Key Takeaways:

  • FDA is seeking assistance from Congress to create a new regulatory pathway that is better designed to regulate products that contain cannabidiol (CBD).
  • In the interim, CBD products (including dietary supplements, conventional foods, and animal foods) on the market are at risk of FDA enforcement as the agency deems "appropriate."

The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol (CBD) products, including products currently marketed as conventional foods and dietary supplements as well as products marketed for animal use. Few details were provided about the proposed pathway. Although not discussed in the announcement, cosmetics and/or inhalable products containing CBD could be included in the new regulatory regime.

According to the statement, FDA intends to work with Congress to develop a new pathway that would be better suited for CBD products, rather than engage in rulemaking that would allow CBD to be used in dietary supplements or conventional foods. The impetus for this decision is in part due to concerns about the safety of long-term use of CBD. In connection with this announcement, FDA denied three citizen petitions requesting that the agency engage in rulemaking to establish regulations under which CBD derived from hemp could be legally marketed as a dietary ingredient in foods and dietary supplements. (See, citizen petitions from Council for Responsible Nutrition (CRN), Consumer Health Products Association (CHPA), and Natural Products Association (NPA).) If legislation is passed, FDA's oversight over the use of other forms of hemp-derived cannabinoid products, such as Delta-8 tetrahydrocannabinoil (THC), in food, supplements, and other FDA-regulated products could also be addressed.

The new regulatory pathway could potentially include risk management tools, such as tailored labeling requirements, prevention of contaminants, limits on CBD content, and risk mitigation strategies such as age limitations. Until this pathway is developed, however, FDA will continue to enforce against CBD and other cannabis-derived products "when appropriate." All CBD products on the market in the interim are therefore at risk, but if history is a guide, FDA's enforcement priorities will primarily focus on products that make therapeutic claims.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.