On Aug. 14, the Ninth Circuit issued its decision in Nacarino v. Kashi Co., providing some much-needed clarity to the FDA’s protein labeling requirements. The decision dealt with two separate cases from the Northern District of California that were consolidated on appeal. Both cases involved state law claims that took issue with the defendants’ use of protein content claims on the front packaging of its products. Specifically, plaintiffs alleged that listing the protein quantity on the front of a label (i.e., “11g Protein” or “PROTEIN 15g”) without including a quality-adjusted percent daily value is false and misleading in violation of state and federal law. The plaintiffs also argued that use of the “nitrogen method,” also known as the “Kjeldahl method” of measuring protein content, is misleading to consumers. Rejecting plaintiffs’ arguments in a 3-0 decision, the Ninth Circuit affirmed the District Court’s orders dismissing the claims.
Understanding plaintiffs’ claims and the Ninth Circuit’s holding requires some background on the nature of protein and federal nutrition-labeling regulations. Protein is an important part of a healthy diet. Protein is necessary for hormone and enzyme production and serves as a crucial energy source. Consuming enough protein is essential in preventing age-related muscle loss and maintaining a healthy immune system. However, not all protein is the same— it comes in various types and qualities. The protein in two different food products containing the same amount of protein by weight may provide different levels of nutritional benefit due to differences in quality. Protein quality is affected by amino acid composition and digestibility. The more “indispensable” amino acids a protein contains (amino acids that are not produced by the body and are derived solely from food) and the more digestible a protein is, the higher its nutritional quality. There are a variety of methods of measuring protein content, each with advantages and disadvantages. The nitrogen or Kjeldahl method is inexpensive, easy to reproduce, and is considered the universal standard of protein quantification. However, the method typically overstates protein content and other methods are more accurate. To reflect protein quality and nutritional value more precisely, manufacturers may apply a protein digestibility-corrected amino acid score (PDCAAS) to measure protein quantity.
Thirty-three years ago, Congress amended the Food, Drug, and Cosmetic Act through the Nutrition Labeling and Education Act (NLEA), which mandated nutrition labeling and the now ubiquitous Nutrition Facts Panel (NFP). Under 21 C.F.R. § 101.9, the FDA requires manufacturers to disclose the quantity of protein and other nutrients contained in the product within the NFP. The FDA also regulates protein content claims that are made outside of the NFP. For example, 21 C.F.R. § 101.13(i)(3) authorizes manufacturers to make nutrient content claims regarding the “amount or percentage of a nutrient” if the claim “does not in any way implicitly characterize the level of the nutrient in the food and it is not false or misleading in any respect.”
Section 101.13 does not include specific rules dictating how protein should be measured in nutrient content claims. Rather, it provides that “compliance with [the] requirements for nutrient content claims… will be determined using the analytical methodology prescribed for determining compliance with nutritional labeling in section 101.9.” The pertinent part of that regulation, section 101.9(c)(7), requires that manufacturers include protein quantity in the NFP measured by “the number of grams of protein in a serving,” and allows protein quantity to be calculated based on the food’s nitrogen content. Critically, if a label includes any additional protein claims, it triggers a provision in section 101.9(c)(7)(i) that requires the manufacturer to display PDCAAS-corrected protein content as a percent daily value figure within the NFP in addition to displaying protein quantity in grams. The Court refers to this regulation as the “trigger provision.”
Plaintiffs argued that Defendants’ protein claims are both false and misleading because the protein quantity claims on the front of the labels were obtained via the nitrogen method and were not PDCAAS-corrected. Thus, plaintiffs contended that the claims overstated the products’ protein content and ignored the imperfect quality of the protein, deceptively implying in violation of state law that all of the protein contained in the products was usable by the human body.
The Ninth Circuit disagreed, holding that the plain language of sections 101.13 and 101.9 allows manufacturers to list protein quantity outside of the NFP without the PDCAAS-adjusted percent daily value so long as the adjusted percent daily value is disclosed within the NFP. The Court also held that the nitrogen method is explicitly allowed under FDA regulations and that Plaintiffs’ claims were therefore preempted by federal law and were properly dismissed by the District Court. This decision demonstrates the Court’s understanding that FDA regulations reflect “a balance that [keeps] costs low for manufacturers without allowing consumers to be misled.” The Court noted that while it is widely accepted that protein has important nutritional value, the FDA has found that protein deficiency is not common in the United States. Taking this into account, the Court concluded that the FDA struck a balance between consumer access to nutritional information and costs to manufacturers when promulgating section 101.9(c)(7), which only requires manufacturers to incur the additional costs of calculating and disclosing PDCAAS if they choose to “market to protein-conscious consumers.”
The Court included these two diagrams to illustrate a typical NFP protein quantity disclosure (right) and corresponding protein content claim (left). Note that because of the “trigger provision,” the inclusion of the “20g Protein” representation on the front of the product necessitates disclosing the PDCAAS-adjusted percent daily value in the NFP (30%).
