Shapiro Quoted on CBD Warning Letters in Vitamin Retailer

March 31, 2021 | Rivkin Rounds Staff | Cannabis | FDA | Legislation and Public Policy

A March 26 article in Vitamin Retailer, “FDA Warns Selling of Topical CBD Products Violates FD&C Act,” discussed the two warning letters recently issued by the U.S. Food and Drug Administration (FDA) to two companies for selling topical pain relief products containing CBD. The FDA claims that the sale of the products violates the Federal Food, Drug, and Cosmetic Act (FD&C Act). Rivkin Radler’s Steven Shapiro was quoted in the article.

Steve commented, “While the warning letters discuss CBD as an inactive ingredient generally, neither warning letter discusses the potential for CBD as an inactive ingredient intended to provide a cosmetic benefit apart from the active ingredient drug indication. Is it possible to include CBD as a topical cosmetic ingredient? IS FDA changing its position?  FDA may have just made it kind of complicated. We know that there is evidence that cannabidiol has some cosmetic benefits, including as a skin conditioner. FDA has exercised enforcement discretion to permit inactive ingredients in OTC topical products to make specific cosmetic claims, and such claims are frequently made for soothing aloe or moisturizing lanolin in various topical OTC Monograph products. As with everything involving CBD, the question of CBD in topical products is another complicated question that will need to be carefully considered and closely watched.”

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