January 31, 2023

Volume XIII, Number 31

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January 30, 2023

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California OEHHA Adopts Safe Harbor Warning Regulations for Cannabis Smoke and Delta-9-THC

Recently, California’s Office of Environmental Health Hazard Assessment (OEHHA) adopted safe harbor warning regulations for cannabis smoke and delta-9-tetrahydrocannabinol (delta-9-THC) under California Proposition 65.[1]

What is Proposition 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65) requires the governor of California to publish, at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity.[2] Among other things, the law prohibits the knowing exposure of any individual to an amount of a listed chemical without first providing a “clear and reasonable warning” to such individual.[3] The law requires these warnings to be provided for Proposition 65 exposures from consumer products, the workplace, and the environment unless “the person responsible can show that the exposure [to a listed carcinogen] poses no significant risk assuming lifetime exposure at the level in question,” or, for a listed reproductive toxin, that the substance “will have no observable effect assuming exposure at 1,000 times the level in question.”[4] Other limited exemptions from the warning requirement also may apply under the law.

Safe Harbor Warning Regulations for Cannabis Smoke and Delta-9-THC

OEHHA initially added cannabis smoke and delta-9-THC to the Proposition 65 list for developmental toxicity in 2020, while cannabis smoke has been listed as a carcinogen since 2009. In late 2021, OEHHA initially proposed the safe harbor warning regulations for cannabis smoke and delta-9-THC. After two updated draft proposals, OEHHA adopted this final version.

The new regulations suggest specific safe harbor methods of transmission and warning language for retail products that can expose consumers to cannabis smoke or delta-9-THC via inhalation, ingestion, or dermal application, and for environmental exposures to cannabis smoke and delta-9-THC at businesses where smoking of cannabis or vaping or dabbing of delta-9-THC occurs.

As is the case with other safe harbor warnings set out in the regulations, the specific warning language is not mandatory. Thus, businesses may use another method or provide other language to satisfy the warning obligations under the law. However, those alternative warnings must satisfy the statutory “clear and reasonable” standard.

In OEHHA’s final statement of reasons for the regulations, the agency stated that “[t]he safe harbor warning content for these regulations identifies the chemical, route of exposure and provides specific information to consumers about the risks of using cannabis products including cancer and, while pregnant, the impact exposures can have on the unborn child.”[5]

The newly adopted rule took effect October 1, 2022, and includes both a one-year phase-in period and an unlimited sell-through provision for products manufactured and labeled with compliant warnings prior to October 1, 2023.

Ian Murray also contributed to this article.


FOOTNOTES

[1] See Cal. Code Regs. tit. 27, §§ 25607.38-25607.47 (2022).

[2] See Cal. Health & Safety Code §§ 25249 et seq.

[3] Cal. Health & Safety Code § 25249.6

[4] Cal. Health & Safety Code § 25249.10(c).

[5] See The Safe Drinking Water and Toxics Enforcement Act of 1986 Proposition 65, Final Statement of Reasons (June 2022), https://oehha.ca.gov/media/downloads/crnr/fsorcannabisdelta9thc080822.pdf.

© 2023 Keller and Heckman LLPNational Law Review, Volume XII, Number 314
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About this Author

Azim Chowdhury, Keller Heckman, ECigarette Research lawyer, FDA Regulatory Compliance Attorney
Partner

Azim Chowdhury joined Keller and Heckman in 2010 and practices in the area of food, drug, and tobacco law. 

Mr. Chowdhury advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and the European Union, with an emphasis on indirect additives used in food-contact materials.  Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation...

202.434.4230
Mitzi Ng Clark, Food, Drug Law, Keller Heckman Law Firm
Partner

Mitzi Ng Clark practices in the area of food and drug law, with an emphasis on food packaging.

Ms. Clark advises domestic and international corporations on a wide range of regulatory issues, ranging from FDA premarket clearance requirements for food-contact materials and local and state regulations concerning plastics and chemicals, to good manufacturing issues and regulatory requirements for food, cosmetics, and animal feed.  Ms. Clark’s practice extends to the international arena, where she counsels clients on regulatory matters in jurisdictions such as Canada, the European Union...

202-434-4238
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