FDA Exploring Additional Regulatory Pathways for CBD Products
In testimony before the U.S. Senate Committee on Agriculture, Nutrition, and Forestry on July 25, FDA’s Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., reiterated that FDA “is committed to advancing hemp products through the Agency’s existing regulatory pathways.” She added that the Agency is “further exploring whether it would be appropriate to make additional regulatory pathways available to hemp products such as those containing cannabidiol (CBD).” However, she did not provide any details on those pathways.
While any CBD food or purported dietary supplement products in interstate commerce is a violation of the Food, Drug, and Cosmetic Act (FD&C Act), FDA’s biggest concern in the marketing of CBD products is with unsubstantiated therapeutic claims to prevent, diagnose, mitigate, treat, or cure serious diseases, Dr. Abernethy told the Senate Committee. She noted several additional concerns, which are described below.
Lack of good manufacturing practices (GMPs) in the production of these products since laboratory analysis have shown that some of the CBD products on the market do not contain the amount of CBD that was listed on the label and confirm the presence of substances, such as THC, not listed on the label.
The use of CBD in non-drug products will have wider distribution than its use in drugs, to include sensitive populations.
The possibility that allowing CBDS to be marketed as a dietary supplement or in a food will deter clinical research to substantiate additional therapeutic uses for cannabis-derived compounds.
As previously reported on this blog, FDA held a public hearing on May 31, 2019, to obtain scientific data and information about the safety of FDA-regulated products containing CBD. FDA opened a public docket to collect comments as part of that hearing. The Agency received 4,492 comments by the time the docket closed on July 16, 2019. In a July 23 press release concerning a warning letter that FDA sent to a company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety, Dr. Abernethy explained that FDA remains committed to evaluating the Agency’s regulatory policies related to other types of CBD products. With respect to a timeline, she stated, “We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD.” Keller and Heckman attorneys are well versed on the regulation of CBD and other cannabis-derived products.