Almost on a weekly basis, clients ask our California cannabis attorneys to review and provide advice and guidance on their packaging and labeling for their cannabis and cannabis products pursuant to California’s Medicinal and Adult-Use Cannabis Regulation and Safety Act (MAUCRSA). This means that our California cannabis attorneys have committed to memory the applicable packaging and labeling rules set forth under MAUCRSA and by the California Department of Food and Agriculture (CDFA) and the California Department of Public Health (CDPH). Between the two, CDFA deferred to CDPH on packaging and labeling for flower, and CDPH really only regulated packaging and labeling for cannabis infused products under the emergency rules. The packaging and labeling rules are not rocket science, but they’re immensely important for MAUCRSA compliance and consumer safety. However, none of the CDPH regulations or even MAUCRSA mention the applicability of Proposition 65 to California cannabis and cannabis products.
In addition to reviewing countless packaging and labeling content under MAUCRSA, our California marijuana business lawyers have also done a good amount of clean up of non-compliant packaging and labeling related to poor or uninformed legal advice regarding how Prop. 65 applies in the context of California cannabis. Failure to comply with Prop. 65 usually means disaster for the unwary business owner, ranging from costly and aggressive lawsuits to being shut down by the state.
The Safe Drinking Water and Toxic Enforcement Act of 1986 (a/k/a Prop. 65), requires the Office of Environmental Health Hazard Assessment (OEHHA) to publish a list of chemicals known to cause cancer, birth defects or other types of reproductive harm. The list now includes more than 1,000 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 Prop. 65 warnings since all flower contains/produces “marijuana smoke.” In addition, oils, wax, vapes, etc. usually contain at least one chemical on OEHHA’s list. Given this fact, there is hardly a cannabis business in California that won’t find itself subject to Prop. 65 warning requirements at some point. And none of the state agencies in charge of MAUCRSA are going to assist licensees in figuring out what they need to do to protect themselves under Prop. 65.
The first question cannabis businesses need to ask themselves in a Prop. 65 analysis is whether they’re subject to Prop. 65 at all. Who’s exempt? It’s a short list:
- Businesses with fewer than 10 employees and government agencies.
- Businesses are also exempt from the warning requirement “if the exposures they cause are so low as to create no significant risk of cancer or are significantly below levels observed to cause birth defects or other reproductive harm.” How low you ask? The exposure levels are different for each chemical type–for cancer causing chemicals, for example, no warning is required if the chemical exposure is calculated to result in “not more than one excess case of cancer in 100,000 individuals exposed over a 70-year lifetime.” You can find the Prop. 65 allowable exposure levels here.
Availing yourself of this second exemption is going to be very difficult, complex, and expensive to prove. It likely isn’t worth it if you even think you’re close to exceeding the allowable exposure levels.
Once you determine that Prop. 65 applies to you, you then need to identify the type of warning you need based on your product(s) and the relevant chemicals. And to really throw in a twist, you should know that new Prop. 65 regulations take effect on August 30, 2018. In turn, only the new safe harbor warnings should be used for products manufactured on and after August 30, 2018 (though you can still use the old September 2008 safe harbor warnings for product made before that date).
One of the most important changes with the new regulations is that you now need to actually identify at least one triggering chemical depending on the type of harm caused by that chemical. Specifically, OEHHA mandates that:
If, for example, there are five possible chemical exposures from a given product, and all five chemicals are listed only as carcinogens, then the business would only be required to name one of those five chemicals in the warning. . . If there are exposures to both carcinogens and reproductive toxicants, a business would be required to name one of the chemicals that is a carcinogen and one of the chemicals that is a reproductive toxicant, but the business could choose to identify more chemicals in the warning.
In turn, your new Prop. 65 warning will look like one of the following (plus the required symbol at the beginning and to the left of the warning):
- For carcinogens: “WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”
- For reproductive toxicants: “WARNING; This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
- For exposures to both listed carcinogens and reproductive toxicants: “WARNING; This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
- For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant: “WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
In certain circumstances, short-form warnings for consumer products are allowed so long as minimum font requirements are met. Specifically, in addition to other content requirements, the short-form warning must be “in a type size no smaller than the largest type size used for other consumer information on the product and in no case in a type size smaller than 6-point type.”
Unfortunately, I still see cannabis products floating around that completely ignore or bungle Prop. 65 requirements, making these businesses sitting ducks for bounty-hunter plaintiffs and their attorneys. You’ve really only gone halfway in your MAUCRSA packaging and labeling analysis if you haven’t considered whether Prop. 65 applies to your business and what you need to do to duck in under the safe harbors. So, double check whether Prop. 65 applies to you and what you need to do to protect your business to ensure that you’re not on the wrong end of any Prop. 65 litigation.