October 21, 2019

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FDA Reiterates That Scientific Data and Safety Information are Required to Support a Regulation or Formal Enforcement Discretion Policy on the Use of CBD in Foods

Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Industry wants FDA to create an exception by regulation to the FD&C Act prohibition that currently makes it illegal to add CBD to a food or market CBD as a dietary supplement.  Some would alternatively be satisfied with a formal nonenforcement policy from FDA on the statutory prohibition.

At a May 31, 2019 meeting, discussed in this blog, FDA pointed out that it has never issued a regulation to create an exception to the statutory prohibition against the use in food of a substance that has been approved as a drug.  Confirming there is no policy of enforcement discretion with respect to the use of CBD, FDA also remarked on a lack of research to support the safety of CBD for use in food and dietary supplements.  The docket, FDA-2019-N-1482, solicits information on safety (including whether there is a threshold level that could appropriately be considered safe for), manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

A June 14, 2019 statement by Dr. Amy Abernethy, FDA’s Principal Associate Commissioner for Policy, reiterates that outstanding questions related to the safety of CBD products must be addressed before a regulatory framework can be established for lawfully marketing foods and dietary supplements containing CBD.  Dr. Abernathy indicated that upon review of the docket (which she indicated may remain open past the current July 2, 2019 deadline for comments), FDA will identify gaps and examine “how additional research can be performed quickly and efficiently to address critical questions about the safety and effectiveness of CBD.”

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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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