Last week the U.S. Food and Drug Administration (FDA) held a 9-hour public hearing on the issues surrounding its potential regulation of hemp-derived cannabidiol, more commonly referred to as CBD. The panel heard from over 100 speakers, running the gamut from academics, cannabis trade associations and manufacturers, to state officials, members of the agricultural community, patients and anti-marijuana groups.
While many in the highly-lucrative cannabis industry have been hoping for quick action from the FDA in the resolution of complex legal issues surrounding CBD regulation, particularly in light of the recent passage of the 2018 Farm Bill and FDA’s approval last year of Epidiolex, the first FDA-approved drug containing CBD, the May 31 hearing, and the sheer number of issues raised, suggests that guidance from FDA may still be a fair distance away.
During the course of the hearings and information-gathering process, the FDA panel’s questions focused on several key issues that serve to highlight to primary areas of concern for FDA’s CBD Working Group.
- Health risks associated with CBD and other cannabis-derived products. The panel repeatedly questioned speakers regarding the safety and efficacy of CBD and requested data to back up claims from some speakers that CBD has been “proven” to be safe. The panel also called upon stakeholders to provide information regarding the presence of heavy metals, pesticides and other potential contaminants in CBD products.
- Proper dosing and delivery methods of CBD products. Testimony from speakers regarding the theoretical establishment of dosing requirements, in general and as affiliated with varying delivery methods (i.e. edible producing, vaping, topical application) was inconsistent. FDA requested more data from stakeholders on this issue.
- Proper labeling. Associated with the dosing issue is the proper labeling of CBD products and the lack of any clear rules.
- The creation of a balanced regulatory scheme that takes into consideration both dietary supplements and prescription drug development. FDA is aware that it must somehow address the growing demand for safe dietary supplements containing CBD with concerns that the supplement market may negatively impact the development of prescription-level CBD-derived drugs.
- Safety issues for “vulnerable” groups. Among the many unknowns, FDA is concerned with the effects of CBD exposure on vulnerable populations such as children, pregnant women and the elderly.
As discussed in our April Client Alert, “FDA Schedules hearing on Cannabis Regulation,” under current rules, it remains unlawful to market any food or dietary supplements containing CBD, let alone make specific claims regarding CBD’s effectiveness in treating diseases such as cancer or Alzheimer’s, and companies making such claims run the risk of legal action by the government, up to and including product seizure and injunction. Those involved in the CBD industry should remain aware that at this time, none of that has changed, and pending resolution of the issues raised at the hearing the rules remain the same.
For any questions related to the content of this alert, or the regulation of CBD products in general, please contact any member of the FisherBroyles Pharmacy and Health Care Law team.