Date: 10-09-2018

Case Style:

Case Number: 16-55532

Judge: Frederick Block

Court: United States Court of Appeals for the Ninth Circuit on appeal from the Southern District of California (San Diego County)

Plaintiff's Attorney: Greg Weston and David Elliot

Defendant's Attorney: Jacob M. Harper and Nicole S. Phillis

Description: 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”).

Outcome: 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.

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