: Jimmy Fremgen / B. & P. / (916) 319-3301 FN: 0000922

Date of Hearing: May 3, 2017

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 175

Author:(Chau) – As Introduced Ver:January 17, 2017

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

SUMMARY:

This bill establishes an approval process for recreational edible marijuana product packaging and labeling, whereby packaging and labeling are required to be reviewed and approved by the Bureau of Medical Cannabis Regulation (Bureau) prior to their use.

It also establishes a fee for the purpose, in an amount not to exceed the actual and reasonable costs of administering the program, and establishes related timelines and an appeals process.

FISCAL EFFECT:

1. One-time, start-up administrative costs to the Bureau to develop regulations implementing the approval program are expected to be absorbable within existing resources.
2. Significant ongoing costs to implement a “prior approval” process, estimated in the range of $530,000 for the last half of fiscal year 2017-18, and $900,000 per year thereafter (funded through fee revenue). There could be a large workload over the first year or two as numerous products are introduced to market, with lower ongoing costs once the market more fully stabilizes. This estimate includes potential administrative hearing costs, which would depend on the volume of noncompliance and appeals of Bureau rulings.
3. Potential short-term reduced tax revenues to the GF and the California Marijuana Tax Fund. Given the timing of this bill, and given licenses are to be issued beginning January 1, 2018, if this bill significantly slows the availability of products to market, it could potentially reduce the number of edible marijuana products sold and a reduce related tax revenue for the first year or until the program has reached a steady state. Revenues from existing state and local sales taxes, as well as a 15% retail excise tax to be collected on recreational marijuana purchases under current law, would likely be impacted by any process that slowed the availability of products to market.

COMMENTS:

1. Purpose. This bill is sponsored by the American Federation of State, County and Municipal Employees and the Union of American Physicians and Dentists to ensure the safety of children and proper labeling of edible cannabis products.
2. Labeling Requirements. Proposition 64, or the Adult Use of Marijuana Act (AUMA), requires that prior to the delivery or sale of marijuana and marijuana products, they must be labeled and placed in a resealable, child-resistant package, and must not be made attractive to children. The inserts must also be prominently displayed in a clear and legible fashion and include specified information. This bill would require prior approval of the labels to ensure they are compliant with the law.
3. Budget Trailer Bill Proposal. With the passage of AUMA, many inconsistencies were created between implementation of the state's existing Medical Cannabis Regulation and Safety Act (MCRSA) and AUMA. The Governor, through proposed budget trailer bill language (TBL), is recommending several proposals to address the differences between MCRSA and AUMA. There is no proposal to develop a prior approval process for labels.
4. Label requirements for beer. Prior to January 1, 2016, beer producers submitted their labels to the Department of Alcoholic Beverage Control (ABC) for approval. With the growth of craft breweries, this practice caused a backlog of label approvals. AB 893 (Stone), Chapter 410, Statutes of 2015, ceased this practice and instead required beer labels to meet federal requirements and required registration of the beer brand with ABC with specified requirements.
5. Related Legislation. A large number of cannabis-related bills have been introduced this year. The following bills address some aspect of cannabis labeling: AB 823 (Chau), AB 1606 (Cooper), SB 175 (McGuire), SB 663 (Nielsen), and SB 794 (Stern).

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 25, 2017

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 175

Author:(Chau) – As Introduced Ver:January 17, 2017

SUBJECT: Adult-use marijuana: marketing: packaging and labeling.

SUMMARY: Requires the Bureau of Marijuana Control (Bureau) to approve the package and label of an edible marijuana product, as specified. Specifically, this bill:

1. Requires that before a manufacturer introduces an edible marijuana product (edible) into commerce in California, he or she must submit the packaging and labeling to the Bureau for approval in a manner required by the Bureau.
2. Requires the Bureau to determine whether the packaging and labeling are in compliance with specified requirements, including requirements that the packaging be child resistant and not attractive to children.
3. Gives the Bureau 60 days in which to determine whether the packaging and labeling of edibles are in compliance with this bill and to notify the manufacturer in writing. Requires the Bureau to notify the manufacturer of the delay and at what date within the following 30 days the determination is expected to be made, if the determination is not made within 60 days.
4. Requires the Bureau, if it determines that the edible packaging and labeling are not in compliance with this bill, to notify the manufacturer, in writing, of the reasons for noncompliance. Gives the manufacturer 60 days after receiving the notice of noncompliance to redesign and submit the packaging and labeling for that product for reassessment by the Bureau. Requires the Bureau to make a determination on the new packaging within 30 days of resubmission and notify the manufacturer of that determination in writing.
5. Requires the Bureau, if, after resubmission, it still determines that the packaging and labeling are not in compliance with this bill, to notify the manufacturer, in writing, of the reasons for noncompliance. Authorizes the manufacturer to request an administrative hearing with the Bureau within 30 days after the date of the Bureau’s notice.
6. Requires, anytime a manufacturer proposes to make a material change to the packaging or labeling of an edible, that packaging and labeling be submitted to the Bureau.
7. Authorizes the Bureau to charge a fee to the manufacturer for administration of this bill in an amount no greater than the amount required to cover the actual and reasonable costs of administering the approval program.

EXISTING LAW:

1. Establishes Proposition 215, referred to as the Compassionate Care Act, which legalized the possession and cultivation of marijuana for personal medical use upon recommendation of a physician and ensures that patients and their primary caregivers are not subject to criminal prosecution or sanction. Creates within the Department of Public Health (DPH), a voluntary Medical Marijuana Identification Card program for the registration of patients using medical marijuana and their primary caregivers.
2. Enacts the Medical Cannabis Regulation and Safety Act (MCRSA) to regulate numerous aspects of medical cannabis in California, including cultivation, transportation, storage, testing, labelling, manufacture and sale codified pursuant to AB 243 (Wood), Chapter 688, Statutes of 2015; AB 266 (Bonta), Chapter 689, Statutes of 2015; and, SB 643 (McGuire), Chapter 719, Statutes of 2015.
3. Establishes within the Department of Consumer Affairs the Bureau of Medical Cannabis Regulation for the licensure and regulation of medical cannabis.
4. Establishes, through the voter initiative process, Proposition 64 or Adult Use of Marijuana Act of 2016 (AUMA) which permits adults 21 years of age or older to legally grow, possess, and use cannabis for non-medical purposes, as specified. Authorizes, beginning January 1, 2018, the sale and distribution of cannabis through a regulated business.
5. Renames the Bureau of Medical Marijuana Regulation (now referred to as the Bureau of Medical Cannabis Regulation) as the Bureau.
6. Specifies packaging and labeling requirements for marijuana and marijuana products.
7. Requires DPH to promulgate regulations governing the licensing of marijuana manufacturers and testing laboratories. Requires DPH to develop procedures to ensure that testing of marijuana and marijuana products occurs prior to distribution as specified; specifies how often licensees shall test marijuana and marijuana products, as specified; and requires the destruction of harvested batches whose testing samples indicate noncompliance with health and safety standards developed by DPH, as specified.

FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, as it pertains to marijuana legalization in California, children must come first. In a recent newspaper article, Colorado Governor John Hickenlooper was adamant that his state “didn’t regulate edibles strongly enough at first.” As a result, Colorado experienced a spike in emergency room visits by children who had consumed marijuana products, and one instance of an underage individual dying after ingesting marijuana. In an attempt to curb the potential for unsafe packaging and marketing of edible marijuana products to children, Washington requires their State Liquor and Cannabis Board to approve the labeling and packaging for all marijuana infused products, prior to offering these items for sale in retail stores. With edibles growing in popularity as an alternative form for consuming marijuana, it is important that we establish a packaging and labeling approval process to ensure that these products are child resistant, and not made in a way that is specifically attractive to children.
2. BACKGROUND.
   1. Labeling Requirements. AUMA requires that prior to the delivery or sale of marijuana and marijuana products, they must be labeled and placed in a resealable, child resistant package, and must not be made attractive to children. The inserts must also be prominently displayed in a clear and legible fashion the following information, as prescribed by the Bureau or DPH: i) manufacture date and source; ii) for packages containing only dried flower, the net weight of marijuana in the package; iii) identification of the source and date of cultivation, the type of marijuana or marijuana product and the date of manufacturing and packaging; iv) the appellation of origin, if any; v) list of pharmacologically active ingredients, as specified; vi) for marijuana products, a list of all ingredients and disclosure of nutritional information, as specified; vii) a list of any solvents, nonorganic pesticides, herbicides, and fertilizers that were used, as specified; viii) a warning if nuts or other known allergens are used; ix) information associated with the unique identifier issued by the Department of Food and Agriculture; and, x) and the following statements, in bold print:
      
      For marijuana:
      
      “GOVERNMENT WARNING: THIS PACKAGE CONTAINS MARIJUANA, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. MARIJUANA MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. MARIJUANA USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF MARIJUANA IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION.”

For marijuana products:

“GOVERNMENT WARNING: THIS PRODUCT CONTAINS MARIJUANA, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. MARIJUANA PRODUCTS MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. THE INTOXICATING EFFECTS OF MARIJUANA PRODUCTS MAY BE DELAYED UP TO TWO HOURS. MARIJUANA USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF MARIJUANA PRODUCTS IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION.”

• 1. Protection of minors. AUMA also includes provisions to ensure the protection of minors, including prohibiting the sale of marijuana or marijuana products to persons under 21 years of age, prohibit designing marijuana products to be appealing to children or easily confused with commercially sold candy or foods that do not contain marijuana.
     
  2. Journal of the American Medical Association (JAMA) Article. A JAMA Pediatrics article was published in 2016 entitled Unintentional Pediatric Exposures to Marijuana in Colorado, 2009-2015. The authors of this article examined the effect of the legalization of recreational marijuana on unintentional pediatric exposures by evaluating data on hospital admissions at a tertiary children’s hospital and cases at a regional poison center (RPC) between 2009 and 2015. Study participants included children younger than 10 years who were evaluated at the hospital’s emergency department, urgent care centers, or an inpatient unit and RPC cases for marijuana exposure. The authors identified 81 children (62 included in the analysis), evaluated at the hospital and 163 marijuana exposure calls to a Colorado RPC. For 10 exposure scenarios, the product was not in a child-resistant container; for an additional 40 scenarios (34%), poor child supervision or product storage was reported. Edible products were responsible for 51 exposures (52%).
     
  3. Governor’s Budget Trailer Proposal. With the passage of AUMA, many inconsistencies were created between implementation of MCRSA and AUMA. The Governor, through proposed budget trailer bill language (TBL), is recommending several proposals to address the differences between MCRSA and AUMA. Among other provisions, the TBL provides for: i) maintenance of local autonomy of zoning and planning decisions while providing state regulators with local compliance information; ii) adoption of AUMA’s vertical integrated licensing structure for both adult use and medicinal cannabis licensees; iii) maintenance of AUMA’s open distribution model allowing for a business to hold multiple licenses; iv) limitations on the number of Type 3 (medium size) cultivation licenses consistent with MCRSA; v) amendment of AUMA to include the same environmental protection requirements as MCRSA; and, vi) moving licensure of testing laboratories from the DPH to the Bureau. Specifically, this TBL also states that a cannabis product is misbranded if its labeling is false or misleading in any particular, or its labeling or packaging does not conform to specified requirements.
     
  4. Label requirements for beer. Prior to January 1, 2016, beer producers submitted their labels to the Department of Alcoholic Beverage Control (ABC) for approval. With the growth of craft breweries, this practice caused an incredible backlog of label approvals. AB 893 (Stone), Chapter 410, Statutes of 2015, ceased this practice and instead required beer labels to meet federal requirements and required registration of the beer brand with ABC with specified requirements.
     

1. SUPPORT. Supporters such as the County of Los Angeles, Consumer Federation of California, California State PTA, and California Police Chiefs Association state that this bill ensures that packaging for marijuana or marijuana products meet the state’s health and safety regulations, and this bill protects children and youth and prevents accidental marijuana ingestion. The American Federation of State, County and Municipal Employees states in support that this bill strikes an appropriate balance between public health and the needs of the marijuana industry by protecting California’s youth while not infringing upon the success of this emerging sector.
2. DOUBLE REFERRAL. This bill is double referred; it was heard in the Assembly Committee on Business and Professions on April 18, 2017, and passed out on a 11-3 vote.
3. RELATED LEGISLATION.
   1. AB 823 (Chau) requires each single serving of an edible marijuana product to be stamped, marked, or otherwise imprinted directly on the product with a universal symbol, as specified. AB 823 specifies the required size and visibility of the universal symbol. AB 823 is pending in Assembly Health Committee.
      
   2. AB 1606 (Cooper) requires a certified testing service, in addition to tests required under existing law, to determine, using a representative sample, the uniform disbursement of cannabinoids throughout a marijuana product and the accuracy of the labeled dosage. AB 1606 is pending in Assembly Appropriations Committee.
   3. SB 794 (Stern) requires each single serving of an edible marijuana product to be stamped, marked, or otherwise imprinted directly on the product with a universal symbol, as specified. Requires edible marijuana products to be sold in packaging that is tamper-proof, child resistant, and, if the product contains more than one serving, resealable. SB 794 is pending hearing in the Senate Business, Professions and Economic Development Committee.
      

REGISTERED SUPPORT / OPPOSITION:

Support

American Federation of State, County and Municipal Employees (co-sponsor)

Union of American Physicians and Dentists (co-sponsor)

American College of Emergency Physicians, California Chapter

California Police Chiefs Association

California State PTA

Common Sense Kids Action

Community Action, Service & Advocacy

Consumer Federation of California

County of Los Angeles

Gatekeeper Innovation

Nurse-Family Partnership

Saving Lives Camarillo

Smart Approaches to Marijuana

Youth Forward

Opposition

None on file.

Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097

Date of Hearing: April 18, 2017

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Rudy Salas, Chair

ABPCA Bill Id:AB 175

Author:(Chau) – As Introduced Ver:January 17, 2017

NOTE: This bill is double referred, and if passed by this Committee, it will be referred to the Assembly Committee on Health.

SUBJECT: Adult-use marijuana: marketing: packaging and labeling.

SUMMARY: This bill requires manufacturers of edible cannabis products to submit packaging for each product intended for sale in California to the Bureau of Medical Cannabis Regulation (Bureau) within the Department of Consumer Affairs (DCA) for review; and provides a 60 day review period for the Bureau to ensure that packaging meets the standards established in the division for child resistant packaging. This bill requires the Bureau to notify the manufacturer in writing and the manufacturer may pursue a reassessment of the packaging and labeling; any time a manufacturer makes a material change to the packaging or labeling of a product, it must resubmit it to the Bureau for evaluation. to cover the cost of the evaluation, the bill permits the Bureau to charge a fee to manufacturers.

EXISTING LAW:

1. Requires a manufacturer, prior to delivery or sale, to label and place marijuana products in a resealable, child resistant package. Packages and labels shall not be made to be attractive to children and must be labeled clearly as containing a marijuana product. (Business and Professions Code (BPC) Section 26120)
2. All marijuana and products must be labeled and must include the manufacture date and source, the appellation of origin (if any), list of pharmacologically active ingredients, a list of all ingredients and nutritional information, any solvents, nonorganic pesticides, or fertilizers, a warning if allergens are used in manufacturing, and one of the following statements: (BPC Section 26120)
   • For marijuana: GOVERNMENT WARNING: THIS PACKAGE CONTAINS MARIJUANA, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. MARIJUANA MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. MARIJUANA USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF MARIJUANA IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION.”
   • For marijuana products: “GOVERNMENT WARNING: THIS PRODUCT CONTAINS MARIJUANA, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. MARIJUANA PRODUCTS MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. THE INTOXICATING EFFECTS OF MARIJUANA PRODUCTS MAY BE DELAYED UP TO TWO HOURS. MARIJUANA USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF MARIJUANA PRODUCTS IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION.”
3. Requires that marijuana products shall:
   • Not be designed to appeal to children or be easily confused with commercially available candy or foods.
   • Have a standardized dosage up to 10 milligrams tetrahydrocannabinol (THC) per serving.
   • Be scored or easily broken up into standardized serving sizes if the product contains more than one serving and is in solid form.
   • Be homogenized to ensure uniform distribution of cannabinoids throughout the product.
   • Be manufactured and sold in sanitary conditions and provided to customers with sufficient information to enable informed consumption. (BPC Section 26130)
4. Prohibits the sale or transfer of marijuana products to minors and forbids the presence of anyone under the age of 21 on any licensed premises. (BPC Section 26140)

THIS BILL:

1. Requires manufacturers, before introducing an edible marijuana product to market in California, to submit the packaging and labeling to the Bureau to be evaluated for whether the packaging and labeling comply with the requirements set in law.
2. Requires the Bureau to complete its initial determination within 60 days and if there is a delay, must notify the manufacturer at which date the determination is expected to be made. Determinations must be made in writing.
3. Requires that if the Bureau determines that the packaging and labeling are not in compliance, then the manufacturer shall have 60 days to redesign and submit the packaging for reassessment. The Bureau must then make the determination within 30 days and notify the manufacturer in writing.
4. Requires that, if, after resubmission, the Bureau still does not approve the design, the manufacturer may request an administrative hearing within 30 days of the Bureau’s notice.
5. Requires that any time a manufacturer seeks to make a change to the packaging or labeling, the manufacturer must resubmit the packaging and labeling to the Bureau for reassessment.
6. Permits the Bureau may charge a fee to the manufacturer to cover the costs of administering the approval process.

FISCAL EFFECT: Unknown. This bill is keyed fiscal by legislative counsel.

COMMENTS:

Purpose. This bill is sponsored by the National Union of American Physicians and Dentists as well as the American Federation of State, County and Municipal Employees (AFSCME) AFL-CIO. According to the author, “As it pertains to marijuana legalization in California, children must come first. In a recent newspaper article, Colorado Governor John Hickenlooper was adamant that his state “didn’t regulate edibles strongly enough at first.” As a result, Colorado experienced a spike in emergency room visits by children who had consumed marijuana products, and one instance of an underage individual dying after ingesting marijuana. In an attempt to curb the potential for unsafe packaging and marketing of edible marijuana products to children, Washington requires their State Liquor and Cannabis Board to approve the labeling and packaging for all marijuana infused products, prior to offering these items for sale in retail stores. With edibles growing in popularity as an alternative form for consuming marijuana, it is important that we establish a packaging and labeling approval process to ensure that these products are child resistant, and not made in a way that is specifically attractive to children.”

Background. This bill seeks to protect minors from cannabis products by requiring cannabis product manufacturers to submit labeling and packaging for any new cannabis product to the Bureau for evaluation of conformance with statute.

The bill also places strict prohibitions on the collection and use of data from underage users, explicitly stating that personally identifiable information may not be collected in the course of advertising or seeking to advertise marijuana or related products and services.

History of Legal Cannabis in California - In 1996, California voters passed Proposition 215, legalizing the use of medical cannabis (MC) in the state. In October 2015, nearly 20 years after the authorization of the use of MC, Governor Jerry Brown signed into law a trio of bills [AB 243 (Wood), Chapter 688, Statutes of 2015, AB 266 (Bonta, Cooley, Jones-Sawyer, Lackey, and Wood), Chapter 689, Statutes of 2015, and SB 643 (McGuire), Chapter 719, Statutes of 2015] collectively known as the Medical Cannabis Regulation and Safety Act (MCRSA). MCRSA established the state's first regulatory framework for MC. In 2016, the voters of California passed Proposition 64, the Adult Use of Marijuana Act (AUMA), to legalize the recreational use of cannabis in the state by 2018.

As of 2016, 28 states, the District of Columbia, and Guam allow MC programs. Even though California was the first to authorize the medical use of cannabis, it was the only state that allowed cannabis-use without a robust state regulatory framework until passage of MCRSA. States with MC laws generally have a form of patient registry, which may provide some protection against arrest for possession up to a certain amount of cannabis for personal medicinal use. A limited number of states restrict MC usage to products with low to zero THC and high CBD concentrations, in an effort to more strictly limit the use of THC due to its known psychoactive effects. To date, eight states, Alaska, Colorado, Oregon, Washington, California, Nevada, Massachusetts, Maine, and the District of Columbia have legalized recreational cannabis.

The authors of AUMA sought to make use of much of the regulatory structure and authorities set out by MCRSA while making a few notable changes to the structure being implemented. In addition, the AUMA approved by the voters adopted the January 1, 2018 deadline for state implementation of recreational cannabis in addition to the regulations required in MCRSA that are scheduled to take effect on the same date. The same agencies as under MCRSA remain responsible for implementing regulations for adult use.

Under AUMA, the Department of Consumer Affairs (DCA), continues to serve as the lead regulatory agency for all cannabis, both medical and non-medical, and renames the existing Bureau of Medical Cannabis Regulation as the Bureau of Marijuana Control. AUMA includes 19 different license types compared to the 17 in MCRSA and authorizes DCA (and the Bureau) the exclusive authority to create and regulate a license for transportation of cannabis.

While the language of AUMA allows for modifications to the law by majority vote of the legislature, any legislative changes inconsistent with the original intent of the law may require voter approval. If the state and its various agencies of jurisdiction have not finalized regulations, hired staff, and created technology solutions by January 1, 2018, it is unclear how wide-sweeping and detrimental the consequences may be.

Child-Resistant Marijuana Packaging – The regulation of cannabis has been subdivided between three state agencies: 1) the California Department of Food and Agriculture (CDFA) will regulate the cultivation of cannabis, 2) the Department of Public Health (DPH) will regulate cannabis products, including edibles, and 3) the Bureau under the direction of DCA will regulate commerce and handle the largest segment of enforcement. Agencies are in the process of creating regulations in accordance with MCRSA and are expected to release the initial regulations in April of 2017.

Current law requires marijuana products to be labeled and packaged in a resealable, child-resistant package and stipulates that packages and labels shall not be made attractive to children. The law does not state by which standards packaging would be determined to be child resistant or what constitutes labeling that is unattractive to children. There are a number of such vague prescriptions in current law that will be clarified by regulation when it is implemented. Most relevant to this bill will be the regulations issued by DPH regarding edibles and their manufacture and sale. These regulations have been broadly outlined, including the likely restriction on anything other than “shelf-stable” products and an emphasis on preventing the diversion and accidental consumption of cannabis products by minors, however it is not clear how these regulations would tackle the issues raised in this bill.

The cannabis industry, regulators, and lawmakers are concerned about the accidental consumption of cannabis and cannabis products by children. In response to these concerns, the California Cannabis Industry Association (CCIA) released a white paper on October 26, 2016 outlining its position on this issue. Specifically, the paper highlights concerns that child resistant packaging is only intended to prevent access by children five years of age or younger and that child resistant packaging fails to prevent teens from accessing cannabis. This issue is bolstered by data from the Washington Poison Center, which indicates that in 2015 it received 272 calls for exposure to cannabis products, of which, 46 percent, 126 calls, were regarding children. Of those 126 calls, most involved teens, nearly 25 percent of all cannabis related poison center calls statewide. (Washington Poison Center Toxic Trends Report: 2015 Annual Cannabis Report)

Pediatric Cannabis Exposure - In September 2016, the American Medical Association published a study comparing the incidence of exposure to cannabis before and after the legalization of recreational cannabis and found that Colorado saw more cases of unintentional pediatric exposure to cannabis that the rest of the United States. Specifically the study found that the mean rate of exposure increased from 1.2 per 100,000 population two years prior to legalization to 2.3 per 100,000 population two years after legalization. (Wang, Le Lait, Deakyne, et al. “Unintentional Pediatric Exposures to Marijuana in Colorado, 2009-2015” JAMA Pediatrics.) While Colorado’s increase of 34 percent per year of exposure is higher than other states, it is notable that pediatric cannabis exposure is on the rise generally in the United States, increasing 19 percent over the same time period. The study found that when the source of the exposure was known, 48 percent included cannabis edibles and 40 percent of scenarios were attributed to poor-child supervision or product storage. For 9 percent of cases, the product was not in a child resistant container.

Similar Statewide Labeling Approvals – As recently as 2015, beer makers in the state were required to submit labels to the California Department of Alcohol Beverage Control (ABC) in a similar effort to protect the health, safety and welfare of the people of the state. This practice was ceased by the passage of AB 893 (Stone, Chapter 410, Statutes of 2015) as the growth of the craft beer industry had led to a large backlog of label approvals at ABC, creating a bottleneck in the industry that prevented inventory from getting to shelves in a timely fashion and created economic harm to brewers. The bill placed the responsibility for compliance on brewers and granted full authorization to ABC to enforce noncompliance.

Current Related Legislation. AB 350 (Salas) requires that marijuana products shall not be manufactured in the shape of a person, animal, insect, fruit, or any other shape normally associated with candy. STATUS: This bill has been referred to the Assembly Committee on Health

AB 389 (Salas) requires the Bureau to establish and make available a guide for consumers to educate the public on the regulation of medical and nonmedical marijuana. STATUS: This bill has been referred to the Assembly Committee on Business and Professions

AB 64 (Bonta, Cooley, Jones-Sawyer, Lackey, Wood) seeks to reconcile a number of differences between MCRSA and AUMA to provide clarity in regulation and enforcement of both medical and recreational cannabis. STATUS: This bill has been referred to the Assembly Committee on Business and Professions and will be heard on April 18, 2017

Prior Related Legislation. AB 266 (Bonta, Cooley, Jones-Sawyer, Lackey, Wood) part of the legislative package that became known as MCRSA, and required the regulation of medical cannabis products, including edibles.

ARGUMENTS IN SUPPORT:

Union of American Physicians and Dentists “AB 175 is ultimately about keeping California children safe and healthy during their formative years, which we believe to be of utmost importance.”

Community Action Service Advocacy for Safe & Healthy Neighborhoods “[We are] pleased to support AB 175 because it puts child safety first, and aims to make sure that marijuana commercialization is implemented in a safe responsible way.”

Gatekeeper Innovation Inc. “AB 175 is a good step towards putting child safety first, and aims to make sure that marijuana legalization is implemented in a safe and responsible way. We hope that the legislature will continue to push for the safe storage of medical marijuana products, and for those reasons we are pleased to support your bill.”

Saving Lives Camarillo “[We are] pleased to support AB 175 because it puts child safety first, and aims to make sure that marijuana commercialization is implemented in a safe, responsible way.”

Youth Forward “We appreciate your efforts through AB 175 to create a more robust review process of marijuana packaging and labeling to insure that marijuana products are not designed to appeal to kids and are labeled appropriately.”

Nurse Family Partnership “[We are] pleased to support AB 175 because it puts child safety first, and aims to make sure that marijuana legalization is implemented in a safe, responsible way.”

Consumer Federation of California “AB 175 provides important oversight for marijuana-infused edible products and protections against marketing practices that may appeal to children.”

American Federation of State, County, and Municipal Employees (AFSCME), AFL-CIO “California has a responsibility to protect the health and wellbeing of its residents, especially youth. As such, AFSCME strongly urges legislative approval for this measure in order to appropriately address public health concerns.”

California Chapter of the American College of Emergency Physicians “AB 175 is an important injury prevention measure that amends the Control, Regulate, and Tax Adult Use of Marijuana Act (AUMA).”

Common Sense Kids Action “AB 175 puts kids first by ensuring that as California legalizes the adult use of marijuana, children are protected from the potential for unsafe packaging and targeted marketing for edible marijuana products.”

California Police Chiefs Association Inc. “As the Legislature works to develop one system for cannabis regulation, we urge you to monitor any shifts in regulatory jurisdiction to assure that AB 175 works seamlessly with the broader effort to reconcile the Medical Cannabis Regulation and Safety Act and the Adult Use of Marijuana Act.”

National Association of Social Workers “(NASW-CA) supports AB 175 (Chau), which would require manufacturers of adult use marijuana to receive approval from the Bureau of Marijuana Control before releasing edible products, to ensure that the products are in compliance with child safety and marketing provisions specified under Proposition 64.”

California Association of Highway Patrolmen “We thank you for authoring this legislation and we look forward to its successful passage.”

California Children’s Hospital Association “AB 175 will ensure that manufacturers package their edible marijuana-infused products in compliance with these provisions, helping to protect children from inadvertent and potentially toxic exposure.”

California State PTA “California State PTA strongly supports these requirements for the protection of all children and youth and again asks for your aye vote to set strong standards for marijuana edible regulations in advance of the act taking effect on January 1, 2018”

ARGUMENTS IN OPPOSITION:

California Cannabis Industry Association “CCIA fully supports the need to curb the potential for unsafe packaging and marketing of edible cannabis products to children. That is why we have been proactively working with the California Department of Public Health, which is tasked with developing regulations governing cannabis manufacturers and standards for the manufacturing and labeling of all manufactured cannabis products, including edibles.

CCIA’s work also includes the development of a website promoting safe and responsible cannabis use, as well as several white papers on child resistant packing, safe manufacturing practices, and a code of conduct for responsible cannabis advertising and marketing.

Specifically, we must oppose your bill for the following reasons:

● AB 175 is premature. The California Department of Public Health is expected to release its draft regulations later this month. Therefore, it is premature to be imposing additional requirements in advance of those regulations.

● AB 175 will slow down the implementation of the new regulatory system for cannabis. Requiring that the state create a system for approving all packaging on top of the work the licensing entities are already having to do is not practical at this time.

● AB 175 creates possible liability for the state. Requiring that a state regulator be the deciding factor in determining what packaging is attractive to children and what isn't, opens the state up to potential liability.”

POLICY ISSUES FOR CONSIDERATION: The prevention of accidental ingestion of cannabis and cannabis products by not only minors, but any unintentional consumer, is of paramount importance to the Legislature and regulators. However, it is unclear if the provisions contained in this legislation will be effective at doing so. There are a number of packaging solutions that are already available to the industry that may achieve the goal of preventing children from consuming cannabis products. It is unclear if the pending regulations from DPH will be sufficient to prevent accidental consumption. Further, in the 2016 American Medical Association study, only 9 percent of cases of accidental exposure involved cannabis or cannabis products that were not in child-resistant packaging.

Additionally, while the aforementioned report from the Washington Poison Center demonstrates an uptick in cannabis related calls from 2014 to 2015, the vast majority of these cases involved teenage children who would likely not be deterred by child resistant packaging. The most common clinical effects displayed were drowsiness/lethargy and tachycardia. To ensure that diversion and exposure are prevented to populations over the age at which children learn how to operate child resistant packaging, other solutions outside of packaging and labeling should be considered.

It is unclear if the Bureau will be able to recoup its costs through fee collection, most of which would likely be cash since the cannabis industry is largely unbanked. As packaging review program is not currently active, it is difficult to know what the scope of agency involvement would be and how many additional staff would be necessary to implement the bill effectively should it be enacted. Also, since DPH is the regulating agency for the manufacture and regulation of cannabis edibles, it is unclear how much institutional knowledge is present at the Bureau within DCA to carry out this work.

While the emphasis of the state is and should be placed on consumer protection rather than industry convenience, it is unclear whether extended timelines for approval of edible packaging and labeling would lead to diversion of products to the black market or circumvention of the review process all together. The initial time period for review of 60 days, followed by possible extensions of 30 days, an appeal of 60 days, another review period of 30 days, and a potential extension of an additional 30 days for an administrative hearing, could extend the overall process for nearly six months, tying up potential inventory and risking legal action from manufacturers or diversion.

The author should consider working with the Bureau and stakeholders to determine whether further action should be taken to prevent exposure to cannabis products by teens and to evaluate whether the Bureau is equipped and capable of fulfilling its mandate under this legislation.

IMPLEMENTATION ISSUES:

The existing text is that the bill references the division generally, without citing which part of statute must be complied with. This ambiguity may cause confusion for manufacturers and the enforcement staff alike, especially in light of pending regulations. Further, creating additional review processes in addition to the compliance already required in statute may cause a delay in the implementation of regulations. While the timeline in the bill provides accommodations to both the Bureau and industry to accommodate logistical challenges and possible delays, the extended time period could cause temptation for manufacturers or employees to engage in product diversion or could result in economic harm.

REGISTERED SUPPORT:

Union of American Physicians and Dentists

Community Action Service Advocacy for Safe & Healthy Neighborhoods

Saving Lives Camarillo

Gatekeeper Innovation Inc.

Youth Forward

Nurse Family Partnership

Consumer Federation of California

American Federation of State, County, and Municipal Employees (AFSCME), AFL-CIO

California Chapter of the American College of Emergency Physicians

Common Sense Kids Action

California Police Chiefs Association Inc.

National Association of Social Workers

California Association of Highway Patrolmen

California Children’s Hospital Association

California State PTA

REGISTERED OPPOSITION:

California Cannabis Industry Association

Analysis Prepared by: Jimmy Fremgen / B. & P. / 916-319-3301