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First Circuit Reinstates Consumer Action Previously Dismissed on FDCA Preemption Grounds


In 2014, Ronda Kaufman brought a proposed nationwide class action against drug store giant CVS alleging that the labeling of its Vitamin E supplements misled consumers about heart health benefits. Kaufman's complaint, among other causes, alleged violation of the New York Consumer Protection Act (NYCPA) which makes unlawful "[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service."

The label of the CVS-branded supplement in question featured four relatively straight-forward structure/function claims that Vitamin E:

  1. "supports antioxidant health;"
  2. helps "maintain healthy blood vessels;"
  3. "supports heart health;" and
  4. "supports the immune system."

Kaufman alleged that she was misled by some of these claims, particularly the "heart health" claim, believing the supplement she purchased would reduce her risk of heart disease when it, in fact, does not.

In January 2016, the United States District Court for the District of Rhode Island, in Kaufman v. CVS Caremark Corp., dismissed Kaufman's complaint with prejudice on the basis that federal law preempts Kaufman's claims under the Federal Food Drug and Cosmetic Act (FDCA).

On Tuesday, September 6, 2016, the First Circuit in Kaufman v. CVS Caremark Corp., reversed the district court's decision and held that Kaufman's complaint plausibly alleged that the label claims in question were misleading in a manner that violated the FDCA, thus federal preemption did not prohibit Kaufman's right to seek redress at the dismissal stage. Importantly, the decision keeps alive the growing notion that, in certain instances, product substantiation standards – thought to be exclusively within the province of federal regulatory agencies – may be challenged under state unfair competition laws.

In so holding, the First Circuit recognized that compliance with the FDCA provides a complete defense to suit, but that neither the FDCA nor any state law poses any bar to recovery under the NYCPA to the extent that recovery is predicated on a failure of a dietary supplement label to comply with the requirements of the FDCA. In other words, the Court held that CVS only enjoys federal preemption if its label claims satisfy the FDCA's statutory requirements. The First Circuit then engaged in a quasi-claim substantiation analysis which, according to the Court, turned on whether Kaufman's complaint adequately alleged that CVS lacks "substantiation" that its "heart health" structure/function claims are truthful and not misleading; and, relatedly, whether seven Vitamin E studies referenced by Kaufman in her complaint, standing alone, constituted the required adequate substantiation, as CVS suggested.

In analyzing the studies – which the Court determined was appropriate at the dismissal stage because the complaint directly referenced and purported to summarize the studies – the Court found that none were designed to test the statement that Vitamin E functions to support heart health. Rather, the Court concluded that the studies largely tested the hypothesis that Vitamin E prevents certain diseases – something the structure/function claims at issue do not allege and, in fact, directly disclaim. The Court also noted that some of the studies plausibly suggest that Vitamin E, when taken in doses of 400 IU or more, as the CVS label recommends, may actually play a role in harming heart health.

The Court therefore concluded that while the FDCA grants sellers of dietary supplements a preemptive license to describe on a label "the role of a nutrient or dietary ingredient," Congress did not similarly grant a preemptive license with respect to describing "a role" of a dietary ingredient that may mislead consumers by omitting mention of a directly related, conflicting role. According to the Court, "[i]f Vitamin E's actual role is both to support and to harm heart health, depending on the dosage actually supplied, then a label on a product presented in the harmful dosage yet revealing only the former aspects of the vitamin's role relative to health is incomplete in a way that could be material to the consumer's exercise of choice in deciding whether to buy the product." In that regard, the Court found that judicial consideration of omissions of material facts fits with the mandate of the FDCA that a seller's substantiation show that a claim be both "truthful and not misleading." If a dietary supplement "functions to harm health in the supplied or recommended dosage, a label claiming that the product supports health is plausibly viewed as misleading within the meaning of [the FDCA]." For these reasons, the Court concluded that the studies referenced in the complaint did not render implausible Kaufman's allegation that substantiation for CVS's heart health claims does not exist. Accordingly, the Court concluded Kaufman adequately pled that CVS's labeling of its Vitamin E supplement fails to comply with the requirements of the FDCA, and thus preemption does not bar Kaufman's right to proceed under New York's unfair competition law.

Notwithstanding the unique factual circumstances permitting the Court to review the studies at the dismissal stage, the Kaufman decision is a proverbial "shot across the bow" to dietary supplement manufacturers and distributors who have long relied on the protections of the FDCA as a shield from state law consumer liability. Kaufman, at its most basic, reflects a narrowing judicial interpretation of FDCA preemption and stands to embolden plaintiffs' attorneys seeking to challenge dietary supplement substantiation standards under state unfair competition laws.

For more information about how this issue may affect your business or related matters, please contact the author of this alert, Kyle Diamantas, or any member of the Firm's FDA Group.

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