Background
Many food companies now make quantitative protein content claims on the front of pack or elsewhere on their product labels outside the Nutrition Facts Label (NFL), such as the example from a recent case below:
FDA regulations direct manufacturers to use the “nitrogen method”—which generally calculates protein content by multiplying the nitrogen content of the food by 6.25—when calculating the amount of protein reported inside the NFL. Companies have generally used the same method for protein claims made elsewhere on the label, i.e., outside the NFL.
A surge of recent class action lawsuits (three in the last month alone) have alleged that quantitative protein claims outside the NFL, such as the “11g Protein” claim on the front of the cereal box pictured above, must be based on the “Protein Digestibility Corrected Amino Acid Score” (PDCAAS), which is a way of adjusting the amount of reported protein to reflect its purported digestibility. According to these plaintiffs, using the nitrogen method for quantitative protein claims outside the NFL can be deceptive and/or misleading to the extent it overstates the digestible amount of protein in the product. These plaintiffs claim this supposed issue is particularly pronounced with products using “plant-based” protein, which can sometimes have lower protein digestibility scores. Food manufacturers have generally taken the stance, however, that FDA regulations do not require use of the PDCAAS method to calculate protein content claims and that doing so would in fact create consumer confusion to the extent the amount of protein reported inside the NFL (based on the nitrogen method) would differ from the amount claimed elsewhere on the pack (calculated using the PDCAAS method under plaintiffs’ theory).
Court Dismisses Complaint Against Kashi With Prejudice
While one court in the Northern District of California had permitted plaintiffs to proceed on this theory in 2020, the tide may be turning in manufacturers’ favor. Last week, Judge Chhabria (also of the Northern District of California) squarely answered whether it can be false or misleading for a manufacturer to make protein content claims outside the NFL based on the nitrogen method: “The answer is no.” See Nacarino v. Kashi Co., No. 21-CV-07036-VC, 2022 WL 390815, at *1 (N.D. Cal. Feb. 9, 2022). In his decision dismissing a complaint against Kashi on preemption grounds, the court reasoned that “[g]iven the FDA’s express approval of the nitrogen-content method and failure to require manufacturers to adjust for protein quality when stating the amount of protein in the nutrition label, it does not make sense to read the regulations as barring manufacturers from making identical statements elsewhere on their packaging.”
In reaching this conclusion, the court found persuasive a recent Q&A the FDA had posted to its website indicating that manufacturers can use either the nitrogen or PDCAAS method for calculating protein content claims outside the NFL. As the court observed, the FDA has now “clearly stated that its regulations do not require protein content statements to adjust for digestibility, demonstrating that ‘uncorrected’ claims are not inherently misleading within the meaning of the regulation.” In addition, Judge Chabbria “declin[ed] to follow [the] lead” of courts that had come out the other way on this issue, noting that he “sees the issue differently” and that those earlier decisions “came down before the FDA issued its most recent guidance on the topic.”
Looking Ahead
Judge Chhabria’s decision may prove valuable to other food manufacturers that are currently defending claims based on their use of the nitrogen method for calculating protein content claims made outside the NFL. Covington is monitoring those cases and developments in this area closely, and is happy to consult with companies that may be evaluating protein claims on their labels, including on best practices for making such claims.