Today’s case – Smith v. Hi-Tech Pharmaceuticals, Inc., — S.E.2d –, 2022 WL 2285920 (Ga. Ct. App. Jun. 24, 2022 — does not break new ground. But it is a published decision by a state appellate court and for that reason, it deserves some attention.
Plaintiff, a resident of Washington, DC, brought a single claim under the District of Columbia Consumer Procedures and Protection Act (“DC CPPA”) alleging that defendant manufactured dietary supplements containing methylsynephrine which plaintiff claims is an unapproved drug ingredient. By omitting that fact, plaintiff alleges defendant’s labeling was misleading. Id. at *1. The trial court dismissed the claim as both impliedly preempted under Buckman and as raising issues that are within the primary jurisdiction of the FDA. Id. at *2. The Georgia Court of Appeals disagreed on preemption but agreed on primary jurisdiction.
While a ruling against preemption is disappointing, the holding is narrowly tailored to the DC consumer fraud statute and dietary supplements. First the court discussed express preemption. The labeling of dietary supplements is governed by an amendment to the FDCA known as the Nutrition Labeling and Education Act (“NLEA”). NLEA contains an express preemption clause prohibiting states from establishing any labeling requirement that is not identical to the requirements of the NLEA. Id.at *3. However, if the state law requirements mirror or parallel the federal requirements, it is not preempted. It is a violation of the DC CPPA to misrepresent or fail to state a material fact. Id.at *4. Similarly, while the FDA’s authority over dietary supplements is more limited than over drugs and devices, the FDCA does require supplement labels to be truthful and not misleading. Since both acts require the labeling of dietary supplements not to be misleading, the court found the claims were parallel and therefore, the federal act did not expressly preempt the state act. Id.at *5.
On implied preemption, the trial court relied on Buckman to find that plaintiff’s attempt to enforce the FDCA was preempted. Not surprisingly, most of the cases relied on by defendant regarding Buckman involved medical devices or OTC drugs – products subject to stricter FDA requirements and control than dietary supplements. The appellate court found Buckman inapplicable to dietary supplements because of the NLEA’s express savings clause: “The NLEA shall not be construed to preempt any provision of State law, unless such provision is expressly preempted.” Id. That’s pretty much the only reason Buckman did not apply.
Fortunately, that did not end the inquiry. “Primary jurisdiction is a judicially created doctrine whereby a court of competent jurisdiction may dismiss or stay an action pending resolution of some portion of the actions by an administrative agency.” Id. at *6 (citation omitted). In other words, if a court finds that there are technical or policy questions that should be addressed first by the regulatory agency with authority over the industry, the court has discretion to defer to the agency. Here, the primary questions were whether methylsynephrine is a dietary ingredient as that term is defined by the FDCA and whether it was safe, and at what dosages. Plaintiff argued that FDA had already decided the question based on warning letters it issued. But as many other courts have also ruled, warning letters are not final agency action and therefore not conclusive. Id.at *8. Therefore, the court did not abuse its discretion in invoking the primary jurisdiction doctrine.
Without preemption, the court’s dismissal with prejudice was overturned, but the case has been remanded to the trial court to decide whether a dismissal without prejudice or a stay pending FDA action is appropriate. Either way the case will await a final agency action, which could moot the issue or send case back for round two on preemption.