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From Health Law Daily, October 15, 2018

Dietary supplement protein source labeling claims not preempted

By David Yucht, J.D.

A California consumer claim alleging misbranding of a protein supplement’s protein sources was not preempted by the federal Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.). The Ninth Circuit found, however, that the that the FDC Act preempted claims regarding the labeling’s allegedly misleading statement regarding the amount of protein in the supplement. A claim based on an allegedly misleading tweet was properly dismissed because no connection was made between the tweet and the consumer’s purchase of the product (Durnford v. MusclePharm Corp., October 12, 2018, Berzon, M.).

Protein supplement label. A consumer brought claims against MusclePharm Corporation, a manufacturer of nutritional supplements, for making false or misleading statements about the protein in one of its products, Arnold Schwarzenegger Series Iron Mass®. The nutrition panel on the product stated that a single serving of 95 grams of the supplement contains 40 grams of protein, or 72% of the recommended daily value. The consumer alleged that MusclePharm had engaged in "nitrogen spiking" by inflating measurements of the supplement’s protein content by using non-protein substances and thereby rendered the supplement falsely or misleadingly labeled. Elsewhere, the label indicated that each serving contained "40g of a potent blend of hydrolyzed beef protein and lactoferrin protein." A trial level court dismissed the action finding that it was preempted by the FDC Act because any declarations of protein content on a product label could not be false or misleading if the listed amount of protein reflected measurements made in accordance with federal regulations which allowed a manufacturer to use nitrogen content as a proxy for protein content. The protein source claim was preempted, according to the lower court because the consumer did not allege that his study which showed a lack of true protein "conformed to the FDA requirements" for measuring protein content.

Protein composition. The Ninth Circuit reversed the lower court’s dismissal of the consumer’s protein composition claim. The protein composition theory was that the product’s label misled the consumer into believing the protein came entirely from genuine protein sources—hydrolyzed beef protein and lactoferrin—rather than nitrogen-spiking agents. This theory was not based on the misleading nature of nitrogen spiking, but on the label’s misleading suggestion that all of the protein in the product came from specific sources. The consumer’s argument did not involve the amount of protein, but the protein’s composition. The FDA’s testing protocol was relevant only to the amount of protein, but not to the composition of protein. This claim was therefore not preempted by federal law.

Total protein and nitrogen spiking. The appellate court, however, upheld the lower court’s dismissal of the consumer’s claim premised on the amount of protein in the supplement as well as his claim based on an allegedly false tweet. The FDC Act requires the disclosure of the "amount" of "total protein" in the nutrition panel, and FDA regulations approve of the use of nitrogen as a proxy in complying with that requirement. These regulations have the same preemptive effect as a statute, and so foreclose the possibility of liability under state law for nitrogen spiking. Moreover, the consumer claimed that he was misled by a tweet from MusclePharm stating that it did not use nitrogen-spiking agents to inflate its protein figures. However, nothing in the complaint connected this tweet to his purchase of the product. Accordingly, any claim of consumer fraud based on this tweet was insufficiently pleaded and properly dismissed.

The case is No. 16-15374.

Attorneys: Mary Bondy Reiten (Terrell Marshall Law Group PLLC) for Tucker Durnford. Linda E. Maichl (Ulmer & Berne, LLP) and Thomas A. Evans (Alston & Bird LLP) for MusclePharm Corp.

Companies: MusclePharm Corp.

MainStory: TopStory FDCActNews SupplementNews PreemptionNews AlaskaNews ArizonaNews CaliforniaNews HawaiiNews IdahoNews MontanaNews NevadaNews OregonNews WashingtonNews

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