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.

Photo of Olivia Dworkin Olivia Dworkin

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge…

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge medical technologies and digital health products and services, Olivia regularly helps new and established companies navigate a variety of state and federal regulatory, legislative, and compliance matters throughout the total product lifecycle. She has experience counseling clients on the development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical applications, general wellness products, medical device data systems, administrative support software, and products that incorporate artificial intelligence, machine learning, and other emerging technologies.

Olivia also assists clients in advocating for legislative and regulatory policies that will support innovation and the safe deployment of digital health tools, including by drafting comments on proposed legislation, frameworks, whitepapers, and guidance documents. Olivia keeps close to the evolving regulatory landscape and is a frequent contributor to Covington’s Digital Health blog. Her work also has been featured in the Journal of Robotics, Artificial Intelligence & Law, Law360, and the Michigan Journal of Law and Mobility.

Photo of Cort Lannin Cort Lannin

Cortlin Lannin is a litigator who defends clients in high-stakes complex matters, specializing in class action cases implicating consumer protection and competition claims. He approaches his matters with efficiency and creativity, developing thoughtful strategies to resolve cases and investigations early and on favorable…

Cortlin Lannin is a litigator who defends clients in high-stakes complex matters, specializing in class action cases implicating consumer protection and competition claims. He approaches his matters with efficiency and creativity, developing thoughtful strategies to resolve cases and investigations early and on favorable terms.

On behalf of a range of clients in the food, beverage, and consumer packaged goods industries, Cort has navigated pre-complaint disputes and defended multiple class actions implicating deceptive and false advertising practices under California’s UCL, FAL, and CLRA, and other states’ false advertising and unfair competition laws. Cort also has a depth of experience with competition matters, having represented clients in civil class action litigation, non-public governmental investigations of both the civil and criminal variety, and internal investigations. He has had a lead role in cases and investigations implicating the high tech industry, alleged “no-poach” agreements, and price-fixing and similar cartel conduct. He is also a leader in the antitrust bar and the recent chair of the Antitrust Section of the Bar Association of San Francisco.

Cort is a co-chair of Covington’s LGBT+ Affinity Group and is deeply involved in the firm’s efforts to recruit, mentor, and promote diverse attorneys, including LGBT+ attorneys.

Prior to joining Covington, Cort was a national political consultant who specialized in polling and focus group research. He leverages this research background in his litigation practice, particularly in defending consumer cases.