Monday, October 15, 2018

FDCA doesn't preempt false advertising suit based on claims about protein source

Durnford v. MusclePharm Corp., --- F.3d ----, 2018 WL 4938190, No. 16-15374 (9th Cir. Oct. 12, 2018)

Durnford brought the usual California consumer claims against MusclePharm for making false or misleading statements about the protein in one of its supplements. The district court dismissed Durnford’s action as preempted by the FDCA, reasoning that any declarations of protein content anywhere on a product label could not be false or misleading if the listed amount of protein reflected measurements made in accordance with federal regulations concerning the federally mandated nutrition panel. The court of appeals reversed: the FDCA and its implementing regulations governed the calculation and disclosure of protein amounts, but Durnford could still base state-law claims on allegedly false statements about the source or composition of protein.

The supplement is marketed as a muscle-building or weight-gain product, with a focus on its “revolutionary 5-stage mass delivery system.” The second stage is described as “Muscle plasma protein technology: 40g of a potent blend of hydrolyzed beef protein and lactoferrin protein.” The fourth stage is described as “Performance growth & muscle volumizer: Creatine and BCAA nitrates help promote muscular strength, size and endurance.” The ingredients correspond to the stages, including the “Muscle Plasma Protein Matrix,” consisting of “Hydrolyzed Beef Protein, Lactoferrin” and the “Performance Growth & Muscle Volumizer,” consisting of “Creatine Monohydrate, L-Glycine, BCAA Nitrates (Leucine, Iso-Leucine, Valine) ... , D-Ribose” respectively. The nutrition panel states that a single serving of the supplement contains 40 grams of protein, or 72% of the recommended daily value.

Durnford alleged that MusclePharm engaged in “protein spiking” or “nitrogen spiking” — the practice of inflating measurements of a supplement’s protein content using non-protein substances, specifically creatine monohydrate and free-form amino acids (l-glycine, leucine, iso-leucine, and valine), and that its true protein value was not 40 grams per serving, but 19.4 grams per serving.  MusclePharm also tweeted that product reviews accusing it of nitrogen spiking were “fake …. We don’t do anything like that. All products legit and scientifically backed[.]”

FDA regulations allow a manufacturer to use nitrogen content as a proxy for protein content, thus permitting the practice of nitrogen spiking, and the FDCA preempts non-identical state law requirements, so that was it, according to the district court.

The court of appeals began with a presumption against preemption for areas of traditional state police power such as consumer protection. Nonetheless, Durnford’s protein content theory of misbranding—that he was misled by the 40-gram figure on the nutrition panel—was foreclosed by the FDCA, which requires the disclosure of the total amount of protein; FDA regulations set out the proper means of calculating that amount, using nitrogen as a proxy, so it doesn’t matter whether doing so is misleading. (The court noted that Durnford didn’t challenge the regulation under Chevron for authorizing an inherently misleading means of calculating protein.)

However, Durnford’s “protein composition” theory of misbranding was that the label misled him into believing the protein, in whatever amount, came entirely from genuine protein sources — hydrolyzed beef protein and lactoferrin — rather than nitrogen-spiking agents. The court of appeals found his premise correct: the label twice identifies specific protein sources, then apparently distinguishes those protein sources from nitrogen compounds, which are listed and identified separately not as protein, but as “performance growth and muscle volumizer.” The label continues that the proteins are present in the amount of “40g of a ... blend of ... beef protein and lactoferrin” — the same amount of protein claimed per serving on the nutrition panel. The ingredients list repeats the distinction: hydrolyzed beef protein and lactoferrin are part of the “protein technology,” and the free-form amino acids are “muscle volumizer.”

Durnford’s theory was thus that the label falsely disclaimed nitrogen spiking. This adequately alleged misbranding, and was not preempted by rules about how protein was to be measured, though the complaint didn’t sufficiently connect the one tweet to Durnford’s injury and was thus on its own inadequate.

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