WARNING: California Prop 65 Enforcement of THC Listing from CBD Products Became Effective January 3, 2021
As of January 3, 2021, the one-year grace period to comply with the California Prop 65 Clear and Reasonable Warning requirements for delta-9-tetrahydrocannabinol (known as THC) came to a close and the enforcement period has now begun. OEHHA, the enforcing agency for Prop 65, added THC to the Prop 65 chemicals list last year on January 3, 2020. It is listed as a chemical known to cause reproductive harm.
As many in the CBD-industry are likely aware, Cannabis (Marijuana) Smoke was added to the Prop 65 chemicals list as a carcinogen in 2009 and enforcement of the Clear and Reasonable Warning requirements began thereafter. However, in January 2020, it was also classified as a reproductive toxin. Enforcement of the Clear and Reasonable Warning requirements specifically for reproductive toxicity from CBD (Marijuana) Smoke began on January 3, 2021 as well.
Currently, there are no safe harbor levels for THC and CBD (Marijuana) Smoke. Therefore, any detectable amount of THC (or Cannabis / Marijuana Smoke) in a product may require a Prop 65 warning. For THC in particular, this applies notwithstanding the fact that federal law does not regulate CBD products that contain 0.3% or less THC by dry weight (i.e., cannabis containing less than 0.3% THC is considered to be “hemp” as opposed to “marijuana” according to 7 U.S.C. § 1639o(1)). Therefore, for products that result in any exposure to THC, a Prop 65 warning for reproductive harm may still be required, and now for Cannabis (Marijuana) Smoke products, an additional warning for reproductive harm (on top of cancer) may be required.
Ultimately, CBD suppliers, manufacturers, and distributors are responsible under Prop 65 for determining whether their products cause any exposure to THC in order to comply with the Clear and Reasonable Warning requirements. Retailers will also need to apply any warning labels provided by manufacturers and distributors to products and/or post any warnings on their websites.
Now that the effective date for THC compliance under Prop 65 is here, citizen-plaintiff groups will likely begin filing notices of violation for failure to warn for THC-products. It will be critical for CBD and cannabis companies to evaluate their products for Prop 65 compliance and have a defensible position if it is determined a Prop 65 warning is not required.
Squire Patton Boggs will continue to keep you posted on the latest developments in this area and can assist with any questions regarding Prop 65 requirements.
Copyright Squire Patton Boggs.
The opinions expressed in this update are those of the author(s) and do not necessarily reflect the views of the Firm, its clients, or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
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California Enacts New Warning Requirements Applicable to Cannabis and CBD Products
California’s Proposition 65 – which already poses daunting compliance challenges for a wide range of industries – is now set to apply more broadly to cannabis and cannabidiol (“CBD”) products. Beginning January 3, 2021, companies who manufacture, distribute, or sell at retail delta-9-tetrahydrocannabinol (“THC”) products in California – including CBD products made with industrial hemp – will be required to warn consumers that exposure to THC is known to the state of California to cause reproductive harm.
California’s Safe Drinking Water and Toxic Enforcement Act of 1986, known commonly as “Prop 65,” is a state law that requires labeling of products that contain chemicals that the state has designated as being known to cause cancer, birth defects or other reproductive harm. Cannabis (marijuana) smoke has been listed as a carcinogen (only) since 2009, but THC has not been previously listed. That changed on January 3, 2020, when the state listed both cannabis smoke and THC as reproductive toxins under Proposition 65. Therefore, cannabis smoke is now listed for both cancer and reproductive harm, and THC has been added to the Prop 65 list for the first time.
The listing does not include a safe harbor limit, meaning that products with any detectable level of THC – including products that contain less than 0.3% THC in conformance with federal law – will require Prop 65 warning labels. As a result, products made or infused with CBD (and which contain any detectable level of THC) must be labeled in accordance with Prop 65.
Prop 65’s warning requirements apply to any business in the chain of distr ibution, including manufacturers, distributors and retailers — including out-of-state companies selling products in California. Companies that sell cannabis or CBD products in California can take advantage of the safe harbor warning provisions of Prop 65 and avoid potential litigation by providing warnings that satisfy the complex and specific requirements of the regulation. It will be important for these companies to consult with experienced regulatory counsel prior to creating packaging or labeling to ensure that they comply with Prop 65 and other labeling requirements promulgated by the California Department of Public Health (“CDPH”).
THC products sold without warnings (or with warnings that do not satisfy the regulation) can expose sellers to Prop 65 enforcement actions brought by government agencies or individuals. Prop 65 allows the state to pursue enforcement actions or violations, and fines can be substantial – up to $2,500 per day per violation. In practice, however, Prop 65 is “enforced” primarily by an aggressive plaintiffs’ bar (seeking quick settlements) that often targets groups of products by filing citizen suits immediately after the waiting period on a newly listed chemical expires. It would not be surprising if the cannabis industry quickly becomes a target of these “sue and settle” efforts, given that the recently eased regulatory atmosphere around these products had led to a concomitant rise in their marketing and sale.
Again, entities subject to the new Prop 65 THC warning requirements have until January 3, 2021 to develop packaging, warnings and labels compliant with Prop 65’s safe harbor provisions. Foley has extensive experience with both Prop 65 and the regulation of cannabis/CBD products. Our strategic approach to the provision of warnings, if necessary and available, is compliant with the regulation, cost-effective, and less burdensome than placing labels on every product. We provide all relevant services, including review of product packaging, labels and warnings, as well as review and drafting contracts to allocate Prop 65 liability across the supply chain to optimize protection for your business.