California's Office of Environmental Health Hazard Assessment’s (OEHHA) announced on March 15, 2019, that it is collecting public comments regarding the inclusion of cannabis on the Proposition 65 list of substances known to cause birth defects. Such a finding by OEHHA would require those in the California cannabis industry to change their warning labels, informing users of the risk of birth defects.

One of the many challenges facing the cannabis industry is ensuring compliance with a state’s evolving labeling and warning requirements. Manufacturers, distributors and retailers in the California cannabis industry may have to anticipate further changes in light of the State developing new information about cannabis and related products.

As background, the California Safe Drinking Water and Toxic Enforcement Act of 1986 (often know as Proposition 65 or Prop 65) requires manufacturers, distributors and retailers to post a “clear and reasonable” warning on products or packaging that contain certain regulated carcinogens (causing cancer) or reproductive toxicants (causing birth defects). Products containing these chemicals are not banned – but warnings are required prior to individuals being exposed to the chemicals. At the moment, over 900 chemicals are regulated under Prop 65.

California announced on March 15, 2019, it is taking public comments on whether cannabis related products should carry warning labels indicating potential linkage to birth defects. Specifically, the California OEHHA announced it is inviting comments from interested parties to determine whether Marijuana, Marijuana Smoke, Cannabis Extracts, and Δ-9-Tetrahydrocannabinol (THC) cause “developmental toxicity,” which would result in manufacturers and retailers posting new warnings on such products.

Prop 65 should not be a new concept to those in the California cannabis industry as Marijuana smoke was added to the Prop 65 substance list on June 19, 2009, after OEHHA determined that marijuana smoke was “clearly shown, through scientifically valid testing … to cause cancer.” Additionally, a number of Prop 65 labeling requirement updates took effect on August 31, 2018, forcing many in the industry to alter their labels and warnings.

This new study by OEHHA could result in a broader impact in two ways:

  • First, it expands the list of potentially covered products from marijuana smoke to marijuana and products containing cannabis extracts.
  • Second, the warning language for “cancer and reproductive toxicity” differs from warnings only for cancer, which would require changes in packaging and communications between not only commercial parties, but also ultimately between commercial parties and consumer end-users.

OEHHA is providing the public with an opportunity to provide information relevant to the assessment of developmental toxicity until Monday 29 April 2019. Public comments can be submitted at: oehha.ca.gov.

Reed Smith attorneys focused on the cannabis industry and Proposition 65 are closely monitoring this development as it may dramatically alter the language of compliant warning labels and greatly expand the scope of products requiring compliance with Prop 65. Penalties for failing to comply with the warning requirements can include monetary sanctions of up to $2,500 per day and per exposure, as well as awarding attorneys fees to private citizens who frequently bring Prop 65 claims on behalf of the public as “private attorney generals.”