Under the sponsorship of Representatives Morgan Griffith (R-VA) and Angie Craig (D-MN), congressional lawmakers recently renewed their effort to force the Food and Drug Administration’s (FDA) hand in regulating cannabidiol (CBD) products. The two proposed bills would require FDA to do what it stated in early 2023 it could not do: regulate CBD and other hemp-derived foods and dietary supplements under existing Food, Drug, and Cosmetic Act (FDCA) pathways.
The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 (HR 1629) would explicitly make hemp, CBD derived from hemp, and any other ingredient derived from hemp lawful for use as a dietary supplement, provided the product complies with all other existing requirements for dietary supplements with new dietary ingredients. The CBD Product Safety and Standardization Act (HR 1628) would add a new “Food Containing Cannabidiol Derived From Hemp” section to the FDCA, which would establish that food containing CBD derived from hemp must conform to certain existing FDCA requirements regarding approved use of food additives. It further directs FDA to issue regulations establishing:
- A maximum amount of CBD allowed per serving;
- Labeling and packaging requirements; and
- Conditions of intended use.
HR 1628 also would exempt food containing CBD from the FDCA’s prohibition on introducing foods that add an approved drug into interstate commerce.
Although introduced in the last session, these bills did not advance. Given that FDA explicitly announced it lacks the tools needed to regulate CBD under existing FDCA pathways, some think these bills may gain more momentum this session. However, since these bills attempt to fit foods and supplements containing CBD into existing FDCA frameworks, it will be interesting to see how the agency reacts to the proposals.
Why It Matters
Those selling foods or supplements containing hemp-derived CBD, or wanting to enter this market, should watch the bills’ progress closely since they represent some lawmakers’ preferred approach for regulating CBD foods and supplements in the U.S. Further, major industry groups — e.g., the U.S. Hemp Roundtable, the American Herbal Products Association, Council for Responsible Nutrition, and the National Cannabis Industry Association — endorse these bills. Were they to pass, CBD product manufacturers must become versed in existing regulations applicable to supplements and food additives and prepare their operations to comply with existing food and supplement regulations.