Many food companies now make quantitative claims about protein content on the front of the package or elsewhere on their product labels outside of the Nutrition Facts Label (NFL), as in the example of a recent case below:
FDA regulations direct manufacturers to use the “nitrogen method” – which typically 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 wave of recent class action lawsuits (three in the past month alone) have alleged that quantitative protein claims outside of the NFL, such as the “11g Protein” claim on the front of the cereal box pictured above , must be based on “Protein”. Digestibility Corrected Amino Acid Score” (PDCAAS), which is a way to adjust the amount of reported protein to reflect its claimed digestibility. According to these applicants, the use of the nitrogen method for quantitative protein claims outside of NFL may be misleading and/or misleading to the extent that it overestimates the digestible amount of protein in the product. These complainants claim that this supposed problem is particularly pronounced with products using “plant-based” proteins, which can sometimes have lower protein digestibility scores. However, food manufacturers have generally taken the position that FDA regulations do not require the use of the PDCAAS method to calculate protein content claims and that this would in fact amount to to create consumer confusion that the amount of protein declared in the NFL (based on the nitrogen method) would differ from the amount claimed elsewhere on the package (calculated using the PDCAAS method according to applicants’ theory ).
Court dismisses complaint against Kashi with bias
As a court in the Northern District of California cleared the plaintiffs to pursue this theory in 2020, the tide may be turning in favor of the manufacturers. Last week, Judge Chhabria (also of the Northern District of California) squarely answered whether it might be wrong or misleading for a manufacturer to make claims about protein content outside of the NFL based on the method. nitrogen: “The answer is no”. See Nacarino v. Kashi Co., no. 21-CV-07036-VC, 2022 WL 390815, at *1 (ND Cal. February 9, 2022). In its decision dismissing a claim against Kashi on preemptive grounds, the court held that “[g]Given the FDA’s express endorsement of the nitrogen content method and the fact that manufacturers were not required to adjust for protein quality when stating the amount of protein on the nutrition label , it does not make sense to interpret the regulations as prohibiting manufacturers from making identical claims elsewhere on their packaging. »
In coming to this conclusion, the court found persuasive a recent Q&A that the FDA posted on its website stating that manufacturers can use That is nitrogen Where 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 claims of protein content to adjust for digestibility, demonstrating that ‘uncorrected’ claims are not inherently misleading. within the meaning of the regulations”. Moreover, Judge Chabbria “declines[ed] to follow [the] leader” of the courts that had ruled the other way on this issue, noting that he “sees the issue differently” and that these earlier rulings “were issued before the FDA issued its most recent guidance. on the subject”.
Judge Chhabria’s ruling may prove valuable to other food manufacturers currently defending claims based on their use of the nitrogen method to calculate protein content claims made outside of the NFL. Covington is closely monitoring these cases and developments in this area, and is happy to consult with companies that may be evaluating protein claims on their labels, including best practices for making such claims.