Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca9-12-56726/USCOURTS-ca9-12-56726-0/pdf.json

Parties Involved:
Johnson & Johnson
Appellee
McNeil Nutritionals, LLC
Appellee
Robert Reid
Appellant

Document Text:

FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

ROBERT REID, on Behalf of Himself

and All Others Similarly Situated,

Plaintiff-Appellant,

v.

JOHNSON & JOHNSON and MCNEIL

NUTRITIONALS, LLC,

Defendants-Appellees.

No. 12-56726

D.C. No.

3:11-cv-01310-

L-BLM

OPINION

Appeal from the United States District Court

for the Southern District of California

M. James Lorenz, Senior District Judge, Presiding

Argued and Submitted

June 5, 2014—Pasadena, California

Filed March 13, 2015

Before: Alex Kozinski, Stephen S. Trott,

and Consuelo M. Callahan, Circuit Judges.

Opinion by Judge Callahan

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2 REID V. JOHNSON & JOHNSON

SUMMARY*

Standing / Preemption

The panel affirmed in part, and reversed in part, the

district court’s decision dismissing a false advertising lawsuit

brought against Johnson & Johnson and McNeil Nutritionals,

LLC, concerning assertions McNeil made about its product

Benecol, a substitute for butter or margarine.

McNeil declared on Benecol’s label that the product

contained “No Trans Fat” because the amount of trans fat in

Benecol was so insignificant that it was authorized under the

Food and Drug Administration’s regulations to make that

statement. McNeil also contended that Benecol satisfied the

standards set forth in a 2003 FDA letter that authorized its

plant stanol esters statements, and was entitled to preemptive

effect.

The panel held that the plaintiff-appellant had standing to

challenge McNeil’s statements. The panel also held that

appellant’s state law claims for relief were not preempted. 

Specifically, the panel held that appellant’s claims were not

preempted to the extent they were predicated on McNeil’s

trans fat statements. In addition, the panel declined to afford

preemptive effect to agency actions that did not carry the

force of law under United States v. Mead Corp., 533 U.S.

218, 234 (2001), and its progeny; and applying the rule, the

panel held that the FDA’s 2003 letter lacked preemptive

effect. Finally, the panel held that appellant’s action was not

* This summary constitutes no part of the opinion of the court. It has

been prepared by court staff for the convenience of the reader.

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REID V. JOHNSON & JOHNSON 3

barred by the primary jurisdiction doctrine, which allows

courts to stay proceedings or dismiss a complaint without

prejudice pending resolution of an issue within the special

competence of an administrative agency. The panel remanded

for further proceedings. 

COUNSEL

Jack Fitzgerald (argued), Gregory S. Weston, and Melanie

Persinger, The Weston Firm, San Diego, California; Ronald

A. Marron and Beatrice Skye Resendes, The Law Offices of

Ronald A. Marron, APLC, San Diego, California, for

Plaintiff-Appellant.

Matthew I. Kaplan (argued), Mollie F. Benedict, and Amanda

Villalobos, Tucker Ellis LLP, Los Angeles, California, for

Defendants-Appellees.

OPINION

CALLAHAN, Circuit Judge:

Robert Reid appeals the district court’s decision

dismissing his false advertising lawsuit against Johnson &

Johnson and McNeil Nutritionals, LLC (collectively,

“McNeil”). Reid challenges a number of McNeil’s assertions

about its product, Benecol. Benecol is a vegetable oil-based

spread that McNeil sells as a healthy substitute for butter or

margarine. Among other things, on Benecol’s label, McNeil

prominently declares that the product contains “No Trans

Fat” and contains plant stanol esters that lower cholesterol. 

Benecol, however, does contain trans fat. McNeil

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4 REID V. JOHNSON & JOHNSON

nonetheless contends that the amount of trans fat in the

product is so insignificant that it is authorized under the Food

and Drug Administration’s (FDA) regulations to make the

statement. It is also undisputed that Benecol does not comply

with the terms of the FDA’s regulation authorizing plant

stanol ester-based health claims. McNeil contends that

Benecol nonetheless satisfies the standards set forth in a 2003

FDA letter that authorizes its plant stanol esters statements

and is entitled to preemptive effect.

The district court found that Reid lacked standing to

challenge the statements and that Reid’s claims for relief

were preempted. However, the district court rejected

McNeil’s arguments that Reid’s action was barred by the

primary jurisdiction and abstention doctrines. We conclude

that Reid has standing, that Reid’s claims for relief are not

preempted, and that Reid’s action is not barred by the primary

jurisdiction doctrine. Accordingly, we reverse the district

court’s standing and preemption decisions, affirm the district

court’s decision not to invoke the primary jurisdiction

doctrine, and remand for further proceedings.

I

A

McNeil manufactures and sells Benecol.1 Benecol is

manufactured with partially hydrogenated vegetable oil,

1 The facts are drawn from Reid’s complaint. See Salameh v. Tarsadia

Hotel, 726 F.3d 1124, 1128 (9th Cir. 2013) (“Because the district court

dismissed the complaint on the pleadings, the facts come from the second

amended complaint, except where otherwise noted.”), cert. denied, 134 S.

Ct. 1322 (2014).

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REID V. JOHNSON & JOHNSON 5

which contains artificial trans fat. According to Reid,

“[a]rtificial trans fat does not exist in nature, and the human

body has not evolved to digest it.” It is “a toxic food additive

that, in the amounts present in Benecol, negatively affects

blood cholesterol levels.”

Low density lipoprotein (“LDL”), or “bad” cholesterol,

carries cholesterol to arteries and tissues. High density

lipoprotein (“HDL”), or “good” cholesterol, “takes

cholesterol away from tissues to the liver, where it is removed

from the body.” High levels of LDL cholesterol and low

levels of HDL cholesterol are associated with an increased

risk of heart disease. The consumption of artificial trans fat

“increases ‘bad’ LDL cholesterol and decreases ‘good’ HDL

cholesterol.” Consequently, consuming partially

hydrogenated vegetable oil “causes cardiovascular [] disease,

diabetes and cancer.”

Benecol also contains plant stanol esters. Consuming

plant stanols has been shown to reduce LDL cholesterol and

thus the risk of heart disease. According to Reid, the partially

hydrogenated vegetable oil in Benecol counteracts any

positive effect associated with plant stanol esters in the

product.

The outside packaging for Benecol includes the following

statements:

• “Proven to Reduce Cholesterol”

• “No Trans Fat”

• “No Trans Fatty Acids”

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6 REID V. JOHNSON & JOHNSON

• “Use at least 2 servings of spread per day

with your meals and snacks. Each serving

contains 0.85 g of Plant Stanol Esters (0.5

g plant stanols). BENECOL® Spreads

can help you meet the National

Cholesterol Education Program

Guidelines recommended amount of 2 g

plant stanols/sterols per day.”

• “Plant Stanol Esters, the unique ingredient

found only in BENECOL® Spreads, are

derived from natural plant components

found in vegetable oils such as soy. Plant

Stanol Esters [sic] proven ability to lower

cholesterol is supported by over 25

studies, including one reported in the New

England Journal of Medicine.”

• “Products containing 0.7 g or more of

Plant Stanol Esters per serving eaten twice

a day with meals for a daily intake of at

least 1.4 g may reduce the risk of heart

disease as part of a diet low in saturated

fat and cholesterol. A serving of

BENECOL® spread contains 0.85 g of

Plant Stanol Esters.”

The outer packing depicts several heart icons, and the

packaging for Benecol Light spread also depicts vegetables. 

The interior packaging, which a consumer would not see

unless he or she opened the package (presumably, after

purchasing it), further states:

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REID V. JOHNSON & JOHNSON 7

The name BENECOL® brings together Bene,

meaning “good” and col, for “cholesterol”. 

BENECOL® offers you a great way to reduce

your cholesterol with a delightfully goodtasting spread. Did you know that 2 or more

servings of BENECOL® Spreads each day:

TReduces “bad” (LDL) cholesterol

TReduces total cholesterol

TWorks to further reduce cholesterol for

those on cholesterol—lowering statin

medications

TBlocks cholesterol from being absorbed into

your body

It also explains:

How can BENECOL® Spreads have 0 grams

trans fat if they contain partially hydrogenated

oils?

A small amount of partially hydrogenated oils

are used in BENECOL® Spreads to maintain

a semi-solid structure and to enhance the

melting characteristics of the BENECOL®

Regular Spread. As a result, BENECOL®

Spreads[] contain an extremely low level of

trans fat. The FDA allows foods containing

less than 0.5 grams of trans fat/serving to be

labeled 0 grams trans fat, since this is

considered an insignificant amount.

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8 REID V. JOHNSON & JOHNSON

Reid contends that he is a lay consumer with no

background in nutrition or food science. He purchased

Benecol at three different stores in California over a period of

more than three years prior to filing the complaint. He asserts

that he did so based on McNeil’s representations in its

advertisements and on its packaging. Benecol costs more

than similar products, and Reid contends that he would not

have been willing to pay as much as he did—if anything at

all—for Benecol had he not been misled.

B

Reid filed his complaint on June 14, 2011. He alleged

that McNeil’s plant stanol esters-based health and “No Trans

Fat” claims were not authorized under the FDA’s regulations

and were false. He further asserted that the “Proven to

Reduce Cholesterol” and related statements were false and

misleading and rendered Benecol an improperly marketed

drug. He also contended that McNeil created Benecol’s name

and used heart graphics and vegetable depictions to reinforce

its deceptive statements and to convey misleading

information about Benecol’s health benefits. He asserted

claims for relief on behalf of a putative class of Benecol

purchasers under California’s Unfair Competition Law

(“UCL”), Cal. Bus. & Prof. Code §§ 17200–10; False

Advertising Law (“FAL”), Cal. Bus. & Prof. Code

§§ 17500–09; and Consumer Legal Remedies Act (“CLRA”),

Cal. Civ. Code §§ 1750–84.

The district court granted McNeil’s motion to dismiss. 

Initially, the district court decided that Reid had sufficiently

alleged an economic injury, but lacked standing because he

failed to plead reasonable reliance on anymisrepresentations. 

The district court further concluded that Reid’s claims for

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REID V. JOHNSON & JOHNSON 9

relief were preempted under federal law. It held that

McNeil’s plant stanol esters statements complied with a 2003

FDA letter where the agency discussed its intentions about

enforcing certain requirements for health claims about plant

stanol esters, and it found that McNeil’s cholesterol reduction

and trans fat statements complied with FDA regulations. The

court rejected McNeil’s arguments that it should stay or

dismiss the case under the primary jurisdiction or abstention

doctrines. It also denied Reid’s request to take judicial notice

of a number of FDA warning letters. Reid appealed and we

have jurisdiction pursuant to 28 U.S.C. § 1291.

II

We review de novo a district court’s order granting a

motion to dismiss on preemption grounds, for lack of

standing, or for failure to state a claim upon which relief can

be granted. Lily v. ConAgra Foods, Inc., 743 F.3d 662, 664

(9th Cir. 2014) (preemption); Mont. Shooting Sports Ass’n v.

Holder, 727 F.3d 975, 979 (9th Cir. 2013) (standing), cert.

denied, 134 S. Ct. 955 (2014); Henry A. v. Willden, 678 F.3d

991, 998 (9th Cir. 2012) (failure to state a claim). We review

the district court’s “ultimate decision” to exercise or “decline

to exercise jurisdiction for abuse of discretion, but conduct de

novo review of the court’s application of the primary

jurisdiction doctrine.” N. Cnty. Commc’ns Corp. v. Cal.

Catalog & Tech., 594 F.3d 1149, 1154 (9th Cir. 2010)

(quoting Rhoades v. Avon Prods., Inc., 504 F.3d 1151, 1162

n.11 (9th Cir. 2007)).

III

The district court appeared to dismiss Reid’s claims for

relief for lack of standing under California’s standing

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10 REID V. JOHNSON & JOHNSON

requirements for the UCL, FAL, and CLRA. To establish

standing to bring a claim under these statutes, plaintiffs must

meet an economic injury-in-fact requirement, which demands

no more than the corresponding requirement under Article III

of the U.S. Constitution. Hinojos v. Kohl’s Corp., 718 F.3d

1098, 1104 (9th Cir. 2013). In a false advertising case,

plaintiffs meet this requirement if they show that, by relying

on a misrepresentation on a product label, they “paid more for

a product than they otherwise would have paid, or bought it

when they otherwise would not have done so.” Id. at 1104

n.3, 1108; see also POM Wonderful LLC v. Coca-Cola Co.,

134 S. Ct. 2228, 2234 (2014) (“A consumer who is

hoodwinked into purchasing a disappointing product may

well have an injury-in-fact cognizable under Article III

. . . .”). Reid undoubtedly satisfied this individual reliance

requirement, as he alleged that he would not have been

willing to pay as much as he did for Benecol, if anything, if

he had not been misled byMcNeil’s misrepresentations about

Benecol’s health effects.

The district court nevertheless decided Reid lacked

standing because he failed to “set forth alleged facts showing

that Benecol’s statements may deceive a reasonable

consumer.” It is true that violations of the UCL, FAL, and

CLRA are evaluated from the vantage point of a “reasonable

consumer.” Williams v. Gerber Prods. Co., 552 F.3d 934,

938 (9th Cir. 2008). Under that test, a plaintiff must “show

that members of the public are likely to be deceived.” Id.

(internal quotation marks omitted). But the reasonable

consumer standard, unlike the individualreliance requirement

described above, is not a standing requirement. Rather, it

raises questions of fact that are appropriate for resolution on

a motion to dismiss only in “rare situation[s].” Id. at 939.

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REID V. JOHNSON & JOHNSON 11

Even if the district court intended to dismiss Reid’s

complaint for failure to state a claim upon which relief can be

granted, it erred. The district court found that McNeil’s

“alleged misrepresentations would not likely deceive a

reasonable consumer” in light of its disclosures on its

ingredient list (i.e., the presence of partially hydrogenated

vegetable oil). However, as we have previously stated: “We

do not think that the FDA requires an ingredient list so that

manufacturers can mislead consumers and then rely on the

ingredient list to correct those misinterpretations and provide

a shield for liability for the deception.” Williams, 552 F.3d at

939. Regardless, it is far from clear that typical consumers

understand that a product containing partially hydrogenated

vegetable oil necessarily has trans fat, so even if an ingredient

list has a curative effect in some cases, it might not here. 

Reid’s allegations of misrepresentations are plausible enough

to survive a motion to dismiss.

IV

The district court also found that Reid’s claims for relief

were preempted. The parties’ arguments invoke express and

conflict preemption. Express preemption exists when a

statute explicitly addresses preemption. See Chicanos Por La

Causa, Inc. v. Napolitano, 558 F.3d 856, 863 (9th Cir. 2009). 

Conflict preemption applies when it is impossible to comply

with both federal and state law or when state laws stand as

obstacles to accomplishing federal objectives. See id. As will

be made clear, whether Reid’s claims are preempted turns on

our interpretation of the FDA’s actions. The preemption

analysis turns on whether the challenged statements are

authorized bythe FDA’s regulations or other pronouncements

of similar legal effect. See Holk v. Snapple Beverage Corp.,

575 F.3d 329, 339–40 (3d Cir. 2009). Before analyzing the

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12 REID V. JOHNSON & JOHNSON

statements at issue, we first set forth the statutory and

regulatory framework.

A

The Nutritional Labeling and Education Act (“NLEA”)

amended the Food, Drug, and Cosmetic Act (“FDCA”) to

“establish[] uniform food labeling requirements, including the

familiar and ubiquitous Nutrition Facts Panel found on most

food packages.” Lily, 743 F.3d at 664. The “NLEA also

provides that no state may ‘directly or indirectly establish any

requirement for the labeling of food that is not identical’ to

the federal requirements.” Id. at 664–65 (quoting 21 U.S.C.

§ 343-1(a)(5)) (ellipsis omitted). “The phrase ‘not identical

to’ means ‘that the State requirement directly or indirectly

imposes obligations or contains provisions concerning the

composition or labeling of food that are not imposed by or

contained in the applicable federal regulation or differ from

those specifically imposed by or contained in the applicable

federal regulation.’” Id. at 665 (quoting 21 C.F.R.

§ 100.1(c)(4)) (alteration marks omitted). The NLEA also

provides, however, that it does not preempt any state law

unless the law is “expressly preempted.”2 Holk, 575 F.3d at

337–38. The NLEA does not preempt state law-based causes

of action that are identical to the federal labeling

requirements. See POM Wonderful, 134 S. Ct. at 2238 (“[B]y

taking care to mandate express preemption of some state

laws, Congress if anything indicated that it did not intend the

FDCA to preclude requirements arising from other sources.”

(emphasis added)); Farm Raised Salmon Cases, 175 P.3d

1170, 1178–84 (Cal. 2008).

2 Other federal laws, however, may still preempt labeling claims. See

Holk, 575 F.3d at 336 & n.4.

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REID V. JOHNSON & JOHNSON 13

Under the FDA regulations, the general rule is that

“nutrient content claims” are not permitted on food labels. 

Nutrient content claims are statements that “expressly or

implicitly characterize[] the level of a nutrient.” 21 C.F.R.

§ 101.13(b). However, the regulations do authorize some

nutrient content claims. These include statements about the

amount or percentage of a nutrient that are consistent with the

labeling regulations (e.g., “less than 3 g of fat per serving”),

similar statements that include a disclaimer (e.g., “only 200

mg of sodium per serving, not a low sodium food”), or

statements that do not characterize the level of nutrient and

are not false or misleading (e.g., “100 calories”). Id.

§ 101.13(i). For authorized nutrient content claims,

statements may use “[r]easonable variations in the spelling of

terms . . . and their synonyms” provided that they “are not

misleading (e.g., ‘hi’ or ‘lo’).” Id. § 101.13(b)(4).

In addition to regulating nutrient content claims, FDA

regulations require labels to include the familiar “Nutrition

Facts” box, dubbed the “nutrition label” by federal

regulations. Companies are required to disclose information

about the presence of specified nutrients in this label. Id.

§ 101.9(c). Though the nutrition label clearly contains

information about nutrient content, the claims made in it are

not considered “nutrient content claims” for the purposes of

FDA regulations. See id. § 101.13(c). While a required

statement inside a nutrition label escapes regulations reserved

for nutrient content claims, the identical statement outside of

the nutrition label is still considered a nutrient content claim

and is therefore subject to section 101.13. As a result, a

requirement to state certain facts in the nutrition label is not

a license to make that statement elsewhere on the product.

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14 REID V. JOHNSON & JOHNSON

FDA regulations specifically address trans fat. They

provide that trans fat should generally be disclosed in the

nutrition label “except that label declaration of trans fat

content information is not required for products that contain

less than 0.5 grams of total fat in a serving if no claims are

made about fat, fatty acid or cholesterol content.” Id.

§ 101.9(c)(2)(ii). The regulation further provides:

If the serving contains less than 0.5 gram, the

content, when declared, shall be expressed as

zero. Except as provided for [under the

provisions allowing for simplified format

labeling], if a statement of the trans fat

content is not required and, as a result, not

declared, the statement “Not a significant

source of trans fat” shall be placed at the

bottom of the table of nutrient values.

Id.

Outside the nutrition label, claimants may make nutrient

content claims such as “fat free,” “no fat,” “zero fat,” or

“negligible source of fat” on labels where the food contains

less than 0.5 grams of fat per serving and certain other

conditions are met. Id. § 101.62(b). There is a parallel

regulation permitting similar claims about “saturated fat,” see

id. § 101.62(c), but not about “trans fat.” The FDA

considered authorizing a “trans fat free” claim but decided

not to enact the regulation in light of “insufficient scientific

information.” See Food Labeling: Trans Fatty Acids in

Nutrition Labeling, Nutrient Content Claims, Health Claims,

68 Fed. Reg. 41,434, 41,464–65 (July 11, 2003).

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REID V. JOHNSON & JOHNSON 15

In addition to nutrient content claims, the FDA has

specifically authorized some health claims. See 21 C.F.R.

§ 101.14. Such claims, however, must be “complete, truthful,

and not misleading.” Id. § 101.14(d)(2)(iii). These

specifically include plant stanol esters health claims. Id.

§ 101.83. The applicable regulation states:

A health claim associating diets that include

plant sterol/stanol esters with reduced risk of

heart disease may be made on the label or

labeling of a food . . . provided that . . . [t]he

claim states that diets that include plant

sterol/stanol esters “may” or “might” reduce

the risk of heart disease [and] . . . [t]he claim

specifies the daily dietary intake of plant

sterol or stanol esters that is necessary to

reduce the risk of [coronary heart disease or

“CHD”] and the contribution one serving of

the product makes to the specified daily

dietary intake level. Daily dietary intake

levels of plant sterol and stanol esters that

have been associated with reduced risk of

[CHD] are . . . 3.4 g or more per day of plant

stanol esters. . . . The claim [must also

specify] that the daily dietary intake of plant

sterol or stanol esters should be consumed in

two servings eaten at different times of the

day with other foods.

Id. § 101.83(c)(2). The claim may also “state that the

relationship between intake of diets that include plant

sterol/stanol esters and reduced risk of heart disease is

through the intermediate link of ‘blood cholesterol’ or ‘blood

total and LDL cholesterol.’” Id. § 101.83(d)(2). The

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16 REID V. JOHNSON & JOHNSON

regulations further provide that the authorization only applies

to foods that meet the 1.7 grams/serving threshold (i.e., two

servings amounting to 3.4 grams) and “contains 10 percent or

more of the Reference Daily Intake or the Daily Reference

Value for vitamin A, vitamin C, iron, calcium, protein, or

fiber per reference amount customarily consumed prior to any

nutrient addition.” Id. §§ 101.83(c)(2)(iii)(A)(2), (D),

101.14(e)(6).

In 2003, the FDA issued a letter in response to a request

from Cargill Health & Food Technologies that the FDA state

its intention not to enforce certain requirements of the plant

stanol esters regulation. In the letter, the FDA indicated that

it “will consider exercising enforcement discretion with

regard to the use of a claim about reduced risk of CHD in the

labeling of phystosterol containing food” that did not meet

the requirements in the regulation. Among other things, the

FDA also indicated that qualifying health claims had to relate

to foods containing 400 mg per serving, had to specify “that

the daily dietary intake of phytosterols that may reduce the

risk of CHD is 800 milligrams (mg) or more per day,” and the

food had to satisfy the regulation’s other requirements

(suchas the 10 percent nutrient requirement). See id.

§ 101.83(c)(2)(iii)(B)–(D).

The FDA has also recognized that “a heart symbol” can

constitute a health claim. Id. § 101.14(a)(1). Where a health

claim is authorized and “where any graphic material (e.g., a

heart symbol) constituting an explicit or implied health claim

appears on the label or labeling, the reference statement or the

complete claim shall appear in immediate proximity to such

graphic material.” Id. § 101.14(d)(2)(iv). Most health claims

based on the benefits of consuming the substance “must

specify the daily dietary intake necessary to achieve the

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REID V. JOHNSON & JOHNSON 17

claimed effect, as established in the regulation authorizing the

claim.” Id. § 101.14(d)(2)(vii). Health claims must also

conform “to all specific provisions in the appropriate

section.” Id. § 101.14(e)(2).

B

The challenged statements can be grouped into two

categories: (1) trans fat nutrient content claims; and (2) plant

stanol esters-based health claims.3

1

The preemption analysis of the “No Trans Fat” claim

turns on whether the statement is authorized by FDA 

regulations. These regulations create two categories of

nutrient content claims, “expressed” and “implied,” imposing

a different set of requirements for each type of claim. 21

C.F.R. § 101.13(b)(1)–(2). The “No Trans Fat” claim is an

expressed claim because it “is [a] direct statement about the

level . . . of [trans fat] in the food.” Id. § 101.13(b)(1). FDA

regulations authorize expressed claims that “do[] not in any

way implicitly characterize the level of the nutrient in the

food and [are] not false or misleading in any respect (e.g.,

‘100 calories’ or ‘5 grams of fat’).” See id. § 101.13(i)(3).

3 Reid also challenges McNeil’s use of various symbols on Benecol’s

label. McNeil’s ability to use these symbols depends on its authority to

make the trans fat nutrient content claims and plant stanol esters-based

health claims. Because we find that none of Reid’s other claims are

preempted, his challenges to these symbols also survive. Furthermore, 

Reid acknowledges that his contention that Benecol is a misbranded

cholesterol drug is only viable “[a]bsent regulatory allowance,” meaning

that it also rises or falls with his other health claims.

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18 REID V. JOHNSON & JOHNSON

The FDA has provided guidance about whether a “No

Trans Fat” nutrient content claim is permissible for products

containing small amounts of trans fat. In one of its warning

letters,4the FDA indicated that “No Trans Fat” is “an

unauthorized nutrient content claim . . . which has not been

defined by FDA.” The agency noted that the letter’s recipient

could “make a truthful statement on a product’s label that

specifies the amount of trans fat per serving.” See 21 C.F.R.

§ 101.13(i). In a second letter, the FDA similarly indicated

that “trans fat-free” is an “unauthorized nutrient content

claim.” We defer to the FDA’s interpretation of its own

rules, even if the product of an informal and non-final

process,5

unless its interpretation is clearly erroneous. See

Pub. Lands for the People, Inc. v. U.S. Dep’t of Agric.,

697 F.3d 1192, 1199 (9th Cir. 2012) (“Where an agency

interprets its own regulation, even if through an informal

process, its interpretation of an ambiguous regulation is

4 Reid argues that the district court erred by failing to take judicial notice

of the warning letters and that we should take judicial notice of the letters. 

Judicial notice, however, is unnecessary for materials establishing the

legal principles governing a case. Von Saher v. Norton Simon Museum of

Art at Pasadena, 592 F.3d 954, 960 (9th Cir. 2010); see also Von Koenig

v. Snapple Beverage Corp., 713 F. Supp. 2d 1066, 1073 (E.D. Cal. 2010)

(considering FDA warning letters for the purposes of a motion to dismiss). 

Accordingly, it is not necessary for us to take judicial notice of the

warning letters in order to consider them. Because we do consider the

letters, it is also unnecessary for us to determine whether the district court

erred by failing to do so.

5 The FDA uses warning letters, among other enforcement measures, to

police objectionable food and beverage labels in lieu of a preapproval

process. POM Wonderful, 134 S. Ct. at 2239. Although “informal and

advisory,” the FDA issues warning letters to obtain voluntary and prompt

corrective action for what it considers to be significant violations of the

FDCA. The warning letters are publicly available on the FDA’s website.

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REID V. JOHNSON & JOHNSON 19

controlling under Auer [v. Robbins, 519 U.S. 452, 461

(1997),] unless plainly erroneous or inconsistent with the

regulation.” (internal citations and alteration marks omitted)),

cert. denied, 133 S. Ct. 1464 (2013).

A nutrient content claim fails if it is “false or misleading

in any respect.” 21 C.F.R. § 101.13(i)(3) (emphasis added). 

Because Benecol contains some trans fat (between 0 and 0.5

grams per serving), its “No Trans Fat” claim is misleading in

at least one respect. The structure of FDA labeling

regulations bolsters this conclusion. As noted, under section

101.62(b)–(c), the FDA has expressly allowed “No Fat” and

“No Saturated Fat” claims for products that contain less than

0.5 grams of fat or saturated fat per serving. By contrast, the

FDA explicitly decided not to authorize a “No Trans Fat”

claim in light of a lack of scientific information. See 68 Fed.

Reg. 41,434, 41,464–65. If a “No Trans Fat” claim is not

“false or misleading” under 21 C.F.R. § 101.13 (i)(3), a “No

Fat” or “No Saturated Fat” claim cannot be treated

differently. This would mean that section 101.62(b)–(c) is

redundant: If section 101.13(i)(3) authorizes “No Fat” and

“No Saturated Fat” claims for products with small amounts

of fat or saturated fat, then why would the FDA go to the

trouble of promulgating a separate regulation expressly

allowing these claims? It would be incongruous to have the

same rule for both “No Fat”/“No Saturated Fat” and “No

Trans Fat” claims, as the former is expressly permitted while

the latter is not due to a lack of scientific consensus about the

dangers of trans fat. Thus, the FDA’s reading of

section 101.13(i)(3)—that the regulation does not authorize

“No Trans Fat” claims—makes the most sense of the overall

labeling regime, as it gives meaning to section 101.62(b)–(c).

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20 REID V. JOHNSON & JOHNSON

McNeil says its “No Trans Fat” claim is the equivalent of

its statement on the nutrition label that Benecol contains 0

grams of trans fat per serving, a statement it must make under

section 101.9(c)(2)(ii). FDA regulations allow a label to

include synonyms of authorized nutrient content claims, id.

§ 101.13(b)(4), which McNeil claims is exactly what its “No

Trans Fat” claim is. But, as noted, claims required on a

nutrition label under section 101.9(c), like Benecol’s “0

grams trans fat per serving” claim, are not nutrient content

claims and thus are not covered by section 101.13(b)(4)’s

synonym rule. That McNeil must say Benecol contains 0

grams of trans fat per serving on its nutrition label makes no

difference here.

The district court found that “No Trans Fat” was not

misleading, as any reasonable consumer would infer that

Benecol contains trans fat, given that partially hydrogenated

vegetable oil is disclosed as an ingredient. As noted,

however, there is no reason to believe that consumers

understand that partially hydrogenated vegetable oil contains

trans fat. Consequently, we conclude that Reid’s claims for

relief are not preempted to the extent they are predicated on

McNeil’s trans fat statements.

2

As for the plant stanol esters and cholesterol reduction

claims, McNeil admits that the claims fall short of 21 C.F.R.

§ 101.83(c)(2), which permits health claims related to plant

stanol esters that meet certain requirements. These health

claims do, however, meet the criteria described in the FDA’s

2003 letter about its enforcement intentions. McNeil argues

that, in spite of its noncompliance with section 101.83(c)(2),

the 2003 letter “created [a] federal policy preempting state

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REID V. JOHNSON & JOHNSON 21

law.” We must decide whether this letter is entitled to

preemptive effect.6

The SupremacyClause gives federal authorities the power

to preempt state law by declaring that the “Constitution, and

the Laws of the United States . . . [are] the supreme Law of

the Land.” U.S. Const. art. VI, cl. 2. “The phrase ‘Laws of

the United States’ encompasses both federal statutes

themselves and federal regulations that are properly adopted

in accordance with statutoryauthorization.” City of New York

v. FCC, 486 U.S. 57, 63 (1988). Thus, “a federal agency

acting within the scope of its congressionally delegated

authority may . . . render unenforceable state or local laws

that are otherwise not inconsistent with federal law.” Id. at

64 (internal quotation marks omitted). Because the

Supremacy Clause privileges only “[l]aws of the United

States,” an agency pronouncement must have the force and

effect of federal law to have preemptive force. See Fellner v.

Tri-Union Seafoods, LLC, 539 F.3d 237, 245 (3d Cir. 2008);

Wabash Valley Power Ass’n, Inc. v. Rural Electrification

Admin., 988 F.2d 1480, 1485–86 (7th Cir. 1993). Beyond the

constitutional text, there is nothing to guide us in determining

whether an agency action creates “law” for Supremacy

Clause purposes.

6 Although Reid suggests that the cholesterol reduction claims are not

authorized even if the 2003 letter is entitled to preemptive force, the FDA

explicitly found that “[t]he scientific evidence establishes that including

plant sterol/stanol esters in the diet helps lower blood total and LDL

cholesterol levels.” 21 C.F.R. § 101.83(b)(2). Thus, it appears that if

Benecol contains the minimum amounts necessary to make the health

claims at issue, it is consequently also proven to reduce cholesterol as far

as the FDA is concerned.

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22 REID V. JOHNSON & JOHNSON

The Supreme Court has created a framework for deciding

whether Congress contemplated that a particular agency

pronouncement would have the force and effect of federal

law in the Chevron context. Under Chevron, when an agency

fills a gap in a statute that Congress explicitly or implicitly

left open for that agency to fill, its “regulations are given

controlling weight unless they are arbitrary, capricious, or

manifestly contrary to the statute.” Chevron, U.S.A., Inc. v.

Natural Res. Def. Council, Inc., 467 U.S. 837, 843–44 (1984). 

In other words, it’s the agency’s job—not ours—to fill with

“law” the statutory interstices Congress left open. We

intervene only when in doing so the agency has acted

unreasonably, exceeded the authority Congress delegated to

it, or failed to observe required procedures. But only those

agency pronouncements that Congress intended to carry the

“force of law” require Chevron-level deference, and we

determine whether an agency spoke with such force under the

standard set forth in United States v. Mead Corp., 533 U.S.

218, 234 (2001), and its progeny.

We conclude that this standard is pertinent to the

preemption analysis here. In both Chevron and preemption

contexts, a central inquiry is whether an agency has validly

created federal law pursuant to the gap-filling power

delegated to it by Congress. In the former situation, we

decide whether Chevron-level deference is due because

Congress intended for the agency’s pronouncement to carry

the force of law; in the latter, we decide whether state law is

preempted because Congress intended for the agency’s

pronouncement to carry the binding and exclusive force of

federal law. Creation of federal law should demand at least

the same formality for purposes of preemption as it does for

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REID V. JOHNSON & JOHNSON 23

purposes of Chevron deference.7 We therefore join the Third

Circuit in declining to afford preemptive effect to agency

actions that do not carry the force of law under Mead and its

progeny. See Fellner, 539 F.3d at 245.

Applying this rule here, the 2003 letter lacks preemptive

effect. While some agency actions short of notice-andcomment rulemaking may have the force of law,

“enforcement guidelines” like those set forth in the FDA’s

letter “are beyond the Chevron pale.” Mead, 533 U.S. at 234.

To begin, the letter itself does not indicate that the FDA

“set out with a lawmaking pretense in mind.” Id. at 233. The

letter is couched in tentative and non-committal terms. The

letter does not promise that the FDA will not enforce its

existing regulation applicable to health claims about plant

stanol esters. Instead, the letter provides that the FDA

“intends to consider the exercise of enforcement discretion”

in certain circumstances. The FDA has separately stated,

however, that such letters indicate that it “does not intend to

object to the use of the claim specified in the letter, provided

that the products that bear the claim are consistent with the

stated criteria.” Thus, the FDA appears to regard the letter as

providing firmer guidance regarding its own enforcement

discretion than the 2003 letter’s tentative language would

suggest. Still, the letter’s plain language does not authorize

any health claims that conflict with the FDA’s existing plant

stanol esters rule. The letter only expresses the FDA’s

7 We do not reach the question of how “the presumption against

preemption,” and the federalism concerns that animate it, might further

guide our evaluation of the preemptive effect of an action by the FDA

implementing the FDCA. See Wyeth v. Levine, 555 U.S. 555, 565 (2009);

Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005).

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24 REID V. JOHNSON & JOHNSON

“intent” to “consider” enforcement discretion while the FDA

continues deliberations regarding whether a change to that

rule is appropriate. The FDA’s equivocal language regarding

its intention to foreclose its own ability to enforce noncompliance with existing rules is a good indication that it did

not intend to foreclose state law challenges to health claims

that do not comply with existing rules.

Reading the FDA’s 2003 letter in the context of the

FDCA’s statutory scheme also militates against a finding of

preemption. The FDA can approve health claims effective

immediately, pending consideration of public comment and

publication of a final regulation. 21 U.S.C. § 343(r)(7). In

fact, the FDA issued its 2000 plant stanol esters rule pursuant

to this authority, and thereby approved of certain health

claims about plant stanol esters effective immediately. Food

Labeling: Health Claims; Plant Sterol/Stanol Esters and

CoronaryHeart Disease, 65 Fed. Reg. 54,686, 54,713–54,714

(Sept. 8, 2000). The fact that the FDA did not invoke this

authority in setting forth the enforcement criteria in the 2003

letter also indicates that the FDA did not intend to issue a

standard with the force of law that would foreclose the public

protections under state law food labeling and false advertising

claims.

Similarly, we are not convinced that Congress intended

for an FDA pronouncement like that set forth in the 2003

letter to have the binding and exclusive effect of federal law. 

Giving the 2003 letter preemptive effect would effectively

open an additional shortcut allowing the FDA to authorize

health claims without notice and comment. Shortcuts are not

inherently bad and, again, some agency actions short of

notice-and-comment rulemaking may have the binding and

exclusive force of federal law. But Congress demonstrated

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REID V. JOHNSON & JOHNSON 25

that it knew how to create such a shortcut in enacting

21 U.S.C. § 343(r)(7), indicating that Congress did not intend

to create an additional, unstated means of rulemaking by way

of letters tentatively stating the FDA’s enforcement

discretion.

Finally, while not determinative of our decision, we are

concerned that allowing the FDA effectively to authorize

health claims by way of statements of its enforcement policy

could place those authorizations beyond judicial review. This

is so because agency decisions not to take enforcement action

are usually committed to agency discretion by law and thus

generally not subject to judicial review under the

Administrative Procedure Act. See 5 U.S.C. § 701(a)(2);

Heckler v. Chaney, 470 U.S. 821, 828–35 (1985). 

Foreclosing challenges to, and judicial review of, the FDA’s

health claim approvals likely would not serve Congress’s

goals in the FDCA of increasing the protections of public

health and safety. See POM Wonderful, 134 S. Ct. at 2234

(“The FDCA statutory regime is designed primarily to protect

the health and safety of the public at large.”). Indeed,

Congress was careful to preserve judicial review of the

FDA’s actions even where the FDA makes a proposed

regulation effective immediately, pending consideration of

public comment and publication of a final regulation. 

21 U.S.C. § 343 (r)(7) (“Such proposed regulations shall be

deemed final agency action for purposes of judicial review.”).

For these reasons, we hold that Reid’s claims for relief are

not preempted by the FDA’s 2003 enforcement letter. We

note that this conclusion, of course, in no way indicates that

Reid’s state law claims have merit.

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26 REID V. JOHNSON & JOHNSON

V

McNeil also asserts that the district court erred by

rejecting its argument that Reid’s action is barred by the

primaryjurisdiction doctrine. McNeil argues that the primary

jurisdiction doctrine applies here because “FDA expertise is

required to resolve the question of whether Benecol contains

sufficient plant stanol esters to reduce cholesterol and

whether the insignificant amount of trans fats undermine the

positive impact of plant stanol esters.” McNeil further

suggests that the FDA is in the process of an “ongoing

regulatory review” pending the completion of its final plant

stanol esters rule.

“The primary jurisdiction doctrine allows courts to stay

proceedings or to dismiss a complaint without prejudice

pending the resolution of an issue within the special

competence of an administrative agency.” Clark v. Time

Warner Cable, 523 F.3d 1110, 1114 (9th Cir. 2008). It “is a

prudential doctrine under which courts may, under

appropriate circumstances, determine that the initial

decisionmaking responsibility should be performed by the

relevant agency rather than the courts.” GCB Commc’ns, Inc.

v. U.S. S. Commc’ns, Inc., 650 F.3d 1257, 1263–64 (9th Cir.

2011) (internal quotation marks omitted). “It is useful . . . in

instances where the federal courts do have jurisdiction over

an issue, but decide that a claim requires resolution of an

issue of first impression, or of a particularly complicated

issue that Congress has committed to a regulatory agency.” 

Id. at 1264 (internal quotation marks omitted). It applies in

“limited circumstances” and is “not designed to secure expert

advice from agencies every time a court is presented with an

issue conceivably within the agency’s ambit.” Clark,

523 F.3d at 1114 (internal quotation marks omitted).

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REID V. JOHNSON & JOHNSON 27

McNeil’s argument has some facial appeal because the

preemption issues in this case turn on the interpretation and

applicability of the FDA’s regulations and other actions. 

Nonetheless, the argument is ultimately unpersuasive. The

FDA has already addressed some issues that McNeil

identifies as requiring further regulatory review. For

example, the FDA has specifically declined to authorize “No

Trans Fat” nutrient content claims, and has issued warning

letters to companies making such claims.

Reid’s claims present no issues of first impression, as the

FDA has already addressed the substantive issues raised here. 

Regarding plant stanol esters, there is already an interim final

rule on the books. Plus, it has been over a decade since the

FDA indicated that it would issue a new final plant stanol

esters rule.8 Cf. Baykeeper v. NL Indus., Inc., 660 F.3d 686,

692 (3d Cir. 2011) (concluding that there was little risk of

inconsistent rulings that would support the application of the

primary jurisdiction doctrine where the agency had not issued

any rulings for several years). Similarly, there is no

indication that the FDA is contemplating authorizing “No

Trans Fat” statements.9 The issue that this case ultimately

8 Any final rule might not govern the preemption analysis for the time

period covered by Reid’s action. See Elim Church of God v. Harris,

722 F.3d 1137, 1141–42 (9th Cir. 2013).

9 The FDA has shown no signs of backing away from its determination

that “trans fat free” nutrient content claims are not authorized. It stated:

Since 2003, both controlled trials and observational

human studies published on trans fatty acid

consumption have consistently confirmed the adverse

effects of trans fatty acid consumption on intermediary

risk factors (e.g., serum lipoproteins) and the increased

risk of CHD . . . . [Several notable] expert panels all

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28 REID V. JOHNSON & JOHNSON

turns on is whether a reasonable consumer would be misled

by McNeil’s marketing, which the district courts have

reasonablyconcluded theyare competent to address in similar

cases. See, e.g., Chacanaca, 752 F. Supp. 2d at 1124.

The “deciding factor” in determining whether the primary

jurisdiction doctrine should apply is “efficiency.” Rhoades

v. Avon Prods., Inc., 504 F.3d 1151, 1165 (9th Cir. 2007). 

Because the FDA has made considered judgments on the

legal issues in this case, we reject McNeil’s argument. See id. 

Consequently, the district court properly declined to dismiss

or stay the case pursuant to the primary jurisdiction doctrine.

VI

McNeil further argues that Reid’s action is barred by

California’s judicial abstention doctrine. See Alvarado v.

Selma Convalescent Hosp., 153 Cal. App. 4th 1292,

1297–1303 (2007). Having dismissed Reid’s claims on

preemption grounds, the district court never addressed this

issue. We therefore leave it for the district court’s

consideration on remand.

concluded that there is no threshold intake level for

industrially-produced trans fat that would not increase

an individual’s risk of CHD, or adverse effects on risk

factors for CHD. Moreover, the panels also agree that

trans fatty acids have a stronger effect on the risk of

CHD than saturated fatty acids.

Tentative DeterminationRegarding Partially Hydrogenated Oils; Request

for Comments and for Scientific Data and Information, 78 Fed. Reg.

67,169, 67,172 (Nov. 8, 2013). Accordingly, the FDA has tentatively

concluded that there is no scientific consensus that partially hydrogenated

oils, as the primary dietary source of artificial trans fat, are safe for use in

food. See id. at 67,173.

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REID V. JOHNSON & JOHNSON 29

VII

Reid’s basic contention in this case is that Benecol is

improperly being marketed and sold to consumers as health

food. At this early stage of the proceedings, we cannot say

whether he is right or wrong. It is clear, however, that

Benecol’s label prominently states that Benecol contains “No

Trans Fat.” That statement is not true. Although Benecol

may contain a relatively small amount of trans fat per serving,

the FDA found that the existing scientific evidence was not

sufficient for it to approve “No Trans Fat” claims. Despite

this finding, McNeil made such a claim. Given that the FDA

has indicated in warning letters that claims like “No Trans

Fat” are not authorized, McNeil cannot shield itself from

liability with the FDA’s regulations. We also hold that an

FDA letter stating a tentative enforcement policy does not

preempt state law. Consequently, we reverse the district

court’s decision dismissing Reid’s action. We affirm the

district court’s decision to the extent that it declined to invoke

the primary jurisdiction doctrine. We remand for further

proceedings consistent with this opinion.

AFFIRMED in part, REVERSED in part, and

REMANDED.

Parties shall bear their own costs.

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