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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