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From Health Law Daily, March 27, 2015

Sun still shining on consumer’s challenge to Neutrogena’s SPF labeling

By Bryant Storm, J.D.

A court dismissed some of a consumer’s class action claims against Neutrogena related to the sun protection factor (SPF) labeling of the manufacturer’s sunscreen products due to the fact that the consumer had not purchased the products upon which the claims were based. The court allowed the consumer’s claims to proceed insofar as they were premised on purchased products and alleged that Neutrogena’s product labeling misled consumers by coupling high SPF values with higher prices. The court was not persuaded by Neutrogena’s attempts to dismiss the claims on standing and jurisdictional grounds (Dapeer v. Neutrogena Corporation, March 25, 2015, Cooke, M.).

Sunscreen. Nathan Dapeer purchased Neutrogena Ultra Sheer Body Mist, SPF 30 (Neutrogena Body Mist) and Neutrogena Beach Defense Broad Spectrum SPF 70 Lotion (Neutrogena Beach Defense) due to his beliefs that (1) Neutrogena Body Mist ‘provided water resistant SPF 30 level protection for a full 80 minutes after application’; (2) Neutrogena Beach Defense ‘was waterproof and provided ‘sun barrier’ protection from the sun’s harmful UV radiation’; and (3) Neutrogena Beach Defense, a high SPF sunscreen, provided ‘superior sun protection.’” Dapeer alleged that he would not have purchased the products had he known that they were not water resistant for 30 minutes, did not provide protection from ultraviolet (UV) radiation, and that higher SPF values did not necessarily equate with higher UV type B (UVB) radiation protection when compared to lower SPF sunscreen products. Dapeer brought a lawsuit on behalf of himself and purchasers of over twenty other Neutrogena products, seeking declarative, injunctive, and monetary relief, on the grounds that the manufacturer engaged in deceptive and misleading labeling in violation of Florida consumer deception laws. Neutrogena moved to dismiss the complaint.

Standing. In its motion to dismiss, Neutrogena asserted that Dapeer’s claims were inadequate due to the fact that he lacked standing, the court lacked jurisdiction, and the claims were preempted by the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 301). The court held that Dapeer lacked standing on any claims related to products he did not purchase. Additionally, because Dapeer did not allege any risk of future injury, the court held that Dapeer could not be granted an injunction because there was no future harm that he needed protection against. The court also noted that Neutrogena removed the “water + sun barrier” label from its new products, further eliminating any future risk to Dapeer.

Preemption. The court held that the FDA “heavily regulates” the sunscreen industry by requiring specific SPF values and labeling under 21 C.F.R. Sec. 201.327(a)(1). The FDA has not yet, however, established minimum or maximum allowable SPF values. Neutrogena asserted that Dapeer was attempting to impose labeling requirements on the manufacturer that were in addition to or different from FDA requirements. On the other hand, Dapeer asserted that he was merely alleging that Neutrogena’s marketing, combining high SPF ratings and a premium price, misled consumers about the product’s efficacy. The court held that to the extent Dapeer challenged “as false and misleading the way that Neutrogena marketed its products—by combining SPF values with higher prices—those claims were not expressly preempted.” The court cautioned that although the high SPF value claims were being allowed to proceed, given the nature of the motion to dismiss, the court did not have significant faith in underlying merit of those claims.

Jurisdiction. Neutrogena also challenged Dapeer’s claims under the theory of primary jurisdiction, asserting that resolution of the issue was best left to the FDA and not a court. The court disagreed with Neutrogena and decided that it was competent to answer the question of the false and misleading nature of the product labeling.

The case is No. 14-22113.

Attorneys: Andrea R. Gold (Tycko & Zavareei, LLP) for Nathan Dapeer. Abigail M. Lyle (Hunton & Williams) for Neutrogena Corp.

Companies: Neutrogena Corp.

MainStory: TopStory LabelingNews DrugBiologicNews MisbrandingNews SafetyNews FDCActNews OTCNews FloridaNews

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