Elena Nacarino v. Kashi Company

FOR PUBLICATION

UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT

ELENA NACARINO; MEGAN No. 22-15377
TAYLOR,
D.C. No. 3:21-cv-
Plaintiffs-Appellants, 07036-VC

v.
OPINION
KASHI COMPANY,

Defendant-Appellee.

MOLLY BROWN; ADINA No. 22-15658
RINGLER; CHRISTIAN LEMUS,
D.C. No. 3:21-cv-
Plaintiffs-Appellants, 07388-VC

v.

KELLOGG COMPANY,

Defendant-Appellee.

Appeal from the United States District Court
for the Northern District of California
Vince Chhabria, District Judge, Presiding
2 NACARINO V. KASHI CO.

Argued and Submitted May 10, 2023
San Francisco, California

Filed August 14, 2023

Before: Sidney R. Thomas, Morgan Christen, and Daniel
A. Bress, Circuit Judges.

Opinion by Judge Christen

SUMMARY *

Federal Preemption / Product Labeling

The panel affirmed on different grounds the district
court’s dismissal of two complaints alleging that food
product labels advertising the amount of protein in the
products were false and misleading under both federal and
state law.
The federal Food, Drug, and Cosmetic Act expressly
preempts all state statutes and law that establish
requirements for the labeling of food that are not identical to
the federal requirements set forth by statute and Food and
Drug Administration (“FDA”) regulations. Under FDA
regulations, even if protein quantity is calculated using a
federally approved method, promoting a protein’s quantity
outside of the label’s Nutritional Facts Panel could be
misleading if the product contains lower-quality protein and

*
This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
 NACARINO V. KASHI CO. 3

the Nutritional Facts Panel does not disclose the percent
daily value of the protein adjusted for the protein’s quality.
The panel rejected Plaintiffs’ arguments that the protein
claims on Defendants’ labels were false because the nitrogen
method for calculating protein content overstated the actual
amount of protein the products contained. The panel held
that FDA regulations specifically allow manufacturers to
measure protein quantity using the nitrogen method, to
display that value in the Nutritional Facts Panel, and to use
it to make a quantitative nutrient content claim.
The panel rejected Plaintiffs’ arguments that the protein
claims on Defendants’ labels were misleading because the
“amount of digestible or usable protein the Products actually
deliver to the human body is even lower” than the actual
amount of protein the products contain. The panel held that
Defendants’ protein claims could be misleading under FDA
regulations if they did not accurately state the quantity of
protein or if the products did not display the quality-adjusted
percent daily value in the Nutritional Facts Panel. However,
Plaintiffs’ complaints did not allege that the challenged
protein claims were misleading within the meaning of the
federal regulations.
The panel held that, to the extent that state law would
hold Defendants to a different standard, Plaintiffs’ state-law
claims were expressly preempted.
Finally, the panel held that the FDA regulations are not
ambiguous and are sufficient to support the preemption
holding, but the agency’s interpretations of its own
regulations reinforce that conclusion.
4 NACARINO V. KASHI CO.

COUNSEL

Matthew T. McCrary (argued), Gutride Safier LLP, Boulder,
Colorado; Seth A. Safier, Gutride Safier LLP, San Francisco,
California; for Plaintiffs-Appellants.
Andrianna Kastanek (argued) and Dean N. Panos, Jenner &
Block LLP, Chicago, Illinois; Alexander M. Smith, Jenner
& Block LLP, Los Angeles, California; for Defendants-
Appellees.

OPINION

CHRISTEN, Circuit Judge:

In these consolidated appeals, we must decide whether
food product labels that advertise the amount of protein in
the products are false or misleading. Plaintiffs allege that the
products’ front labels are false and misleading because they
overstate the products’ protein quantity and implicitly
exaggerate protein quality. The district court disagreed. It
reasoned that the protein claims on Defendants’ front labels
could not be false or misleading under federal law because
Defendants measured protein quantity using a method
approved by the Food and Drug Administration. Because
any state labeling requirements that differ from federal
requirements are preempted, and the court concluded that
Defendants’ labels comply with federal law, the court
dismissed Plaintiffs’ complaints.
We agree with the district court’s analysis of the
preemption principles that apply to these appeals, and with
the court’s ultimate conclusion that Plaintiffs’ claims are
 NACARINO V. KASHI CO. 5

preempted. But we read the federal food labeling regulations
differently. Even if protein quantity is calculated using a
federally approved method, promoting a product’s protein
quantity outside of the label’s Nutrition Facts Panel could be
misleading if the panel does not disclose the percent daily
value of protein adjusted for the protein’s quality. Here, we
nevertheless affirm the district court’s dismissal of
Plaintiffs’ complaints because neither of them alleges that
the Nutrition Facts Panels on Defendants’ product labels
omitted the required protein quality-adjusted percent daily
value information.
I
Two putative class actions are at issue in these appeals:
Nacarino v. Kashi Co., No. 22-15377, and Brown v. Kellogg
Co., No. 22-15658. The complaints were filed in the
Northern District of California, and they asserted materially
identical state-law consumer protection claims for unfair
business practices, unjust enrichment, and fraud. Both
complaints alleged that the front labels on several of
Defendants’ products are “false and misleading” under state
and federal law. In Plaintiffs’ view, the front labels of
Defendants’ products “broadly tout protein quantity while
ignoring . . . the poor quality proteins in their products.”
Plaintiffs argue that Defendants’ protein claims are false and
misleading because the human body cannot absorb and use
all the protein in foods that contain low-quality protein.
We review de novo an order granting a motion to dismiss
for failure to state a claim, and construe a complaint’s
allegations in favor of the plaintiff. Bolden-Hardge v. Off.
of Cal. State Controller, 63 F.4th 1215, 1220 (9th Cir. 2023).
A district court may dismiss a complaint when its allegations
“give rise to an affirmative defense that clearly appears on
6 NACARINO V. KASHI CO.

the face of the pleading.” Boquist v. Courtney, 32 F.4th 764,
774 (9th Cir. 2022). “Preemption, on which the defendant
bears the burden, can be such a defense.” Pardini v.
Unilever U.S., Inc., 65 F.4th 1081, 1084 (9th Cir. 2023)
(internal citation omitted).
The Food, Drug, and Cosmetic Act (FDCA), 1 as
amended by the Nutrition Labeling and Education Act
(NLEA), 2 expressly preempts all state statutes and law that
“directly or indirectly establish any requirement for the
labeling of food that is not identical to the federal
requirements” set forth by statute and Food and Drug
Administration (FDA) regulations. Hawkins v. Kroger Co.,
906 F.3d 763, 769 (9th Cir. 2018) (internal quotation marks
omitted) (quoting Reid v. Johnson & Johnson, 780 F.3d 952,
959 (9th Cir. 2015)). 3 The FDCA express-preemption
provision relevant here is 21 U.S.C. § 343-1(a)(5). “The
preemption analysis turns on whether the challenged
statements are authorized by the FDA’s regulations or other
pronouncements of similar legal effect.” Reid, 780 F.3d at
959. The parties dispute whether the state-law requirements
that Plaintiffs invoke differ from the requirements imposed
by the FDCA and its implementing regulations. As we
explain, we conclude that federal law authorizes Defendants’
quantitative protein claims, and that Plaintiffs’ state-law
claims seek to impose different requirements from those

1
Pub. L. No. 75-717, 52 Stat. 1040 (1938).
2
Pub. L. No. 101-535, 104 Stat. 2353 (1990).
3
See 21 U.S.C. § 343-1(a)(5); see also id. § 343(q)(1)(D), (r)(1)(A),
(r)(2)(A)(i); 21 C.F.R. § 100.1(b)(5), (c)(4)(ii).
 NACARINO V. KASHI CO. 7

prescribed by federal law. As such, Plaintiffs’ state-law
claims are preempted. 4
II
A
Understanding Plaintiffs’ claims requires some
background on the nature of protein and federal nutrition-
labeling regulations. The complaints allege that protein,
composed of amino acid chains, varies in quality based on
its digestibility and the balance of the amino acids it
contains. Different protein sources supply different amounts
of amino acids. Some amino acids are considered essential
because the human body cannot make them on its own. This
means that two food products containing the same amount
of protein by weight may differ in two important respects:
how much of the food’s protein can be absorbed and used by
the human body, and how well the food’s protein will fulfill
a person’s nutritional needs.
The FDCA, enacted in 1938, establishes that a food is
misbranded if its labeling is “false or misleading in any
particular.” 5 In 1990, Congress amended the FDCA through

4
Plaintiffs also argue that the district court erred by failing to
acknowledge or apply the presumption against preemption. But
“[w]hen, as here, ‘the statute contains an express pre-emption clause, we
do not invoke any presumption against pre-emption but instead focus on
the plain wording of the clause, which necessarily contains the best
evidence of Congress’ pre-emptive intent.’” Int’l Bhd. of Teamsters,
Loc. 2785 v. Fed. Motor Carrier Safety Admin., 986 F.3d 841, 853 (9th
Cir. 2021) (quoting Puerto Rico v. Franklin Cal. Tax-Free Tr., 579 U.S.
115, 125 (2016)). Regardless, the result in this case would be the same
even if there were a presumption against preemption that needed to be
overcome.
5
21 U.S.C. § 343(a).
8 NACARINO V. KASHI CO.

the NLEA and mandated nutrition labeling—and the now-
ubiquitous Nutrition Facts Panels (NFPs)—on many
products. 6 The NLEA and its implementing regulations
require manufacturers to include on food labels NFPs that
disclose the number of calories and the amount of fat,
carbohydrates, and protein in their products. 7 NFPs are
usually printed on the side or back of a product’s packaging. 8
The statute and regulations, including 21 C.F.R. § 101.13,
specify what claims manufacturers may make about a food’s
nutrient content on product labels outside of the NFP, such
as on the front label. 9 When manufacturers make a claim
outside the NFP that describes the amount of one of the
nutrients required to be included in the NFP, FDA
regulations refer to the statement as a “nutrient content
claim,” or, if the statement describes protein, a “protein
claim.” 10 The challenged claims here are protein claims
because they appear outside the NFP and characterize the
amount of protein in the products. For example, the front
label on a box of Kashi Go Cinnamon Crisp cereal includes
an “11g Protein” claim, and the front label on Kellogg’s
Special K cereal includes a “PROTEIN 15g” claim.
There are different regulations for front labels and NFPs,
but the front-label regulations explicitly refer to, and
incorporate, some standards from the NFP regulations.
Relevant here, section 101.13(i)(3) authorizes manufacturers
to make nutrient content claims about the “amount or

6
Id. § 343(q); see Hawkins, 906 F.3d at 769; Reid, 780 F.3d at 959.
7
21 U.S.C. § 343(q)(1)(C)–(D); 21 C.F.R. § 101.9(c).
8
See 21 C.F.R. §§ 101.2, 101.9(i), (j)(13), (j)(17).
9
21 U.S.C. § 343(r)(1)(A); 21 C.F.R. § 101.13(b); see id. § 101.2(a).
10
21 C.F.R. § 101.13(b); see id. § 101.9(c)(7)(i).
 NACARINO V. KASHI CO. 9

percentage of a nutrient” outside the NFP if the claim “does
not in any way implicitly characterize the level of the
nutrient in the food and it is not false or misleading in any
respect.” 11
Section 101.13 does not include a specific rule for
measuring protein for purposes of nutrient content claims.
Rather, section 101.13(o) provides that “compliance with
[the] requirements for nutrient content claims . . . will be
determined using the analytical methodology prescribed for
determining compliance with nutritional labeling in
§ 101.9,” an NFP regulation. 12 The pertinent part of that
regulation, section 101.9(c)(7), requires that manufacturers
include protein quantity in the NFP measured by “the
number of grams of protein in a serving,” and allows protein
quantity to be calculated based on the food’s nitrogen
content. 13 This measure of protein quantity can be
“corrected” to more accurately reflect the food’s nutritive
value by multiplying the measured protein content by the
“protein digestibility-corrected amino acid score”

11
Id. § 101.13(i)(3). This provision includes two examples of
permissible nutrient content claims: “100 calories” and “5 grams of fat.”
Id. Plaintiffs do not dispute that, like these examples, the challenged
nutrient content claims do not implicitly characterize the level of a
nutrient in Defendants’ products. The quantitative protein claims at issue
here are a type of “expressed nutrient content claim,” a term that the
regulations define as “any direct statement about the level (or range) of
a nutrient in the food.” Id. § 101.13(b)(1).
12
Id. § 101.13(o).
13
Id. § 101.9(c)(7).
10 NACARINO V. KASHI CO.

(PDCAAS), a measure of protein quality. 14 High-quality
proteins, such as whey, have a PDCAAS of 1, and lower-
quality proteins, including many plant-based proteins, have
a PDCAAS of less than 1. Critical for purposes of these
appeals, if a label includes a protein claim (by definition, a
claim outside the NFP), it triggers a provision in section
101.9(c)(7)(i) that requires the manufacturer to display
PDCAAS-corrected protein content as a percent daily value
figure within the NFP in addition to displaying protein
quantity in grams. 15 We refer to this provision as the “trigger
provision.”
The following exemplar product label illustrates how
these interlocking regulations work. 16 The “20g Protein”
nutrient content claim on the front of the exemplar label
matches the protein quantity displayed in the NFP. The
percent daily value figures for adults are calculated using a
reference value of 50 grams. 17 Because the percent daily
value figure shown in the exemplar NFP (30%) is less than
the gram value of the protein content divided by 50 grams
(20g ÷ 50g = 40%), the NFP indicates a lower-quality
protein with a PDCAAS of less than 1.

14
Id. The regulations specify how to calculate protein content using the
nitrogen method and how to adjust that value using PDCAAS. See id.
§ 101.9(c)(7) & (7)(ii).
15
Id. § 101.9(c)(7)(i).
16
We include these illustrations solely to show how the regulations for
nutrient content claims interact with the regulations for NFPs.
17
See 21 C.F.R. § 101.9(c)(7)(iii).
 NACARINO V. KASHI CO. 11

B
Plaintiffs argue that Defendants’ protein claims are both
false and misleading—violating state and federal law—
because the labels overstate the products’ protein content
and imply that all of the protein contained in the products is
usable by the human body. In its motion to dismiss the
Nacarino complaint, Kashi argued that Plaintiffs’ state-law
claims were preempted because the FDA regulations
authorize quantitative protein claims outside the NFP and the
challenged protein claims are fully compliant with the
federal regulations. Kashi also argued that explicit “FDA
guidance” from an FDA webpage contradicts Plaintiffs’
argument that federal law requires Kashi to remove the
protein claims from its product labels.
The district court granted Kashi’s motion and dismissed
the complaint with prejudice. See Nacarino v. Kashi Co.,
584 F. Supp. 3d 806, 807 (N.D. Cal. 2022). The court
concluded that accepting Plaintiffs’ theory would require it
“to find that an FDA-approved protein measurement
12 NACARINO V. KASHI CO.

technique is inherently misleading,” an interpretation it
deemed implausible. Id. at 810. The district court also
dismissed Brown, finding the claims alleged there
indistinguishable from those alleged in Nacarino. 18
Two months before oral argument in our court, the
district court issued a ruling in a similar case, Rausch v.
Flatout, Inc., No. 22-cv-04157-VC, ___ F. Supp. 3d ____,
2023 WL 2401452 (N.D. Cal. Mar. 8, 2023). The Rausch
defendant advertised protein content on its front labels
without including the quality-adjusted percent daily value
figure in the NFP. Id. at *2. The district court denied a
motion to dismiss the Rausch complaint. Id. at *6. In doing
so, the court retreated from the statement in its order granting
the motion to dismiss the Nacarino complaint—that an
“FDA-approved protein measurement technique” could not
be misleading within the meaning of the FDA regulations—
and instead held that “prominently advertising a product’s
protein quantity outside of the nutrition facts panel is
misleading (within the meaning of the [FDCA] and the
FDA’s regulations), if the manufacturer doesn’t include the
quality-adjusted percent in the nutrition facts panel.” Id. at
*5. Before hearing oral argument, we requested
supplemental briefing to address the district court’s ruling in
Rausch. Now, having considered the parties’ briefing, we
clarify that a protein claim could be misleading within the
meaning of the applicable food labeling regulations if the
NFP does not disclose the product’s protein quality and the
product contains lower-quality protein.

18
No party has argued on appeal that Nacarino and Brown are
distinguishable.
 NACARINO V. KASHI CO. 13

III
We interpret a regulation based on its plain language and
in the context of the regulatory scheme, and defer to an
agency’s interpretation of its own regulation only when it is
“genuinely ambiguous.” Kisor v. Wilkie, 139 S. Ct. 2400,
2415 (2019); see Christensen v. Harris County, 529 U.S.
576, 588 (2000). Plaintiffs’ complaints allege that the
challenged protein claims are: (1) false because the nitrogen
method overstates the actual amount of protein the products
contain; and (2) misleading because the “amount of
digestible or usable protein the Products actually deliver to
the human body is even lower” than the actual amount of
protein the products contain. 19 We address these arguments
in turn.
A
The text and structure of the federal regulations preclude
Plaintiffs’ argument that Defendants’ protein claims are
false. “False” means “[c]ontrary to fact or truth.” 20
Plaintiffs focus narrowly on the text of two parts of the

19
FDA regulations do not specify a standard for “false or misleading,”
but the agency has issued guidance stating that it employs a “reasonable
consumer” standard. See 67 Fed. Reg. 78002-01, 78003 (Dec. 20, 2002);
id. at 70004 (rejecting the Ninth Circuit’s earlier interpretation of the
FDCA as protecting “‘the ignorant, the unthinking, and the credulous’
consumer” (quoting United States v. El-O-Pathic Pharmacy, 192 F.2d
62, 75 (9th Cir. 1951)). After the FDA issued this guidance, we have
applied the reasonable consumer standard to FDCA preemption claims.
See, e.g., Hawkins, 906 F.3d at 771 (citing Reid, 708 F.3d at 962–63).
20
False, Am. Heritage Dictionary (5th ed. 2022),
https://ahdictionary.com/word/search.html?q=false
[https://perma.cc/9L5D-UKQM].
14 NACARINO V. KASHI CO.

regulation addressing nutrient content claims. 21 This
overlooks that interlocking regulatory provisions for nutrient
content claims and NFPs work together to create an
integrated regulatory scheme, and that examining the
scheme as a whole reveals a more complete story. Section
101.13(o) provides that compliance with the requirements
for nutrient content claims, such as the quantitative protein
claims challenged here, is determined using section 101.9’s
“analytical methodology.” And section 101.9(c)(7)
authorizes the use of the nitrogen method to measure protein
quantity. See Durnford v. MusclePharm Corp., 907 F.3d
595, 603 (9th Cir. 2018) (noting that 21 C.F.R. § 101.9(c)(7)
“allow[s] nitrogen to be used on the [NFP] as a proxy for
protein content”). In other words, section 101.13(o)
expressly allows Defendants to make a nutrient content
claim based on the nitrogen method, as they have done here.
Plaintiffs do not dispute that Defendants used the
nitrogen method to measure the amount of protein in their
quantitative protein claims. Instead, they argue that
Defendants’ protein claims are false because Defendants
could have measured protein content more accurately by
directly measuring the products’ amino acid content. 22 Our
decision in Durnford cuts against Plaintiffs’ argument.
In Durnford, the plaintiff alleged that defendant
MusclePharm spiked its product with nitrogenous

21
See 21 C.F.R. § 101.13(c) & (i)(3).
22
Measuring a product’s amino acid content is a separate step that is
required to calculate the PDCAAS for that product. See Rep. of the Joint
FAO/WHO Expert Consultation on Protein Quality Evaluation, U.N.
Doc. E/1/12.91/2300, at 35 (1989), https://perma.cc/CK4M-NH5K; 21
C.F.R § 101.9(c)(7)(ii) (incorporating by reference the “Report of the
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation.”).
 NACARINO V. KASHI CO. 15

compounds to falsely inflate its protein content. Id. at 601.
We held that the plaintiff’s state-law claim based on the
protein quantity listed in the NFP was expressly preempted
by 21 C.F.R. § 101.9(c)(7) because that regulation “allow[s]
the use of nitrogen content as a proxy for protein” and the
label’s NFP reflected the product’s nitrogen content. Id. at
602. We observed that the FDCA’s prohibition on “false or
misleading statements in general” did not alter the analysis
because the plaintiff did not argue that section 101.9(c)(7)’s
designation of the nitrogen method for measuring protein
quantity “exceeded [the agency’s] congressionally delegated
authority.” Id. (first citing Chevron, U.S.A., Inc. v. Nat. Res.
Def. Council, Inc., 467 U.S. 837, 843 (1984); and then citing
United States v. Mead Corp., 533 U.S. 218, 227 (2001)).
Plaintiffs here make an argument similar to the one
Durnford rejected—that a protein quantity calculated using
the authorized nitrogen method is false because it overstates
what Plaintiffs consider to be the true amount of protein.
This argument fails because the regulations specifically
allow manufacturers to measure protein quantity using the
nitrogen method, to display that value in the NFP, and to use
it to make a quantitative nutrient content claim.
Plaintiffs argue that allowing section 101.9(c)(7)’s NFP
rules to determine whether a protein claim is “false or
misleading” would render 101.13(c) superfluous. We are
not persuaded. Section 101.13(c) provides that when
information required or permitted in the NFP—such as
protein quantity—is displayed outside the NFP, it becomes
subject to section 101.13’s requirements for nutrient content
claims. 23 We agree with Plaintiffs that, on its own, the
requirement that a statement be made in the NFP “does not

23
21 C.F.R. § 101.13(c).
16 NACARINO V. KASHI CO.

give the manufacturer license to make the same claim
elsewhere on the product.” Hawkins, 906 F.3d at 771; see
Reid, 780 F.3d at 963. But in the case of quantitative protein
claims (e.g., “11g Protein”), section 101.13 provides that
such claims may be based on the nitrogen method prescribed
by section 101.9(c)(7) to calculate protein content. The key
provision is section 101.13(o), which directs that compliance
with requirements for nutrient content claims will be
determined using the “analytical methodology” for NFPs in
section 101.9(c)(7). 24 Section 101.9(c)(7) includes the
nitrogen method. Read together, sections 101.13(o) and
101.9(c)(7) permit manufacturers to make protein claims
that state protein quantity measured using the nitrogen
method. This does not render 101.13(c) superfluous; our
decisions in Reid and Hawkins illustrate that section
101.13(c) still has independent effect in instances when the
agency has authorized statements to appear in the NFP but
has declined to authorize those statements elsewhere on the
package.
In Hawkins, the plaintiff challenged a nutrient content
claim that a product contained “0g Trans Fat per serving.”
906 F.3d at 767. In fact, the product did contain trans fat,
and Hawkins brought state-law claims similar to those in
Nacarino and Brown. Id. At the relevant time, the pertinent
provision of section 101.9 included a rounding rule for
disclosing fat content for various types of fat, including trans
fat: “[I]f the serving contains less than 0.5 gram, the content
shall be expressed [in the NFP] as zero.” Id. at 770 (quoting
21 C.F.R. § 101.9(c)(2)(ii) (2015)).
In considering whether this provision preempted
Hawkins’s claims, we observed that, under section

24
See id. § 101.13(c) & (o); see also id. § 101.9(c)(7)(i)–(iii).
 NACARINO V. KASHI CO. 17

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.” Id.
The Hawkins court was not writing on a blank slate: Reid
had already held that a product label that contained the
statement “No Trans Fat” was false where a product actually
contained some trans fat. Id. (citing Reid, 780 F.3d at 963).
Reid and Hawkins rested on the observation that a different
rule that specifically addressed nutrient content claims about
fat content

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 771 (emphasis added) (quoting Reid, 780 F.3d at 962).
Reid explained:

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
18 NACARINO V. KASHI CO.

regulation does not authorize “No Trans Fat”
claims—makes the most sense of the overall
labeling regime . . . .

780 F.3d at 963.
Here, there is no comparable separate regulation or other
indicia that the FDA specifically allowed some protein
claims, but not quantitative protein claims. Contrary to
Plaintiffs’ argument that the regulations do not authorize
quantitative protein claims based on the nitrogen method, the
interlocking provisions of the FDA’s regulatory scheme
provide that: (1) the nitrogen method may be used to
calculate protein quantity in the NFP and to make
quantitative protein claims, see 21 C.F.R. §§ 101.9(c)(7),
101.13(o); and (2) if a product label includes a protein claim
outside the NFP, section 101.9(c)(7)(i)’s trigger provision
requires the manufacturer to also include the PDCAAS-
corrected percent daily value inside the NFP, id.
§ 101.9(c)(7)(i) (“A statement of the corrected amount of
protein per serving . . . may be placed on the [NFP], except
that such a statement shall be given if a protein claim is made
for the product . . . .” (emphases added)). Reading section
101.13(o) alongside section 101.9(c)(7)(i) demonstrates that
food manufacturers are authorized to make protein claims
based on the nitrogen method, so long as they also include
the quality-adjusted protein content as a percent daily value
in the NFP. See United States v. Grandberry, 730 F.3d 968,
981–82 (9th Cir. 2013) (“[A] statute or regulation should be
construed so that effect is given to all its provisions, so that
no part will be inoperative or superfluous, void or
insignificant.” (alteration accepted) (quoting Corley v.
United States, 556 U.S. 303, 314 (2009)).
 NACARINO V. KASHI CO. 19

Reading section 101.13(i)(3) to authorize quantitative
protein claims based on the nitrogen method, so long as the
NFP also displays a PDCAAS-corrected percent daily value
figure, reconciles the overall labeling regime and gives
meaning to all the relevant regulatory provisions, including
the trigger provision. Plaintiffs’ complaints do not allege
that Defendants’ protein claims fail to accurately represent
nitrogen-measured protein content or that Defendants’ NFPs
omitted the percent daily value figures required by the
trigger provision. Accordingly, the complaints do not allege
that the challenged protein claims are “false” within the
meaning of section 101.13(i)(3).
B
Plaintiffs separately contend that the challenged protein
claims are misleading because they imply that consumers
will “receive all the nutritional and dietary benefits” of the
specified quantity of protein. “Mislead” means “[t]o give a
wrong impression or lead toward a wrong conclusion,
especially by intentionally deceiving.” 25 Plaintiffs argue
that protein claims like “11g Protein” and “PROTEIN 15g”
on Defendants’ labels are misleading, even if they are
technically accurate as to the amount of protein, because
they inflate the nutritive value of low-quality protein.
Plaintiffs point to our decision in Williams v. Gerber
Products Co., 552 F.3d 934 (9th Cir. 2008), and a more
recent Seventh Circuit opinion that relied on Gerber—Bell
v. Publix Super Markets, Inc., 982 F.3d 468 (7th Cir. 2020)—
to argue two points. First, Plaintiffs contend that

25
Mislead, Am. Heritage Dictionary (5th ed. 2022)
https://ahdictionary.com/word/search.html?q=mislead
[https://perma.cc/BF5C-358T].
20 NACARINO V. KASHI CO.

manufacturers cannot “mislead consumers [on the front
label] and then rely on the [NFP] to correct those
misinterpretations and provide a shield for liability for the
deception.” Gerber, 552 F.3d at 939. Second, Plaintiffs
posit that “average consumers are not likely to be aware of
the nuances of the FDA’s regulations” pertaining to how the
percent daily value requirements in the NFP account for
protein quality. Bell, 982 F.3d at 482.
Neither of these cases assist Plaintiffs’ cause. Gerber is
inapt because it did not address federal law. The front label
at issue in Gerber juxtaposed the words “Fruit Juice” with
images of “oranges, peaches, strawberries, and cherries.”
552 F.3d at 936. The plaintiffs alleged that the front label
was deceptive because “the only juice contained in the
product was white grape juice from concentrate.” Id. Our
court agreed, but we did so under California law and
explicitly declined to consider whether the FDCA preempted
the plaintiffs’ claims because the defendants failed to raise
preemption in the district court, forfeiting the issue. Id. at
937. Gerber thus suggests the claims presented in the
Nacarino and Brown complaints could be cognizable under
state law, but the case provides no guidance as to whether
they are preempted.
The Seventh Circuit’s Bell decision is more instructive
because that court considered FDCA preemption and
concluded that those plaintiffs’ claims could proceed. The
challenged front labels in Bell stated that defendants’
products contained “100% Grated Parmesan Cheese.” 982
F.3d at 473. The plaintiffs alleged that the products actually
contained “between four and nine percent added cellulose
powder and potassium sorbate,” and that this was indicated
only in fine print on a back-label ingredients list. Id. The
Bell defendants argued that the FDCA expressly preempted
 NACARINO V. KASHI CO. 21

the plaintiffs’ state-law claims because FDA regulations
authorized (and required) defendants to market the products
as “Grated Parmesan Cheese.” Id. at 483–86 (quoting 21
C.F.R. § 133.146(c) & (d)(3)(i)). 26 The Seventh Circuit
rejected defendants’ express preemption argument because
the applicable federal regulations were silent on the modifier
“100%.” Id. at 483–84. Accordingly, a false-or-misleading
state-law claim about “100% Grated Parmesan Cheese” was
not expressly preempted, even though a claim about “Grated
Parmesan Cheese” would have been preempted. Applying
this logic here, a false-or-misleading state-law claim about
something like “11g High-Quality Protein” or “11g
Digestible Protein” would not be preempted, even though a
claim about “11g Protein” is preempted. Citing three Ninth
Circuit cases in accord, Bell explained that, “[a]bsent
contrary language,” the FDCA’s express-preemption
provision does not defeat state-law claims based on
“deceptive statements that sellers add voluntarily to their
labels or advertising.” Id. at 484. 27
Bell differs from these consolidated cases because the
regulations at issue here include “contrary language” that
directly addresses the kind of deception that Plaintiffs allege.
Section 101.9(c)(7)(i) contemplates that advertising protein
quantity outside the NFP can be misleading within the

26
The Bell defendants made express-preemption and conflict-
preemption arguments, see 982 F.3d at 483, but only the former are
relevant to this case because the Nacarino and Brown Defendants assert
only an express-preemption defense.
27
In addition to Durnford and Hawkins, the Seventh Circuit cited our
decision in Astiana v. Hain Celestial Group, Inc., which held that the
FDCA did not expressly preempt a claim that a cosmetics label’s use of
“natural” was deceptive where federal regulations did not address the use
of “natural.” 783 F.3d 753, 758 (9th Cir. 2015).
22 NACARINO V. KASHI CO.

meaning of section 101.13(i)(3) if the manufacturer does not
comply with the trigger provision’s requirement to include a
PDCAAS-corrected percent daily value figure in the NFP.
See Food Labeling: Nutrient Content Claims, General
Principles, Petitions, Definition of Terms, 56 Fed. Reg.
60421-01, 60426 (Nov. 27, 1991) (explaining that section
101.13(i)(3) addresses the concern that “a statement
declaring that the product contained a specified amount of a
nutrient could be misleading” when it gives consumers “the
false impression that the product would assist them in
maintaining healthy dietary practices relative to the amount
of the nutrient consumed when it, in fact, would not”).
The text and structure of the FDA regulations
demonstrate that Defendants’ protein claims could be
misleading if they did not accurately state the quantity of
protein (according to the analytical methodology prescribed
in section 101.9(c)(7)) or the products did not display the
quality-adjusted percent daily value in the NFP. But the
Nacarino and Brown complaints did not allege that
Defendants failed either to: (1) report accurately the quantity
of protein on the front label pursuant to the nitrogen method;
or (2) include the required percent daily value figure in the
NFP as required by the trigger provision. We see no
indication that Plaintiffs could have made these allegations
with respect to the products listed in the complaints, and
Plaintiffs have not suggested that the defects in their
complaints could be cured by amendment. Plaintiffs’
complaints do not allege that the challenged protein claims
are misleading within the meaning of the federal regulations.
To the extent that state law would hold Defendants to a
different standard, Plaintiffs’ claims are expressly
preempted.
 NACARINO V. KASHI CO. 23

C
The regulations are not ambiguous and are sufficient to
support our preemption holding, but the agency’s
interpretation of its own regulations reinforces that
conclusion. We “may properly resort to an agency’s
interpretations and opinions for guidance, as they constitute
a body of experience and informed judgment.” Hernandez
v. Garland, 38 F.4th 785, 789 (9th Cir. 2022) (quoting
Orellana v. Barr, 967 F.3d 927, 934 (9th Cir. 2020)). We
weigh agency interpretations according to their “power to
persuade.” Skidmore v. Swift & Co., 323 U.S. 134, 140
(1944). 28
Plaintiffs’ complaints quote an agency memo that
accompanied a final rule amending section 101.9(c)(7)’s
rules for measuring and displaying protein content in the
NFP. See Food Labeling: Mandatory Status of Nutrition
Labeling and Nutrient Content Revision, Format for
Nutrition Label, 58 Fed. Reg. 2079-01 (Jan. 6, 1993). The
complaints reproduce only a single line from the memo,
which included the FDA’s observation that “[i]nformation
on protein quantity alone can be misleading on foods that are
of low protein quality.” Id. at 2101. The rest of the memo
more comprehensively explains the agency’s reasoning. See
id. at 2101–06. First, the FDA memo acknowledged
comments it received that calculating PDCAAS scores for
every product would “not provide flexibility” and would be
“unnecessarily burdensome and expensive.” Id. at 2104.
The memo made clear that the agency did “not agree [with

28
See also Kisor, 139 S. Ct. at 2416 (“[W]e have deferred to ‘official
staff memoranda’ that were ‘published in the Federal Register . . . .’”
(quoting Ford Motor Credit Co. v. Milhollin, 444 U.S. 555, 566 n.9, 567
n.10 (1980))).
24 NACARINO V. KASHI CO.

the comments] that the PDCAAS should be eliminated,” id.,
but it did agree that a PDCAAS-adjusted score should not be
required for all products because “protein deficiency is not
common in the United States,” even though “protein quality
is still of concern for certain segments of the population,” id.
at 2102. The FDA ultimately determined that “nutrition
labeling must allow consumers to readily identify foods with
particularly low quality protein to prevent them from being
misled by information on only the amount of protein
present.” Id.
In other words, the agency struck a balance that kept
costs low for manufacturers without allowing consumers to
be misled. It concluded that “the additional costs associated
with determination of the PDCAAS, which are necessary to
calculate the percent of the [daily recommended value] for
protein, are not warranted on foods . . . unless protein claims
are made.” Id. (emphasis added). The memo explained that
including the percent daily value in the NFP is “satisfactory”
to “allow consumers to readily identify foods of low protein
quality.” Id. Section 101.9(c)(7)(i)’s trigger provision
reflects this compromise, requiring information on protein
quality in the NFP for products that manufacturers market to
protein-conscious consumers, but not for labels that do not
tout protein content outside the NFP. The FDA’s
consideration and rejection of a rule requiring PDCAAS-
corrected percent daily value for every product provides
additional support for our conclusion that a product’s
quantitative protein claims based on uncorrected values
calculated using the nitrogen method are not false or
misleading within the meaning of the regulations when
PDCAAS-corrected percent daily value is included in the
NFP.
 NACARINO V. KASHI CO. 25

Our conclusion is also supported by another source of
agency guidance: an industry-facing FDA “Frequently-
Asked-Questions” (FAQ) webpage. 29 The weight we may
accord to this webpage “depend[s] upon the thoroughness
evident in its consideration, the validity of its reasoning, its
consistency with earlier and later pronouncements, and all
those factors which give it power to persuade, if lacking
power to control.” Skidmore, 323 U.S. at 140. The webpage
appears on the FDA’s official website, and it states that it is
intended to respond to “the most frequently asked questions
[the FDA has] received.” Industry Resources. The webpage
does not purport to authorize nutrient content claims, but it
does clarify the agency’s view of how the front-label and
NFP regulations interact, which is relevant to whether a
nutrient content claim is authorized by section 101.13(i)(3):

[Section Header:] Label Claims
[Question:] There are separate methods for
determining the number of grams of protein in
a serving for declaration on the [NFP] and for
determining the percent Daily Value of protein
for the [NFP] (21 CFR 101.9(c)(7)). Which
method should be used when calculating
protein values for use in protein nutrient
content claims?
[Answer:] The regulation for nutrient content
claims in 21 CFR 101.13(o) states that . . .
compliance with requirements for nutrient

29
Industry Resources on the Changes to the Nutrition Facts Label, U.S.
Food & Drug Admin. (Jan. 11, 2022), https://www.fda.gov/food/food-
labeling-nutrition/industry-resources-changes-nutrition-facts-label
[https://perma.cc/FY86-VVH9] [hereinafter Industry Resources].
26 NACARINO V. KASHI CO.

content claims . . . will be determined using the
analytical methodology prescribed for
determining compliance with [NFP] labeling in
21 CFR 101.9.
By design, 21 CFR 101.9(c)(7) specifically
provides for two different methods for
determining protein values. The regulation
states, in 21 CFR 101.9(c)(7), that protein
content may be calculated [using the nitrogen
method]. Additionally, 21 CFR 101.9(c)(7)(ii)
provides the method for determining protein
content using [PDCAAS] for use in calculating
the percent Daily Value [for display in the
NFP].
Determination of compliance for protein
nutrient content claims will be based on the use
of the methods provided in 21 CFR
101.9(c)(7), including either of the methods
mentioned above.

Id. Because the definition of “nutrient content claim”
excludes a statement made in the NFP, see 21 C.F.R.
§ 101.13(c), the webpage expresses the agency’s guidance
that quantitative protein claims based on the nitrogen method
comply with the federal regulatory scheme, citing section
101.13(o) as a basis for this determination. Though not
dispositive, the agency’s webpage supports our view that
federal law authorizes Defendants’ challenged protein
 NACARINO V. KASHI CO. 27

claims. Having consulted the Skidmore factors, we find the
interpretation on the agency’s webpage persuasive. 30
IV
The intricacy of the FDA’s nutrition-labeling regulations
reflects the agency’s careful compromises among the diverse
interests of its stakeholders. If Plaintiffs believe that a
reasonable consumer would assume that all proteins are
created equal, and that any products marketed as containing
a certain quantity of protein provide identical protein-based
health benefits, they are free to urge the FDA to amend the
regulations or to challenge the agency’s rules as inconsistent
with its statutory mandate. In this case, sustaining Plaintiffs’
challenge to Defendants’ protein claims would indirectly
establish a requirement for food labeling that differs from the
federal requirements, so the FDCA preempts Plaintiffs’
state-law claims. The district court properly dismissed the
Nacarino and Brown complaints.
AFFIRMED.

30
Defendants also argue that the district court erred by denying Kashi’s
request to take judicial notice of emails between industry lawyers and
FDA officials. Unlike the Federal Register memo and the FAQ website,
the agency’s regulations disclaim that such statements reflect the FDA’s
official position or “otherwise obligate or commit the agency to the
views expressed.” 21 C.F.R. § 10.85(k); see Maner v. Dignity Health, 9
F.4th 1114, 1126 (9th Cir. 2021) (quoting Kisor, 139 S. Ct. at 2414).