Proposition 65 cannabis regulations are no joke, and they continue to change. For better or worse, the Safe Drinking Water and Toxic Enforcement Act of 1986 (a/k/a Prop. 65) has long plagued California businesses. Cannabis businesses are no exception (see here and here). Prop. 65 requires businesses to provide “a clear and reasonable warning before they cause an exposure to a chemical listed as known to the state to cause cancer or reproductive toxicity.”
The Office of Environmental Health Hazard Assessment (OEHHA), the agency in charge of implementing and overseeing Prop. 65, publishes and updates the list of chemicals known to cause cancer, birth defects or other types of reproductive harm. That list now includes hundreds of chemicals. Effective June 19, 2009, marijuana smoke was added to the Prop. 65 list of chemicals known to cause cancer. OEHHA’s Carcinogen Identification Committee “determined that marijuana smoke was clearly shown, through scientifically valid testing according to generally accepted principles, to cause cancer.” Technically then, all cannabis flower is subject to Proposition 65 cannabis warnings, because all flower contains/produces “marijuana smoke” and because there is no safe harbor level per OEHHA. In addition, oils, wax, vapes, etc. usually contain at least one chemical on OEHHA’s list.
In January 2020, OEHHA added “THC” to the list of chemicals known to cause reproductive harm. At the same time, OEHHA also determined that “marijuana smoke”, in addition to being listed as a cancer-causing carcinogen, also causes reproductive harm (which will definitely change the content of the safe harbor language on flower products across the industry). There was a one-year grace period for cannabis businesses to comply with the Prop. 65 safe harbor warning label provisions, and that grace period ended in January of last year.
New Prop. 65 Regulations for California Cannabis
At the beginning of August 2022, OEHHA tweaked the Prop. 65 rules around cannabis again. Now, the new regulations address “exposures to listed cannabis (marijuana) smoke and Delta-9-THC”. We also now have “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 to cannabis smoke and delta-9-THC at businesses where smoking of cannabis or vaping or dabbing of delta-9-THC occurs.” New regulations go into effect on October 1, 2022, and there’s a one-year phase-in period as well as an unlimited sell-through provision for products manufactured and labeled with compliant warnings before October 1, 2023.
What Cannabis Businesses Need to Know About New Prop. 65 Cannabis Regulations
There are eight pages of new regulation for cannabis businesses to digest. Here are the highlights:
The following is impacted by these new regulations: cannabis products intended to be smoked, delta-9-THC, cannabis smoke, Delta-9-THC from Ingested Products, Delta-9-THC from Vaping or Dabbing Products, Delta-9-THC from Dermally Applied Products, and “cannabis (marijuana) smoke or delta9-tetrahydrocannabinol (delta-9-THC), in the ambient air in designated smoking, vaping, or dabbing areas”. Nothing is being left behind in California’s cannabis industry when it comes to the application of Prop. 65.
Prop. 65 predominantly impacts the labeling of consumer products and location disclaimers. Cannabis manufacturers are going to feel the pinch of having to re-do their labels to accommodate the new safe harbor language for the foregoing products. These safe harbors are key because, while voluntary, they represent a business’s de facto compliance with Prop. 65 and the label warnings themselves are deemed “clear and reasonable” if they follow the safe harbor language, which is an essential defense against the Prop. 65 bar.
For cannabis products made before October 1, 2023 that use either of the on-the-label warning methods of transmission in subsections Section 25602(a)(3)-(a)(4) of existing Prop. 65 rules and that also comply with Section 25603, those labels will be deemed clear and reasonable regardless of when the product is sold to a consumer. Until October 1, 2023, cannabis businesses are essentially free to rely on the old safe harbors for those products manufactured before October 1, 2023, and those products can be “sold through” at any time. However, any products manufactured after that date need to comply with the new safe harbor language, as applicable.
For all warnings on any cannabis label, shelf tag, or “specific sign” after October 1, 2023, they must contain the symbol required in Section 25603(a)(1), the word “WARNING:” in all capital letters and bold print, and the following based on product type:
For cannabis smoke and delta-9-THC from a cannabis product intended to be smoked: “Smoking cannabis increases your cancer risk and during pregnancy exposes your child to delta-9-THC and other chemicals that can affect your child’s birthweight, behavior, and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.
For “ingested products”: “Consuming this product exposes you to carcinogens including [name one or more listed carcinogens], and during pregnancy exposes your child to delta-9-THC, which can affect your child’s behavior and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.” Where the product only exposes the consumer to one listed carcinogen, the business may use the phrase “the carcinogen” rather than “carcinogens including” in the warning.
For vapes and “dabbing” products: “Vaping or dabbing this product during pregnancy exposes your child to delta-9-THC, which can affect your child’s behavior and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.”, or if the product also exposes consumers to one or more listed carcinogens, “Vaping or dabbing this product exposes you to carcinogens including [name one or more listed carcinogens], and during pregnancy exposes your child to delta-9-THC, which can affect your child’s behavior and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.” Where the product only exposes the consumer to one listed carcinogen, the business may use the phrase “the carcinogen” rather than “carcinogens including” in the warning.
For topicals: “Using this product during pregnancy exposes your child to delta-9-THC, which can affect your child’s behavior and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.” or, if the product will also expose consumers to one or more listed carcinogens, “Using this product exposes you to carcinogens including [name one or more listed carcinogens] and during pregnancy exposes your child to delta-9-THC, which can affect your child’s behavior and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.” Where the product only exposes the consumer to one listed carcinogen, the business may use the phrase “the carcinogen” rather than “carcinogens including” in the warning.
Even consumption lounges are not off the hook when it comes to “environmental exposure”. All spaces that allow for smoking, vaping, or dabbing must now have an 8 1/2 by 11-inch sign printed in no smaller than 22-point type and enclosed in a box posted both at the entrance to and within the area in which the exposure occurs, with warnings that are “readable and conspicuous to customers”, which say:
In designated areas where cannabis smoking occurs, or both cannabis smoking and delta-9-THC vaping or dabbing occur, the words, “Breathing the air in this area exposes you to cannabis smoke, which increases your cancer risk and, during pregnancy, exposes your child to delta-9-THC and other chemicals that can affect your child’s birthweight, behavior, and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.”, or
In designated areas where delta-9-THC vaping or dabbing occurs, but cannabis smoking does not, the words, “Breathing the air in this area during pregnancy exposes your child to delta-9-THC, which can affect your child’s behavior and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.”, or
In a designated area where delta-9-THC vaping or dabbing occurs, but cannabis smoking does not, and where consumers can be exposed to one or more listed carcinogens in ambient air, “Breathing the air in this area exposes you to carcinogens including [name one or more listed carcinogens] and during pregnancy exposes your child to delta-9-THC, which can affect your child’s behavior and learning ability. For more information go to www.P65Warnings.ca.gov/cannabis.” Where the product only exposes the consumer to one listed carcinogen, the business may use the phrase “the carcinogen” rather than “carcinogens including” in the warning.”
Public Comments
As it always does, OEHHA took public comment on these new regulations prior to adoption. See here. Interestingly, when asked about an increase in plaintiff’s litigation because of these new and increased warnings, OEHHA replied that:
There is no indication that businesses using the existing general consumer safe harbor warning have encountered additional litigation and OEHHA does not anticipate such an increase will occur with the proposed regulations. Further, the proposed safe harbor warnings are not mandatory. Adopting safe harbor warnings that are specific to cannabis and delta-9-THC exposures will give businesses an optional way to comply with Proposition 65 and provide a defense against enforcement actions. Further, the amended proposal includes a one year phase-in period, as well as an unlimited sell through period for products manufactured before the end of the one year phase-in period that are labeled in accordance with existing Sections 25602 and 25603. Both provisions will help reduce costs for businesses to comply with the new safe harbor warning regulations.
Hopefully, OEHHA is right about this where almost all potential Prop. 65 litigation is immediately settled where businesses simply do not have the funds to defend the allegations being made against them, which is why Prop. 65 has turned into a cash cow over the years for plaintiff’s attorney’s.
In any event, even though there’s unlimited sell-through and a one year grace period, cannabis businesses should be re-tooling their labels ASAP to ensure they comply with the new laws and so that they arm themselves with adequate defenses against enterprising Prop. 65 plaintiffs.
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