KYM PARDINI, ET AL V. UNILEVER UNITED STATES, INC., No. 21-16806 (9th Cir. 2023)
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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.
The Ninth Circuit affirmed the district court’s Fed. R. Civ. P. 12(b)(6) dismissal. 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. The panel also rejected Plaintiffs’ argument that Butter! Spray is a “butter substitute” based on how it is marketed so it should be treated as “butter” for serving size purposes, too. The court explained that 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, the FDCA preempts their serving size claims.
Court Description: 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 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, 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.
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