Trucker Durnford v. MusclePharm Corp.

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

the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C.

§§ 301–399i, 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. We

disagree. As here relevant, the FDCA and its implementing

regulations concern only the calculation and disclosure of

protein amounts. They say nothing about the source or

composition of protein, factors which underlie one of

Durnford’s several theories of consumer deception.

4 DURNFORD V.MUSCLEPHARM

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, including the “Arnold

Schwarzenegger Series Iron Mass” supplement (“the

Supplement”) here at issue. Durnford is a California citizen

who purchased the Supplement from a sports nutrition

retailer in 2014.

The Supplement is marketed as a muscle-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.”

1 We refer to the product’s packaging as a whole as the “label.” We

refer to the federally mandated declaration of nutritional content within

the label as the “nutrition panel.” As will be explained, the latter is

subject to a unique set of stringent federal regulations.

DURNFORD V.MUSCLEPHARM 5

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.

6 DURNFORD V.MUSCLEPHARM

As should be 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-Leucine, Valine)

. . . , D-Ribose.” The nutrition panel states that a single

DURNFORD V.MUSCLEPHARM 7

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”), Cal. Bus. & Prof. Code

§§ 17200–17210; False Advertising Law (“FAL”), Cal. Bus.

& Prof. Code §§ 17500–17509; and Consumer Legal

Remedies Act (“CLRA”), Cal. Civ. Code §§ 1750–1784;

and for breach of express warranty. The express warranty

claim was premised on the theory that the Supplement’s

“labeling, marketing and advertising constitute express

warranties and became part of the basis of [the] bargain” —

a bargain struck, according to the complaint, “at the time

[consumers] purchased the Product.”

2 According to the complaint, because nitrogen is used as marker for

protein, manufacturers seeking a low-cost way of inflating their protein

figures are known to “spike” their formulations with nitrogen-rich

additives that provide little or none of the benefit of actual protein. Freeform

amino acids —amino acids that are not bound together in complex

chains, as proteins are —are sometimes used as nitrogen-spiking agents.

8 DURNFORD V.MUSCLEPHARM

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 at 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” about 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

DURNFORD V.MUSCLEPHARM 9

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” referred 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, 21 U.S.C. § 343-

1(a)(5), the district court concluded that even if the label

might be considered misleading, California consumer law

could not be used to create liability for an FDA-compliant

measurement.

The district court ruled for MusclePharm on the “Protein

Composition Claim” on preemption grounds as well, but on

narrower reasoning. The court accepted the theory that

MusclePharm’s label falsely or misleadingly suggested that

the Supplement contained 40 grams of protein derived

entirely from hydrolyzed beef protein and lactoferrin and

therefore not from nitrogen spiking. The court also accepted

that a misbranding theory of that kind went beyond a claim

3 The Secretary of Health and Human Services (“HHS”) has

“authority to promulgate regulations for the efficient enforcement of” the

FDCA. 21 U.S.C. § 371(a). The agency within HHS responsible for

FDCA regulations is the FDA. We therefore refer to the relevant

regulations in this case as “FDA regulations.”

10 DURNFORD V.MUSCLEPHARM

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

DURNFORD V.MUSCLEPHARM 11

identical to the requirement of section 343(r)

of this title.4

21 U.S.C. § 343-1(a) (emphases added).5 Section 343(q)

addresses the information that must be disclosed in a

nutrition panel under the FDCA. See 21 U.S.C. § 343(q)(1),

(q)(5)(F); Revision of the Nutrition and Supplement Facts

Labels, 81 Fed. Reg. 33,742, 33,744 (May 27, 2016). As

here relevant, the section provides that food is deemed

“misbranded” unless its nutrition panel includes a statement

of the product’s “total protein.” 21 U.S.C. § 343(q)(1)(D).

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 . . . .” 21 C.F.R. § 101.9(c)(7). This

regulation applies equally to ordinary food and to dietary

supplements, “except that [for dietary supplements] the

sample for analysis shall consist of a composite of

12 subsamples (consumer packages) or 10 percent of the

number of packages in the same inspection lot, whichever is

smaller, randomly selected to be representative of the lot.”

21 C.F.R. § 101.36(f)(1).

Section 343(r) addresses statements concerning

nutritional content other than those required to be included

4 Both section references are to title 21 of the United States Code.

5 This section and the sections cited within it were added to the

FDCA in 1990 in the Nutrition Labeling and Education Act (“NLEA”),

Pub. L. No. 101-535, 104 Stat. 2353 (Nov. 8, 1990). For simplicity, we

refer to the NLEA provisions as part of the FDCA except as necessary

to distinguish them.

12 DURNFORD V.MUSCLEPHARM

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. 21 U.S.C.

§ 343(r)(1)–(2). A separate provision of the FDCA provides

another, broader description of misbranding. According to

section 343(a), “food shall be deemed to be misbranded . . .

[if] its labeling is false or misleading in any particular.”

21 U.S.C. § 343(a).

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.” 21 C.F.R. § 100.1(c)(4). Instead,

the federal statute displaces “obligations or . . . provisions

concerning the composition or labeling of food . . . [that]

[a]re not imposed by or . . . [that] [d]iffer from those

specifically imposed by” the FDCA.6 21 C.F.R.

§ 100.1(c)(4)(i)–(ii).

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

6 In the absence of a specific congressional delegation of authority

to interpret the scope of preemption, agency interpretations regarding the

scope of preemption are not entitled to deference under Chevron, U.S.A.,

Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984). See Wyeth v.

Levine, 555 U.S. 555, 576 (2009). Durnford has not, however,

challenged the FDA’s interpretation of the preemptive effect of the

FDCA, so we assume its applicability.

DURNFORD V.MUSCLEPHARM 13

2364 (codified at 21 U.S.C. § 343-1 note) (“The [NLEA]

shall not be construed to preempt any provision of State law,

unless such provision is expressly preempted under [section

343-1].”); Hawkins v. The Kroger Co., No. 16-55532, slip

op. at 8 (9th Cir. Oct. 4, 2018) (citing Reid v. Johnson &

Johnson, 780 F.3d 952, 959 (9th Cir. 2015)). Second, a

presumption against preemption applies to the extent the

FDCA is used to displace state law in an area of traditional

state police power. See Wyeth v. Levine, 555 U.S. 555, 565

& n.3 (2009); Holk v. Snapple Beverage Corp., 575 F.3d

329, 334–35 (3d Cir. 2009). Consumer protection falls well

within that category. See Medtronic, Inc. v. Lohr, 518 U.S.

470, 485 (1996).

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 of nitrogen spiking and so not an accurate

measurement of true protein content. This theory is

foreclosed by the FDCA.

The FDCA requires the disclosure of the “amount” of

“total protein” in the nutrition panel, 21 U.S.C.

§ 343(q)(1)(D), and FDA regulations approve of the use of

nitrogen as a proxy in complying with that requirement,

14 DURNFORD V.MUSCLEPHARM

21 C.F.R. § 101.9(c)(7). These regulations have the same

preemptive effect as a statute, Fidelity Fed. Sav. & Loan

Ass’n v. de la Cuesta, 458 U.S. 141, 153–54 (1982), and so

foreclose the possibility of liability under state law for

nitrogen spiking.

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 specific 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.

DURNFORD V.MUSCLEPHARM 15

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 of 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.” 21 C.F.R. § 101.9(c)(7)(i). The

corrected amount of protein per serving “is equal to the

actual amount of protein . . . per serving [in grams]

multiplied by the amino acid score corrected for protein

digestibility.” 21 C.F.R. § 101.9(c)(7)(ii). The “correction”

is therefore not to remove nitrogen-spiking agents, as

Durnford suggests, but to account for digestibility. This

digestibility correction has no apparent impact on the

validity of the MusclePharm label, nor has Durnford

suggested any. And although Durnford notes that a separate

regulation states that “[p]rotein shall not be declared on

labels of products that, other than ingredients added solely

for technological reasons, contain only individual amino

7 As the nitrogen-as-protein regulation has not been challenged, this

opinion should not be taken as either approving it or disapproving it.

16 DURNFORD V.MUSCLEPHARM

acids,” the Supplement is not such a product. 21 C.F.R.

§ 101.36(b)(2)(i) (emphasis added). It contains more than

just individual amino acids.

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 composition” 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 concluded, however,

that Durnford’s claims were nonetheless preempted because

he did not allege that he had any independent study

contradicting the label that used the FDA’s elaborate 12-

sample testing protocol. See 21 C.F.R. § 101.36(f)(1).

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.

DURNFORD V.MUSCLEPHARM 17

As an initial matter, the premise behind 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 freeform

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 disputed testing protocol is a

8 We need not address whether plaintiffs are ever required to allege,

at the pleading stage, that there are tests contradicting the nutrition panel

that comply with the FDA’s testing protocols. We note, however, that

plaintiffs are generally not expected to provide evidence in support of

their claims at the pleading stage, see Cafasso, U.S. ex rel. v. Gen.

Dynamics C4 Sys., Inc., 637 F.3d 1047, 1055 (9th Cir. 2011), nor are

they required to plead the “probability” of their entitlement to relief,

Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In addition, FDCA

preemption, like all federal preemption, is an affirmative defense.

Lusnak v. Bank of Am., N.A., 883 F.3d 1185, 1194 n.6 (9th Cir. 2018).

“Only when the plaintiff pleads itself out of court — that is, admits all

the ingredients of an impenetrable defense — may a complaint that

otherwise states a claim be dismissed under Rule 12(b)(6).” Xechem,

Inc. v. Bristol-Myers Squibb Co., 372 F.3d 899, 901 (7th Cir. 2004); see

also Scott v. Kuhlmann, 746 F.2d 1377, 1378 (9th Cir. 1984) (per

curiam).

18 DURNFORD V.MUSCLEPHARM

requirement for “[c]ompliance with this section,” 21 C.F.R.

§ 101.36(f)(1) — that is, for compliance with the section of

FDA regulations determining the proper means of

calculating protein content in dietary supplements. See also

21 C.F.R. § 101.9(g). But Durnford’s protein composition

theory is not concerned with the total amount of protein in

the Supplement; it is concerned with the source of that

protein. Durnford argues that, whatever the true protein

amount in grams per serving, the label falsely or

misleadingly suggested that that protein is entirely

composed of two kinds of actual, genuine protein. In other

words, according to Durnford, the label falsely disclaims

nitrogen spiking.

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

9 MusclePharm argues that lack of reliance offers an alternative

ground for affirmance, at least as to the three statutory claims. See

Kwikset Corp. v. Superior Court, 51 Cal. 4th 310, 326 (2011).

MusclePharm notes, correctly, that the complaint makes sparse, generic

allegations regarding Durnford’s reliance on the Supplement’s label, and

fails to explain Durnford’s reasons for purchasing the product. But the

district court declined to address this issue, and speculated that an

inference of reliance might be reasonable under the circumstances. We

decline to reach the question of reliance in the first instance, particularly

as the district court retains the discretion, on remand, to grant the

plaintiffs leave to amend the complaint so as better to allege reliance on

the misbranding.

MusclePharm also argues that failure to plead fraud with

particularity is an alternative ground for affirmance. But apart from a

possible reliance problem, the “who, what, when, where, and how”

required by Federal Rule of Civil Procedure 9(b) are evident in the

allegations supporting Durnford’s protein composition theory. See

Kearns v. Ford Motor Co., 567 F.3d 1120, 1124 (9th Cir. 2009).

DURNFORD V.MUSCLEPHARM 19

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 complaint is inadequate.

IV

The FDCA, in light of its implementing regulations,

preempts a misbranding theory premised on the

Supplement’s use of nitrogen-spiking agents to inflate the

measurement of protein for the nutrition panel. It does not,

however, preempt a 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 district court’s order

of dismissal is REVERSED, and this case is REMANDED

for further proceedings consistent with this opinion.