Cannabis Regulation Update: FDA Announces Public Meeting on Cannabis; FDA and FTC Issue Warning Letters to Manufacturers of CBD Products; Proposal to Add Cannabis Extracts and THC to Proposition 65

This post summarizes several regulatory developments related to cannabis and cannabisderivatives, including cannabidiol (CBD). The Food and Drug Administration (FDA) recently announced it will hold a public meeting on May 31, 2019 and open a docket for public comments to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. FDA, in coordination with the Federal Trade Commission (FTC), also issued three Warning Letters to companies marketing CBD products positioned as foods and dietary supplements.

The Warning Letters explain that FDA determined these products are unapproved new drugs, while the FTC indicated that efficacy claims appearing in these products’ advertising may not be substantiated by competent and reliable evidence. Finally, California’s Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed to include THC and “cannabis extracts” on the Proposition 65 list of developmental toxicants. We discuss each of these developments in further detail.

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