Shavonda Hawkins v. The Kroger Company

Trans fat has become increasingly recognized as a

dangerous substance and a leading cause of numerous serious

ailments, including heart disease and diabetes. Food and Drug

Administration (“FDA”) regulations govern the information

reported within a food product’s Nutrition Facts Panel on the

product’s label.1 As for trans fat, FDA regulations provided,

at all relevant times, that if the product contained “less than

0.5 gram” trans fat, as it did in this case, it was required to tell

the consumer on the Nutrition Facts Panel that it contained

0 grams trans fat, even though it contained this dangerous

food additive.

We are asked to determine, inter alia, whether these FDA

trans fat regulations governing the contents of the Nutrition

Facts Panel preempt California’s unfair competition laws

proscribing false or misleading advertising elsewhere on a

food product’s label. We hold that they do not; accordingly,

the plaintiff can challenge the legitimacy of defendant’s

product advertising on the face of the label that it contains

“0g Trans Fat per serving.” In doing so, we take the occasion

to reinforce and apply our holding in Reid v. Johnson &

Johnson that “a requirement to state certain facts in the

1 Somewhat confusingly, the FDA regulations refer to the ubiquitous

box that contains nutritional facts as “nutrition labeling,” 21 C.F.R.

§ 101.9, while also referring to the rest of the product’s exterior as

labeling. For clarity, and consistent with other decisions of this Court, this

decision uses “Nutrition Facts Panel” to refer to the “nutrition labeling,”

see, e.g., Lilly v. ConAgra Foods, Inc., 743 F.3d 662, 664 (9th Cir. 2014),

and all other references to labels to refer to information outside the

Nutrition Facts Panel.

HAWKINS V. THE KROGER COMPANY 5

nutrition label is not a license to make that statement

elsewhere on the product.” 780 F.3d 952, 960 (9th Cir. 2015)

(emphasis added).

I

Hawkins’ complaint alleges the following:2 The Kroger

Company (“Kroger”) sells Kroger Bread Crumbs (“KBCs”)

in stores in California, including the supermarket chain

Ralph’s. Hawkins regularly purchased KBCs at several

Ralph’s locations between 2000 and 2015. In making the

purchases, she relied on the information contained on the face

of the label that the product contained “0g Trans Fat per

serving.” In August 2015, she discovered that, contrary to the

claim on the label, KBCs “contained artificial trans fat, and

caused heart disease, diabetes, cancer, and death.”3

2 We must “accept the complaint’s well-pleaded factual allegations as

true, and construe all inferences in the plaintiff’s favor for the purposes of

evaluating a motion to dismiss under Federal Rule of Civil Procedure

12(b)(6).” Ariz. Students’ Ass’n v. Ariz. Bd. of Regents, 824 F.3d 858, 864

(9th Cir. 2016).

3 On June 17, 2015, the FDA had released a Final Determination

Regarding PHOs (“2015 Final Determination”), in which it declared:

“[T]here is no longer a consensus among qualified experts that partially

hydrogenated oils (PHOs), which are the primary dietary source of

industrially-produced trans fatty acids (IP-TFA) are generally recognized

as safe (GRAS) for any use in human food. ” 2015 Final Determination,

80 Fed. Reg. 34650, 34650 (June 17, 2015). However, the 2015 Final

Determination did not prohibit use of PHOs in food until June 18, 2018,

to allow small businesses time to adjust, minimize market disruptions, and

allow growth, harvest, and processing of new crops. Id. at 34668–69. On

May 21, 2018, the FDA extended this compliance date, providing a range

of new compliance dates depending on whether the manufacturer

petitioned for a new date and the date on which the food was

manufactured. Final Determination Regarding Partially Hydrogenated

HAWKINS V. 6 THE KROGER COMPANY

In October 2015, Hawkins brought a putative class action

against Kroger seeking to represent a class of consumers who

were misled by the label (“the labeling claims”) and had used

the dangerous product (“the use claims”). The complaint

alleged violations of the California Unfair Competition Law

(“UCL”), Cal. Bus. & Prof. Code § 17200 et seq., False

Advertising Law (“FAL”), Cal. Bus. & Prof. Code § 17500

et seq., Consumer Legal Remedies Act (“CLRA”), Cal. Civ.

Code § 1750 et seq., and common law claims for breach of

implied warranty of merchantability and breach of express

warranty. It sought damages, pre-judgment and postjudgment

interest, injunctive4 and declaratory relief,

attorneys’ fees, and costs.

The district court granted Kroger’s Rule 12(b)(6) motion

to dismiss, with prejudice, holding that Hawkins lacked

standing to bring these claims, and, alternatively, that the

labeling claims were preempted by federal law.

The district court reasoned that plaintiff lacked standing

to bring her labeling claims because it believed that she did

not allege that she read the “0g Trans Fat per serving” label

on the face of the label and therefore could not establish

reliance or injury. It alternatively held that the labeling claims

Oils, 83 Fed. Reg. 23358, 23359 (May 21, 2018) (“2018 Final

Determination”).

4 Hawkins has since stated that “[b]ecause Kroger no longer engages

in the conduct described in the complaint, [she] almost certainly would not

pursue such relief on remand.” Hawkins’s Suppl. Br. at 3.

HAWKINS V. THE KROGER COMPANY 7

were preempted.5 The district court dismissed Hawkins’s use

claims for lack of standing because her alleged injuries were

too speculative. The district court did not address whether the

use claims would be preempted.

Because we disagree with all of the district court’s

holdings, we reverse and remand for further proceedings.

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.” Reid, 780 F.3d at 958.

A. Labeling Claims

1. Standing

We turn first to Hawkins’s statutory standing to bring her

labeling claims. California law requires plaintiffs alleging

UCL and FAL claims to show that they “ha[ve] suffered

injury in fact and ha[ve] lost money or property as a result of

the unfair competition.” Cal. Bus. & Prof. Code §§ 17204

(UCL); see id. § 17535 (FAL); Hinojos v. Kohl’s Corp.,

718 F.3d 1098, 1103 (9th Cir. 2013) (UCL and FAL standing

requirement are identical) (citing Kwikset Corp. v. Sup. Ct.,

5 The district court commingled the questions of statutory standing

and preemption, but these are two distinct legal issues and will be

addressed separately. We note also that “a dismissal for lack of statutory

standing is properly viewed as a dismissal for failure to state a claim rather

than a dismissal for lack of subject matter jurisdiction.” Vaughn v. Bay

Envtl. Mgmt., Inc., 567 F.3d 1021, 1024 (9th Cir. 2009).

HAWKINS V. 8 THE KROGER COMPANY

246 P.3d 877, 884 (Cal. 2011)). A plaintiff is required to

show “‘some form of economic injury’ as a result of his

transactions with the defendant.” Hinojos, 718 F.3d at 1104

(quoting Kwikset, 246 P.3d at 885). However, “the quantum

of lost money or property necessary to show standing is only

so much as would suffice to establish injury in fact.” Kwikset,

246 P.3d at 886.

California law also requires causation—namely, that the

plaintiff relied on the misrepresentation on the label. “A

consumer who relies on a product label and challenges a

misrepresentation contained therein can satisfy the standing

requirement of section 17204 by alleging . . . that he or she

would not have bought the product but for the

misrepresentation.” Id. at 890. “That assertion is sufficient to

allege causation [and it] is also sufficient to allege economic

injury.” Id.; see also Davidson v. Kimberly-Clark Corp.,

889 F.3d 956, 965 (9th Cir. 2018).

Hawkins alleges that she relied upon the label and would

not have bought the product without the misrepresentation.

For example, paragraph 76 of the complaint states: “Plaintiff

relied on Defendant’s ‘0g trans fat’ claim as a substantial

factor in her purchases”; paragraph 101 states: “Plaintiff

purchased the Kroger Bread Crumbs believing they had the

qualities she sought based on the Products’ deceptive

labeling”; and paragraph 107 states: “Plaintiff, on at least one

occasion, would not have purchased the Kroger Bread

Crumbs absent Defendant’s misrepresentation.”

In holding that Hawkins did not plead reliance, the district

court misread Hawkins’s complaint. It interpreted the

complaint as alleging that she did not read the “0g Trans Fat

per serving” product label until August 2015, fifteen years

HAWKINS V. THE KROGER COMPANY 9

after she began purchasing the product. However, the

paragraph cited by the district court to support its conclusion

reads, “Plaintiff first discovered Defendant’s unlawful acts

described herein in August 2015, when she learned that

Kroger Bread Crumbs contained artificial trans fat . . . .”

Compl. ¶ 74 (emphases added). This paragraph does not

allege that she first read the label in August 2015; it alleges

she first discovered the label was misleading on that date. The

district court did not address the three paragraphs where

Hawkins concretely alleged that she relied on the label.

Because Hawkins adequately alleged that she relied on

the label’s misrepresentations and would not have purchased

the product without those misrepresentations, she has

adequately alleged standing for her labeling claim.

2. Preemption

We next turn to whether Hawkins’s state law mislabeling

claim challenging the statement “0g Trans Fat per serving” is

preempted by federal regulations.

a. Preemption Generally

Preemption is guided by two principles: first, “the

purpose of Congress is the ultimate touchstone in every preemption

case,” and second, “[i]n all pre-emption cases, and

particularly in those in which Congress has ‘legislated . . . in

a field which the States have traditionally occupied,’ . . . we

‘start with the assumption that the historic police powers of

the States were not to be superseded by the Federal Act

unless that was the clear and manifest purpose of Congress.’”

Wyeth v. Levine, 555 U.S. 555, 565 (2009) (alterations in

HAWKINS V. 10 THE KROGER COMPANY

original) (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485

(1996)).

b. The NLEA

“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.’” Reid, 780 F.3d 959 (alterations in original)

(quoting Lilly, 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. (quoting Lilly, 743 F.3d at

664–65); see also 21 U.S.C. § 343-1(a)(5).

“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.’” Reid,

780 F.3d at 959 (quoting, with alterations, Lilly, 743 F.3d at

665); see also 21 C.F.R. § 100.1(c)(4). However, the NLEA

“does not preempt any state law unless the law is ‘expressly

preempted.’” Id. (quoting Holk v. Snapple Beverage Corp.,

575 F.3d 329, 337–38 (3d Cir. 2009)); nor does it “preempt

state law-based causes of action that are identical to the

federal labeling requirements,” id. (citing POM Wonderful

LLC v. Coca-Cola Co., 134 S. Ct. 2228, 2238 (2014)).

Therefore, if FDA regulations expressly permit the claim

“0g Trans Fat per serving” on the face of a product’s

HAWKINS V. THE KROGER COMPANY 11

packaging, any state law claim to the contrary would be

preempted.

c. The Nutrition Facts Panel and Nutrient Content

Claims

The FDA regulations at issue here can broadly be

separated into two categories. First, there are rules, contained

in 21 C.F.R. § 101.9, governing what must be stated within

the Nutrition Facts Panel, including the amount of various

nutrients, such as fat, saturated fat, trans fat, sodium, and

carbohydrates. Second, there are rules governing “nutrient

content claims” made elsewhere on the product. These are

claims that “expressly or implicitly characterize[] the level of

a nutrient,” 21 C.F.R. § 101.13(b); they are further subdivided

between general and specific rules, 21 C.F.R. §§ 101.13

(general rules), 101.62 (specific rules regarding fat).

Critically, the rules that govern claims made within the

Nutrition Facts Panel and the rules that govern nutrition

content claims elsewhere on the label are different:

“Information that is required or permitted by § 101.9 . . . and

that appears as part of the nutrition label, is not a nutrient

content claim . . . . If such information is declared elsewhere

on the label . . . it is a nutrient content claim and is subject to

the requirements for [such] claims.” 21 C.F.R. § 101.13(c).

Without § 101.13(c), this would be a simple case. At the

time Hawkins made the purchases, the relevant regulation

provided that within the Nutrition Facts Panel, “[i]f the

serving contains less than 0.5 gram, the content shall be

expressed as zero.” 21 C.F.R. § 101.9(c)(2)(ii) (2015).

Therefore, the claim “0g Trans Fat per serving” was not only

permitted within the panel, but mandated. However, since,

HAWKINS V. 12 THE KROGER COMPANY

under § 101.13(c), a statement as to the amount of a nutrient

mandated inside the Nutrition Facts Panel is not necessarily

permitted by the FDCA elsewhere on the packaging, further

analysis is required to determine if the FDCA allows the same

“0g Trans Fat per serving” claim elsewhere on the label. The

district court erred by not performing this analysis.

d. Reid v. Johnson & Johnson

In Reid, we determined that the statement “No Trans Fat”

was not allowed outside of the Nutrition Facts Panel since the

product did contain trans fat, notwithstanding that the

Nutrition Facts Panel reported that it contained 0g trans fat.

780 F.3d at 963. As we wrote:

Though the nutritional 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 21 C.F.R. § 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.

Id. at 960.

“No Trans Fat” was an “expressed” nutrient content claim

because it was “[a] direct statement about the level . . . of

[trans fat] in the food.” Id. at 962 (alterations in original)

(quoting § 101.13(b)(1)). Therefore, under the regulations, it

could only be made if it did “not in any way implicitly

HAWKINS V. THE KROGER COMPANY 13

characterize the level of the nutrient in the food and [was] not

false or misleading in any respect.” 21 C.F.R. § 101.13(i)(3).

We held that “No Trans Fat” was misleading because a

reasonable consumer might infer that the product did not

contain trans fat. Reid, 780 F.3d at 962–63.

We “bolster[ed]” this conclusion in Reid by noting that

under §§ 101.62(b)–(c) “the FDA has expressly allowed ‘No

Fat’ and ‘No Saturated Fat’ nutrient content 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’ nutrient content claim in light

of a lack of scientific information.” Id. at 962 (citing Food

Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient

Content Claims and Health Claims, 68 Fed. Reg. 41434,

41464–65 (July 11, 2003)). Thus, the only interpretation

which gave full meaning to each word of the regulations was

that the claim “No Trans Fat” was not authorized. Therefore,

we rejected the defendant’s argument that, because it was

required to state the product had “0 grams trans fat per

serving” within the Nutrition Facts Panel, it should be

allowed to make an equivalent claim elsewhere on the label.

Reid, 780 F.3d at 963.

e. The Present Case

Reid squarely controls here. As in Reid, we have an

expressed nutrient content claim that the product does not

contain trans fat. Also as in Reid, the manufacturer was

required to state that the product had “0g trans fat per

serving” within the Nutrition Facts Panel. And, just as in

Reid, because of § 101.13(c), this requirement did not give

the manufacturer license to make the same claim elsewhere

on the product, and the rest of the product labeling was

HAWKINS V. 14 THE KROGER COMPANY

subject to the rules governing nutrition content claims,

including that the claim not be “false or misleading in any

way.” 21 C.F.R. § 101.13(i)(3).

It makes no difference that here the label outside the

Nutrition Fact Panel stated that the product had “0g Trans

Fat,” whereas in Reid it was “No Trans Fat.” Just as in Reid,

a consumer reading the label could be misled into believing

that the product was free of trans fat.

Moreover, like in Reid, the regulations also bolster our

conclusion in this case. In addition to authorizing “no fat”

and “no saturated fat” claims, §§ 101.62(b)–(c) also

authorize “zero fat” and “zero saturated fat” claims. But just

as the regulations do not authorize a “no trans fat” claim, they

also do not authorize a “zero trans fat” claim. And we see no

rational difference between “zero” and “0.” Spelling out the

number does not change its meaning.6 To hold otherwise

would create an illogical rule where the claim “zero trans fat”

is misleading but “0 trans fat” is not.7

We are not the first to note that the FDA’s food

regulations promulgated under the NLEA are “inconsistent

and incomprehensive”: “A regulatory scheme intended to

6 We note the FDA regulations themselves treat “zero” and “0” as

equivalent; the rounding rule at issue here instructs to round down to

“zero” within the Nutrition Facts Panel. See 21 C.F.R. § 101.9(c)(2)(ii)

(2015).

7 The district court relied on Carrea v. Dreyer’s Grand Ice Cream,

Inc., 475 F. App’x 113 (9th Cir. 2012), an unpublished memorandum

disposition that predates Reid. We are not bound by Carrea, see 9th Cir.

R. 36-3(a), and, for the reasons stated in the text, we do not find its

reasoning persuasive.

HAWKINS V. THE KROGER COMPANY 15

convey accurate and clear information to consumers is instead

mind-bogglingly complex and confusing.” Diana R.H.

Winters, The Magical Thinking of Food Labeling: The NLEA

As A Failed Statute, 89 Tul. L. Rev. 815, 842 (2015). In

particular, “the difficult and complex interaction between the

preemption requirements” and “the level of specificity at

which preemption must be determined” have caused “a large

amount of judicial resources [to be] expended in the

determination of these preliminary issues.” Id. at 850.8

In this case, as we have explained, the “rounding rules”

applicable to the Nutrition Facts Panel do not apply to the

nutrient content claim on the face of the label. And unlike

other products, where the distinction may not be inimical to

the public health, falsely advertising that a food product does

not contain trans fat is a health hazard.9

8 The present case is a perfect example of the degree of difficulty in

sorting out and tracking down the applicable regulations. Even the current

status of the trans fat rounding rules is unclear. On May 27, 2016, the

FDA issued a final rule called “Food Labeling: Revision of the Nutrition

and Supplemental Facts Labels,” in which it purported to reaffirm the rule

that a product containing less than 0.5 grams of trans fat must list the

amount as zero grams. 81 Fed. Reg. 33742, 33787–88 (May 27, 2016).

However, the actual amendments to the regulation removed subsection

21 C.F.R. § 101.9(c)(2)(ii) entirely. See 81 Fed. Reg. at 33979. The

revised version mandates the declaration of “total fat” with similar

rounding rules but makes no mention of trans fat.

9 No challenge was mounted in this case under the Administrative

Procedure Act as to whether the trans fat rounding regulation was

“arbitrary or capricious.” See 5 U.S.C. § 706(2)(A); Chevron, U.S.A., Inc.

v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 844 (1984). That issue is,

therefore, not before us.

HAWKINS V. 16 THE KROGER COMPANY

Because the FDA regulations do not authorize the

contested statement, Hawkins’s labeling claims are not

preempted.

B. Use Claims

Hawkins also brought a set of claims under the theory

that, under California law, it is illegal to include trans fat in

products since it is not fit for human consumption and is an

unlawful food additive. As noted, these claims were

dismissed for lack of standing because the district court

viewed the injuries as too speculative. Unlike the labeling

claims, the court did not address whether the use claims were

preempted.

1. Standing

Hawkins has statutory standing for the same reason she

has statutory standing to bring her labeling claims—it is

sufficient for a consumer to allege that she bought a product

she would not have otherwise bought if she had known the

product was harmful. Davidson, 889 F.3d at 965–66.

2. Preemption

Kroger argues, as an alternative ground for dismissal of

the use claims, that they are preempted by the FDA’s 2015

Final Determination that PHOs are no longer GRAS because

the FDA gave food companies the three-year window before

it would begin enforcement of the new determination.10 2015

10 We note that in another recent case brought by Hawkins

challenging the use of PHOs in food, a panel of this court “assume[d]

without deciding that Hawkins’s claims are not preempted by federal

HAWKINS V. THE KROGER COMPANY 17

Final Determination, 80 Fed. Reg. at 34651. This three-year

window was statutorily embraced in 2016 when, as part of the

Consolidated Appropriations Act of 2016, Pub. L. No. 114-

113, 129 Stat. 2242 (“2016 CAA”), Congress enacted

language stating no PHOs “shall be deemed unsafe . . . and no

food . . . shall be deemed adulterated . . . by virtue of bearing

or containing a [PHO] until” the three-year window expired.

2016 CAA § 754.

“Generally, we do not ‘consider an issue not passed upon

below.’” Foti v. City of Menlo Park, 146 F.3d 629, 638 (9th

Cir. 1998) (quoting Golden Gate Hotel Ass’n v. City & Cty.

of San Francisco, 18 F.3d 1482, 1487 (9th Cir. 1994)). “This

general rule has exceptions, but invocation of those

exceptions is discretionary.” Id.

We decline to exercise our discretion here. The

preemption issue was not fully briefed on appeal by either

party. For example, the analysis may be different as to

purchases prior to the 2015 Final Determination, between the

2015 Final Determination and the passage of the 2016 CAA,

and after the passage of the 2016 CAA. These distinctions

were not addressed.

law.” Hawkins v. AdvancePierre Foods, Inc., 733 F. App’x. 906, 906

(Aug. 10, 2018). The panel affirmed the lower court’s dismissal of the

case on the merits. Id. at 906–07. We leave it to the district court on

remand to assess that non-precedential decision’s persuasive value and

relevance to this case.

HAWKINS V. 18 THE KROGER COMPANY

Thus, we leave it to the district court on remand to decide

in the first instance to what extent, if at all, the state law use

claims are federally preempted.11



* * *



11 Kroger brings a plethora of other alternative grounds to affirm that

were not addressed by the district court. These arguments, many involving

factual allegations, are best presented to the district court in the first

instance on remand. See Winter v. United States, 244 F.3d 1088, 1092 (9th

Cir. 2001) (declining to reach issue “not addressed by the district court”

which “involves the resolution of disputed factual issues”).

III

Hawkins has established standing for her label and use

claims. Her label claims are not preempted. On remand, the

district court shall consider whether the use claims are

preempted.

REVERSED AND REMANDED.