The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions1 released a formal Request for Information (RFI) to the public on July 27, 2023, to gather views about the regulatory pathway for hemp-derived CBD products.
The RFI provides an opportunity for companies, researchers and other stakeholders to register their views with federal policy makers as they seek to develop a new market pathway for CBD in dietary supplements. Until now, the U.S. Food and Drug Administration (FDA) has said it is illegal for manufacturers to sell dietary supplements containing CBD as the Food, Drug and Cosmetic Act (FDCA) prohibits the marketing of a supplement if it contains a substance that is an active ingredient in an approved drug or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. These conditions are true for CBD.
FDA's enforcement of the prohibition to market CBD products has been inconsistent, and the industry, including manufacturers and retailers, has asked for clarity around the pathway to legal marketing. FDA determined it cannot act alone and requested a legislative approach. Congressional healthcare leaders seek the public's input on the best way to create a legal pathway to market CBD products that "prioritizes consumer safety and provides certainty to the U.S. market." The RFI comes from the bipartisan leadership of the committees with jurisdiction over FDA in both the U.S. House of Representatives and U.S. Senate, making it a significant first step in a bipartisan and bicameral effort to clarify the federal rules around legal marketing of CBD. Therefore, responses will be reviewed by those policymakers who will be drafting any statutory changes.
On Jan. 26, 2023, FDA issued a statement saying a new regulatory pathway for CBD is needed and that FDA would work with Congress to make the appropriate statutory changes. In doing so, FDA explicitly rejected the request from some stakeholders that it use a regulatory process to allow the marketing of CBD products as dietary supplements. FDA's action meant that Congress needed to step in to enact changes to federal law.
Following FDA's statement, in March 2023, members of Congress re-introduced legislation meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food additives. For example, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act and the CBD Product Safety and Standardization Act were sponsored by Reps. Morgan Griffith (R-Va.) and Angie Craig (D-Minn.).
The RFI is comprehensive and asks a series of questions, including:
- seeking comments on the concerns FDA has raised with regard to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics) and FDA's view that there is a need for a new regulatory pathway for CBD products
- how Congress or FDA should identify appropriate limits for tetrahydrocannabinol (THC) and other cannabinoids in finished products, how a framework should account for "total THC," including THC acid (THCA), in FDA's regulation of intermediate and finished products, and whether FDA should regulate the manufacture and sale of "semisynthetic derivatives" or "biosynthetic cannabinoids" which are still scheduled under the CSA
- what is currently known about the safety and risk-benefit profile of CBD and other hemp derived cannabinoids and what safety and toxicity data are available to support this knowledge
- what actions, if any, should the federal government take to better understand the potential benefits or harms of CBD products and other cannabinoids
- how a new framework for CBD products should balance consumer safety with consumer access
- what types of claims should product manufacturers be permitted to make about CBD products and how such permitted claims compare to the types of claims that may be made about drugs, foods, dietary supplements and cosmetics
Responses to the RFI must be submitted by Aug. 18, 2023. Congress will review the information it receives to craft legislation, likely later this fall.
1 The RFI was published by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Ranking Member Frank Pallone, Jr., (D-N.J.), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy, M.D. (R-La.).