As we noted in a prior post, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed tailored Prop 65 safe harbor warnings for THC and marijuana smoke, following listing THC for reproductive harm and marijuana smoke as cancer-causing in January 2020 (marijuana smoke was already listed for reproductive harm as of 2009). After considerable public comment and a published final statement of reasons addressing those comments, OEHHA announced on August 8, 2022 that it had approved amendments to the new tailored warnings.
The regulations will become effective on October 1, 2022. However, there is a one-year phase-in period and unlimited sell-through provision for products manufactured and labeled with compliant warnings before October 1, 2023.
In general, these amendments provide “non-mandatory, specific safe harbor exposure warning methods of transmission and content for retail products that can expose consumers to cannabis (marijuana) smoke or delta-9-THC via inhalation, ingestion, or dermal application, and for environmental exposures . . .” However, there are a few important items to note in the newly adopted regulations.
The regulations cover both environmental exposures and consumer product exposures.
This means that cannabis lounges or any designated cannabis smoking areas may require specialized environmental exposure warnings.
The regulations set forth tailored consumer product warnings for inhalation of marijuana smoke or products with THC intended to be smoked, but also a series of separate tailored warnings for THC that is (1) ingested; (2) vaped or dabbed; and (3) dermally applied.
Therefore, it will be important to determine use / route of exposure of the product before determining which label may apply. Currently, there is no guidance from OEHHA on labeling these particular products that may have multiple uses (e.g., ones that may be ingested and dermally applied), so it will be critical to assess the business and legal risks of choosing a particular label, along with considering what might be the primary use of the product.
A cannabis product that provided a general safe harbor warning and was manufactured prior to October 1, 2023 will be deemed clear and reasonable regardless of when the product is sold to a consumer.
While it will of course be important for manufacturers to maintain the manufacture date information, it will also likely be important that this information is shared throughout the supply chain to distributors, retailers, etc. in the event a lawsuit for failure to warn is brought by a Prop 65 plaintiff.
In addition, while not explicit in the regulations, in its Final Statement of Reasons, OEHHA stated that it “disagrees . . . that the short form warning is a sufficient warning for cannabis and delta-9-THC products” and “determined that the short-form warning method . . . does not provide the level of specificity needed for cannabis (marijuana) smoke and delta-9-THC exposures.” Based on this, along with the fact that the short-form warning requirements themselves are undergoing significant amendments, use of a short-form warning for marijuana smoke and THC products may become foreclosed or very limited.
Ultimately, considerations for labeling cannabis products with a specialized warning under Prop 65 raises many unique business concerns. In the very least, however, the sell-through date will give those in the cannabis industry the opportunity to carefully review their Prop 65 compliance program now and seek out legal advice on any labeling updates necessary for selling into the California market.
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.