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CBD in Foods: FDA Requests More Safety Data; Industry Wants Clear Regulatory Path

  • Under current law, cannabidiol (CBD) cannot lawfully be added to a food or marketed as a dietary supplement, Acting FDA Commissioner, Ned Sharpless, MD, emphasized during remarks he made at a public hearing on products containing cannabis or cannabis-derived compounds. FDA held the meeting on May 31, 2019, to obtain scientific data and information about the safety of FDA-regulated products containing these compounds.

  • As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in the drug EPIDIOLEX, the Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits adding it to a food or a dietary supplement.

  • Dr. Sharpless pointed out that while the law allows FDA to issue regulations to create exceptions to the statutory provisions, “FDA has never issued a regulation like that for any substance.” He added that if the Agency were to pursue this course “it would be new terrain for the FDA.” He also expressed concern about the lack of research to support CBD’s broader use in FDA-regulated products, including food and dietary supplements. Dr. Sharpless suggested that this lack of research has resulted in unique complexities for its regulation, including many unanswered questions related to its safety, such as how much CBD is safe to consume in a day or if it will interact with other drugs that a person is taking.

  • Industry suggested that FDA could either issue a regulation permitting CBD as a lawful ingredient in foods and supplements or issue guidance stating that it intends to exercise “formal enforcement discretion with respect to the provisions of the FD&C Act on which FDA bases its position that CBD-containing supplements and foods are unlawful.” (See comments by American Herbal Products Association President Michael McGuffin.) However, Dr. Sharpless noted that FDA “does not have a policy of enforcement discretion with respect to any CBD products.”

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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...