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.
Re-published with the permission of Harris Bricken and The Canna Law Blog
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