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From Health Law Daily, September 7, 2016

Deceptive heart health labeling claims against CVS not preempted, not yet

By Sarah E. Baumann, J.D.

A consumer’s deceptive labeling claims against CVS Caremark Corporation were not preempted by the federal Food, Drug, and Cosmetic Act (FDC Act), since scientific studies cited in an early stage of litigation did not clearly demonstrate that CVS had scientifically substantiated structure/function claims it made on a Vitamin E supplement label. The First Circuit Court of Appeals determined that, without expert testimony, it could not state that the studies rendered implausible a consumer class’s allegation that CVS’ label stating that the supplement "promotes heart health" was deceptive. Furthermore, the consumers plausibly suggested that certain doses of Vitamin E could damage the heart. As a result, the appellate court reversed the district court’s decision dismissing the case (Kaufman v. CVS Caremark Corp., September 6, 2016, Kayatta, W.).

Vitamin E label. CVS’ 100-count packages of Vitamin E 400 International Units (IU) softgels included a statement on the label that the product "supports heart health." A class of consumers who purchased the product filed suit, alleging that the labeling was deceptive pursuant to the New York Consumer Protection Act (N.Y. Gen. Bus. Law sec. 349) and asserting a common law claim for unjust enrichment. A federal district court in Rhode Island dismissed the claims, finding that they were preempted by section 343-1 of the FDC Act, which preempts claims that require food labeling requirements that differ from those required by the FDC Act. The consumer class appealed.

Substantiation. Section 343(r)(6) of the FDC Act permits the inclusion of structure/function claims on labels that "describe [] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans," provided that the manufacturer "has substantiation that such statement is truthful and not misleading." The First Circuit determined that an issue of fact existed as to whether CVS had substantiated the claim that that its supplement promoted heart health using "competent and reliable scientific evidence." The appellate court noted that none of the studies the consumers named were designed to test the theory that Vitamin E supports heart health, but instead addressed whether it prevents certain diseases and that CVS had not cited any others that substantiated its claim.

Furthermore, the class cited to studies suggesting that Vitamin E supplements of 400 IU or higher increased all-cause mortality and that increased Vitamin E intake raised the risk of heart failure. If it were determined that Vitamin E both supports and harms heart health, the court noted, the statement regarding the promotion of heart health could be considered truthful, but misleading. Furthermore, failure to include information about the potential harm could be considered misbranding, as section 321(n) of the FDC Act states that misbranding evaluations must consider not only representations actually made on the label, but those material facts that are not included. For all of these reasons, the First Circuit reversed the decision of the district court dismissing the claim. It also reversed the decision dismissing the unjust enrichment claim, to the extent it referenced deceptive conduct that would render the label misleading under FDC Act section 343(r).

The case is No. 16-1199.

Attorneys: Laura Killian Mummert (Goldman Scarlato & Penny PC) for Ronda Kaufman. Robert M. Andalman (A&G Law LLC) for CVS Caremark Corp. and CVS Pharmacy, Inc.

Companies: CVS Caremark Corp.; CVS Pharmacy, Inc.

MainStory: TopStory CaseDecisions FDCActNews SupplementNews LabelingNews MisbrandingNews PreemptionNews MaineNews MassachusettsNews NewHampshireNews PuertoRicoNews RhodeIslandNews

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