A federal district court in California has upheld a snack food product manufacturer’s protein content labeling, dismissing a putative class action against the company because the statement of protein content challenged by the plaintiffs was permitted by FDA regulations and because the plaintiffs’ state law claims were preempted by federal law (Chong v. KIND L.L.C., No. 3:21-cv-04528-RS, 2022 U.S. Dist. LEXIS 27438, 2022 WL 464149 (N.D. Cal. Feb. 15, 2022)).

In a complaint filed in the U.S. District Court for the Northern District of California, the two plaintiffs alleged that KIND L.L.C. food products did not contain or provide the amount of protein claimed on the front of their packages because the company used “low quality, incomplete protein sources that are of little use to the human body.”

They also alleged that the company had failed to include “% Daily Value” (% DV) figure in the Nutrition Facts panels for some of its products. As a consequence, the plaintiffs contended, the labeling was misleading, and the food products were misbranded under state and federal law.

The court noted that the case was “nearly identical” to a case considered in the same district in which the plaintiff had contended that food product labeling was misleading because the grams of protein were wrongly calculated and because the numbers were not adjusted for “digestibility,” given the particular source of the protein (Minor v. Baker Mills, Inc., No. 3:20-cv-02901-RS, 2020 U.S. Dist. LEXIS 258880 (N.D. Cal. Nov. 12, 2020)).

Calculation Method Disputed

With respect to KIND’s labeling, the district court first noted that there was no dispute that if the company’s labeling practices are consistent with FDA regulations, any state law claims challenging those practices are preempted.

Also, the court said, there was no dispute that KIND was expressly permitted by FDA regulations to state the number of grams of protein in its products’ Nutrition Facts panels using the so-called “nitrogen method.” That method measures the amount of nitrogen and multiplies that amount by 6.25 as an indicator of the protein content. The method could be used, the court noted, without adjusting the number to reflect the digestibility of the particular kind of protein used.

However, the plaintiffs challenging KIND’s labeling, like the plaintiff in Minor, asserted that the proper method for measuring protein for purposes of labeling was the so-called “amino acid method,” under which the protein measurement varies according to the digestibility of the particular kind of protein, which varies depending on how many essential amino acids the protein contains.

Under the amino acid method, the protein source is assigned a factor — for example, a factor of 1 for protein from animal sources (because such protein is fully digestible) or a factor of 0.6 for protein from oats (because only 50% to 60% of the protein in oats is fully digestible). A product’s Protein Digestibility Corrected Animo Acid Score (PDCAAS) is adjusted depending on these digestibility variables.

FDA Regulations

The district court noted that, under FDA regulations, front-of-package statements about the amount of protein in a food product are nutrient content claims (21 C.F.R. §101.13(c)), and a manufacturer making a nutrient content claim for protein must provide a % DV figure in the Nutrition Facts panel (21 C.F.R. §101.9(c)(7)(i)). That figure must be calculated using the PDCAAS, reflecting the amount of digestible protein rather than just the raw number of grams of protein.

However, the court noted, the FDA’s regulations do not specify how the raw number of grams of protein must be calculated before the digestibility factor is applied to produce the PDCAAS. “A producer is free to calculate the quantity of protein using the nitrogen method, then multiply by the appropriate factor based on the type of protein it is, and then use the resulting PDCAAS when calculating what [% DV] is provided by a serving of the product,” the court said.

“A correct reading of the regulations establishes that producers may state grams of protein even outside the Nutrition Facts panel calculated by the nitrogen method, and without adjustment for digestibility,” the court continued.

Rejecting the plaintiffs’ position, the court noted that “the requirement in the regulations to calculate PDCAAS for purposes of stating [% DV] is not a reference to using plaintiff’s ‘amino acid method’ for calculating the raw quantity of protein.”

On this basis, the court granted KIND’s motion to dismiss the plaintiffs’ claims that were based on front-of-packaging statements. Moreover, the court stated, because the defect in the plaintiffs’ complaint lay in its legal theory rather than in its factual allegations, the court would not grant the plaintiffs leave to amend their complaint.

To the extent that the Minor court reached a contrary position, the district court added, that decision was incorrect. Specifically, it said, the Minor court had incorrectly concluded that “where a [% DV] is provided … the protein content used to derive that percentage must be calculated under the amino acid method.”

The district court stated that the Minor court had erroneously conflated the “amino acid score” with the “amino acid method” that the plaintiff in that case had argued needed to be used to calculate the raw number of protein grams. “The two terms refer to very different concepts,” the court hearing the KIND suit said.

Claims Are Preempted

In addition, the district court held that because the plaintiffs were attempting to use state law to impose labeling requirements that went beyond what the FDA regulations require, their claims were preempted.

KIND argued that the plaintiffs’ claims were subject to implied preemption under Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Under Buckman, the manufacturer argued, a consumer may not impose state law food label requirements that are different from those imposed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations, and a consumer has no ability to privately enforce those federal requirements.

The plaintiffs contended that Buckman did not apply because their claims paralleled the FDA regulations. The court agreed that the FD&C Act does not preempt preexisting state common law duties that parallel federal requirements. However, the court added, under Buckman state law claims “that ultimately are dependent on the existence of violations of federal law” are preempted.

“Plaintiffs here are not pursuing preexisting, traditional state tort law claims,” the court said. “Rather, they rely on California’s Sherman Law, which post-dates and is entirely dependent upon the [FD&C Act].” The state statute, the court noted, provides that all FDA food regulations adopted on or after Jan. 1, 1993, “shall be the food labeling regulations of this state.”

“As such,” the court concluded, “plaintiffs’ claims based on the omission of the % DV in some of KIND’s product labels are preempted.” The district court cited Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013), in which the U.S. Court of Appeals for the Ninth Circuit held that the FD&C Act impliedly preempts a state law claim that “originates from, is governed by, and terminates according to federal law.”

As in its ruling on the merits of the plaintiffs’ mislabeling claims, the court said that the defect of the plaintiffs’ complaint with respect to preemption “is one of theory, not factual sufficiency,” and that therefore the court would not grant the plaintiffs leave to file an amended complaint.