By Jeffrey H. Brochin, J.D.
Although the federal Food, Drug and Cosmetic Act (FDC Act) does not permit a private right of action for enforcement of violations of the Act, it does not preempt a state law whose requirements are identical to the FDC Act.
A federal appeals court in California has reversed the decision of the district court that dismissed a lawsuit filed by a California consumer against CVS Health Corporation (CVS) over alleged false labeling of CVS’s glucosamine supplement. The district court erred in applying the doctrine of federal preemption to the case because California’s state law was identical to that of the federal law, and as long as a state law imposes requirements identical to the FDCC Act, the Act will not preempt a consumer’s state law causes of action (Kroessler v. CVS Health Corporation, October 9, 2020, Melgren, E.).
Scientific studies refuted label claims. A California consumer representing a putative class, sued CVS under California law alleging that CVS’s glucosamine-based supplements did not provide the advertised benefits, violated California’s Unfair Competition Law (CUCL) and Consumer Legal Remedies Act, and constituted a breach of express warranty, through the use of false and misleading labels on the supplements. He based his claims on scientific studies that allegedly directly refuted the supplement labels claims that used various terms to indicate that the supplements would support and maintain joint health. CVS moved to dismiss pursuant to federal preemption, which the district court granted, and from which the consumer took the instant appeal.
Disease claims versus structure/function claims. The appeals court noted that the FDC Act distinguishes between "disease claims" and "structure/function claims" that manufacturers might make about their products, applying different regulatory standards to each. A structure/function claim, among other things, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, but such a label claim may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.
Conversely, a disease claim, is one that claims to diagnose, mitigate, treat, cure, or prevent disease, either explicitly or implicitly such as by claiming that a product treats a disease’s characteristic signs or symptoms. The FDA has published regulations defining acceptable structure/function claims that may use general terms such as "strengthen," "improve," and "protect," as long as such claims do not suggest disease prevention or treatment. For example, the claim "helps support cartilage and joint function," would be a permissible structure/function claim.
3-prong test for structure/function claims. Structure/function claims must meet three requirements: (1) the manufacturer has substantiation that the statement is truthful and not misleading; (2) the statement contains a prominent disclaimer that the FDA has not evaluated the statement and that the product is not intended to diagnose, treat, cure, or prevent any disease; and (3) the statement itself does not claim to diagnose, mitigate, treat, cure, or prevent disease. A dietary supplement manufacturer making only structure/function claims regarding its supplement must notify the Office of Nutritional Products, Labeling, and Dietary Supplements in the FDA, and as long as the manufacturer meets those requirements, it may assert structure/function claims without pre-approval from a federal agency.
Consumer’s structure/function claim. The consumer alleged that CVS lacked substantiation for its structure/function claims, and the appeals court ruled that he could sustain that claim as long as his California causes of action sought to hold CVS to standards identical to the FDC Act’s and the FDA’s implementing regulations and guidelines. The district court had ruled that the FDC Act preempts any state-law cause of action seeking to challenge the substantiation of a structure/function claim—including those where the allegations and evidence "match" the structure/function claims—as long as the manufacturer’s claims are proper structure/function claims. Because the court concluded that CVS’s glucosamine labels presented proper structure/function claims under the FDC Act, it held that the consumer’s causes of action were preempted, and, that his citations to studies alleging that glucosamine is "ineffective at supporting or benefiting joint health" ultimately did not matter.
FDA does not occupy the field. However, the appeals court found the foregoing district court reasoning to be in error by greatly expanding the present state of federal preemption jurisprudence under the FDC Act, contrary to public policy. No other circuit has held that the Act preempts any state law cause of action seeking to challenge the substantiation of a structure/function claim—where the allegations and evidence "match" the structure/function claims; rather, it is well established that "supplement makers can be sued for false claims, and no federal preemption exists under the FDC Act either by statute or by implication, since the FDA does not occupy the field and its controls are unaffected by private false advertising suits against supplement makers."
Based on the foregoing, the appeals court reversed and remanded to the circuit court.
The case is No. 19-5567.
Attorneys: Timothy G. Blood (Blood Hurst & O'Reardon LLP) for James Kroessler. Amy Pesapane Lally (Sidley Austin LLP) for CVS Health Corp.
Companies: CVS Health Corp.
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