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
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
April 18, 2023
D.C. No. 4:13-cv-01675-JSW
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.
Opinion by Judge Bress; Dissent by Judge Lucero
SUMMARY**
Food Drug and Cosmetic Act / Preemption
The panel affirmed the district court‘s
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 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 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,
Dissenting, Judge Lucero wrote that the majority erred in its
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.
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
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.
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 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
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 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.
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.
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.
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.”
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.”
The FDA‘s prescribed serving size amounts for the general food supply are set forth in a lengthy “Table 2” appearing at
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.”
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.”
Some items are known as “nondiscrete bulk products.”
We now turn to the more specific regulations governing butter and related products. Table 2 in
| | ||
| 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, mayonnaise-type 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 “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.”
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
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.
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 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.‘”
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 cooking sprays. Neither the FDA regulations nor agency guidance impose these limitations.2
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.
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. 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.”
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 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
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 products with less than 0.5 grams of fat per serving size are required to be labeled as having zero fat. See
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,
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 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 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
consistent with the overall FDA regulations that provide for “spray types” to be measured in seconds, indicating a continuous mist.
- 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 would reverse the 12(b)(6) dismissal by the district court and remand the case for continued proceedings.
Notes
Landgraf v. USI Film Prods., 511 U.S. 244, 265-66 (1994).[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 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.
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).