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FDA Announces New Steps to Advance Regulatory Framework for CBD Products

  • Interest in products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD) has been high for the past couple of years and only increased when Congress passed the 2018 Farm Bill in December 2018.  Among other things, the law established a category for “hemp,” defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., CBD) with extremely low (less than 0.3% on a dry weight basis) concentrations of THC. The changes included removing “hemp” from the Controlled Substances Act, which means it will no longer be an illegal substance under federal law.

  • However, FDA’s authority to regulate CBD or other hemp products did not change with the passage of the 2018 Farm Bill and significant public interest in this area has pushed the Agency to explain its current approach to these products and its intended next steps.  FDA issued a statement in December 2018 repeating its long-held position that it is illegal to use CBD in food and supplement products because CBD is an active ingredient in an approved drug product (Epidiolex) and has been the subject of publicly-disclosed clinical investigations.  Further confusing matters, however, outgoing FDA Commissioner Scott Gottlieb announced during testimony to the Senate Appropriations Committee on March 28, 2019 that FDA was exercising “enforcement discretion” and not taking action against CBD-containing products unless they make “over-the-line claims” (as reported here and here).

  • On April 2, 2019, FDA released a statement from Commissioner Gottlieb that announces several next steps:

    • public hearing will be held on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.

    • The Agency will create a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD and other cannabis-derived ingredients to be lawfully marketed, including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.

    • The Agency will update its webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.

  • In addition to the above, FDA announced that it has issued warning letters to three companies in response to their making unsubstantiated claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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