In response to the growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD), FDA announced steps and actions it is taking to advance the consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under its existing authorities.
Products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, cosmetics, all fall under FDA authorities, and stakeholders are looking to the FDA for clarity on its authorities, the pathways available to market such products lawfully, and FDA-related public health and safety protections. As the agency explains, interest in these products increased last December when Congress passed the Agriculture Improvement Act of 2018 (the 2018 Farm Bill). Among other things, this law established a new category of cannabis classified as “hemp” – defined as cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The 2018 Farm Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law. At the same time, Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.
When the 2018 Farm Bill became law, Commissioner Scott Gottlieb issued a statement explaining FDA’s current approach to these products and its intended next steps. Consistent with the approach and commitments described in that statement, FDA is now taking the following steps:
- A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
- The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
- Updates to its webpage with answers to frequently asked questions on this topic to help the public understand how the FDA’s requirements apply to these products.
- The issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.
For more information on each of these, see Gottlieb’s statement.