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What to Know About FDA’s Recent Statements on CBD

Last week FDA issued a public release on CBD titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis derived Compounds, Including CBD.”

The FDA document does not break much new ground, though it emphasizes again FDA’s concern with the safety of CBD, some of which comes from FDA’s review of the CBD-based epilepsy drug Epidiolex. FDA does not believe it has enough information about certain aspects of CBD, such as what happens if someone takes CBD daily for sustained periods. In addition, FDA specifically identifies as a potential harm the use of CBD with alcohol because of the increased risk of sedation and drowsiness, which can lead to injuries. FDA, in addition to issuing this document, sent 15 warning letters to companies marketing CBD products that FDA views as unapproved drugs primarily because of the drug like claims made for such products.

FDA appears to be on a path toward considering a regulation to allow the marketing of CBD in conventional foods or as a dietary supplement. This approach will likely take a long time—perhaps some 2-4 years—absent legislative changes that do not appear likely in an election year. In the meantime, FDA continues to view putting into interstate commerce a food to which CBD has been added or to market CBD as or in a dietary supplement as a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).




FDA Announces Public Hearing on Products Containing Cannabis or Cannabis-Derived Compounds

On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional information regarding health and safety risks, manufacturing and product quality, marketing, labeling and the sale of such products.

The FDA’s notice announcing the hearing recognizes that the regulatory landscape surrounding cannabis continues to evolve at both the federal and state levels. At the state level, 33 states and Washington, DC, allow for the medical use of marijuana and 14 additional states have medical programs limited to cannabidiol (a/k/a CBD) products. Moreover, 10 states and Washington, DC have legalized marijuana for recreational use, while 13 additional states have decriminalized recreational marijuana possession in some form.

At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334 (often called the 2018 Farm Bill), removed hemp and its derivatives from the Controlled Substances Act, so they are no longer classified as controlled substances under federal law. This has prompted an avalanche of businesses marketing products containing hemp-derived compounds – most notably CBD – in ways that the FDA views as violations of the federal Food, Drug, and Cosmetic Act. According to the FDA, many questions remain concerning the safety implications of the widespread use of these products. Therefore, the FDA seeks relevant information to inform its position in regulating the development and marketing of cannabis products. (more…)




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