Kym Pardini v. Unilever United States, Inc.

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
KYM PARDINI; CARRIE WOOD, No. 21-16806
on behalf of themselves and all others
similarly situated, D.C. No.
4:13-cv-01675-
Plaintiffs-Appellants, JSW
v.
OPINION
UNILEVER UNITED STATES, INC.,
a Delaware corporation,
Defendant-Appellee.
Appeal from the United States District Court
for the Northern District of California
Jeffrey S. White, District Judge, Presiding
Argued and Submitted December 5, 2022
San Francisco, California
Filed April 18, 2023
Before: Carlos F. Lucero, * Daniel A. Bress, and Lawrence
VanDyke, Circuit Judges.
*
The Honorable Carlos F. Lucero, United States Circuit Judge for the
U.S. Court of Appeals for the Tenth Circuit, sitting by designation.
2 PARDINI V. UNILEVER UNITED STATES, INC.
Opinion by Judge Bress;
Dissent by Judge Lucero
SUMMARY **
Food Drug and Cosmetic Act / Preemption
The panel affirmed the district court’s Fed. R. Civ. P.
12(b)(6) dismissal, based on express preemption by the
federal Food Drug and Cosmetic Act (FDCA), of the
plaintiffs’ claims challenging the product label on “I Can’t
Believe It’s Not Butter! Spray.”
The Butter! Spray is a butter-flavored vegetable oil
dispensed in pump-action squirt bottles with a spray
mechanism. The front label on the product states that the
Butter! Spray has 0 calories and 0 grams of fat per
serving. Plaintiffs are a class of consumers who brought
their lawsuit against the then-manufacturer, Unilever United
States, Inc., contending that the product’s label makes
misrepresentations about fat and calorie content based on
artificially low serving sizes.
The district court found that plaintiffs failed to plausibly
allege that Butter! Spray was not a “spray type” fat or oil
under Food and Drug Administration (FDA)
regulations. The district court further held that the FDCA
preempted plaintiffs’ serving size claims. Because the
**
This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
PARDINI V. UNILEVER UNITED STATES, INC. 3
nutrient content claims were predicated on the serving size
claims, those claims also failed on preemption grounds.
The FDCA’s preemption provision can preempt state
law statutory and common law causes of action to the extent
those claims would directly or indirectly impose nutrition
label requirements different than those prescribed by federal
law. The FDA has devised elaborate rules for appropriate
food serving sizes. Under the specific regulations governing
butter and related products, the Butter! Spray falls into two
possible subcategories: “spray types” and “butter,
margarine, oil, shortening.”
The panel held that, as a matter of legal classification,
Butter! Spray was a “spray.” In common parlance, a “spray”
refers to liquid dispensed in the form of droplets, emitted
from a mechanism that allows the product to be applied in
that manner. In addition, the notion that Butter! Spray could
be housed under the FDA’s legal classification for “butter”
is implausible. Plaintiffs agreed that to generate one
tablespoon of “butter,” 40 sprays of Butter! Spray would be
required. Common sense shows that this is not how such a
product is typically used. The panel also rejected plaintiffs’
argument that Butter! Spray is a “butter substitute” based on
how it is marketed, so that it should be treated as “butter” for
serving size purposes, too. Because Unilever properly
characterized Butter! Spray as a “spray type” fat or oil, the
serving size on its nutrition label complied with federal law.
Finally, the panel considered plaintiffs’ argument that
consumers do not typically use just one spray of Butter!
Spray, and that Unilever’s serving size information was
therefore misleading because serving sizes must reflect
customary usage. The panel held that plaintiffs’ theory had
it backwards. It is the FDA that sets the reference amounts
4 PARDINI V. UNILEVER UNITED STATES, INC.
for serving sizes, and to comply with federal law,
manufacturers then identify the relevant product category
and set a serving size that approximates the FDA’s reference
amount for that category. In alleging that consumers use
more than one spray of Butter! Spray, plaintiffs do not raise
a question of fact regarding product classification, but
instead challenge the reference amount customarily
consumed—a value established by the FDA. The proper
forum in which to air such a grievance is the FDA (or
Congress), not the courts. Because plaintiffs’ challenge to
the Butter! Spray serving sizes would “directly or indirectly
establish” a requirement for food labeling that is “not
identical” to federal requirements, 21 U.S.C. § 343-1(a)(4),
the FDCA preempts their serving size claims. It therefore
follows that plaintiffs’ claims about fat and calorie content
are preempted as well.
Dissenting, Judge Lucero wrote that the majority erred
in its Fed. R. Civ. P. 12(b)(6) review by conflating the
plausibility of plaintiffs’ claims with the preemption
evaluation. The result is that Unilever’s burden to establish
preemption is inappropriately lessened. In order to establish
preemption as an affirmative defense, Unilever must prove
that Butter! Spray is properly categorized as a “spray type”
rather than a “butter, margarine, oil, [or] shortening.” He
would hold that Unilever has not carried its burden of
proving that Butter! Spray must be categorized as “spray
type,” and would reverse the 12(b)(6) dismissal and remand
for continued proceedings.
PARDINI V. UNILEVER UNITED STATES, INC. 5
COUNSEL
Ureka E. Idstrom (argued), The Eureka Law Firm, Kansas
City, Missouri; Justin T. Berger and Sarvenaz J. Fahimi,
Cotchett Pitre & McCarthy LLP, Burlingame, California; for
Plaintiffs-Appellants.
James R. Sigel (argued) and Claudia M. Vetesi, Morrison &
Foerster LLP, San Francisco, California; Adam L. Sorensen,
Morrison & Foerster LLP, Washington, D.C.; Megan
Whipp, The Law Office of Megan L. Whipp PC, Beverly
Hills, California; for Defendant-Appellee.
OPINION
BRESS, Circuit Judge:
Over 125 years ago, the Supreme Court decided whether
a tomato is a fruit or a vegetable. See Nix v. Hedden, 149
U.S. 304, 307 (1893) (the answer: a vegetable). In a more
modern iteration of this legal genre, we today decide, in
effect, whether the product “I Can’t Believe It’s Not Butter!
Spray” is a butter or a spray. The question turns out to matter
because the plaintiff consumers contend that the product’s
label makes misrepresentations about fat and calorie content
based on artificially low serving sizes.
We hold that the information on the product’s label
complies with federal food labeling requirements for “spray
type” fats and oils. The product is a spray under federal
regulations, and it was labeled accordingly. We affirm the
district court’s dismissal of plaintiffs’ claims because the
federal Food Drug and Cosmetic Act (FDCA) expressly
preempts them.
6 PARDINI V. UNILEVER UNITED STATES, INC.
I
We recite the facts as alleged in plaintiffs’ complaint.
This is a consumer class action challenging the labels on I
Can’t Believe It’s Not Butter! Spray. To avoid a lengthy
acronym, we will refer to this product as “Butter! Spray.”
“Butter! Spray” is part of the “I Can’t Believe It’s Not
Butter!” product line, consisting of margarine foods and
vegetable oil spreads that are marketed as healthier
alternatives to butter. The implication of the well-known
brand name is, of course, that the product tastes so much like
butter that one could not believe it wasn’t.
Launched in 1994, Butter! Spray is a “butter-flavored
vegetable oil” dispensed in “pump-action squirt bottles”
with a “spray mechanism.” Plaintiffs allege it is “used by
consumers interchangeably with butter.” The front label on
the product states that Butter! Spray has 0 calories and 0
grams of fat per serving. The front label also proclaims that
the product is “Great for Topping & Cooking.” It depicts an
ear of corn, suggesting that Butter! Spray may be used as a
flavoring for corn on the cob.
On the nutrition panel, which appears on the back of the
bottle, the label lists serving sizes for two different
applications: “cooking spray” and “topping.” For each
application, the nutrition panel provides the serving size by
weight and in terms of the number of “sprays.” For the
“cooking spray” application, the serving size is “1 Spray
(0.20g).” When used as a “topping,” the serving size is
stated as “5 Sprays (1g).” For both applications, the nutrition
panel indicates that a serving size has 0 calories and 0 grams
of fat.
This lawsuit, brought against then-manufacturer
Unilever, alleges that Butter! Spray’s nutrient content claims
PARDINI V. UNILEVER UNITED STATES, INC. 7
are misleading because they are based on unrepresentative
serving sizes. As we discuss below, when a product’s FDA-
designated serving size contains amounts of calories and fat
that are below certain thresholds, federal regulations allow
(and in some instances require) the product to be labeled as
having zero calories or fat per serving. Plaintiffs allege that
an entire 12-ounce bottle of Butter! Spray contains 1160
calories and 124 grams of fat. Plaintiffs claim that because
the serving sizes on Butter! Spray are “artificially small,”
Butter! Spray is not, in fact, “0 fat” or “0 calories” per
serving.
In plaintiffs’ view, the serving sizes on the Butter! Spray
nutritional panel are too low to “reflect customary usage.”
“Because consumers use [Butter! Spray] to achieve a
comparable buttery flavor,” plaintiffs also allege that under
the FDCA and its implementing regulations, Butter! Spray
“belongs in the same product category as butter itself with a
required serving size of one tablespoon,” rather than as a
“spray type” fat or oil. The amount of fat and calories that
would be present in a tablespoon of Butter! Spray could not
be represented as “zero” under FDCA regulations. Plaintiffs
allege that consumers have expressed confusion and
frustration upon learning that larger servings of the product
contain non-negligible amounts of calories and fat. Had they
known “the true nature” of Butter! Spray, plaintiffs would
not have purchased the product or would have paid less for
it.
Advancing state law causes of action, plaintiffs sought to
certify a nationwide class of consumers who had purchased
Butter! Spray. After several rounds of proceedings, the
district court, under Rule 12(b)(6), dismissed with prejudice
plaintiffs’ claims based on serving size and nutrient content.
The court found that plaintiffs failed to plausibly allege that
8 PARDINI V. UNILEVER UNITED STATES, INC.
Butter! Spray was not a “spray type” fat or oil under FDA
regulations. The FDCA thus preempted plaintiffs’ serving
size claims. And because the nutrient content claims were
predicated on the serving size claims, those claims also
failed on preemption grounds. Proceedings on other claims
not at issue here ended in the denial of class certification and
summary judgment against the plaintiffs.
Plaintiffs appeal the dismissal of only their serving size
and nutrient content claims, which the district court found
preempted. We review the grant of a Rule 12(b)(6) motion
de novo, construing the allegations of the complaint in
plaintiffs’ favor. Nguyen v. Endologix, Inc., 962 F.3d 405,
413 (9th Cir. 2020). A “complaint may be dismissed when
the allegations of the complaint give rise to an affirmative
defense that clearly appears on the face of the pleading.”
Boquist v. Courtney, 32 F.4th 764, 774 (9th Cir. 2022).
Preemption, on which the defendant bears the burden, Cohen
v. ConAgra Brands, Inc., 16 F.4th 1283, 1289 (9th Cir.
2021), can be such a defense. See, e.g., Durnford v.
MusclePharm Corp., 907 F.3d 595, 602 (9th Cir. 2018).
II
A
Plaintiffs’ lawsuit implicates a vast federal regime
governing food labeling. To understand why plaintiffs’
claims are preempted, it is necessary to describe this scheme
in some detail.
The FDCA creates rules for the labeling of food
products. 21 U.S.C. § 301 et seq. This includes nutritional
information. Id. § 343(q). As a general matter, foods that
are intended for human consumption and offered for sale
must contain labeling that provides “the serving size[,]
PARDINI V. UNILEVER UNITED STATES, INC. 9
which is an amount customarily consumed and which is
expressed in a common household measure that is
appropriate to the food.” Id. § 343(q)(1)(A)(i). The label
must also depict, among other things, the number of calories
and the amount of fat “in each serving size or other measure
of the food.” Id. § 343(q)(1)(C), (D).
As amended by the Nutrition Labeling and Education
Act, the FDCA generally guarantees uniform food labeling
nationwide by expressly prohibiting states from “directly or
indirectly” establishing “any requirement for [the] nutrition
labeling of food that is not identical” to federal requirements.
21 U.S.C. § 343-1(a)(4); see also Lilly v. ConAgra Foods,
Inc., 743 F.3d 662, 664–65 (9th Cir. 2014). The U.S. Food
and Drug Administration (FDA) has interpreted the FDCA
to prohibit “any statute, standard, regulation, or other
requirement . . . issued by a State” that “directly or indirectly
imposes obligations or contains provisions concerning the
composition or labeling of food” additional to or different
from “those specifically imposed by or contained in the
applicable provision (including any implementing
regulation)” of the FDCA. 21 C.F.R. § 100.1(b)(5),
(c)(4)(ii). It is well established that the FDCA’s preemption
provision can preempt state law statutory and common law
causes of action, like the ones plaintiffs assert here, to the
extent those claims would directly or indirectly impose
nutrition label requirements different than those prescribed
by federal law. See, e.g., Riegel v. Medtronic, Inc., 552 U.S.
312, 324 (2008).
The FDA has implemented the FDCA’s nutrition
labeling requirements in voluminous regulations. These
regulations provide that “all nutrient and food component
quantities shall be declared in relation to a serving as defined
in” the regulations. 21 C.F.R. § 101.9(b). The regulations
10 PARDINI V. UNILEVER UNITED STATES, INC.
further require that food labels contain nutrition panels
listing certain information for each serving size, such as
calorie content and fat. Id. § 101.9(c). Particularly relevant
here, if a product has less than 5 calories per serving, the
calorie content per serving “may be expressed as zero.” Id.
§ 101.9(c)(1). If a product has less than 0.5 grams of fat per
serving, the fat content on the nutrition panel “shall be
expressed as zero.” Id. § 101.9(c)(2). Similar rules govern
nutrient content information provided elsewhere on the
product (like the front of the Butter! Spray bottle). See id.
§§ 101.60(b)(1)(i), 101.62(b)(1)(i). These regulations
explain the apparent prevalence of products that contain
nonnegligible amounts of calories and fat based on the total
amount in the food container as sold, but that are nonetheless
(lawfully) labeled and advertised as containing no calories
or fat per serving. 1
Of course, the larger the serving of a food product, the
more calories and fat are ingested. The FDA has thus
devised elaborate rules for appropriate food serving sizes,
rules which are central to this case. Under FDA regulations,
“[t]he term serving or serving size means an amount of food
customarily consumed per eating occasion by persons 4
years of age or older which is expressed in a common
household measure that is appropriate to the food.” Id.
§ 101.9(b)(1). These regulations are highly detailed in
1
If a product states that it contains zero fat because it falls below 0.5
grams / serving but the product also contains fat as an ingredient or “is
generally understood by consumers to contain fat,” the product label
must include “an asterisk that refers to the statement below the list of
ingredients, which states ‘adds a trivial amount of fat,’ ‘adds a negligible
amount of fat,’ or ‘adds a dietarily insignificant amount of fat.’” 21
C.F.R. § 101.62(b)(1)(i)–(ii). The plaintiffs in this case also brought an
“asterisk claim,” but that claim is not before us.
PARDINI V. UNILEVER UNITED STATES, INC. 11
nature. See, e.g., id. § 101.9(b)(2)(i)(E) (“The serving size
for maraschino cherries shall be expressed as 1 cherry with
the parenthetical metric measure equal to the average weight
of a medium size cherry.”). We will thus describe the
serving size rules only as relevant to this case.
Serving size—the “amount of food customarily
consumed per eating occasion”—is set by the FDA “based
on data set forth in appropriate national food consumption
surveys.” Id. § 101.12(a)(1) & Table 2 n.1. Under the
regulations, “[a]n appropriate national food consumption
survey includes a large sample size representative of the
demographic and socioeconomic characteristics of the
relevant population group and must be based on
consumption data under actual conditions of use.” Id.
§ 101.12(a)(3). The FDA bases serving size reference
amounts on “the major intended use of a food,” for example,
“milk as a beverage and not as an addition to cereal.” Id.
§ 101.12(a)(7). The FDA’s ultimate aim is “to ensure that
foods that have similar dietary usage, product
characteristics, and customarily consumed amounts have a
uniform reference amount.” Id. § 101.12(a)(9). Thus,
although people vary in their eating habits, the FDA has
determined that serving sizes should be standardized based
on broader, data-driven generalizations about how foods are
customarily consumed during an eating occasion.
The FDA’s prescribed serving size amounts for the
general food supply are set forth in a lengthy “Table 2”
appearing at 21 C.F.R. § 101.12(b). Serving sizes “shall be
determined from” this table, id. § 101.9(b)(2), which is
entitled “Reference Amounts Customarily Consumed Per
Eating Occasion: General Food Supply,” id. § 101.12(b),
Table 2. The table organizes seemingly everything humans
eat into various product categories and subcategories. For
12 PARDINI V. UNILEVER UNITED STATES, INC.
example, under the first category, “Bakery Products,” we
find items ranging from croissants and pineapple upside-
down cake to melba toast and taco shells. Id. § 101.12(b),
Table 2. Under “Desserts,” we encounter guilty pleasures
such as sundaes and custards. Id. And so on.
The FDA’s table contains three columns. The first is the
product category. Id. The second is the FDA’s “reference
amount,” which is, again, the “amounts customarily
consumed per eating occasion.” Id. § 101.12(a). This is
typically expressed in grams, milliliters, or other similar
measurements. For instance, we are told that the reference
amount for a serving of croutons is 7 grams. Id. § 101.12(b),
Table 2. For smoked or pickled fish, it is 55 grams. Id. For
pickles themselves, 30 grams. Id.
The third column in the FDA’s table is entitled “Label
statement.” “The label statements are meant to provide
examples of serving size statements that may be used on the
label, but the specific wording may be changed as
appropriate for individual products.” Id. § 101.12(b), Table
2 n.4. Thus, to return to croissants, the example label
statement reads: “__ piece(s) (__g).” Id. The FDA instructs
that “[m]anufacturers are required to convert the reference
amount to the label serving size in a household measure most
appropriate to their specific product using” other prescribed
procedures. Id. n.3. “[C]ommon household measure[s]”
include units such as cups, tablespoons, pieces, and so on.
Id. § 101.9(b)(5).
Some items are known as “nondiscrete bulk products.”
Id. § 101.9(b)(2)(iii). These items are not customarily eaten
in discrete units. The regulations give as examples
consumables such as breakfast cereals, flour, and pancake
mixes. Id. For these kinds of products, the serving size
PARDINI V. UNILEVER UNITED STATES, INC. 13
“shall be the amount in household measure that most closely
approximates the reference amount for the product category”
in the reference table. Id.
We now turn to the more specific regulations governing
butter and related products. Table 2 in § 101.12(b) contains
a product category entitled “Fats and Oils,” and within it
several subcategories. We provide this portion of the table
here, which reflects the three columns (product category,
reference amount, and label statement):
Fats and Oils:
Butter, margarine, oil, 1 tbsp 1 tbsp (_ g); 1
shortening tbsp (15 mL)
Butter replacement, 2g _ tsp(s) (_ g)
Powder
Dressings for salads 30 g _ tbsp (_ g);
_ tbsp (_ mL)
Mayonnaise, sandwich 15 g _ tbsp (_ g)
spreads, mayonnaise-
type dressings
About __
Spray types 0.25 g seconds spray
(_ g)
Id.
Butter! Spray does not fall within most of the
subcategories in “Fats and Oils.” It is not a powder or a salad
dressing, nor is it akin to a mayonnaise or sandwich spread.
But two subcategories are possibilities: “spray types” and
14 PARDINI V. UNILEVER UNITED STATES, INC.
“butter, margarine, oil, shortening.” If the latter legal
classification applies, the serving size on the Butter! Spray
nutritional panel was incorrect, as were the fat and calorie
representations. But isn’t Butter! Spray not real butter, the
reader may ask? It turns out that the FDA’s regulations
further provide that “the reference amount for an imitation
or substitute food or altered food, such as a ‘low calorie’
version, shall be the same as for the food for which it is
offered as a substitute.” Id. § 101.12(d). To decide the
preemption question, we thus must resolve, based on the
allegations in the complaint, whether, as a matter of law, I
Can’t Believe It’s Not Butter! Spray should be classified as
a butter/oil or a spray.
B
As a matter of legal classification, it is a spray. Although
plaintiffs claim there are factual disputes at play here, in
truth plaintiffs simply disagree with the FDA’s framework
for how these types of products should be labeled. These
arguments may be readily addressed—and readily
rejected—at the Rule 12(b)(6) stage.
We interpret regulations, like statutes, based on their
plain language. Wards Cove Packing Corp. v. Nat’l Marine
Fisheries Serv., 307 F.3d 1214, 1219 (9th Cir. 2002). In
common parlance, a “spray” in this context refers to liquid
dispensed in the form of droplets, emitted from a mechanism
that allows the product to be applied in that manner. There
is no well-pleaded allegation in the complaint that, in form
and function, Butter! Spray is anything other than a spray.
Images in the complaint and record indicate that the product
comes in a spray bottle, with a finger-activated pump at the
top. Plaintiffs at one point in their operative complaint
themselves reference the product’s “spray mechanism.”
PARDINI V. UNILEVER UNITED STATES, INC. 15
They similarly describe the product as one that is “dispensed
in pump-action squirt bottles.” These allegations support
Unilever’s characterization of Butter! Spray as a spray,
based on the properties of the product and the liquified form
in which it is indisputably applied.
The notion that Butter! Spray could be housed under the
FDA’s legal classification for “butter,” meanwhile, is simply
implausible. The FDA’s “reference amount” for “butter,
margarine, oil, [and] shortening” is 1 tablespoon. 21 C.F.R.
§ 101.12(b), Table 2. Plaintiffs agree that to generate one
tablespoon of Butter! Spray, 40 sprays would be required.
“[C]ommon sense,” Ashcroft v. Iqbal, 556 U.S. 662, 679
(2009), tells us that this is not how such a product is typically
used. Nor does the plaintiffs’ complaint allege otherwise.
The complaint states at one point that some consumers
“report using far more than one spray” and that “[s]ome even
admit to pouring the product.” But under the FDCA and its
implementing regulations, serving sizes are based on
amounts “customarily consumed.” 21 U.S.C.
§ 343(q)(1)(A)(i); 21 C.F.R. §§ 101.9(b)(1), 101.12(a).
There is no well-pleaded allegation in the complaint that
consumers customarily drown their food in 40 sprays of I
Can’t Believe It’s Not Butter! Spray.
And even if this were somehow plausible, the category
of “spray type” would still be the more proper legal
classification when construing the “Fats and Oils” category
as a whole. See Norfolk Energy, Inc. v. Hodel, 898 F.2d
1435, 1442 (9th Cir. 1990) (“In discerning the meaning of
regulatory language, our task is to interpret the regulation as
a whole, in light of the overall statutory and regulatory
scheme, and not to give force to one phrase in isolation.”
(citation and quotation marks omitted)). Plaintiffs argue that
Butter! Spray is a “butter substitute” based on how it is
16 PARDINI V. UNILEVER UNITED STATES, INC.
marketed, so that it should be treated as “butter” for serving
size purposes, too. But under the FDA regulations, a
“substitute” food is not merely one that tastes the same
(believably or not). It is instead defined as a food that “may
be used interchangeably with another food that it resembles,
i.e., that is organoleptically, physically, and functionally
(including shelf life) similar to, and that it is not nutritionally
inferior to unless it is labeled as an ‘imitation.’” 21 C.F.R.
§ 101.13(d).
Plaintiffs have not pleaded facts that would fully satisfy
this technical definition for a product “substitute.” But even
if they could get over that hurdle, and even if we were to
make the implausible assumption that consumers
customarily use 40 sprays of the product per eating occasion,
it would still be more appropriate to place Butter! Spray in
the FDA’s “spray type” category under the familiar principle
that the specific governs the general. See, e.g., Flores v.
Barr, 934 F.3d 910, 917 (9th Cir. 2019) (citing Karczewski
v. DCH Mission Valley LLC, 862 F.3d 1006, 1015–16 (9th
Cir. 2017)). “Spray type” quite plainly encompasses a
narrower category than “butter, margarine, oil, [and]
shortening,” with “spray type” referring to fats and oils that
may be dispensed in a liquid emulsion using a spray
mechanism. Most any oil can fit in the “butter, margarine,
oil, shortening” category, but not every butter or oil-based
product can be sprayed. Treating Butter! Spray as a
butter/oil rather than a spray would threaten to undermine
the specific categorization in the FDA’s regulatory scheme,
potentially rendering the “spray type” category meaningless.
Nor do we agree with plaintiffs that “spray type” should be
limited to aerosolized sprays (like “Pam”) or nonstick
PARDINI V. UNILEVER UNITED STATES, INC. 17
cooking sprays. Neither the FDA regulations nor agency
guidance impose these limitations. 2
Because Unilever properly categorized Butter! Spray as
a “spray type” fat or oil, the serving size on its nutrition label
complied with federal law. For the “cooking spray”
application, the Butter! Spray label lists the serving size as
“1 Spray (0.20g).” A “spray” is a “common household
measure that is appropriate to the food.” 21 C.F.R. §
101.9(b)(1). The FDA’s suggested “label statement” for a
spray is expressed in “seconds” of spray, but the regulations
are clear that the “label statements are meant to provide
examples” which can be revised “as appropriate for
individual products.” Id. § 101.12(b), Table 2 n.4. Thus,
contrary to the dissent’s assertions, nothing required
Unilever to express usage based on “seconds” of spray. For
“spray types,” the FDA reference table provides a mandatory
reference amount of 0.25 grams. Id. § 101.12(b), Table 2.
2
Our fine dissenting colleague would reach a different result in this case
on the theory that the “spray types” category includes only nonstick
cooking sprays. But the dissent purports to base this position on the
FDA’s “agency guidance,” when the agency has made no such
proclamation. The 1994 FDA document on which the dissent relies does
not state that “spray types” only consist of nonstick cooking sprays. And
regardless, the FDA in 2018 updated its guidance on spray types, now
describing as “examples” of this product “[a]ll types of cooking sprays
(e.g., cooking spray olive oil).” See FDA, Guidance for Industry:
Reference Amounts Customarily Consumed for Each Product Category
(2018) (emphasis added). That inclusive guidance undermines the
dissent’s attempt to narrow the “spray types” category to aerosolized
nonstick sprays like Pam. Contrary to the dissent’s assertions, the 2018
FDA guidance poses no retroactivity problem. There has been no
relevant change to the statute or regulations, and the 2018 guidance
merely makes clearer what the 1994 guidance already conveyed: that
“spray types” are not limited to nonstick cooking sprays.
18 PARDINI V. UNILEVER UNITED STATES, INC.
But because Butter! Spray is a “nondiscrete bulk product,”
its serving size “shall be the amount in household measure
that most closely approximates the reference amount for the
product category” in the reference table. Id. § 101.9(b)(iii);
see also id. § 101.12(b), Table 2 n.3. Unilever’s 0.2-gram
figure “closely approximates” the FDA’s reference amount.
Plaintiffs do not state a claim by pointing to the very small
difference between the spray weight on the product label and
the value provided in the FDA reference table.
The Butter! Spray label also lists as an alternative
serving size “5 Sprays (1g)” when the product is used as
“topping” (toppings can be sprayed). Unilever was not
required to include this alternative serving size because
“nondiscrete bulk products” are exempt from FDA
regulations requiring additional nutritional information for
alternative uses. Id. § 101.9(b)(11). But Unilever was not
prohibited from including this information, and plaintiffs do
not state a claim simply because Unilever voluntarily
provided it. Plaintiffs’ assertion that the “5 spray” portion
of the nutritional label is unauthorized is incorrect.
C
Trying a different approach, plaintiffs argue that
consumers do not typically use just one spray of Butter!
Spray, and that Unilever’s serving size information is
therefore misleading because “serving sizes must reflect
customary usage.” In plaintiffs’ view, food manufacturers
must determine how their customers consume food products,
creating a supposed issue of fact both in this case and
presumably every other lawsuit like this alleging that
customers eat more of something than an FDA serving size
would suggest.
PARDINI V. UNILEVER UNITED STATES, INC. 19
Plaintiffs’ theory has it backwards. It is the FDA that
sets the reference amounts for serving sizes based on the data
“set forth in appropriate national food consumption
surveys.” 21 C.F.R. § 101.12(a)(1). To comply with federal
law, manufacturers then identify the relevant product
category and set a serving size that approximates the FDA’s
reference amount for that category. Id. §§ 101.9(b)(2),
101.12(b). In a lawsuit such as this, whether the serving size
listed on the nutritional label is lawful is not a factual
question about consumer behavior, but rather a legal
question that turns on whether the manufacturer identified
the proper product category and complied with the
applicable product category regulations.
In alleging that consumers use more than one spray of
Butter! Spray, plaintiffs do not raise a question of fact
regarding product classification. They instead challenge the
reference amount customarily consumed—a value
established by the FDA. As the district court correctly
recognized, plaintiffs’ approach would allow consumers to
“overcome a motion to dismiss” by “insisting that people
consume more (or less) of a product” than the FDA reference
amount, “rendering all sorts of products mislabeled at a
consumer’s whim.” That is not the law. In view of the
FDCA’s express preemption provision, if plaintiffs believe
that Butter! Spray should have a higher customary usage
reference amount, the proper forum in which to air that
grievance is the FDA (or Congress), not the courts.
Contrary to plaintiffs’ suggestion, our decision in Lilly v.
ConAgra Foods, Inc., 743 F.3d 662 (9th Cir. 2014), provides
plaintiffs no support. There, we considered whether the
FDCA preempted state law claims alleging that ConAgra
misled consumers about the sodium content of its sunflower
seeds. Id. at 663–64. Under the FDCA and its implementing
20 PARDINI V. UNILEVER UNITED STATES, INC.
regulations, a food label must include the sodium content of
the “edible portion” of the food, but it need not include the
sodium content of a “seed, shell, or other inedible
component.” Id. at 665 (citing 21 C.F.R.
§§ 101.9(b)(9), 101.12(a)(6)). It was “indisputabl[e]” in
Lilly that the salted coating is consumed when a sunflower
seed is eaten. Id. The question was then whether “the
sodium content of the edible coating added to sunflower
seeds must, under federal law, be included in the nutritional
information disclosed” on the product package. Id. at 663.
The issue was ultimately a legal one: whether the coating
was an “edible portion” within the meaning of certain FDA
regulations. Id. at 665. We held that it was, which meant
that plaintiffs’ state law claims were not seeking to impose
different requirements than federal law and were thus not
preempted. Id. To the extent Lilly drew on how customers
consumed the product, that the seed coating was intended to
be ingested was, again, “indisputabl[e].” Id. Lilly had
nothing to do with the FDA’s serving size rules, and it did
not somehow direct that customer usage should be evaluated
in answering the preemption question in a case such as this.
In assessing preemption under the FDCA for claims
challenging the serving size on a food product, we do not
work backward from customer usage to a product category
(the FDA’s role), but rather forward from a product category
to the serving size FDA has assigned that category.
Plaintiffs do not dispute that, if Butter! Spray is properly
labeled as a “spray type” fat or oil with a serving size
approximating 0.25 grams (here 0.2 grams), Butter! Spray’s
calorie and fat content representations also comply with
federal law. As we discussed above, for nutrition labels the
FDA regulations allow products with fewer than 5 calories
per serving to be labeled as having zero calories, while
PARDINI V. UNILEVER UNITED STATES, INC. 21
products with less than 0.5 grams of fat per serving size are
required to be labeled as having zero fat. See 21 C.F.R.
§§ 101.9(c)(1)–(2); see also id. §§ 101.60(b)(1)(i),
101.62(b)(1)(i) (similar rules for other product labels). It is
undisputed that the fat and calorie amounts for a 1-spray
serving of Butter! Spray fall below these thresholds (as does
a 5-spray serving). Thus, Butter! Spray nutrient labels that
the dissent calls “deception” fully comply with federal law.
Because plaintiffs’ challenge to the Butter! Spray
serving sizes would “directly or indirectly establish” a
requirement for food labeling that is “not identical” to
federal requirements, 21 U.S.C. § 343-1(a)(4), the FDCA
preempts their serving size claims. It follows that plaintiffs’
claims about fat and calorie content are preempted as well.
Once again, if plaintiffs (or the dissent) believe that the FDA
should not allow products to be labeled as containing zero
fat or calories when a given serving size may contain some
of each, they may raise that issue with the agency. This
argument cannot overcome the FDCA’s express preemption
provision.
AFFIRMED.
LUCERO, Circuit Judge, dissenting:
The proposition that, absent some Canaan miracle, a
bottle of flavored oil containing 1,160 calories and 124
grams of fat can be transformed into zero calories and zero
grams of fat by the simple act of replacing the bottle cap with
a pump device is ludicrous. Yet, that is appellee Unilever’s
defense to appellants’ state law consumer protection claims.
Unilever answers the appellants’ claims not by asserting
some molecular change that would result in such a
22 PARDINI V. UNILEVER UNITED STATES, INC.
transformation, but by asserting that the claims are
preempted by the FDCA. In other words, appellee tells us
that its labelling complies with FDA requirements, allowing
it to label its product as containing zero calories and zero
grams of fat. Because I disagree with my respected
colleagues in their analysis that permits Unilever to engage
in such deception, I must dissent.
As a preliminary matter, the majority errs in its 12(b)(6)
review by conflating the plausibility of appellants’ claims,
as required by Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009),
with the preemption evaluation, required by Reid v. Johnson
& Johnson, 780 F.3d 952, 959-61 (9th Cir. 2015). The two
evaluations are separate and distinct. See, e.g., Ebner v.
Fresh, 838 F.3d 958, 964-67 (9th Cir. 2016); Reid, 780 F.3d
at 958-59; Williams v. Gerber Products Co., 552 F.3d 934,
937-41 (9th Cir. 2008); Painter v. Blue Diamond Growers,
757 F. App’x 517, 518-20 (9th Cir. 2018). What results from
my respected colleagues’ merger of the assessments, is that
Unilever’s burden to establish preemption is inappropriately
lessened.
In order to establish preemption as an affirmative
defense, Unilever must prove, under the Act, the regulations,
and Reid, 780 F.3d at 959-61, that its labelling is authorized.
This means it must prove that I Can’t Believe It’s Not Butter
Spray is properly categorized as a “spray type” rather than a
“butter, margarine, oil, [or] shortening.” In establishing
preemption, I wholeheartedly agree that we begin with the
plain text of the statute. See Jones v. Rath Packing Co., 430
U.S. 519, 525 (1977). This ensures state police powers are
“not to be superseded . . . unless that was the clear and
manifest purpose of Congress.” Rice v. Santa Fe Elevator
Corp., 331 U.S. 218, 230 (1947). If there are “plausible
alternative reading[s]” of express language, we “have a duty
PARDINI V. UNILEVER UNITED STATES, INC. 23
to accept the reading that disfavors pre-emption.” Bates v.
Dow Agrosciences LLC, 544 U.S. 431, 449 (2005).
I do not agree that in the context of the statutory text and
regulations, the term “spray” is clear. Appellants’ complaint
avers that the product at issue “is sold to consumers in a
plastic bottle fitted with a removeable pump-action squirt
nozzle” that “delivers discrete squirts with each push—not a
pressurized aerosol spray like Pam that is dispensed by
pressing down for a period of time.” Accepting that
allegation for 12(b)(6) purposes, I am not ready to declare as
a legal proposition that a “squirt” is a “spray.”
When plain text does not provide clarity, we may
consider agency guidance interpretating the regulations.
Skidmore v. Swift Co., 323 U.S. 134, 140 (1944).
Compellingly, FDA guidelines provide that “spray types”
include exclusively “nonstick cooking sprays (e.g., Pam).”
U.S. Food and Drug Admin., Inspections, Compliance,
Enforcement, & Criminal Investigations, Guide to Nutrition
Labeling & Educ. Act Regs. (Attach. 26)(1994). 1 This is
1
My distinguished colleagues correctly identify a 2018 update to this
guidance document. However, the operative complaint was filed in 2013
and in 2014 the district court granted a motion to dismiss on the issue
before us. As the Supreme Court has succinctly stated:
[T]he presumption against retroactive legislation is
deeply rooted in our jurisprudence, and embodies a
legal doctrine centuries older than our Republic.
Elementary considerations of fairness dictate that
individuals should have an opportunity to know what
the law is and to conform their conduct accordingly;
settled expectations should not be lightly disrupted.
For that reason, the “principle that the legal effect of
conduct should ordinarily be assessed under the law
24 PARDINI V. UNILEVER UNITED STATES, INC.
consistent with the overall FDA regulations that provide for
“spray types” to be measured in seconds, indicating a
that existed when the conduct took place has timeless
and universal appeal.” Kaiser, 494 U.S., at 855, 110 S.
Ct., at 1586 (Scalia, J., concurring). In a free, dynamic
society, creativity in both commercial and artistic
endeavors is fostered by a rule of law that gives people
confidence about the legal consequences of their
actions.
Landgraf v. USI Film Prods., 511 U.S. 244, 265-66 (1994).
The Ninth Circuit regularly applies the applicable law at the time of
filing. See, e.g., Woods v. Kijakazi, 32 F.4th 785, 789-90 (9th Cir.
2022); Friends of Animals v. U.S. Fish & Wildlife Serv., 28 F.4th 19, 24
n.1 (9th Cir. 2022); Whitewater Draw Nat. Res. Conservation Dist. v.
Mayorkas, 5 F.4th 997, 1004 n.1 (9th Cir. 2021); United States v. Patton,
771 F.2d 1240, 1242 n.1 (9th Cir. 1985). Applying this principle to
guidance, this Circuit has noted that finding otherwise would harm
plaintiffs bringing suits. Indep. Training and Apprenticeship Program v.
Cal. Dept. of Indus. Relations, 730 F.3d 1024, 1034-35 (9th Cir. 2013)
(declining to automatically defer to DOL opinion letters issued after
litigation commenced). Unilever can hardly argue otherwise as it could
also claim lack of fair notice if the situation was reversed. Indeed, the
Ninth Circuit has recognized the Due Process concerns of holding a
defendant to requirements published after the claim was filed. United
States v. AMC Entm’t, Inc., 549 F.3d 760, 768-70 (9th Cir. 2008).
In any event, appellee Unilever does not present any arguments
regarding the 2018 guidance. In fact, Unilever addressed the 1994
guidance document briefed by appellants but did not reference the 2018
guidance document in its briefing. It is not our role to guess what
argument Unilever could have made regarding the 2018 guidance. And,
again, this case comes before us on Rule 12(b)(6) review and it is not our
office to enter findings of fact that are contrary to the allegations of the
complaint. On Rule 12(b)(6) review, “we treat the complaint’s
allegations as true and construe them in the light most favorable to the
plaintiff[s].” Nguyen v. Endologix, Inc., 962 F.3d 405, 408 (9th Cir.
2020).
PARDINI V. UNILEVER UNITED STATES, INC. 25
continuous mist. 21 C.F.R. § 101.12(b). It is also consistent
with I Can’t Believe It’s Not Butter online recipes, which
indicate that their product should be used with “no-stick
skillet(s),” clearly implying it is not intended as a “nonstick
cooking spray.”
Inclusion of butter substitutes in the “spray type”
category frustrates regulatory purpose. FDA labelling
guidelines are designed to protect consumers from “false or
misleading” packaging. 21 U.S.C. § 343(a) (2012). As my
majoritarian colleagues state, the categories are meant to
reflect “the major intended use of the food (e.g., milk as a
beverage and not as an addition to cereal).” 21 C.F.R. §
101.12(a)(7):
• The “spray type” category has a major intended
use: “nonstick cooking sprays” that lubricate
pans with continuous sprays measured in
seconds.
• The general “butter, margarine, oil, [and]
shortening” category, measured by the
tablespoon, encompasses products used as an
ingredient or topping.
Our role is to determine if Unilever has proven I Can’t
Believe It’s Not Butter Spray must be categorized as “spray
type.” In my opinion, Unilever has not carried that burden.
In context of the clear language of the statute and
regulations, at trial the fact finder could properly find that I
Can’t Believe It’s Not Butter Spray is categorized in the
“butter, margarine, oil, [and] shortening” category rather
than as a “spray.” Such a finding would well square with the
reality that even though squirted from a bottle, the product
contains the expected calories rather than zero calories. I
26 PARDINI V. UNILEVER UNITED STATES, INC.
would reverse the 12(b)(6) dismissal by the district court and
remand the case for continued proceedings.