FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

KYM PARDINI; CARRIE WOOD, 

on behalf of themselves and all others 

similarly situated,

 

Plaintiffs-Appellants,

 v. 

UNILEVER UNITED STATES, INC., 

a Delaware corporation,

 

Defendant-Appellee.

No. 21-16806 

D.C. No.

4:13-cv-01675-

JSW 

OPINION

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 FDAdesignated 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 upsidedown 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, 

shortening

1 tbsp 1 tbsp (_ g); 1 

tbsp (15 mL)

Butter replacement,

Powder

2 g _ tsp(s) (_ g)

Dressings for salads 30 g _ tbsp (_ g); 

_ tbsp (_ mL)

Mayonnaise, sandwich 

spreads, mayonnaisetype dressings

15 g _ tbsp (_ g)

Spray types 0.25 g

About __ 

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.