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.

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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.

Prior to joining Covington, Olivia was a fellow at the University of Michigan Veterans Legal Clinic, where she gained valuable experience as the lead attorney successfully representing clients at case evaluations, mediations, and motion hearings. At Michigan Law, Olivia served as Online Editor of the Michigan Journal of Gender and Law, president of the Trial Advocacy Society, and president of the Michigan Law Mock Trial Team. She excelled in national mock trial competitions, earning two Medals for Excellence in Advocacy from the American College of Trial Lawyers and being selected as one of the top sixteen advocates in the country for an elite, invitation-only mock trial tournament.

Photo of Cort Lannin Cort Lannin

Cortlin Lannin is a litigator who defends clients in high-stakes antitrust and consumer matters. Described by Chambers USA as “smart, detail-oriented and thorough,” Cort has a depth of experience helping his clients successfully navigate the entire lifespan of these matters, from leading internal…

Cortlin Lannin is a litigator who defends clients in high-stakes antitrust and consumer matters. Described by Chambers USA as “smart, detail-oriented and thorough,” Cort has a depth of experience helping his clients successfully navigate the entire lifespan of these matters, from leading internal investigations to defending government investigations and the class action litigation that routinely follows.

Cort is co-chair of the firm’s global Cartel Defense and Government Investigations practice group and represents companies and individuals facing criminal and civil antitrust investigations, including before the DOJ Antitrust Division and FTC. Cort is also an experienced class action litigator and has defended his clients in cases implicating the high-tech industry, alleged “no-poach” and wage-fixing agreements, price-fixing, and similar conduct. Cort has been recognized as a Top Antitrust Lawyer by the Daily Journal.

Cort has also defended some of the world’s largest consumer-facing companies in class action litigation across courts nationwide. This includes cases alleging false advertising and unfair trade practices under California’s UCL, FAL, and CLRA, and other states’ laws. He is experienced at heading off cases before any complaint is filed and, if necessary, efficiently defeating complaints.

Cort is a co-chair of Covington’s CovPride Resource Group and is deeply involved in the firm’s efforts to recruit, mentor, and promote diverse attorneys. He also maintains an active pro bono practice and is currently leading a team working to preserve transgender adolescents’ access to gender-affirming care.