Regulation of Products Containing Cannabis and Cannabis-Derived Compounds
Immediately following the 2018 Farm Bill being signed into law, the U.S. Food and Drug Administration issued a statement on CBD products intended for human consumption.
The December 20, 2018 statement from FDA Commissioner Scott Gottlieb, M.D. first recognizes that the Agricultural Improvement Act of 2018 changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis and derivatives of cannabis, with less than 0.3 percent – on a dry weight basis – concentrations of TCH. In other words, hemp has been removed from the Controlled Substances Act and is no longer an illegal substance under federal law.
However, any cannabis plant that contains more than 0.3 percent THC will be considered non-hemp cannabis – or marijuana – under federal law and would thus face no legal protection.
While this new legislation is a victory for the hemp industry and its service providers, it has not impacted the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds, including cannabidiol (CBD).
Unapproved and Unsubstantiated Drug Claims
The FDA remains concerned about the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. As a general rule, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which the FDA holds any product marketed as a drug for human or animal use.
Marketing claims that such products are intended to diagnosis, cure, mitigate, treat or prevent diseases must not only go through the FDA drug approval process, they must be adequately substantiated or face Federal Trade Commission enforcement wrath.
Marketing as Dietary Supplements
The use of CBD as an ingredient in foods and supplements comes with very real exposure to regulatory enforcement and other liability. The Federal Food, Drug and Cosmetic Act makes it unlawful to introduce drug ingredients like CBD or THC into the interstate food supply, or to market them as dietary supplements, regardless of whether the substances are hemp-derived.
The FDA previously sent warning letters to companies unlawfully selling CBD products that claimed to prevent, diagnose, treat or cure serious diseases. Some of these products were also in violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
Of course, some foods are derived from parts of the hemp plant that may not contain CBD or THC. Their addition to foods might not raise the same issues as the addition of CBD and THC.
FDA and Marijuana FAQs
The recent FDA statement was no doubt issued to clarify its regulatory authority over cannabis and cannabis-derived substances, which shall continue to be subject to the same authorities and requirements as FDA-regulated products containing any other substance.
The FDA maintains a website with answers to frequently asked questions, which will be updated moving forward to address questions regarding the Agriculture Improvement Act and related regulation.
Although products containing cannabis and cannabis-derived compounds remain subject to the FDA regulation, the Commissioner made clear that pathways exist for those that wish to lawfully introduce these products into interstate commerce. This is a very clear signal that the FDA recognizes the public interest in CBD-infused products and the CBD market.
If you are interested in learning more about this topic, including how to minimize risk in conjunction with related advertising campaigns, work with an experienced cannabis and CBD advertising lawyer prior to disseminating promotional materials or releasing products into commerce.
Richard B. Newman is an advertising law attorney at Hinch Newman LLP. Follow him on Twitter.
Attorney Advertising. For informational purposes only. Not legal advice.