On April 2, 2019, the Federal Food and Drug Administration (FDA) issued a statement and announced a public hearing on consumer products derived from cannabis and its components, including cannabidiol (CBD). Recognizing the need to provide clarity on the authority of FDA to regulate these products, and what pathways are available for marketing them, the agency outlined its next steps:
- A public hearing will be held on May 31, and written comments are being sought from the public.
- FDA is forming 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 possible changes in existing laws. The working group plans to begin sharing information and/or findings with the public as early as Summer 2019.
- Frequently asked questions on FDA’s webpage will continue to be updated to address this subject.
- FDA will continue to issue warning letters to companies marketing CBD products, in particular those making what FDA characterizes as “egregious and unfounded claims that are aimed at vulnerable populations.”
The FDA statement noted that products containing cannabis and cannabis derivatives (such as CBD) are currently being marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things. The agency pointed out that attention to these products increased after passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill). The 2018 Farm Bill established “hemp” as a new classification of cannabis – and defined hemp 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). Although the 2018 Farm Bill removed hemp from regulation under the Controlled Substances Act, Congress retained the FDA’s authority to regulate these products under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. At that time, the FDA issued a statement explaining the agency’s approach to these products.
FDA also announced that it had issued warning letters, in collaboration with the Federal Trade Commission, to three companies, alleging that they made unsubstantiated product claims on product webpages, in online stores, and on social media websites, including the purported ability to limit, treat or cure: cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases. The subject products included oils, salves, gummies, and CBD for dogs.
The FDA statement clarified the agency’s commitment to “protect consumers from companies illegally selling CBD products that claim to prevent, diagnose, treat, or cure serious diseases, such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes.” This includes continuing to monitor the marketplace and taking enforcement action in these cases. At the same time, FDA emphasized the countervailing goal of “exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under [its] authorities to lawfully market these types of products.” The FDA acknowledged in the statement that it could take “some time” to fully resolve the pathways available for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.