As cannabidiol (CBD) products—from body creams to gummies, tinctures, and facial masks—have risen in popularity, so have law enforcement and class actions targeting labeling and advertising claims. After briefly reviewing the regulatory and litigation landscape, we provide tips that, along with individualized legal review, can help avoid legal pitfalls.

Regulation of CBD Products

Under Food and Drug Administration (FDA) regulations, if a substance is an active ingredient in an approved drug or “authorized for investigation as a new drug,” then a product containing that substance normally cannot be sold as a dietary supplement. See “FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol” (current as of Jan. 22), https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd, at Ques. 9, (citing 21 U.S.C. Section 321(ff)(3)(B)) (hereinafter FDA regulation of cannabis).Similarly, FDA rules prohibit foods with active drug ingredients or drug ingredients for which substantial, public clinical investigations have been instituted. According to the FDA, because CBD is an active ingredient in the prescription drug Epidiolex, which is used to treat seizures, CBD cannot be included in dietary supplements or food. If CBD had been marketed either as a dietary supplement or a food before its use in Epidiolex, then it could continue to be marketed that way. However, the FDA has taken the position that it is unaware of CBD being previously marketed in either form.

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