The U.S. Food and Drug Administration (“FDA”) currently takes the position that cannabidiol (CBD) and other cannibinoids cannot be used in dietary supplements and food because of statutory provisions under the Federal Food, Drug, and Cosmetic Act (“FDCA”) that prohibit the sale of products containing an ingredient treated as a drug or involved in clinical trials. Since CBD was the subject of clinical investigations that led to the approval of the drug Epidiolex® (cannabidiol), CBD added to food or dietary supplements may not be legally sold.
When the Federal Agricultural Improvement Act (“Farm Bill”) was signed into law in December 2018, then-FDA Commissioner Scott Gottlieb issued a statement recognizing the public interest in hemp and CBD, but cautioned that, despite the Farm Bill’s passage, Congress had “explicitly preserved the [FDA’s] current authority to regulate products containing cannabis or cannabis-derived compounds.” Additionally, he noted that “it is unlawful to introduce food containing added CBD . . . into interstate commerce, or to market CBD  products as dietary supplements.”
This past week Gottlieb and other experts suggested FDA take interim steps to allow CBD in food and dietary supplements as the Agency’s standard notice-and-comment process for developing a new regulatory pathway may take too long.
As Gottlieb notes, “[t]he CBD craze is getting out of hand [and] FDA needs to act.” He suggested utilizing the current process of submitting new dietary ingredient notifications (“NDIN”) or food additive petitions. Yet, both the NDIN and food additive petition processes are fraught with hurdles requiring clinical and scientific research. Meanwhile, Gottlieb suggests, “FDA could exercise enforcement discretion to allow CBD to be marketed in food as long as the products meet good manufacturing practice requirements . . . adhere to safe levels for purity and potency . . . and demonstrate that CBD has been added in low concentrations that are unlikely to pose health risks.”
In a series of tweets released mid-July by FDA Principal Deputy Commissioner and Acting Chief Information Officer, Amy Abernathy, the Agency is “expediting” its work towards addressing the uncertainty surrounding regulation of hemp-derived CBD. She also stated that the FDA plans to report on the Agency’s progress around end of the summer or early fall.