TUCKER DURNFORD, individually and on behalf of all others similarly situated v. MUSCLEPHARM CORP.
No. 16-15374
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
October 12, 2018
D.C. No. 3:15-cv-00413-HSG
FOR PUBLICATION
OPINION
Appeal from the United States District Court for the Northern District of California Haywood S. Gilliam, Jr., District Judge, Presiding
Argued and Submitted November 15, 2017 San Francisco, California
Filed October 12, 2018
Before: Marsha S. Berzon and Michelle T. Friedland, Circuit Judges, and William K. Sessions III,* District Judge.
Opinion by Judge Berzon
SUMMARY**
Preemption / Food, Drug, and Cosmetic Act
The panel reversed the district court‘s dismissal of an action alleging California consumer claims against MusclePharm Corporation, a manufacturer of nutritional supplements, for making false or misleading statements about the protein in one of its products; and remanded for further proceedings.
The district court dismissed the action as preempted by the Food, Drug, and Cosmetic Act (“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 panel held that, as relevant here, the FDCA and its implementing regulations concerned оnly the calculation and disclosure of protein amounts. Specifically, the panel held that the FDCA preempted a state-law misbranding theory premised on the supplement‘s use of nitrogen-spiking agents to inflate the measurement of protein for the nutrition panel. The panel further held that the FDCA did not, however, preempt a state-law misbranding theory premised on the label‘s allegedly false or misleading implication that the supplement‘s protein came entirely from two specifically named, genuine protein sources. The panel concluded that
plaintiff‘s claims were not preempted to the extent they arose under this theory.
COUNSEL
Matt J. Malone (argued), Susan F. Brown, and Michael F. Ram, Ram Olson Cereghino & Kopczynski, San Francisco, California, for Plaintiff-Appellant.
Michael J. Suffern (argued) and Linda E. Maichl, Ulmer & Berne LLP, Cincinnati, Ohio, for Defendant-Appellee.
BERZON, Circuit Judge:
Tucker Durnford brought California consumer claims against MusclePharm Corporation, a manufacturer of nutritional supplements, for making false or misleading statements about the protein in one of its products. The district court dismissed Durnford‘s action as preempted by thе Food, Drug, and Cosmetic Act (“FDCA“),
Durnford‘s claims are therefore not preempted to the extent they arise under that theory.
I
MusclePharm is a Nevada corporation that produces a line of nutritional supplements,
The Supplement is marketed as a musclе-building or weight-gain product, with a focus on its “revolutionary 5-stage mass delivery system.” According to the Supplement‘s label,1 this “system” consists of “advanced protein technology, elite complex carbs, healthy fats, cutting-edge performance ingredients and a balanced digestive blend.”
The label describes the “stages” of the Supplement‘s “system” in some detail. In particular, 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 nutrition panel at the back of the label also reflects the “five-stage system.” For example, in listing the Supplement‘s ingredients, the front of the label divides ingredients according to the “five stages.” The nutrition panel then repeats the five stages in the same order they appear on the front of the label, and repeats the same jargon in describing them.
As should bе apparent, the second group of ingredients listed on the nutrition panel corresponds to the second stage of the Supplement‘s “system.” This group of ingredients is described as the “Muscle Plasma Protein Matrix,” consisting of “Hydrolyzed Beef Protein, Lactoferrin.” The fourth group of ingredients listed on the nutrition panel corresponds to the fourth stage of the Supplement‘s system. This group of ingredients is described as the “Performance Growth & Muscle Volumizer,” consisting of “Creatine Monohydrate, L-Glycine, BCAA Nitrates (Leucine, Iso-Leucinе, Valine) . . . , D-Ribose.” The nutrition panel states that a single
serving of 95 grams of the Supplement contains 40 grams of protein, or 72% of the recommended daily value.
In January 2015, Durnford brought an action alleging that MusclePharm had engaged in “protein spiking” or “nitrogen spiking” — the practice of inflating measurements of a supplement‘s protein content using non-protein substances — thereby rendering the Supplement falsely or misleadingly labeled.2 Specifically, Durnford alleged that MusclePharm used creatine monohydrate and free-form amino acids (l-glycine, leucine, iso-leucine, and valine) to inflate protein figures. These are the substances that appear at stage four of the Supplement‘s “system.” Durnford also alleged that an independent study of the Supplement demonstrated that its true protein value was not 40 grams per serving, but 19.4 grams per serving.
Durnford brought claims under California‘s Unfair Competition Law (“UCL“),
Durnford also alleged that, at some point, an individual “tweeted at” MusclePharm‘s official Twitter account to ask about the truth behind product reviews accusing MusclePharm of nitrogen spiking. MusclePharm responded via Twitter: “Those [reviews] are fake then. We don‘t do anything like that. All products legit and scientifically backed[.]” The individual who tweeted аt MusclePharm identified himself on Twitter as “Jacob Henderson.” The complaint did not explain who Jacob Henderson was, what relationship he had to Durnford or to this case, when the Twitter interaction took place, or whether Durnford was aware of it.
Durnford did not explain his reasons for purchasing the Supplement. For example, he did not allege that he purchased the product intending to gain weight or add muscle, the likely reason for most purchases of the product. He did state, however, that he “would not have purchased the Supplement had [he] known the true nature of the protein content.” And he alleged that he “purchased the [Supplement] in reliance on [MusclePharm‘s] labeling and marketing claims.”
MusclePharm moved to dismiss the complaint on preemption grounds, for failure to plead reliance adequately, and for failure to plead fraud with particularity. In granting the motion to dismiss, the district court divided Durnford‘s four legal claims into three theories of misrepresentation, each tied to one of MusclePharm‘s “claims” аbout its product. The “Protein Content Claim” referred to the theory that Durnford was misled by the 40-gram figure on the Supplement‘s nutrition panel, as independent testing allegedly revealed that figure to be heavily influenced by nitrogen-rich non-protein substances such as free-form amino acids. The “Protein Composition Claim” referred to
the theory that Durnford was misled by the label‘s suggestion that the product contained 40 grams of protein derived entirely from hydrolyzed beef protein and lactoferrin rather than nitrogen-spiking agents. The “Nitrogen Spiking Claim” referrеd to the theory that Durnford was misled by the statement MusclePharm made on its Twitter account in response to a direct question about nitrogen spiking.
The district court ruled for MusclePharm on preemption grounds with respect to the “Protein Content Claim.” Specifically, the court noted that Food and Drug Administration (“FDA“) regulations allow a manufacturer to use nitrogen content as a proxy for protein content, thus permitting the practice of nitrogen spiking.3 As the FDCA expressly preempts state-law requirements that are “not identical to” those in the FDCA itself,
The district court ruled for MusclePharm on the “Protein Composition Claim”
based purely on the FDA‘s approved methods of calculating protein content. Nonetheless, the district court concluded that Durnford‘s claims, “as currently pled, are preempted,” as Durnford did not allege that his independent study demonstrating a lack of true protein “conformed to the [FDA] requirements” for measuring protein content.
Finally, the district court ruled for MusclePharm on its “Nitrogen Spiking Claim” for failure to plead reliance adequately, a problem the court described as a lack of statutory standing under California‘s consumer protection laws. The court noted that it could be “reasonable to presume that consumers read and rely on product labels when purchasing a supplement.” But the court was unable to draw such an inference regarding the comment made on Twitter.
The district court dismissed the complaint without prejudice to repleading to cure the preemption and reliance problems. Durnford allowed the period for amendment to lapse, and the court entered judgment. This appeal followed.
II
We begin with a review of federal preemption under the relevant provision of the FDCA. The FDCA provides, in relevant part, that
no State . . . may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . (4) any requirement for nutrition labeling of food that is not identical to the requirement of
section 343(q) of this title . . . or, (5) any requirement respecting any claim . . . made in the label or labeling of food that is not
identical to the requirement of
section 343(r) of this title.4
FDA regulations provide guidance as to the acceptable means of calculating “total protein” for purposes of the mandatory nutrition panel. Specifically, “[p]rotein content may be calculated on the basis of the factor 6.25 times the nitrogen content of the food as determined by the appropriate method of analysis . . . .”
Section 343(r) addresses statements concerning nutritional content other than those required to be included
in the nutrition panel. As relevant here, the section provides that products whose labels “characterize[] the level of any nutrient” listed in section 343(q) are deemed misbranded unless they comply with specific requirements, established by regulation, for nutrient disclosures of that kind.
The FDA has promulgated regulations attempting to clarify the scope of express preemption under the “not identical to” standard stated in section 343-1(a). According to the FDA, in preempting state law that would impose requirements “not identical to” those in the FDCA, the statute is not concerned with “the specific words in the [state-law] requirement.”
FDCA preemption is subject to well-established limiting principles. First, federal preemption arising from the provisions at issue in this case is, by statutory prescription, express preemption only. See NLEA § 6(c)(1), 104 Stat. at
2364 (codified at
III
We turn now to review of the order granting MusclePharm‘s motion to dismiss. Our review is de novo. Edwards v. Marin Park, Inc., 356 F.3d 1058, 1061 (9th Cir. 2004). The district court‘s three-part categorization of Durnford‘s claims is a useful framework for evaluating Durnford‘s theories of misbranding, so we adhere to it.
A
The “protein content” theory of misbranding refers to Durnford‘s allegations that he was misled by the 40-gram figure on the Supplement‘s nutrition panel, because it was a product оf nitrogen spiking and so not an accurate measurement of
The FDCA requires the disclosure of the “amount” of “total protein” in the nutrition panel,
Durnford argues otherwise, maintaining that the regulation serves internal “regulatory” purposes and is not intended to have preemptive effect. But the regulation is not just an internal guidance; it is an interpretation of the statutory provision requiring that manufacturers disclose a product‘s protein content, a concept that requires federal agency clarification if there is to be national uniformity in labeling. See Reid, 780 F.3d at 959. Where, as here, “Congress has ‘explicitly left a gap for an agency to fill, there is an express delegation of authority to the agency to elucidate a speсific provision of the statute by regulation,’ and any ensuing regulation is binding unless . . . defective.” United States v. Mead Corp., 533 U.S. 218, 227 (2001) (Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 843–44 (1984)).
Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753 (9th Cir. 2015), is consistent with this conclusion. Astiana held that a state law challenge to a cosmetic labeled “natural” was not preempted because “Astiana [was] not asking [the manufacturer] to modify or enhance any aspect of its cosmetics labels that are required by federal law.” Id. at 758. No statute or regulation governed “the use of ‘natural’ on cosmetics labels.” Id. There was therefore no basis for express preemption in Astiana. Not so here, where disclosure of the amount of protein content on the nutrition panel is required by statute, and the proper means of calculating that amount is set out in the regulation.
That section 343(a) prohibits false or misleading statements in general does not alter our analysis. Durnford has not on appeal challenged as invalid the FDA regulation allowing the use of nitrogen content as a proxy for protein. He does not argue, for example, that the agency has authorized, by regulation, an inherently misleading means of calculating protein, such that it has exceeded its congressionally delegated authority in light оf section 343(a). See Chevron, 467 U.S. at 843; see also Mead, 533 U.S. at 227. Any such argument is thus forfeited.7 See Smith v. Marsh, 194 F.3d 1045, 1052 (9th Cir. 1999).
Durnford‘s remaining arguments against preemption are without merit. Durnford misreads the FDA‘s protein regulation as precluding the use of nitrogen as a benchmark when calculating a percentage of recommended daily value. The regulation provides only that, if a percentage of recommended daily value is declared on the nutrition panel, it should be calculated using the “corrected amount of protein per serving.”
acids,” the Supplement is not such a product.
In sum, federal regulations allow nitrogen to be used on the nutrition panel as a proxy for protein content. Accordingly, a state-law misbranding claim premised on nitrogen spiking — that is, a claim that would permit a state to impose requirements for the measurement of protein for purposes of the federal mandated nutrition panel different from those permitted under the FDCA — is preempted.
B
Durnford‘s “protein comрosition” theory of misbranding is that the Supplement‘s label misled him into believing the Supplement‘s protein came entirely from genuine protein sources — hydrolyzed beef protein and lactoferrin — rather than nitrogen-spiking agents. The district court accepted the possibility that the label created a false or misleading impression in this respect. The district court concluded, however, that Durnford‘s claims were nonetheless preempted because he did not allege that he had any independent study contradicting thе label that used the FDA‘s elaborate 12-sample testing protocol. See
This reasoning misapprehends Durnford‘s protein composition theory. That theory rests not on the misleading nature of nitrogen spiking but on the label‘s misleading suggestion that all of the protein in the Supplement, in whatever amount it exists, comes from specific protein sources. In other words, Durnford‘s argument goes not to the amount of protein, but to its composition. The FDA‘s testing protocol is relevant only to the former.
As an initial matter, the premise bеhind the protein composition theory is correct. The label — separately from the mandatory nutrition panel — twice identifies hydrolyzed beef protein and lactoferrin as the protein sources in the Supplement. The label 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 further states that the Supplement‘s 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. Finally, in its ingredients list, the label repeats the distinction in nomenclature between true proteins and other substances, referring to hydrolyzed beef protein and lactoferrin part of the Supplement‘s “protein technology,” and calling the free-form amino acids “muscle volumizer.”
Under Durnford‘s theory of misbranding, whether or not there was compliance with the FDA‘s 12-sample testing protocol does not matter.8 The
requirement for “[c]ompliance with this section,”
In sum, Durnford‘s complaint adequately alleges facts necessary to support a consumer claim premised on his protein composition theory of misbranding.9 As noted, Durnford brought three California statutory claims, as well
as a claim for breach of express warranty. MusclePharm has made no attempt on appeal to distinguish between the elements of these nominally distinct legal claims for purposes of the protein composition theory, and there is no evident difference. Durnford‘s protein composition theory is therefore ground for reversal as to all claims.
C
Finally, the so-called “Nitrogen Spiking Claim” refers to the theory that Durnford was misled by a tweet from MusclePharm stating that it did not use nitrogen-spiking agents to inflate its protein figures. But nothing in the complaint connects this tweet to Durnford‘s purchase of the Supplement. To the extent Durnford intended the tweet as an independent basis for his claims — rather than simply as illustrative evidence of the way MusclePharm intended its consumers to understand the composition of the Supplement — the cоmplaint is inadequate.
IV
The FDCA, in light of its implementing regulations, preempts a misbranding theory