Existing law provides for the regulation of various chemicals, including chemicals contained in drugs, dietary supplements, and food products.

This bill would prohibit a person or entity an entity, as defined, from manufacturing, distributing, or offering for sale in this state a product that contains tianeptine. tianeptine or that is marketed as containing tianeptine. The bill would make a violation of these provisions punishable by a civil penalty not to exceed $2,500 for a first violation and not to exceed $5,000 for each subsequent violation, upon an action brought by the Attorney General, a city attorney, or a county counsel. The bill would entitle a prevailing plaintiff to an award of reasonable attorneys fees and costs.

Existing law provides for the regulation of various chemicals, including chemicals contained in drugs, dietary supplements, and food products.

This bill would prohibit a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce distributing, or offering for sale in this state a product that contains tianeptine. The bill would make a violation of these provisions punishable by a civil penalty not to exceed $5,000 $2,500 for a first violation and not to exceed $10,000 $5,000 for each subsequent violation, upon an action brought by the Attorney General, a city attorney, a county counsel, or a district attorney. or a county counsel. The bill would entitle a prevailing plaintiff to an award of reasonable attorneys fees and costs.

Existing law, the California Uniform Controlled Substances Act (the act), classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances classified in Schedule V. The act restricts the prescription, furnishing, possession, sale, and use of controlled substances, and makes a violation of those laws a crime, except as specified.

This bill would add the substance tianeptine to Schedule I. By creating a new crime, the bill would establish a state-mandated local program.

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

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

SENATE COMMITTEE ON

Senator Sabrina Cervantes, Chair

2025 - 2026 Regular Session

AB 634 (Jeff Gonzalez) - Tianeptine

Bill Summary:

AB 634 would prohibit an entity from manufacturing, distributing, or offering for sale in this state a product that contains tianeptine or that is marketed as containing tianeptine.

Fiscal Impact:

• The California Department of Justice indicates no significant fiscal impact to the department.
• Unknown, potential workload costs to the courts related to enforcement of civil penalties under the bill (Trial Court Trust Fund, General Fund). While the courts are not funded on a workload basis, an increase in workload could result in delayed court services and would put pressure on the General Fund to increase the amount appropriated for trial court operations.

Background:

According to the National Institute on Drug Abuse (NIDA), tianeptine is an opioid that is not approved by the U.S. Food and Drug Administration (FDA) for any medical use. NIDA-funded research suggests that most people take tianeptine in dietary supplements marketed as cognitive enhancers or nootropics, often sold in convenience stores and online. It may be blended with or taken at the same time as other nootropics (like phenibut and racetams) and is also used with substances such as kratom, kava, and gabapentin. Like other opioids, tianeptine can cause dangerous drops in blood pressure, heart rate, or breathing rate. Research shows that other effects include problems with brain, heart, and digestive function, and that tianeptine can cause symptoms of an opioid use disorder, including tolerance (when one needs to take more of a drug for it to have the same level of effect) and withdrawal, which has been associated with pain and problems with brain, heart, and digestive function. NIDA further states early evidence suggests that tianeptine-related substance use disorder can benefit from medication-assisted treatment.

The FDA has taken steps to protect people from tianeptine products, including warning consumers that tianeptine is an unsafe food additive. In addition, tianeptine is not a dietary ingredient. Further, the FDA has issued warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs, and has also issued import alerts to help detain tianeptine shipments at U.S. borders.

Proposed Law:

Specific provisions of the bill would:

• Prohibit an entity from manufacturing, distributing, or offering for sale in this state a product that contains tianeptine or that is marketed as containing tianeptine.
• Provide that upon an action brought by the Attorney General, a city attorney, or a county counsel, an entity that violates this provision is liable for a civil penalty not to exceed $2,500 for a first violation, and not to exceed $5,000 for each subsequent violation; and provide that a prevailing plaintiff in an action is entitled to an award of reasonable attorney’s fees and costs.

-- END --

SENATE JUDICIARY COMMITTEE

Senator Thomas Umberg, Chair

2025-2026 Regular Session

Bill No: AB 634 (Author:Jeff Gonzalez)

Version: June 8, 2026

Hearing Date: June 23, 2026

Fiscal: Yes

Urgency: No

Consultant: ME

SUBJECT

Tianeptine

DIGEST

This bill prohibits business entities from manufacturing, distributing, or offering for sale products that contain tianeptine. The bill imposes civil penalties on violators and allows public prosecutors to bring actions and recover attorney fees and costs.

EXECUTIVE SUMMARY

Tianeptine is a substance that can cause serious adverse reactions and is included in products sold in California. This bill would ban the manufacture, distribution, or offer for sale of a product that contains tianeptine or that is marketed as containing tianeptine. The bill allows public prosecutors to bring actions for civil penalties against business entities that market or sell tianeptine. The bill specifies that these entities shall not manufacture, distribute, or offer for sale in this state a product that contains tianeptine or that is marketed as containing tianeptine. The civil penalties shall not exceed $2,500 for a first violation and shall not exceed $5,000 for each subsequent violation. The bill specifies that the provisions do not impair or impede any other rights, causes of action, claims, or defenses available under any other law and that the remedies provided in this bill are cumulative with any other remedies available under any other law. The bill entitles a prevailing plaintiff to reasonable attorney’s fees and costs.

The bill is sponsored by the California Narcotic Officers’ Association and is supported by the California Medical Association and other health and safety organizations. The bill is opposed by the Drug Policy Alliance and the American Civil Liberties Union California Action. The bill passed out of the Senate Health Committee on a vote of 11 to 0. Should the bill pass out of this Committee it will then be referred to the Senate Appropriations Committee.

PROPOSED CHANGES TO THE LAW

Existing law provides for the regulation of various products, such as hazardous substances, household substances, items containing lead or mercury, and cosmetics by various entities, including the California Departments of Health Care Services, Public Health, and Toxic Substances Control. (Health & Saf. Code §§ 108040-§109052.)

This bill:

1. Specifies that a sole proprietorship, partnership, limited liability company, corporation, or other business entity shall not manufacture, distribute, or offer for sale in this state a product that contains tianeptine or that is marketed as containing tianeptine.
2. Provides that every product manufactured, distributed, or offered for sale in this state that contains tianeptine or that is marketed as containing tianeptine shall constitute a violation of this section.
3. Allows the Attorney General, a city attorney, or a county counsel to bring an action against an entity that violates the above prohibition.
4. Provides that an entity in violation of the prohibition shall be liable for a civil penalty not to exceed $2,500 for a first violation, and not to exceed $5,000 for each subsequent violation.
5. Provides that the provisions of this bill do not impair or impede any other rights, causes of action, claims, or defenses available under any other law.
6. Provides that the remedies provided in this bill are cumulative with any other remedies available under any other law.
7. Provides that a prevailing plaintiff in an action brought pursuant the provisions of this bill shall be entitled to an award of reasonable attorney’s fees and costs.

COMMENTS

1. Stated need for the bill

According to the author:

AB 634 aims to combat the growing threat posed by Tianeptine, also known as "gas station heroin." This legislation will restrict the commercial manufacturing, selling, and distribution of Tianeptine in California. Tianeptine has been increasingly misused, particularly by individuals seeking an opioid-like effect, despite its unregulated status and the severe risk it poses to the public. The opioid epidemic continues to ravage communities across the nation, and Tianeptine has become a disturbing new threat in this ongoing crisis. This Bill seeks to address this emerging danger and prevent further harm to vulnerable populations, especially those already at risk due to the opioid crisis.

2. Bans the marketing and sale of tianeptine and allows public prosecutors to seek civil penalties and attorney fees for violations

Sponsors of this bill contend that tianeptine is a dangerous substance that can cause serious adverse reactions. This bill is sponsored by the California Narcotic Officers’ Association and would ban the manufacture, distribution, or offer for sale of a product that contains tianeptine or that is marketed as containing tianeptine. Please see the Senate Health Committee analysis of this bill for further details about the regulatory framework and the possible public health dangers of tianeptine.

The bill allows public prosecutors to bring actions for civil penalties against businesses that market or sell tianeptine. The entities subject to this bill’s ban are a sole proprietorship, partnership, limited liability company, corporation, or other business entity. The bill specifies that these entities shall not manufacture, distribute, or offer for sale in this state a product that contains tianeptine or that is marketed as containing tianeptine. The civil penalties shall not exceed $2,500 for a first violation and shall not exceed $5,000 for each subsequent violation. The bill specifies that the provisions do not impair or impede any other rights, causes of action, claims, or defenses available under any other law and that the remedies provided in this bill are cumulative with any other remedies available under any other law. The bill also specifies that a prevailing plaintiff in an action brought pursuant the provisions of this bill shall be entitled to an award of reasonable attorney’s fees and costs. Given the possible danger caused by tianeptine and the lack of a regulatory framework, it is arguably reasonable to prohibit the manufacture, distribution, and offer for sale of products containing the substance and to provide for civil penalties and attorney fees and costs. The bill specifies that only public prosecutors are empowered to bring actions for violations of the prohibition created by this bill. Additionally, the bill’s prohibitions only apply to business entities.

The California Narcotic Officers’ Association write the following in support of the bill:

Tianeptine is a tricyclic antidepressant used in some Latin American, Asian, and European countries but is not FDA approved or regulated for use in the United States. Individuals with an opioid use disorder may be more likely to use tianeptine, as it is inaccurately marketed as a safer alternative to opioids and can have opioid-like effects. The FDA has warned that manufacturers of tianeptine are making inaccurate and unproven claims that use of tianeptine can improve brain function, treat anxiety, depression, pain, opioid use disorder, and other health ailments. Tianeptine inhabits a murky space in U.S. drug regulation. It's illegal to market or sell the drug, but it's also not on the list of federally controlled substances. And while it's in products sold at gas stations and other stores, it's also available to buy online.

Experts warn that it's dangerous to consume any unapproved drug, particularly one that poses the risk of dependency and withdrawal, and that in the case of tianeptine, can cause respiratory depression and severe sedation. Often packaged in colorful, shot-sized bottles, these rogue tianeptine products contain the drug in varying concentrations and have also been found to include dangerous synthetic cannabinoids.

Researchers have learned that tianeptine activates the receptor like other opioids do, like morphine, oxycodone or fentanyl. Repeated use of tianeptine can cause dependence and withdrawal symptoms similar to those of opioid withdrawal, including agitation, nausea, anxiety, diarrhea, and chills. Some cases of withdrawal have been severe, with patients requiring intubation. [ . . . ]

Lack of a federal ban on tianeptine has forced states to act on their own. In 2018, Michigan became the first state to ban sales of the drug, classifying it as a Schedule II controlled substance, the same category as drugs like cocaine and fentanyl. The FDA says at least 12 states have enacted similar bans.

AB 634 seeks to strengthen California's response to the opioid epidemic by closing a dangerous loophole and taking decisive action to safeguard public health and safety. The bill protects Californians from this dangerous substance by prohibiting the manufacturing, distributing, and offering for sale products containing tianeptine.

The Drug Policy Alliance writes the following in opposition to the bill:

We all want safe and healthy communities and share the intent of preventing harms that may result from the use of specific substances. Unfortunately, legislation to sporadically create new punishments or place arbitrary restrictions on specific substances does not accomplish that. California needs to establish a consistent regulatory approach that is centered on ensuring health and safety of consumers and communities. We should evaluate substances of concern with a regulatory process based on studies by relevant scientific, medical, and public health experts, which take into account the potential health and harm-reduction benefits of the substance. Such regulatory processes must also ensure opportunities for meaningful public comment.

Tianeptine is an atypical opioid agonist, which has been shown to induce antidepressant and axiolytic effects, and is prescribed to treat depression and anxiety in a number of countries, including Canada. However, little research has been conducted in the U.S. on the impacts of tianeptine use on health, including its potential association with addiction. Reports suggest that at least some people who use tianeptine do so because they are unable to access appropriate health care: tianeptine use has been reported by people experiencing chronic pain whose opioid prescriptions have been cut off due to DEA prescribing regulations; people looking to curb withdrawal symptoms while tapering off other substances, including illicit opioids; and people with depression or anxiety seeking a low-cost medication. It is possible that if tianeptine were to become entirely unavailable, some people will seek out other substances with different effects and risk profiles, potentially increasing their risk of adverse health consequences, including overdose.

While we appreciate the author’s significant amendments to the original bill, we recommend that the bill be amended to direct the California Health and Human Services Agency and/or the California Department of Public Health to study the dangers and potential value of tianeptine, with input from physicians, scientists, addiction medicine experts, public health professionals, and the public. Given the many complex issues in regulating substances such as this one, it is critical that their perspectives are heard and considered through a regulatory process with a public comment period. We encourage the author and relevant stakeholders to convene a broader dialogue focused on developing a durable, public health-centered framework for evaluating and regulating emerging substances in California.

SUPPORT

California Narcotic Officers’ Association (sponsor)

California Academy of Preventive Medicine

California District Attorneys Association

California Medical Association

California Pharmacists Association

California Society of Addiction Medicine

City of Huntington Beach

Health Officers Association of California

OPPOSITION

American Civil Liberties Union California Action

Drug Policy Alliance

RELATED LEGISLATION

Pending legislation: none known.

Prior legislation: AB 2217 (Weber, 2024) would have prohibited a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce a food product for human consumption that contains tianeptine. A violation of these provisions would have been punishable by a civil penalty not to exceed $5,000 for a first violation and not to exceed $10,000 for each subsequent violation, upon an action brought by the Attorney General, a city attorney, a county counsel, or a district attorney. AB 2217 was held in the Assembly Health Committee.

PRIOR VOTES:

Senate Health Committee (Ayes 11, Noes 0)

Assembly Floor (Ayes 74, Noes 0)

Assembly Appropriations Committee (Ayes 15, Noes 0)

Assembly Judiciary Committee (Ayes 12, Noes 0)

Assembly Health Committee (Ayes 15, Noes 0)

**************

SENATE COMMITTEE ON HEALTH

Senator Akilah Weber Pierson, Chair

BILL NO: AB 634

SUBJECT: Tianeptine

SUMMARY:

Prohibits the manufacturing, distributing, or offering for sale a product that contains tianeptine or that is marketed as containing tianeptine.

Existing law: Provides for the regulation of various products, such as hazardous substances, household substances, items containing lead or mercury, and cosmetics by various entities, including the California Departments of Health Care Services, Public Health (CDPH), and Toxic Substances Control. [HSC §108040-§109052]

This bill:

1. Prohibits an “entity” from manufacturing, distributing, or offering for sale in California a product that contains tianeptine or a product that is marketed as containing tianeptine. Makes every product manufactured, distributed, or offered for sale in California that contains tianeptine or that is marketed as containing tianeptine constitute a violation of this bill. Defines “entity” as a sole proprietorship, partnership, limited liability company, corporation, or other business entity.
2. Requires an entity, upon an action brought by the Attorney General, a city attorney, or a county counsel, that violates the prohibition in this bill to be liable for a civil penalty not to exceed $2,500 for a first violation, and not to exceed $5,000 for each subsequent violation.
3. Specifies that this bill does not impair or impede any other rights, causes of action, claims, or defenses available under any other law. Specifies that the remedies provided in this bill are cumulative with any other remedies available under any other law.
4. Requires a prevailing plaintiff in an action brought pursuant to this bill to be entitled to an award of reasonable attorney’s fees and costs.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, this bill results in possible cost pressures of an unknown but potentially significant amount to the courts in increased workload to adjudicate cases filed as a result of this bill. Although courts are not funded on the basis of workload, increased pressure on the Trial Court Trust Fund may create a demand for increased funding for courts from the General Fund (Trial Court Trust Fund, General Fund). The Department of Justice estimates no significant costs.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, this bill aims to combat the growing threat posed by tianeptine, also known as “gas station heroin.” This legislation will restrict the commercial manufacturing, selling, and distribution of tianeptine in California, which has been increasingly misused, particularly by individuals seeking an opioid-like effect, despite its unregulated status and the severe risk it poses to the public. The opioid epidemic continues to ravage communities across the nation, and tianeptine has become a disturbing new threat in this ongoing crisis. This bill seeks to address this emerging danger and prevent further harm to vulnerable populations, especially those already at risk due to the opioid crisis.
2. Tianeptine. According to the National Institute on Drug Abuse (NIDA), tianeptine is an opioid that is not approved by the U.S. Food and Drug Administration (FDA) for any medical use. NIDA-funded research suggests that most people take tianeptine in dietary supplements marketed as cognitive enhancers or nootropics, often sold in convenience stores and online. It may be blended with or taken at the same time as other nootropics (like phenibut and racetams) and is also used with substances such as kratom, kava, and gabapentin. Like other opioids, tianeptine can cause dangerous drops in blood pressure, heart rate, or breathing rate. Research shows that other effects include problems with brain, heart, and digestive function, and that tianeptine can cause symptoms of an opioid use disorder, including tolerance—when one needs to take more of a drug for it to have the same level of effect—and withdrawal, which has been associated with pain and problems with brain, heart, and digestive function. NIDA further states early evidence suggests that tianeptine-related substance use disorder can benefit from medication-assisted treatment, such as with buprenorphine.
3. FDA warning. According to the FDA website “Tianeptine Products Linked to Serious Harm, Overdoses, Death,” last updated May 2025, people seeking to treat their ailments sometimes mistake a product as being safe because it’s easily available, whether online or even at gas stations. But availability is no indication of effectiveness or safety. This is especially true of tianeptine products, which have been associated with serious health risks and even death. Despite not being approved by the FDA for any reason, some companies are distributing and selling unlawful products containing tianeptine to consumers, including products with high doses. They are also making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions. Although the FDA has warned consumers about tianeptine, vendors continue to market and sell tianeptine for medical uses. The FDA is aware that tianeptine has been sold online—in pill, liquid, and powder forms. Although other countries have approved tianeptine to treat depression and anxiety, some have restricted how tianeptine is prescribed or dispensed, or warned of possible addiction. In the U.S., reports of bad reactions and unwanted effects involving tianeptine are increasing. Annual poison control center cases involving exposure, as reported by the National Poison Data System, have increased nationwide, from four cases in 2013 to about 350 cases in 2024. The FDA has taken steps to protect people from tianeptine products, including warning consumers that tianeptine is an unsafe food additive. In addition, tianeptine is not a dietary ingredient. Further, the FDA has issued warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs, and have also issued import alerts to help detain tianeptine shipments at U.S. borders.
4. Double referral. This bill is double referred. Should it pass out of this Committee, it will be referred to the Senate Committee on Judiciary.
5. Related legislation. AB 1088 (Bains) adds kratom products to the Sherman Food, Drug, and Cosmetic Law. Requires kratom processors to register themselves and their products annually with CDPH and requires laboratory certificates of analysis for all products. Places limits of 75mg mitragynine and 0.57mg of 7-hydroxymitragynine per package and establishes poison prevention packaging and labeling requirements. Prohibits the sale or distribution of kratom products to anyone under 21 years of age at a premise or internet website or application that permits anyone under 21 to enter and remain or complete a purchase of any product. Prohibits the sale or distribution of a kratom product that has a child-attractive flavor. Establishes a 15% retail tax on kratom products purchased for use in the state to fund the Kratom Products Public Health and Safety Fund. AB 1088 is set for hearing on June 17, 2026, in this Committee.
6. Prior legislation. AB 2217 (Weber of 2024) would have prohibited a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce a food product for human consumption that contains tianeptine. AB 2217 would have made a violation of these provisions punishable by a civil penalty not to exceed $5,000 for a first violation and not to exceed $10,000 for each subsequent violation, upon an action brought by the Attorney General, a city attorney, a county counsel, or a district attorney. AB 2217 was not heard in the Assembly Health Committee.

AB 2365 (Haney of 2024) would have enacted the Kratom Consumer Protection Program to provide a regulatory structure for kratom products that would have required manufacturers and distributors to register with CDPH, adhere to certain requirements that include having products tested, and prohibit the sale to persons under 21. AB 2365 was held on the Senate Appropriations Committee suspense file.

1. Support. The California Narcotic Officers’ Association, as sponsor, and other supporters, largely law enforcement groups, state that tianeptine is a tricyclic antidepressant used in some Latin American, Asian, and European countries but is not FDA approved or regulated for use in the United States. Individuals with an opioid use disorder may be more likely to use tianeptine, as it is inaccurately marketed as a safer alternative to opioids and can have opioid-like effects. The FDA has warned that manufacturers of tianeptine are making inaccurate and unproven claims that use of tianeptine can improve brain function, treat anxiety, depression, pain, opioid use disorder, and other health ailments. Tianeptine inhabits a murky space in U.S. drug regulation. It is illegal to market or sell the drug, but it is also not on the list of federally controlled substances. And while it is in products sold at gas stations and other stores, it is also available to buy online. Experts warn that it is dangerous to consume any unapproved drug, particularly one that poses the risk of dependency and withdrawal, and that in the case of tianeptine, can cause respiratory depression and severe sedation. Often packaged in colorful, shot-sized bottles, these rogue tianeptine products contain the drug in varying concentrations and have also been found to include dangerous synthetic cannabinoids. Supporters also argue the lack of a federal ban on tianeptine has forced states to act on their own. In 2018, Michigan became the first state to ban sales of the drug, classifying it as a Schedule II controlled substance, the same category as drugs like cocaine and fentanyl. The FDA says at least 12 states have enacted similar bans and prohibit retailers from shipping to those states.
2. Opposition. The Drug Policy Alliance (DPA) opposes this bill because it establishes new penalties in the absence of any scientific and administrative process for evaluating any potential uses, benefits, risks, and side effects of the substance. DPA advocates for approaches to drugs that prioritize health, equity, social supports, and community wellbeing. Rather than punitive responses to drug use, the state should invest in evidence-based and health-centered interventions for people who use drugs, their families, and their communities. DPA further argues that legislation to sporadically create new punishments or place arbitrary restrictions on specific substances does not accomplish preventing harms that may result from the use of specific substances. California needs to establish a consistent regulatory approach that is centered on ensuring health and safety of consumers and communities. DPA states that we should evaluate substances of concern with a regulatory process based on studies by relevant scientific, medical, and public health experts, which take into account the potential health and harm-reduction benefits of the substance. Such regulatory processes must also ensure opportunities for meaningful public comment. DPA recommends the bill be amended to direct the California Health and Human Services Agency and/or CDPH to study the dangers and potential value of tianeptine, with input from physicians, scientists, addiction medicine experts, public health professionals, and the public. Given the many complex issues in regulating substances such as this one, it is critical that various perspectives be heard and considered through a regulatory process with a public comment period.

SUPPORT AND OPPOSITION:

Support: California Narcotic Officers’ Association (sponsor)

Arcadia Police Officers' Association
Brea Police Association
Burbank Police Officers’ Association

California Academy of Preventive Medicine
California Association of School Police Chiefs
California Coalition of School Safety Professionals
California District Attorneys Association

California Medical Association

California Pharmacists Association
California Reserve Peace Officers Association

California Society of Addiction Medicine
California State Sheriffs’ Association

City of Huntington Beach
Claremont Police Officers Association
Corona Police Officers Association
Culver City Police Officers’ Association
Fullerton Police Officers’ Association
Health Officers Association of California
Los Angeles School Police Management Association
Los Angeles School Police Officers Association
Murrieta Police Officers’ Association
Newport Beach Police Association
Palos Verdes Police Officers Association
Placer County Deputy Sheriffs’ Association
Pomona Police Officers’ Association
Riverside Police Officers Association
Riverside Sheriffs’ Association

Oppose: Drug Policy Alliance

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 634

Author:(Jeff Gonzalez)

As Amended Ver:January 16, 2026

Majority vote

SUMMARY

Prohibits the manufacture, distribution, and offer for sale of tianeptine.

Major Provisions

1. Prohibits a person or entity from manufacturing, distributing, or offering for sale in this state a product that contains tianeptine.
2. Authorizes the Attorney General, a city attorney, or a county counsel to bring a civil action to seek civil penalties against a party that violates the provisions in 1).
3. Provides that a party found liable for a violation of 1) is liable for a civil penalty not to exceed $2,500 for the first violation and not to exceed $5,000 for each subsequent violation.
4. Provides this bill does not impair or impede any other rights, causes of action, claims, or defenses available under any other law.
5. Provides that remedies provided by this bill are cumulative with any other remedies available under any other law.
6. Entitles a prevailing plaintiff in an action brought pursuant to 2) above to an award of reasonable attorney's fees and costs.

COMMENTS

What is tianeptine? Tianeptine is an antidepressant drug approved for the treatment of major depressive disorder in various countries within Europe, Asia, and Latin America. It is not approved for any use in the United States (U.S.) by the U.S. Food and Drug Administration (FDA).

According to a 2023 article published in Pain and Therapy titled "Tianeptine, an Antidepressant with Opioid Agonist Effects: Pharmacology and Abuse Potential, a Narrative Review," tianeptine is an opioid receptor agonist. Tianeptine's opioid-like actions can induce euphoric effects.

Legal status of tianeptine. Tianeptine, also known as "gas station heroin," is not approved by the FDA for medical use. Pursuant to existing federal law, tianeptine is considered an unsafe food additive, making its sale illegal in the U.S. The FDA has taken actions on tianeptine including: issuing multiple consumer advisories and warnings about products with tianeptine as being linked to serious harm, overdose, and death; issuing warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs; and, issuing import alerts to help detain tianeptine shipments at U.S. borders.

Despite this, tianeptine continues to be sold in convenience stores and gas stations in both powder and pill form claiming to treat conditions such as anxiety, depression, pain, and to enhance the users' mood and cognitive function. Tianeptine can be obtained online from independent vendors without a prescription.

In California, The Sherman Food, Drug, and Cosmetic Law (Sherman Law) gives the state Department of Public Health (DPH) the broad regulatory authority to oversee food, drug, and medical device safety and makes violators subject to penalties. The Food and Drug Branch (FDB) of DPH is responsible for complaints regarding commercially processed foods, drugs, medical devices, cosmetics, and certain consumer products affecting Californians. The FDB investigates complaints about products like tianeptine and shares findings with relevant authorities, including local health jurisdictions.

Impacts of tianeptine. According to the FDA, reports of severe side effects involving tianeptine are increasing. Poison control center cases involving tianeptine exposure have increased nationwide, from 11 total cases between 2000 and 2013 to 151 cases in 2020 alone.

The FDA has identified cases in which people experienced other serious harmful effects from abusing or misusing tianeptine by itself or with other drugs, including antidepressants and antianxiety medicines. These effects included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma, and death.

How would this bill change how tianeptine is regulated? It is already illegal to market and sell tianeptine in California, and DPH already has authority to address the illegal sale of tianeptine under the Sherman Law. This bill expressly prohibits the manufacture, distribution, and offer for sale of tianeptine in this state and creates an additional civil penalty structure upon action by the Attorney General, city attorney, or county counsel.

Please see the Assembly Health Committee analysis for additional background.

According to the Author

This bill aims to combat the growing threat posed by tianeptine. The author states that this bill will restrict the commercial manufacturing, selling, delivering, distributing, and holding of tianeptine in California. The author continues that tianeptine has been increasingly misused, particularly by individuals seeking an opioid-like effect, despite its unregulated status and the severe risks it poses to the public. The author contends that the opioid epidemic continues to ravage communities across the nation, and tianeptine has become a disturbing new threat in this ongoing crisis. The author concludes that this bill will strengthen California's response to the opioid epidemic by closing a dangerous loophole and taking decisive action to safeguard public health and safety.

Arguments in Support

This bill is sponsored by the California Narcotic Officers' Association (CNOA), who writes in support, tianeptine inhabits a murky space in U.S. drug regulation. CNOA states that it is illegal to market or sell the drug, but it is also not on the list of federally controlled substances. CNOA continues that while tianeptine is in products sold at gas stations and other stores, it is also available to buy online. CNOA continues that from a law-enforcement and public-safety perspective, tianeptine presents several acute concerns. First, CNOA flags high abuse and addiction potential. CNOA notes that tianeptine acts on opioid receptors and produces opioid-like effects, including euphoria, dependence, and severe withdrawal symptoms. CNOA continues that emergency departments across the country have reported increasing numbers of tianeptine-related overdoses, poisonings, and hospitalizations. Second, CNOA highlights deceptive marketing and easy access. CNOA asserts that products containing tianeptine are often labeled as supplements, energy boosters, or mood enhancers, creating a false perception of safety and enabling access by minors and vulnerable populations. Third, CNOA flags strain on first responders and emergency services. CNOA notes that law-enforcement officers, firefighters, and Emergency Medical Services personnel are increasingly encountering individuals suffering from tianeptine intoxication, withdrawal, or polysubstance abuse, diverting critical resources from other public-safety priorities. Fourth, CNOA contends there is a regulatory gap under current law and absent clear scheduling, enforcement agencies face challenges in removing these dangerous substances from circulation or holding distributors accountable.

Arguments in Opposition

None.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, possible cost pressures of an unknown but potentially significant amount to the courts in increased workload to adjudicate cases filed as a result of this bill. Although courts are not funded on the basis of workload, increased pressure on the Trial Court Trust Fund may create a demand for increased funding for courts from the General Fund (Trial Court Trust Fund, General Fund). The Department of Justice estimates no significant costs.

VOTES

ASM HEALTH: 15-0-1

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

ABS, ABST OR NV: Celeste Rodriguez

ASM JUDICIARY: 12-0-0

YES: Kalra, Dixon, Bauer-Kahan, Bryan, Connolly, Harabedian, Macedo, Pacheco, Papan, Johnson, Stefani, Zbur

ASM APPROPRIATIONS: 15-0-0

YES: Wicks, Hoover, Stefani, Calderon, Caloza, Dixon, Fong, Mark González, Krell, Bauer-Kahan, Pacheco, Pellerin, Solache, Ta, Tangipa

UPDATED

VERSION: January 16, 2026

CONSULTANT: Eliza Brooks / HEALTH / (916) 319-2097 FN: 0002244

Date of Hearing: January 22, 2026

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Buffy Wicks, Chair

ABPCA Bill Id:AB 634

Author:(Jeff Gonzalez) – As Amended Ver:January 16, 2026

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

SUMMARY:

This bill prohibits the manufacture, distribution, or offering for sale of a product containing tianeptine.

Specifically, this bill:

1. Prohibits a person or entity from manufacturing, distributing, or offering for sale in this state a product that contains tianeptine.
   
2. Provides that every product containing tianeptine manufactured, distributed, or offered for sale constitutes a violation.
   
3. Authorizes the Attorney General (AG), a city attorney, or a county counsel to bring a civil action to seek civil penalties for a violation of item 1, above.
   
4. Provides that a party found liable for a violation of item 1, above, is liable for a civil penalty of $2,500 for a first violation and $5,000 for subsequent violations.
   
5. Authorizes a plaintiff that prevails in an action brought pursuant to item 3, above, to recover reasonable attorney’s fees and costs.
   

FISCAL EFFECT:

1. Possible cost pressures of an unknown but potentially significant amount to the courts in increased workload to adjudicate cases filed as a result of this bill. Although courts are not funded on the basis of workload, increased pressure on the Trial Court Trust Fund may create a demand for increased funding for courts from the General Fund (Trial Court Trust Fund, General Fund).
2. The Department of Justice estimates no significant costs.

COMMENTS:

1. Purpose. This bill is sponsored by the California Narcotic Officers’ Association. According to the author:

[This bill] aims to combat the growing threat posed by Tianeptine, also known as "gas station heroin."…Tianeptine has been increasingly misused, particularly by individuals seeking an opioid-like effect, despite its unregulated status and the severe risks it poses to the public. The opioid epidemic continues to ravage communities across the nation, and Tianeptine has become a disturbing new threat in this ongoing crisis. This bill seeks to address this emerging danger and prevent further harm to vulnerable populations, especially those already at risk due to the opioid crisis… With AB 641, California will strengthen its response to the opioid epidemic by closing a dangerous loophole and taking decisive action to safeguard public health and safety.

1. Background. Tianeptine is an antidepressant drug approved for the treatment of major depressive disorder in some countries in Europe, Asia, and Latin America, but is not approved by the federal Food and Drug Administration (FDA) for any use in the U.S. According to a 2023 review article in Pain and Therapy, tianeptine is a full opioid receptor agonist, producing a euphoric high, and carrying a significant risk of overdose. High levels of tianeptine can lead to serious side effects, including sedation, slowed breathing, agitation, irregular heartbeat, and coma or death. Further, tianeptine’s short half-life can lead to rapid withdrawal and increases the drug’s potential for addiction.

Under federal law, tianeptine is considered an unsafe food additive. FDA has issued multiple consumer advisories and warnings about products with tianeptine as being linked to serious harm, overdose, and death. FDA has also issued warnings to companies distributing and selling tianeptine products as dietary supplements and unapproved drugs, and issued import alerts to detain tianeptine shipments at borders. Despite these efforts, tianeptine is sold in convenience stores, gas stations, and online.

According to information provided by the author, 13 states restrict access to tianeptine. In California, the Sherman Law gives the California Department of Public Health (CDPH) authority to enforce food safety requirements. Thus, CDPH already has the authority to address the illegal sale of tianeptine, and may investigate complaints about tianeptine and share findings with relevant authorities, including local health jurisdictions. Local environmental health agencies may request stores voluntarily remove products containing tianeptine and may impound such products. This bill expressly prohibits the manufacture, distribution, or offering for sale of tianeptine in commerce and creates an additional civil penalty structure.

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

Date of Hearing: January 15, 2026

ASSEMBLY COMMITTEE ON JUDICIARY

Ash Kalra, Chair

ABPCA Bill Id:AB 634

Author:(Jeff Gonzalez) – As Amended Ver:January 5, 2026

As Proposed to be Amended

SUBJECT: Tianeptine

KEY ISSUE: should the manufacturing, distribution, and saleS of tianeptine be prohibited in California?

SYNOPSIS

While unknown to many Californians, the drug tianeptine is an atypical tricyclic antidepressant that is authorized in some European and Asian counties to treat depression, anxiety, and irritable bowel syndrome. However, existing federal law in the United States neither approves nor disapproves of the drug, resulting in tianeptine existing in a legal grey area. As a result of the legal ambiguity surrounding the drug, some parties sell pills containing tianeptine in convenience stores and gas stations. When taken at high doses, like those provided in the over-the-counter sales in this country, the drug provides less of an antidepressive effect and instead produces a high similar to that of heroin. Given that roadside stores are the most frequent seller of the drug, tianeptine is commonly referred to as “gas station heroin” and unfortunately produces similar addictive effects.

Given the dangers of tianeptine, this bill prohibits its manufacturing, distribution, or sales in this state. The bill imposes civil penalties for violating the prohibition and authorizes civil law enforcement to seek these civil penalties. Proposed amendments narrow the scope of the prohibition in order to avoid implicating low-level gas station employees who have no authority over what is sold in convenience stores. Amendments also provide for civil cost recovery to promote enforcement, and make a minor clarifying change to avoid a potential dormant commerce clause violation.

This measure is sponsored by the California Narcotics Officers’ Association who highlight the extreme dangers posed by tianeptine and the shortcomings of the existing enforcement system. Although prior versions of this measure were opposed by criminal justice reform groups, the current iteration of the bill utilizing civil enforcement has no registered opposition. This bill will be heard in the Health Committee prior to this hearing.

SUMMARY: Prohibits the manufacturing, distribution, or sales of tianeptine in California. Specifically, this bill:

1. Prohibits a person or entity from manufacturing, distributing, or offering for sale in this state a product that contains tianeptine.
2. Authorizes the Attorney General, a city attorney or a county counsel to bring a civil action to seek civil penalties against a party that violated 1).
3. Provides that a party found liable for a violation of 1) is liable for a civil penalty of $2,500 for a first offense and $5,000 for subsequent violations.
4. Authorizes a plaintiff that prevails in an action brought pursuant to 2) to recover reasonable attorney’s fees and costs.
5. Clarifies that nothing in the bill impairs or impedes any other rights, causes of action, claims, or defenses available under any other law, and that the remedies provided in this bill are cumulative with any other remedies available under any other law.

EXISTING LAW:

1. Establishes the Sherman Food, Drug, and Cosmetic Law, to be administered by the Department of Public Health, to enforce food and drug safety regulations. (Health and Safety Code Section 109875 et seq.)
2. Imposes a criminal fine of $1,000 and a term of imprisonment of not more than one year in county jail for a first violation of the Sherman Food, Drug, and Cosmetic Law. (Health and Safety Code Section 111825(a).)
3. Provides that if a violation of the Sherman Food, Drug, and Cosmetic Law involves the removal, sales or disposal of an embargoed food, drug, device, or cosmetic without the permission of an authorized agent of the Department of Public Health or an applicable superior court, if convicted, the criminal fine is authorized to reach up to $10,000 in addition to the jail time specified in 2). (Health and Safety Code Section 111825(b).)
4. Authorizes the Attorney General, any district attorney, or any city attorney to bring an action pursuant to 2) or 3). (Health and Safety Code Section 111840.)

FISCAL EFFECT: As currently in print this bill is keyed fiscal.

COMMENTS: Tianeptine is an atypical tricyclic antidepressant that is authorized in some European counties to treat depression, anxiety, and irritable bowel syndrome. Due to the drugs atypical nature, it is only approved internationally at low doses and under medical supervision. The drug has never been approved by the United States Food and Drug Administration for use in this country, however, the drug has also never been labeled as a controlled substance by the federal government. Although the Food and Drug Administration has issued numerous warnings about the drug, due to the legally ambiguous federal standards, some companies continue to sell the product. As a result of the lack of clear regulations surrounding the sale and use of tianeptine consumers are exposed to significant medical risks.

Following the lead of several other states, this bill would prohibit a person from manufacturing, distributing, or offering tianeptine for sale in California. In support of this measure the author states:

AB 634 aims to combat the growing threat posed by Tianeptine, also known as "gas station heroin." This legislation will restrict the commercial manufacturing, selling, delivering, distributing, and holding of Tianeptine in California. Tianeptine has been increasingly misused, particularly by individuals seeking an opioid-like effect, despite its unregulated status and the severe risks it poses to the public. The opioid epidemic continues to ravage communities across the nation, and Tianeptine has become a disturbing new threat in this ongoing crisis. This Bill seeks to address this emerging danger and prevent further harm to vulnerable populations, especially those already at risk due to the opioid crisis. With AB 634, California will strengthen its response to the opioid epidemic by closing a dangerous loophole and taking decisive action to safeguard public health and safety.

What is tianeptine. As noted, tianeptine is an atypical tricyclic antidepressant that is authorized in some European and Asian counties to treat depression, anxiety, and irritable bowel syndrome. According to researchers at Virginia Commonwealth University, tianeptine leads to an uptick in serotonin levels in the brain, thus causing users to feel a sense of euphoria. While such euphoria may be great for those suffering from depression, when the drug is consumed at higher dosage levels that euphoria turns into a high more analogous to taking heroin than to an antidepressant. (Mia Stephens, What you need to know about ‘gas station heroin’, VCU Health News (July 8, 2025) available at: https://www.vcuhealth.org/news/what-you-need-to-know-about-gas-station-heroin/.) Unfortunately, because the product is largely unregulated in this country, it is included in pills frequently sold over the counter at places like gas stations and convenience stores, leading to the drug’s street moniker of “gas station heroin.” (Id.)

Unfortunately, much like heroin, high levels of tianeptine consumption can lead to serious side effects including sedation, slowed breathing, agitation, irregular heartbeat, and in some cases coma or death. Even more troubling, the United States Food and Drug Administration notes tianeptine has similar addictive characteristics to heroin and can produce opioid-like withdrawals. (Tianeptine Products Linked to Serious Harm, Overdoses, Death, United States Food and Drug Administration, available at: https://www.fda.gov/consumers/consumer-updates/tianeptine-products-linked-serious-harm-overdoses-death.)

Tianeptine remains largely unregulated in the United States. Because tianeptine is not listed on the federal schedule of controlled substances and yet is also not approved by the United States Food and Drug Administration, national regulation of the drug is spotty at best. According to the author at least a dozen individual states have moved to regulate or prohibit tianeptine. In California, the drug is regulated under the Sherman Food, Drug, and Cosmetic Law. However, it is not clear that the California Department of Public Health is actively enforcing prohibitions against the drug’s sale or use in California and there does not appear to be any meaningful statutory prohibition or regulation of the drug in this state.

This bill recognizes the dangers that tianeptine presents to the general public, and thus prohibits the drug’s manufacturing, distribution, or sale in this state. Seeking to avoid returning to the bygone era of simply criminalizing all drugs, this bill aims to impose civil penalties on those found to have violated the above prohibitions. The bill imposes civil penalties of $2,500 for a first violation and $5,000 for subsequent violations. As proposed to be amended, given that the bill imposes civil penalties, the bill vests enforcement in the state’s civil law prosecutors; specifically, the Attorney General, city attorneys and county counsels. As is standard for civil penalty measures passed by this Committee, the bill authorizes fee and cost recovery for prevailing plaintiffs. Finally, the measure adopts a savings clause to ensure that it does not limit any other existing tools, including enforcement under the Sherman Food, Drug, and Cosmetic Law, should the bill be enacted.

Proposed amendments eliminate a dormant commerce clause conflict and narrow the scope of the bill to avoid unintended consequences. This bill was recently amended to remove it from criminal enforcement and vest enforcement with civil authorities. However, those amendments still structure the measure in a manner far more analogous to a Penal Code criminal statute than a civil penalty regime. For example, the bill did not define a violation, which is necessary for determining penalty levels in civil statutes, but not charging counts in criminal law. Furthermore, the bill retained district attorney enforcement which, in keeping with this Committee’s pattern and practice, is not appropriate for civil enforcement. Furthermore, Section 111840 of the Health and Safety Code already provides district attorneys with enforcement authority under the Sherman Food, Drug, and Cosmetic Law. Finally, the bill in print lacks cost recovery provisions, undermining the likelihood it would be used to robustly enforce the new prohibition on tianeptine. Accordingly, as a result of discussions with the author as well as the Committee on Health, the author is proposing the following amendments to better align the bill with existing civil penalty statutes. The bill will now read:

109024. (a) (1) A person or entity shall not manufacture, sell, deliver, distribute, hold, or offer for sale, in this state in commerce a product that contains tianeptine.

(2) Every product manufactured, distributed, or offered for sale in this state shall constitute a violation of this section.

(b) (1) Upon an action brought by the Attorney General, a city attorney, or a county counsel, or a district attorney, a person or entity that violates subdivision (a) shall be liable for a civil penalty not to exceed two thousand five hundred dollars($2,500) five thousand dollars ($5,000) for a first violation, and not to exceed five thousand dollars ($5,000) ten thousand dollars ($10,000) for each subsequent violation.

(2) This section does not impair or impede any other rights, causes of action, claims, or defenses available under any other law. The remedies provided in this section are cumulative with any other remedies available under any other law.

(c) A prevailing plaintiff in an action brought pursuant to (b) shall be entitled to an award of reasonable attorney’s fees and costs.

Finally, the amendment in subdivision (a) changing the term “in commerce” to “in this state” is designed to avoid an inadvertent dormant commerce clause violation, as California cannot legally prohibit a product from being manufactured in another jurisdiction.

Ongoing discussions will likely further refine this bill. The author concedes, especially in light of the recent reframing of the enforcement of this bill, that the measure remains a work in progress. Although the amendments to subdivision (a), highlighted above, narrow the scope of potential violations and thus dramatically lessen the risk of an overbroad enforcement of this measure, the author is pledging to this Committee (and the Health Committee) to refine the language to ensure that low-level sales employees are not inadvertently targeted by this bill. While the amendments that limit violations to those primarily committed by ownership or management level positions, thus protecting a clerk who does not decide what is offered for sale in a store, significantly narrow the bill, a more explicit safe harbor may be needed for these frontline staff. Accordingly, the author pledges to continue to work with stakeholders to ensure only those with command-and-control decisions related to tianeptine are exposed to liability. This Committee will continue to monitor these discussions, but given the serious dangers posed by tianeptine, this measure is an important step to protecting California consumers.

ARGUMENTS IN SUPPORT: This bill is sponsored by the California Narcotic Officers’ Association. In support of the bill the Narcotic Officers write:

Tianeptine is a tricyclic antidepressant used in some Latin American, Asian, and European countries but is not FDA approved or regulated for use in the United States. Individuals with an opioid use disorder may be more likely to use tianeptine, as it is inaccurately marketed as a safer alternative to opioids and can have opioid-like effects. The FDA has warned that manufacturers of tianeptine are making inaccurate and unproven claims that use of tianeptine can improve brain function, treat anxiety, depression, pain, opioid use disorder, and other health ailments.

Experts warn that it's dangerous to consume any unapproved drug, particularly one that poses the risk of dependency and withdrawal, and that in the case of tianeptine, can cause respiratory depression and severe sedation. Often packaged in colorful, shot-sized bottles, these rogue tianeptine products contain the drug in varying concentrations and have also been found to include dangerous synthetic cannabinoids.

The lack of a federal ban on tianeptine has meant states have been acting on their own. In 2018, Michigan became the first state to ban sales of the drug, classifying it as a Schedule II controlled substance, the same category as drugs like cocaine and fentanyl. The FDA says at least 12 states have enacted similar bans and prohibits retailers from shipping to those states.

AB 634 addresses these concerns by clarifying in statute that tianeptine is illegal to be sold or distributed in California.

REGISTERED SUPPORT / OPPOSITION:

Support

California Narcotics Officers’ Association

Opposition

None on file

Analysis Prepared by: Nicholas Liedtke / JUD. / (916) 319-2334

Date of Hearing: January 13, 2026

ASSEMBLY COMMITTEE ON HEALTH

Mia Bonta, Chair

ABPCA Bill Id:AB 634

Author:(Jeff Gonzalez) – As Amended Ver:January 5, 2026

SUBJECT: Tianeptine.

SUMMARY: Prohibits the sale of tianeptine. Specifically, this bill:

1. Prohibits a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale in commerce a product that contains tianeptine.
2. Makes a person or entity that violates 1) liable for a civil penalty not to exceed $5,000 for the first violation and not to exceed $10,000, upon an action brought by the Attorney General, city attorney, county counsel, or district attorney.
3. Provides this bill does not impair or impede any other rights, causes of action, claims, or defenses available under any other law.
4. Provides that remedies provided by this bill are cumulative with any other remedies available under any other law.

EXISTING FEDERAL LAW:

1. Establishes the Federal Food, Drug and Cosmetic Act (FDCA) which among various provisions, gives the United States (U.S.) Food and Drug Administration (FDA) authority to oversee the safety of food, drugs, medical devices, and cosmetics. [21 United States Code (U.S.C.) § 301, et seq.]
2. Defines a "food additive" as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized as safe under the conditions of its intended use, as specified. [21 U.S.C. § 321]
3. Provides that a substance added to food is unsafe unless the substance conforms to the terms of an exemption for investigational use, or unless the substance is in conformance with a regulation describing the conditions under which the substance may be safely used. [21 U.S.C. § 348]
4. Deems a food adulterated if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe, as specified. [21 U.S.C. § 342]

EXISTING STATE LAW:

1. Enacts the Sherman Food, Drug, and Cosmetic (Sherman) Law, enforced by the State Department of Public Health (DPH), which provides broad authority for DPH to enforce food safety requirements. [Health and Safety Code (HSC) § 109875, et seq.]
2. Establishes penalties for violations of the Sherman Law, including a fine of up to $1,000, or up to $10,000 for repeated violations. [HSC § 111825]

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

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill aims to combat the growing threat posed by tianeptine, also known as "gas station heroin." The author states that this bill will restrict the commercial manufacturing, selling, delivering, distributing, and holding of tianeptine in California. The author continues that tianeptine has been increasingly misused, particularly by individuals seeking an opioid-like effect, despite its unregulated status and the severe risks it poses to the public. The author contends that the opioid epidemic continues to ravage communities across the nation, and tianeptine has become a disturbing new threat in this ongoing crisis. The author asserts that this bill seeks to address this emerging danger and prevent further harm to vulnerable populations, especially those already at risk due to the opioid crisis. The author concludes that this bill will strengthen California’s response to the opioid epidemic by closing a dangerous loophole and taking decisive action to safeguard public health and safety.
2. BACKGROUND.
   1. What is tianeptine? Tianeptine is an antidepressant drug approved for the treatment of major depressive disorder in various countries within Europe, Asia, and Latin America. It is not approved for any use in the United States (U.S.) by the FDA.

According to a 2023 article published in Pain and Therapy titled “Tianeptine, an Antidepressant with Opioid Agonist Effects: Pharmacology and Abuse Potential, a Narrative Review,” tianeptine is an opioid receptor agonist. Tianeptine’s opioid-like actions can induce euphoric effects.

• 1. Legal status of tianeptine. Tianeptine, also known as “gas station heroin,” is not approved by the FDA for medical use. Pursuant to existing federal law above, tianeptine is considered an unsafe food additive, making its sale illegal in the U.S. As part of its post-market surveillance of food ingredients, the FDA developed an inventory of certain food ingredients deemed unsafe because they are unapproved food additives that are not generally recognized as safe when used as intended. The FDA released this inventory to the public on July 12, 2023. Tianeptine is included in this inventory. The FDA has taken actions on tianeptine including: issuing multiple consumer advisories and warnings about products with tianeptine as being linked to serious harm, overdose, and death; issuing warning letters to companies distributing and selling unlawful tianeptine products as dietary supplements and unapproved drugs; and, issuing import alerts to help detain tianeptine shipments at U.S. borders.

Despite this, tianeptine continues to be sold in convenience stores and gas stations in both powder and pill form claiming to treat conditions such as anxiety, depression, pain, and enhance the users’ mood and cognitive function. Tianeptine can be obtained online from independent vendors without a prescription. According to a National Public Radio article titled, “8 things to know about the drug known as ‘gas station heroin’,” these products are often packaged in colorful, shot-sized bottles, containing tianeptine in varying concentrations and have also been found to include dangerous synthetic cannabinoids.

A March 2024 publication by the North Carolina General Assembly titled “Regulation of Tianeptine – State by State Overview” shows that at least 13 states regulate tianeptine. Seven states have listed it as a Schedule I drug, including Alabama, Florida, Georgia, Indiana, Kentucky, Ohio and Virginia. Michigan and Tennessee have listed tianeptine as a Schedule II drug. Mississippi state law has listed tianeptine as a Schedule III drug.

In California, the Sherman Law gives DPH the broad regulatory authority to oversee food, drug, and medical device safety and makes violators subject to penalties. The Food and Drug Branch (FDB) of DPH is responsible for complaints regarding commercially processed foods, drugs, medical devices, cosmetics, and certain consumer products affecting Californians. The FDB investigates complaints about products like tianeptine and shares findings with relevant authorities, including local health jurisdictions. Local environmental health agencies can request stores to voluntarily remove products containing tianeptine and can impound such products. Local environmental health agencies also provide materials about risks of these substances.

• 1. Impacts of tianeptine. According to the FDA, reports of severe side effects involving tianeptine are increasing. Poison control center cases involving tianeptine exposure have increased nationwide, from 11 total cases between 2000 and 2013 to 151 cases in 2020 alone.

The FDA has identified cases in which people experienced other serious harmful effects from abusing or misusing tianeptine by itself or with other drugs, including antidepressants and antianxiety medicines. These effects included agitation, drowsiness, confusion, sweating, rapid heartbeat, high blood pressure, nausea, vomiting, slowed or stopped breathing, coma, and death.

• 1. How would this bill change how tianeptine is regulated? It is already illegal to market and sell tianeptine in California, and DPH already has authority to address the illegal sale of tianeptine under the Sherman Law. This bill expressly prohibits the manufacture, sale, delivery, distribution, holding, or offer for sale of tianeptine in commerce and creates an additional civil penalty structure upon action by the Attorney General, city attorney, county counsel or district attorney.

1. SUPPORT. This bill is sponsored by the California Narcotic Officers’ Association (CNOA), who writes in support, tianeptine inhabits a murky space in U.S. drug regulation. CNOA states that it is illegal to market or sell the drug, but it is also not on the list of federally controlled substances. CNOA continues that while tianeptine is in products sold at gas stations and other stores, it is also available to buy online. CNOA continues that from a law-enforcement and public-safety perspective, tianeptine presents several acute concerns. First, CNOA flags high abuse and addiction potential. CNOA notes that tianeptine acts on opioid receptors and produces opioid-like effects, including euphoria, dependence, and severe withdrawal symptoms. CNOA continues that emergency departments across the country have reported increasing numbers of tianeptine-related overdoses, poisonings, and hospitalizations. Second, CNOA highlights deceptive marketing and easy access. CNOA asserts that products containing tianeptine are often labeled as supplements, energy boosters, or mood enhancers, creating a false perception of safety and enabling access by minors and vulnerable populations. Third, CNOA flags strain on first responders and emergency services. CNOA notes that law-enforcement officers, firefighters, and Emergency Medical Services (EMS) personnel are increasingly encountering individuals suffering from tianeptine intoxication, withdrawal, or polysubstance abuse, diverting critical resources from other public-safety priorities. Fourth, CNOA contends there is a regulatory gap under current law and absent clear scheduling, enforcement agencies face challenges in removing these dangerous substances from circulation or holding distributors accountable.
2. RELATED LEGISLATION.
   1. AB 1088 (Bains) of 2025 adds kratom products and products containing 7-hydroxymitragynine (7-OH products), as defined, to the Sherman Law. Prescribes specified quantities of alkaloids present in kratom products and 7-OH products. Prohibits the sale of kratom products and 7-OH products to those under 21 years of age. Requires the packaging of kratom products and 7-OH products to be child resistant and prohibits the sale and manufacture of a kratom product or 7-OH product that is attractive to children. AB 1088 is a two-year bill in Senate Health Committee.
3. PREVIOUS LEGISLATION.
   1. AB 2217 (Weber) of 2024 would have, commencing January 1, 2027, prohibited a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce a food product for human consumption that contains tianeptine. Would have made a violation of these provisions punishable by a civil penalty not to exceed $5,000 for a first violation and not to exceed $10,000 for each subsequent violation, upon an action brought by the Attorney General, a city attorney, a county counsel, or a district attorney. AB 2217 was not heard in the Assembly Health Committee.
   2. AB 2365 (Haney) of 2024 would have added kratom products, as defined, to the Sherman Law and required processors of kratom products to register with DPH. Would have authorized DPH to establish an annual fee for processors and would have authorized the fee to be based on certain criteria, including annual sales in California. AB 2635 would have prescribed specified quantities of alkaloids present in kratom products and would have established labeling and packaging requirements. The bill would have required that kratom products be registered with DPH annually, which would include certification by a laboratory specifying that the product meets certain qualifications. Additionally, the bill would have prohibited the sale of kratom leaf and kratom products to those under 21 years of age and would have prohibited the sale and manufacture of a kratom product that is attractive to children or an inhalable kratom product. AB 2365 also would have authorized DPH to take various enforcement actions, including executing interagency agreements for the implementation of these provisions, among others. AB 2635 was held on the Senate Appropriations Committee’s suspense file.
   3. AB 418 (Gabriel), Chapter 328, Statutes of 2023 prohibits a person or entity, commencing January 1, 2027, from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce a food product for human consumption that contains any of the following substances: Brominated vegetable oil (BVO); Potassium bromate; Propylparaben; or, Red dye 3. Makes a violation of these provisions punishable by a civil penalty not to exceed $5,000 for a first violation and not to exceed $10,000 for each subsequent violation, upon an action brought by the Attorney General, a city attorney, a county counsel, or a district attorney.
   4. AB 82 (Weber) of 2024 would have prohibited a retail establishment from selling, transferring, or otherwise furnishing dietary supplements for weight loss or over-the-counter (OTC) diet pills, as defined, to any person under 18 years of age without a prescription. Would have required DPH to determine which dietary supplements and OTC diet pills would be subject to AB 82, in a manner consistent with specified criteria. Would have exempted a violation of this bill from existing penalties provisions that subjects violations of the Sherman Law to misdemeanor penalties and instead provides for a civil penalty for violations of this bill of up to $250, assessed in a civil action brought by the Attorney General or any district attorney, county counsel, or city attorney in any court of competent jurisdiction. Would have exempted a retail clerk from any civil penalty for a violation of AB 82 but specifies that this exemption does not apply to a retail clerk who is a willful participant in an ongoing conspiracy to violate the provisions of AB 82. Would have made the provisions of this bill operative on January 1, 2026, and included a severability clause. AB 82 was held on the Senate Appropriations Committee’s suspense file.
   5. AB 1341 (C. Garcia) of 2021 was substantially similar to AB 82 and would have also required DPH to develop a notice stating that certain dietary supplements or OTC diet pills may contribute to specified health conditions or death and required a retail establishment to post this notice, and additionally exempted a retail clerk from being subject to disciplinary action or discharge by the retail establishment, for a violation of this bill, but specifies that this exemption does not apply to a retail clerk who is a willful participant in an ongoing conspiracy to violate the provisions of this bill. AB 1341 was vetoed by Governor Newsom who stated in part:

“DPH is prepared to work with the legislature next session to address sales age limits and other potential legislative actions to address the responsible sale of dietary supplements for weight loss and OTC diet pills that do not require the state to undertake lengthy and costly pharmacological studies on the many supplements on the market today.”

1. DOUBLE REFERRAL. This bill has been double-referred; upon passage of this Committee, it will be referred to the Assembly Judiciary Committee.
2. POLICY COMMENT. In addition to the penalties specified under the Sherman Law, this bill creates a civil penalty for a person who manufactures, sells, delivers, distributes, holds, or offers tianeptine for sale. Previous legislation, which would have created similar civil penalties for diet pills, included an exemption for retail clerks, as described in 5) d) and e) above. The author may wish to consider working with stakeholders to ensure that retail clerks are not subject to civil penalty or retaliation when a retailer is illegally selling tianeptine.

REGISTERED SUPPORT / OPPOSITION:

Support

California Narcotics Officers’ Association

Opposition

None on file

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

Date of Hearing:

Chief Counsel: Andrew Ironside

ASSEMBLY COMMITTEE ON PUBLIC SAFETY

Nick Schultz, Chair

ABPCA Bill Id:AB 634

Author:(Jeff Gonzalez) – As Introduced Ver:February 13, 2025

SUMMARY:

Makes tianeptine a Schedule I controlled substance under California’s Uniform Controlled Substances Act (UCSA).

EXISTING LAW:

1. Lists controlled substances in five “schedules” - intended to list drugs in decreasing order of harm and increasing medical utility or safety - and provides penalties for possession of and commerce in controlled substances.  Schedule I includes the most serious and heavily controlled substances, with Schedule V being the least serious and most lightly controlled substances. (Health & Saf. Code, §§ 11054-11058.)
2. Makes possession of most Schedule I controlled substances a misdemeanor, except that a person with at least one prior conviction for a serious or violent felony, or a crime requiring sex offender registration, is guilty of a felony punishable by 16 months, two years, or three years. (Health & Saf. Code, § 11350.)
3. Makes possession of a Schedule I controlled substance when the person has two or more prior convictions of specified drug crimes, including possession, an alternate felony/misdemeanor punishable by up to one year in county jail or by 16 months, two years, or three years. (Health & Saf. Code, § 11395, subd. (b)(1).)
4. Makes a second or subsequent conviction of the above punishable in state prison if a felony. (Health & Saf. Code, § 11395, subd. (b)(2).)
5. Makes the possession for sale or purchase for purposes of sale of most Schedule I controlled substances punishable by two, three, or four years. (Health & Saf. Code, § 11351.)
6. Makes transporting, importing into the state, selling, furnishing, administering, or giving away, or attempting to import into this state or to transport, most Schedule I controlled substances a felony punishable by imprisonment for three, four, or five years. (Health & Saf. Code, § 11352.)
7. Provides that every person 18 years of age or over, who hires, employs, or uses a minor to unlawfully transport, carry, sell, give away, prepare for sale, or peddle most Schedule I controlled substances, or who unlawfully sells, furnishes, administers, gives, or offers to sell, furnish, administer, or give, any such controlled substance to a minor, shall be punished by imprisonment in the state prison for three, six, or nine years. (Health & Saf. Code, § 11353.)
8. Provides that any person 18 years of age or over who is convicted specified violations related to, among other acts, the sale, transport, or furnishing of most Schedule I controlled substances, or of a conspiracy to commit one of those offenses, where the violation takes place upon the grounds of, or within 1,000 feet of, a public or private elementary, vocational, junior high, or high school during hours that the school is open for classes or school-related programs, or at any time when minors are using the facility where the offense occurs, shall receive an additional punishment of three, four, or five years at the court’s discretion. (Health & Saf. Code, § 11353.6, subd. (a).)
9. Any person 18 years of age or older who is convicted of the above violation which involves a minor who is at least four years younger than that person, as a full and separately served enhancement to that provided above, shall be punished by imprisonment for three, four, or five years at the court’s discretion. (Health & Saf. Code, § 11353.6, subd. (b).)
10. Enacts the Sherman Law, enforced by Department of Public Health, which provides broad authority for DPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but DPH is permitted, by regulation, to adopt additional food labeling regulations. (Health & Saf. Code, § 109875, et seq.)
11. Prohibits any person from engaging in the manufacturing, packing, or holding of any processed food unless the person has a valid registration as a food processing facility from the DPH under the Sherman Law. (Health & Saf. Code, § 110460.)
12. Establishes penalties for violations of the Sherman Law, including a fine of up to $1,000, or up to $10,000 for repeated violations. (Health & Saf. Code, § 111825.)
13. Prohibits any manufacturer, wholesaler, retailer, or other person from selling, transferring, or otherwise furnishing specified dietary supplements. (Health & Saf. Code, § 110423.2.)

FISCAL EFFECT:

Unknown

COMMENTS:

1. Author's Statement: According to the author, “AB 634 aims to combat the growing threat posed by Tianeptine, also known as "gas station heroin." This legislation will add Tianeptine to the Schedule 1 list of controlled substances in California. Tianeptine has been increasingly misused, particularly by individuals seeking an opioid-like effect, despite its unregulated status and the severe risks it poses to the public. The opioid epidemic continues to ravage communities across the nation, and Tianeptine has become a disturbing new threat in this ongoing crisis. This Bill seeks to address this emerging danger and prevent further harm to vulnerable populations, especially those already at risk due to the opioid crisis. With AB 641, California will strengthen its response to the opioid epidemic by closing a dangerous loophole and taking decisive action to safeguard public health and safety.”
   
2. Tianeptine: Tianeptine is an antidepressant approved for use to treat major depressive disorder in countries in Asia, Europe, and Latin America but has been not approved for use in the United States.^[1] “[It] has shown potential benefits in addressing anxiety and irritable bowel disease” as well.^[2] In the United States, it is generally sold online or at convenient stores as a powder, a pill, or a liquid. At high doses, it can produce a high and feelings of euphoria.^[3] Misuse can lead to dependence and, in rare cases, death.^[4]
   
   According to the Drug Enforcement Administration:
   

In August 2018, CDC published an analysis of the tianeptine-related calls to the NPDS between 2000 and 2017. During the first 14 years of the study period (2000– 2013), NPDS reported a total of 11 tianeptine exposure calls. From 2014 through 2017, NPDS reported 207 calls [2014 (5 calls); 2015 (38); 2016 (83); 2017 (81)]. In addition, NPDS reported 29 withdrawal-associated calls, of which 21 (72.4%) calls involved tianeptine only. Among these withdrawal-associated calls, the most commonly reported adverse effects included agitation, nausea, vomiting, tachycardia, hypertension, diarrhea, tremor, and diaphoresis.^[5]

According to the FDA, between 2015 and 2022, “Two deaths were reported [nationwide] as a result of tianeptine use.”^[6] In 2024, the CDC issued a report after tianeptine exposure calls in New Jersey increased to 20 calls from 17 patients, up from two or fewer cases per year.^[7] Six of the patients reported “coingesting [tianeptine with] other substances.”^[8] Seven of the patients required intubation, although the report does not state how many of those patients were among the coingesting group.^[9] Fourteen patients reported consuming a brand of tianeptine that contained kava, another unregulated substance.^[10] Notably, analyses of samples of that brand of tianeptine also found synthetic weed, which is illegal to sell in California.^[11] (See Health & Saf., § 11357.5) None of the exposures resulted in death.^[12]

1. The California Uniform Controlled Substances Act: In 1970, Congress passed the Comprehensive Drug Abuse Prevention and Control Act, which established a framework for federal regulation of controlled substances. Title II of the act is the Controlled Substances Act (CSA), which placed controlled substances in one of five “schedules.”
   

The schedule on which a controlled substance is placed determines the level of restriction imposed on its production, distribution, and possession, as well as the penalties applicable to any improper handling of the substance… [W]hen DEA places substances under control by regulation, the agency assigns each controlled substance to a schedule based on its medical utility and its potential for abuse and dependence.^[13]

Substances are added to or removed from schedules through agency action or by legislation.^[14]

State laws generally follow the federal scheduling decisions, and “they are relatively uniform across jurisdictions because almost all states have adopted a version of a model statute called the Uniform Controlled Substances Act (UCSA).”^[15] California adopted the UCSA in 1972. (Stats. 1972, ch. 1407, § 3.)

With few exceptions, California generally has aligned its Uniform Controlled Substances Act (UCSA) with the federal government’s scheduling decisions. (See People v. Ward (2008) 167 Cal.App.4th 252, 259 [“In the California Uniform Controlled Substances Act, California adopted the five schedules of controlled substances used in federal law and in the Uniform Controlled Substances Act”]; Williamson v. Bd. Of Medical Quality Assurance (1990) 271 Cal.App.3d 1343, 1352, fn. 1. [“Effective January 1, 1985, Schedules I through V of the California Uniform Controlled Substances Act were revised so as to generally parallel the five schedules contained in the Federal Controlled Substances Act.”].) The federal government has not listed tianeptine on any of the five schedule under the CSA.

1. Effect of the Bill: This bill would make tianeptine a Schedule I controlled substance under the UCSA. By placing it on Schedule I, this bill would create significant criminal penalties for such conduct. In most cases, possession of a Schedule I controlled substance generally is a misdemeanor. (Health & Saf. Code, § 11350.) However, after the passage of Prop 36, the possession of a Schedule I controlled substance when the person has two or more prior convictions of specified drug crimes, including possession, is an alternate felony/misdemeanor punishable by up to one year in county jail or by imprisonment for up to three years, generally in county jail. (Health & Saf. Code, § 11395, subd. (b)(1).) A second or subsequent conviction of the above is punishable in state prison if a felony. (Health & Saf. Code, § 11395, subd. (b)(2).)
   
   Possession for sale or purchase for purposes of sale of most Schedule I controlled substances is punishable by imprisonment for two, three, or four years. (Health & Saf. Code, § 11351.) Transporting, importing into the state, selling, furnishing, administering, or giving away, or attempting to import into this state or to transport, a Schedule I controlled substance is punishable by imprisonment for three, four, or five years. (Health & Saf. Code, § 11352.) A person 18 years of age or over who is convicted specified violations related to, among other acts, the sale, transport, or furnishing of a Schedule I, or of a conspiracy to commit one of those offenses, where the violation takes place upon the grounds of, or within 1,000 feet of, a public or private elementary, vocational, junior high, or high school during hours that the school is open for classes or school-related programs, or at any time when minors are using the facility where the offense occurs, could receive an additional punishment of up to five years. (Health & Saf. Code, § 11353.6, subd. (a).)
   
   Currently, there are no existing criminal penalties for tianeptine-related conduct. As such, this bill would take a currently legal substance and apply the most serious criminal penalties to conduct related to that substance. The author may wish to consider a more modest approach.
   
   For example, like Tianeptine, Kratom is a legal substance with effects similar to those of opioids. Per the United States Drug Enforcement Administration (DEA), consumption of kratom tree leaves produces a stimulant effect in low doses, and a sedative effect in high doses. Consumption of kratom in high doses can also lead to psychotic symptoms, and psychological and physiological dependence. According to the DEA, the abuse of kratom has increased markedly in recent years. Several cases of psychosis resulting from use of kratom have been reported, where individuals addicted to kratom exhibited psychotic symptoms, including hallucinations, delusion, and confusion. And Kratom has resulted in fatal overdoses.^[16] Yet Kratom has not been placed on any schedule under the federal Controlled Substances Act.
   
   Unlike this bill, however, AB 1088 (Bains) would add kratom products to the Sherman Food, Drug, and Cosmetic Law, prescribe specified quantities of alkaloids present in kratom products, prohibits the sale of kratom products to those under 21 years of age, require the packaging of kratom products to be child resistant, and prohibit the sale and manufacture of a kratom product that is attractive to children. This approach may better achieve the goal of reducing harmful public health outcomes without burdening the state and law enforcement with increased incarceration and enforcement costs.
   
2. Criminal Penalties and Drug Use: Ample research on the impact of increasing penalties for drug offenses on criminal behavior has called into question the effectiveness of such measures. In a report examining the relationship between prison terms and drug misuse, PEW Charitable Trusts found “[n]o relationship between drug imprisonment rates and states’ drug problems,” finding that “high rates of drug imprisonment did not translate into lower rates of drug use, arrests, or overdose deaths.”^[17] According to PEW, “[A] large body of prior research…cast[s] doubt on the theory that stiffer prison terms deter drug misuse, distribution, and other drug-law violations.”^[18] PEW concludes:

Putting more drug-law violators behind bars for longer periods of time has generated enormous costs for taxpayers, but it has not yielded a convincing public safety return on those investments. Instead, more imprisonment for drug offenders has meant limited funds are siphoned away from programs, practices, and policies that have been proved to reduce drug use and crime.^[19]

Based on this research, one might reasonably question whether creating stiff penalties for tianeptine would meaningfully impact the drug’s availability or the number of people who use it.

1. Argument in Support: According to California Narcotic Officers’ Association, “U.S. poison control centers are reporting a dramatic spike in cases involving tianeptine — a drug that isn't FDA approved, and poses overdose and dependency risks. Tianeptine, however, doesn’t just bind to the mu opioid receptor, It actually activates the receptor like other opioids do, like morphine or like oxycodone or like fentanyl.
   
   “It's currently illegal to market or sell tianeptine as a drug, but it's also not on the list of federally controlled substances. As a result, it is widely available at gas stations, vape shops and online as a ‘supplement.’ The FDA refers to tianeptine as ‘an unapproved drug associated with serious health risks and even death.’
   
   “Tianeptine has never been cleared by the U.S. Food and Drug Administration for medical use, so it's sold in the U.S. as a nootropic, a substance promising to enhance users' mood and cognitive function.
   
   “Experts warn that it's dangerous to consume any unapproved drug, particularly one that poses the risk of dependency, withdrawal, respiratory depression and even death as does tianeptine. It’s often packaged in colorful, shot-sized bottles, containing the drug in varying concentrations without proper disclosures to the public about the true contents. Many tianeptine products have been found to include dangerous synthetic cannabinoids as well.
   
   “Lack of a federal ban on tianeptine has forced states to act on their own. In 2018, Michigan became the first state to ban sales of the drug, classifying it as a Schedule II controlled substance, the same category as drugs like cocaine and fentanyl. The FDA says at least 12 states have enacted similar bans to protect their residents. California should do the same. Tianeptine is a dangerous, addictive and unregulated product that should not be made available for sale in our state.”
   
2. Argument in Opposition: According to the Drug Policy Alliance, “We all want our loved ones and communities to be safe, but criminalizing tianeptine and other commonly-available substances will not effectively protect or improve the health of those seeking such substances, and instead will cause other harms. It will result in increased criminalization of people who use drugs, exposing them to additional criminal charges and potentially increased sentences, and have the unintentional consequence of fostering an illicit market for such substances and substantially similar chemical compounds.
   
   “Tianeptine is an antidepressant drug approved for the treatment of major depressive disorder in some countries outside of the United States. It has been shown to have potential benefits in addressing anxiety, irritable bowel disease, and declines mental cognition.1,2 Tianeptine has been shown to be comparable with fluoxetine, or ‘Prozac” in a number of studies on its efficacy as an antidepressant and been shown to treat Major depressive disorder (MDD), one of the most common mental disorders in the United States, which can lead to severe impairments thatinterfere with one’s ability to carry out major life activities.3,4 Patients without access to “first-line antidepressant treatments” tend to have a more severe course of illness and are at an increased risk of suicide.
   
   “At this time, however, tianeptine is not approved for any use by the United States Federal Drug Administration (FDA) and is not regulated in many states. As a result, manufacturers and distributors of products containing the substance are not subject to controls on product marketing, concentrations, testing, age verification, requirements for bundling naloxone with the product, or per-consumer quantity limits.
   
   “One of the consequences with scheduling substances on Schedule I, the most strictly controlled category, designates them as having no medical use and subject to the highest penalties. Criminalizing certain formulations simply incentivizes more innovation so that suppliers will produce new and different molecular compounds to avoid criminalization. This could actually lead to the development and dissemination of more potent or risky drugs.
   
   “Scheduling tianeptine, particularly on Schedule I, will also create barriers to critically needed research on the drug at a time when we need more research to understand its effects and uses. Scheduling drugs makes them more difficult for researchers to access and procure for research purposes, and can have a chilling effect on research for fear of legal repercussions or barriers to Institutional Review Board (IRB) approval. There is still a great amount information that is not well understood about Tianeptine, including how various doses act in the body, potential interaction with medications and other drugs, how to treat and manage withdrawal among dependent users, medication treatments for people who are addicted to these drugs, and also potential novel medical uses.
   
   “The schedules of controlled substances in California and elsewhere are generally designed to weigh the “potential for abuse”, accepted medical use, and public health risks of a drug. Adding Tianeptine as a controlled substance without conducting scientific and medical evaluations that are necessary in the drug scheduling process undermines the process for scheduling drugs and imposing criminal penalties. It remains uncertain how the classification of Tianeptine on Schedule I could be justified without additional research.
   
   “Instead of hastily criminalizing tianeptine as a controlled substance, policymakers should focus on health-centered approaches: improving access to mental health services, expanding overdose-prevention and harm-reduction services (including community-based drug checking programs), peer-led outreach and street-medicine programs, strengthening our good samaritan statute, and increasing access to Medically Assisted Treatment (i.e. methadone and buprenorphine), and expanding access to and training around naloxone, and evidence-based drug education and voluntary treatment.
   
   “Overdose deaths are preventable, but expanded criminalization causes more harm and stands in the way of saving lives. Criminalization creates instability, blocks access to jobs and housing, increases overdose risk, and leads to more dangerous substances. A vast body of evidence has found that adding criminal penalties does not reduce overdose rates or the supply of drugs.5 Instead, it creates a dangerous cycle that exposes people who use drugs to newer and potentially more dangerous alternatives from unknown sources. Criminalizing tianeptine will likely lead to the emergence of other, potentially more deadly substances in the illicit drug supply. Effective solutions center support, not punishment.”
   
3. Related Legislation:
   
   1. AB 1088 (Bains) would, among other things add kratom and other specified products to the Sherman Food, Drug, and Cosmetic Law (Sherman Law), prohibit the sale of those products to persons under 21 years of age, and require the packaging of those products to be child resistant. AB 1088 is pending a hearing in the Assembly Appropriations committee.
      
   2. SB 6 (Ashby) would make xylazine also known as “tranq,” a Schedule III drug under UCSA.
      
4. Prior Legislation:
   
   1. AB 2018 (Rodriguez), Chapter 98, Statutes of 2024, removed fenfluramine as a controlled substance under the UCSA.
   2. AB 2217 (Weber), of the 2023-2024 Legislative Session, would have provided that, commencing on January 1, 2027, no person or entity may manufacture, sell deliver, distribute, hold, or offer for sale, in commerce a food product for human consumption that contains tianeptine, subject to civil penalties of between $5,000 and $10,000 for each violation. The hearing on AB 2217 was canceled at the request of the author.
   3. AB 2365 (Haney), of the 2023-2024 Legislative Session, would have established the Kratom Consumer Protection Program to provide a regulatory structure for kratom products, as provided. AB 2365 was held on the Senate Appropriations Committee suspense file.
   4. AB 3029 (Bains) would make xylazine, also known as “tranq,” a Schedule III drug under California’s UCSA, contingent on the federal government adding xylazine to Schedule III of the federal CSA. AB 3029 was held in suspense in the Senate Appropriations Committee.
   5. SB 1502 (Ashby), of the 2023-2024 Legislative Session, would have made xylazine also known as “tranq,” a Schedule III drug under UCSA. AB 1502 failed passage in this committee.

REGISTERED SUPPORT / OPPOSITION:

Support

California District Attorneys Association
California Narcotic Officers' Association
California State Sheriffs' Association
Union Station Homeless Services

Oppose

ACLU California Action
California Public Defenders Association (CPDA)
Californians United for a Responsible Budget
Drug Policy Alliance
Ella Baker Center for Human Rights
Initiate Justice Action
Justice2jobs Coalition
LA Defensa
San Francisco Public Defender
Smart Justice California, a Project of Tides Advocacy
Universidad Popular

Analysis Prepared by:

Andrew Ironside / PUB. S. / (916) 319-3744

1. Edinoff et al., Tianeptine, an Antidepressant with Opioid Agonist Effects: Pharmacology and Abuse Potential, a Narrative Review (Jul. 15, 2023) <https://pmc.ncbi.nlm.nih.gov/articles/PMC10444703/> [last visited Apr. 25, 2025]. ↑

2. Ibid. ↑

3. Tianeptin: Is safe use possible? Mayo Clinic < https://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/tianeptine-is-safe-use-possible/art-20562252#:~:text=When%20taken%20in%20small%20doses,of%20tianeptine%20can%20be%20fatal.> [last visited Apr. 25, 2025]. ↑

4. Ibid. ↑

5. DEA, Tianeptine (Apr. 2025) <https://www.deadiversion.usdoj.gov/drug_chem_info/tianeptine.pdf> [last visited Apr. 25, 2025]. ↑

6. Hoffman-Pennesi et al., Tianeptine Product Adverse Event Reports from FDA CFSAN Adverse Event Reporting System (CAERS), 2015-2022, FDA; see also, Musa, Some tianeptine products recalled as CDC links drug to ‘cluster of sever illness’, CNN.com (Feb. 1, 2024) < https://www.cnn.com/2024/02/01/health/tianeptine-illness-recall/index.html> [last visited Apr. 25, 2025]. ↑

7. Hoffman-Pennesi, supra. ↑

8. Ibid. ↑

9. Ibid. ↑

10. Musa, supra. ↑

11. Ibid. ↑

12. Counts et al, Notes from the Field: Cluster of Severe Illness from Neptune’s Fix Tianeptine Linked to Synthetic Cannabinoids—New Jersey, June-November 2023, CDC (Feb. 1, 2024) https://www.cdc.gov/mmwr/volumes/73/wr/mm7304a5.htm?s_cid=mm7304a5_e&ACSTrackingID=USCDC_921DM121333&ACSTrackingLabel=This%20Week%20in%20MMWR%3A%20Vol.%2073%2C%20February%201%2C%202024&deliveryName=USCDC_921-DM121333 [last visited Apr. 25, 2025]. ↑

13. The Controlled Substances ACT (CSA): A Legal Overview for the 118^th Congress, Congressional Research Service (Jan. 19, 2023) p. 2 <https://crsreports.congress.gov/product/pdf/r/r45948> [last visited Mar. 28, 2024]. ↑

14. Id. at p. 9. ↑

15. Id. at 4. ↑

16. Freund et al., Hundreds died using kratom in Florida. It was touted as safe. Tampa Bay Times (Dec. 7, 2023) <https://project.tampabay.com/investigations/deadly-dose/kratom-overdose-deaths-florida-mitragynine-testing/> [last visited Apr. 25, 2025]. ↑

17. PEW, More Imprisonment Does Not Reduce State Drug Problems (Mar. 2018) p. 5 <https://www.pewtrusts.org/-/media/assets/2018/03/pspp_more_imprisonment_does_not_reduce_state_drug_problems.pdf> [last viewed Feb. 6, 2023]; see generally, Przybylski, Correctional and Sentencing Reform for Drug Offenders (Sept. 2009) < http://www.ccjrc.org/wp-content/uploads/2016/02/Correctional_and_Sentencing_Reform_for_Drug_Offenders.pdf> [last visited Mar. 20, 2023]. ↑

18. PEW, supra. See generally, Przybylski, Correctional and Sentencing Reform for Drug Offenders (Sept. 2009) ↑

19. Ibid. ↑