In 2021, there were 325 class action cases filed against food and beverage companies, the highest count to date. As the number of cases filed against food and beverage companies has increased, certain trends have emerged in the type of claims plaintiffs bring. For example, “all natural” cases were once all the rage and then cases challenging the use of “vanilla” entered the scene. Recently, cases against protein labeling claims have begun to emerge. Plaintiffs have been challenging protein labeling claims in three ways. First, plaintiffs have claimed that a popular method to calculate protein content is misleading. Second, plaintiffs have challenged front of package labels claiming products have a certain quantity of protein without adjusting for protein quality or digestibility. Third, plaintiffs have claimed companies have unlawfully omitted percent daily value of protein figures on the Nutrition Facts panel.

All protein labeling cases are brought under state law. Particularly, most of these cases are brought under California state law because almost all are filed in the Northern District of California. Although the plaintiffs are alleging the labels are false and misleading as defined in the Federal Food Drug and Cosmetic Act (FFDCA), the FFDCA does not grant private citizens a right of action. Only the Food and Drug Administration (FDA) can bring actions under the FFDCA. Although plaintiffs cannot bring actions under the FFDCA, they can bring actions under state law as long as (1) they satisfy all procedural requirements such as standing, (2) the state law claim pre-dates the FFDCA, and (3) the alleged violation of state law is either not addressed by the FFDCA or is also a violation of the FFDCA. See 21 U.S.C. § 343-1(a)(5); see Buckman v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001); and see Nacarino v. Kashi Company, 21-cv-07036 (N.D. Cal. Feb. 9, 2022). If FDA’s regulations permit the challenged statements, then the state law claims are expressly preempted. Id.

Inaccurate Protein Testing method

When plaintiffs first started filing claims challenging protein labeling, they argued that the methodology companies use to calculate the grams of protein in a product caused an overstatement of the protein content. FDA’s regulations allow food companies to calculate the quantity of protein using one of two methods. The judge in Nacarino v. Kashi, one of the prominent cases in this area, explained:

“the amount of protein in food can be measured directly by calculating its amino acid content (a technique the plaintiffs call “amino acid content testing”). But protein can be measured indirectly too. The more protein that a product has, the more nitrogen there will be. Thus, the amount of protein in a product can be estimated by multiplying its nitrogen content by some factor (6.25, as it turns out). As the complaint describes the procedures, direct measurement will always be the more reliable technique.”

The plaintiffs in Nacarino argued that using the nitrogen content method misleads consumers because the method is inaccurate and a food might contain less protein than stated. The judge, however, held that because FDA’s regulations allow the nitrogen content method, the plaintiffs’ claim was preempted. The judge explained that “FDA has made a value judgement that the nitrogen-content method, while perhaps not as accurate as direct-measurement techniques, is sufficient.” To support this holding, the judge pointing to a January 2022 FDA guidance which clarifies that food manufacturers can use the nitrogen content method when expressing the protein content of a food.

Front of Pack Protein Claim Not Adjusted for Digestibility

Humans digest different types are proteins at different rates. For example, humans fully digest whey protein, but can only digest and use about half the protein derived from oats. See Nacarino. Under FDA’s regulations, food manufacturers must include the quantity of protein in a food, expressed in grams, but are not required to include a measurement of quality or digestibility.

In Nacarino, the plaintiffs also argued that the statement “11g of Protein” without a disclaimer that not all grams are digestible on the front label of Kashi branded products was false and misleading. However, the FDA’s regulations permit the use of statements such as “11g of Protein” without further clarifying the digestibility of that protein. The judge explained that “FDA permits manufacturers to list the amount of protein in a product without correcting for digestibility” and “the regulations refer to this unadjusted figure as the ‘actual amount of protein’ in a product.” Nacarino (citing 21 C.F.R. § 101.9(c)(7)(iii)).

In Chong v. Kind, 3:21-cv-04528 (N.D. Cal. Feb. 15, 2022), another leading case in this area, the plaintiffs similarly argued that “KIND’s products do not contain or provide the amount of protein claimed on the front [label] because KIND uses ‘low quality, incomplete protein sources that are of little use to the human body.’” The court noted that FDA’s regulations expressly permit food manufacturers to state the amount of protein without adjusting for digestibility in the Nutrition Facts panel. The question before the court, however, was whether food manufacturers may use the unadjusted protein content measurement elsewhere on a food label or package. The Chong court cited to the Nacarino decision and held “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.”

Percent of Daily Value in the Nutrition Facts Panel

Most recently, plaintiffs have begun bringing claims alleging food manufacturers’ omission of a protein percent daily value (%DV) calculations in Nutrition Facts panels is misleading. Under FDA’s regulations, food manufacturers are only required to include the %DV for protein if the food label contains a protein nutrient content claim. See 21 C.F.R. § 101.9(c)(7)(i). The %DV for protein is calculated using the Protein Digestibility Corrected Amino Acid Score; therefore, the %DV gives a measure of protein quality or digestibility. Stated differently, food manufacturers do not have to include a %DV calculation unless they also include a protein nutrient content claim such as “high in protein”.

The plaintiffs in Chong also argued that KIND’s failure to include a %DV calculation in the Nutrition Facts panel was misleading. In response, KIND argued that the plaintiff’s claims were impliedly preempted under Buckman v. Plaintiff’s Legal Committee. Under Buckman, a state law claim avoids preemption if it “predates the federal enactments in question” and does “not exist solely by virtue of those enactments.” The Chong court found that the plaintiffs were “not pursing pre-existing, traditional, state tort law claims, rather they rel[ied] on California’s Sherman Law, which post-dates and is entirely dependent upon the FDCA, in that it expressly adopts the FDCA and regulations as state law.” Therefore, the court held “plaintiff’s claims on the omission of the %DV in some of KIND’s product labels are preempted” and granted KIND’s motion to dismiss.

Other than Buckman preemption, courts have granted motions to dismiss with leave to amend on the grounds that the plaintiffs failed to allege standing. This means that the plaintiffs failed to show they read and relied on the Nutrition Facts panel when they decided to purchase the product in question. In Swartz v. Dave’s Killer Bread, Inc., 4:21-cv-10053 (N.D. Cal. May 5, 2022), the court stated the plaintiff “failed to show that his injury is fairly traceable to the alleged misrepresentation (defendant’s omission of %DV from the nutrition label) or that requiring Defendants to include %DV on the nutrition label would redress his alleged confusion over the protein content of the products he purchased.”

There are a handful of other cases currently being litigated in the Norther District of California in which the plaintiffs are arguing the defendant unlawfully omitted the %DV from the Nutrition Facts panel. In each case, the defendant has filed a motion to dismiss arguing that the plaintiff’s claims are impliedly preempted under Buckman and that the plaintiff lacks standing. Some defendants are arguing that their products do not contain a nutrient content claim and, therefore, are not required to include a %DV calculation. These defendants use terms such as “protein packed” and argue that such terms are mere puffery and not a nutrient content claim.

Conclusion

As many plaintiffs have stated in their complaints, “consumers are increasingly health conscious and, as a result, many consumers seek foods high in protein”, and consumers “reasonably expect that each product will provide the actual amount of protein per serving claimed on the front of the product package”. Complaint, Nacarino. With this in mind, plaintiffs have argued that food manufacturers have mislead them into believing products contain more protein than they actually do. Plaintiffs have challenged food manufacturers’ protein claims on three main grounds: (1) the manufacturer used an inaccurate protein quantity calculation, (2) the manufacturer did not adjust the protein quantity for digestibility or quality, and (3) the manufacturer failed to include a %DV calculation in the Nutrition Facts panel. Despite little success with these claims—due to defendants successfully arguing that plaintiffs’ claims are preempted and lack standing—plaintiffs continue to file cases on these grounds.

 

 

To read the Nacarino order granted Kashi’s motion to dismiss, click here.

To read the Chong order granting KIND’s motion to dismiss, click here.

To read the Swartz order granting Dave’s Killer Bread’s motion to dismiss, click here.

To learn more about food labeling generally, visit NALC’s food labeling reading room, here.

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