• On June 24, the Court of Appeals of Georgia held that Plaintiff Shawn Smith’s deceptive product labeling case raised questions best left to the FDA.

• By way of background, in 2016, the FDA issued warning letters to seven companies stating that methylsynephrine used in the companies’ dietary supplements does not meet the definition of a “dietary ingredient” under the Federal Food, Drug, and Cosmetic Act (FDCA), rendering any product containing this ingredient and labeled as a “dietary supplement” misbranded. Relying on these letters, Smith sued Hi-Tech Pharmaceuticals under the District of Columbia Consumer Procedures and Protection Act for misleading consumers by “omitting that methylsynephrine is an unapproved drug that has been linked to adverse health events.” The state trial court dismissed the case with prejudice on grounds that the claims were preempted by the FDCA and raised issues within the FDA’s jurisdiction.

• On appeal, a panel of judges found that the claims were not subject to preemption. However, they affirmed the trial court’s determination that the claims fall within the FDA’s primary jurisdiction because the questions require the agency’s expert determination of dietary ingredients.  The plaintiff argued that the warning letters describe the FDA’s final position that methylsynephrine does not qualify as a dietary ingredient; however, holding that the warning letters are only “regulatory letters [that] do not constitute final agency action,” the Court of Appeals remanded to the trial court to decide whether a stay or dismissal without prejudice is appropriate.

• An attorney for the plaintiff reports that there is no indication the FDA plans to reconsider the questions at issue because there is no “pending agency action.” Keller and Heckman will continue to monitor this litigation.

Nicholas Prust, Natalie Rainer, and Frederick Stearns also contributed to this article.