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Senators Ask FDA to Update Federal Regulations Governing Use of CBD in Food, Beverages, and Dietary Supplements

  • As previously reported on this blog, the Agriculture Improvement Act (also known as “the 2018 Farm Bill”) removed hemp from the Controlled Substances Act, which means it is no longer an illegal substance under federal law.  However, the 2018 Farm Bill does not affect FDA’s authority to regulate derivatives of cannabis (e.g., CBD) or other hemp products, or change the regulatory requirements for such materials in FDA-regulated products like food, dietary supplements, cosmetics, or drugs.  As previously mentioned, FDA released a statement clarifying their position on the use of cannabis or cannabis-derived compounds in food and dietary supplements.  In sum, it is still illegal to sell a food or dietary supplement that contains added CBD or THC in interstate commerce.

  • In a January 15, 2019 letter to FDA Commissioner Scott Gottlieb, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) urged the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements. The Senators state that “outdated regulations limits producers from taking full advantage of the industrial hemp market by, for example, prohibiting food products containing CBD from being sold across state lines.”  The Senators note there has been increasing widespread public interest in the production and use of CBD, and that farmers in both Oregon and nationwide are poised to make substantial economic gains should the regulations be updated.

  • As of the time of this blog’s publication, the government has been partially shutdown for 33 days. The Senators recognize that FDA is therefore operating with limited staff, and thus conclude the letter with a request for FDA’s response to the following set of questions within 30 calendar days of the government reopening:

  1. What steps are the agency advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?

  2. What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverages or dietary supplement, including into interstate commerce?

  3. Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverages or dietary supplement by the agency?

  4. With the agency consider issuing a regulation, or pursuing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages or dietary supplements that cross state lines?
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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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