Courts in the Northern District of California continue to turn away lawsuits alleging that food and beverage companies must adjust protein content claims to account for protein digestibility.  In Brown v. Nature’s Path Foods, Inc., 2022 WL 717816 (N.D. Cal. Mar. 10, 2022), Judge Gilliam observed that recent FDA guidance reaffirms that companies may use the “nitrogen method” for protein content claims and that the agency’s “regulations do not require protein content claims to adjust for digestibility or to be calculated using amino acid contest testing.”  Because plaintiff was seeking to impose requirements under state law that the FDA does not, her claims were preempted.  The following month, Judge Chhabria granted a motion to dismiss in Brown v. Kellogg Company, 2022 WL 983268 (N.D. Cal. Apr. 1, 2022), concluding that those plaintiffs did not raise “any basis on which to distinguish the claims in [the] case” from another he had recently dismissed, as discussed here.  The next month, Judge Orrick reached the same conclusion in Brown v. Van’s Int’l Foods, Inc., 2022 WL 1471454 (N.D. Cal. May 10, 2022), concluding that “FDA regulations permit protein content claims to be calculated via the nitrogen method.”  This brought to five the number of recent decisions squarely rejecting plaintiffs’ theory that manufacturers cannot use the nitrogen method for protein content claims, including earlier decisions discussed here and here.

These cases often assert another theory of liability: that manufacturers are required by FDA regulations to include a “percent daily value” figure for protein in the Nutrition Facts Label (NFL) if they make a protein content claim elsewhere on the package, and that failing to include that “%DV” can be false or misleading under state law.  The courts have not yet adopted a uniform approach to these claims.  In Chong v. Kind LLC, 2022 WL 464149 (N.D. Cal. Feb. 15, 2022), the court held that such claims were subject to implied preemption under Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), because the claims were “ultimately . . . dependent on the existence of violations of federal law.”  In other words, in the court’s view plaintiff’s claim under California law existed solely by virtue of FDA requirements.  Judge Orrick disagreed with this reasoning in Van’s, noting he “did not read Buckman or its progeny as sweeping so broadly” and concluding plaintiff was “suing for conduct that violates the FDCA, but not because the conduct violates the FDCA.”  Even though he found Buckman preemption did not apply, Judge Orrick nevertheless dismissed this theory in light of plaintiff’s failure to “plausibly allege that she was deceived by the omission of digestibility-adjusted protein figure from the Nutrition Facts panel.”  Judge Gilliam in Nature’s Path likewise dismissed this theory based on plaintiffs’ failure to plead reliance on the NFL, and thus expressly declined to reach the Buckman question.            

Taken as a whole, these five cases suggest that claims challenging a manufacturer’s use of the nitrogen method for protein content claims are unlikely to gain much traction in the Northern District of California.  However, a consensus approach has not yet emerged for claims challenging a manufacturer’s failure to include a “%DV” in the NFL—although the recent decisions certainly point to vulnerabilities in this theory that a savvy defendant should seek to develop.  More developments in this area are likely, as plaintiffs in three of the five cases (Kashi, KIND, and Kellogg) have now appealed the dismissal of their claims to the Ninth Circuit.

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.