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California’s ever-expanding regulation of consumer products is now focusing on delta-9-tetrahydrocannabinol (“THC”). THC has been added to the Proposition 65 list, which will likely impact companies that manufacture or sell cannabidiol (“CBD”) and marijuana products. Effective Jan. 3, 2020, Proposition 65 lists cannabis (marijuana) smoke (“cannabis smoke”) and THC as reproductive toxicants.

Proposition 65 is a law requiring that companies provide cancer and/or reproductive harm warnings for any of approximately 900 listed substances – view the full Proposition 65 list here. Enforcement of the warning requirement begins one year after a new listing; accordingly, businesses will not be subject to enforcement actions for cannabis smoke (as a reproductive toxicant) or THC until Jan. 3, 2021. Notwithstanding the one-year grace period, companies should not ignore this issue until 2021. Packaging may need to be updated, and product formulations evaluated, so businesses should immediately take steps to assess whether their products will remain compliant with Proposition 65 in light of these new listings.

The listing of THC will likely impact businesses more than the listing of cannabis smoke as a reproductive toxicant. Why? Cannabis smoke has been listed as a carcinogen under Proposition 65 for over a decade. For businesses distributing cannabis products that are smoked, the new cannabis smoke listing means existing Proposition 65 warnings may only need to be updated to reference reproductive toxicity in addition to cancer.

However, THC has not been listed in any capacity until now. The listing of THC will impact a broader range of products under Proposition 65. Most significantly, CBD products applied topically or ingested may be subject to Proposition 65 warning requirements. While the 2018 Farm Bill exempts CBD products with 0.3% or less THC from the definition of “marijuana” under the Federal Controlled Substances Act, federal law does not directly apply to Proposition 65. As a result, CBD companies relying on the federal THC standard may still be subject to Proposition 65, because Proposition 65 does not currently recognize a THC safe harbor exposure level. Thus, any detectable level of THC could subject a company to Proposition 65 enforcement. Moreover, cannabis products that are not smoked, such as edibles and vape cartridges, will also potentially be required to provide a Proposition 65 warning for THC. Companies that manufacture or distribute CBD products or cannabis products that are not smoked would be wise to assess their products for compliance now to minimize the risk of facing future bounty hunter private enforcement actions under Proposition 65.

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Photo of Justin J. Prochnow Justin J. Prochnow

Justin J. Prochnow assists companies with regulatory, business, and legal needs in the beverage, food, dietary supplement, cosmetic, medical device, and OTC industries. Justin works closely with companies to ensure regulatory compliance with statutes and regulations enforced by the Food and Drug Administration,

Justin J. Prochnow assists companies with regulatory, business, and legal needs in the beverage, food, dietary supplement, cosmetic, medical device, and OTC industries. Justin works closely with companies to ensure regulatory compliance with statutes and regulations enforced by the Food and Drug Administration, the Federal Trade Commission and other regulatory agencies. This includes the review of product labels, labeling, advertising, websites and other marketing materials. Justin assists companies with responding to governmental and regulatory actions, including FDA inspections and warning letters, FTC Civil Investigative Demands, and ASRC and NAD cases. He prepares and reviews business documents for industry members, including consulting, manufacturing, supply and distribution agreements. Justin and his team also defend industry companies from both governmental agencies and civil litigators in litigation ranging from breach of contract cases to the growing number of class actions alleging false and misleading advertising.

Meet Justin Prochnow

Photo of Will Wagner Will Wagner

Will Wagner focuses his practice in the areas of consumer product defense and regulatory enforcement litigation, including California’s unique Proposition 65, California regulatory actions pertaining to labeling and emissions of Volatile Organic Compounds (VOC) from consumer products, and actions under the Consumer Legal…

Will Wagner focuses his practice in the areas of consumer product defense and regulatory enforcement litigation, including California’s unique Proposition 65, California regulatory actions pertaining to labeling and emissions of Volatile Organic Compounds (VOC) from consumer products, and actions under the Consumer Legal Remedies Act (CLRA) and Unfair Competition Law (UCL). Will also handles writ actions related to administrative decisions and procedures, along with commercial disputes and accessibility cases under the Americans With Disabilities Act.