Last week, FDA submitted to Congress the report on CBD (“CBD Report”) that the agency was directed to prepare by the Further Consolidated Appropriations Act, 2020. Concurrently, the Commissioner issued a statement that summarizes the agency’s progress to date, and a consumer update that emphasizes the agency’s safety-related concerns. Altogether, the documents suggest that greater clarity on the regulatory path for some categories of CBD products is not on the near horizon.
At the heart of FDA’s difficulty in discerning that path is insufficient scientific data regarding the safety of CBD. The agency cites several potential risks that have come to light thus far (e.g., livery injury, drug-drug interactions, and possible male reproductive toxicity), and points to numerous questions that remain unanswered, particularly with respect to the potential effects of sustained use. Although FDA is conducting or sponsoring some research, the agency is reiterating its call for submission of data to the docket established in connection with the public hearing held last May. Yesterday, the agency issued a notice of the reopening of that docket for an indefinite time to facilitate submission of “data that may help to address uncertainties and data gaps related to the CBD.” FDA’s wish list is long, and includes studies that address:
- risk of liver injury
- toxicities of active metabolites
- impact on the male reproductive system
- effect of co-administration with other substances, including medicines, alcohol, and dietary supplements
- impact on neurological development
- sedative effects
- transdermal penetration and pharmacokinetics
- safety of long-term or cumulative exposure, including in vulnerable populations
- effects of different routes of administration on CBD’s safety profile
- effect on food and non-food producing animals
- potential for bioaccumulation
In the interim, FDA acknowledges in its CBD Report that the horse – neigh, the entire herd – has left the barn, with a “vast proliferation of CBD consumer products” since passage of the 2018 Farm Bill. FDA continues to view CBD products that make therapeutic claims as posing the greatest risk to public health, but also expresses “serious concerns” about contaminants such as heavy metals and THC, false claims pertaining to composition or levels of CBD, and marketing to vulnerable subpopulations such as children. As a potential next step, FDA is considering the issuance of a “risk-based” enforcement policy; however, that policy “would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway.” In other words, even that won’t be easy – or quick.