Elena Nacarino v. Kashi Company, 77 F.4th 1201

Background

Consolidated appeals from two putative class actions (Nacarino v. Kashi; Brown v. Kellogg) alleging front-label protein claims are false or misleading because they overstate usable protein and ignore low protein quality.
Plaintiffs claim front labels tout grams of protein but mislead consumers about digestibility/quality (i.e., not all grams are equally usable due to amino-acid balance and digestibility).
FDA labeling scheme: 21 C.F.R. §101.9(c)(7) permits the nitrogen method to measure grams of protein and provides for PDCAAS (protein digestibility–corrected amino acid score) adjustment; 21 C.F.R. §101.13(o) ties nutrient-content claims outside the Nutrition Facts Panel (NFP) to the NFP analytical methodology; the §101.9(c)(7)(i) “trigger” requires PDCAAS-adjusted % Daily Value in the NFP when a protein claim appears outside the NFP.
The district court dismissed the complaints, finding the nitrogen method is FDA-authorized, defendants’ labels complied with federal regs, and state-law claims imposing different labeling requirements are preempted.
The Ninth Circuit affirmed dismissal on express-preemption grounds but clarified: quantitative protein claims outside the NFP may be misleading if the NFP fails to display the PDCAAS-adjusted %DV; here plaintiffs did not allege any omission of the required PDCAAS-adjusted %DV, so their claims were preempted.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether front‑label quantitative protein claims are "false" because the nitrogen method overstates usable protein	The nitrogen proxy overstates true usable protein; defendants could have measured amino‑acid content directly	Nitrogen method is an FDA‑authorized analytical method; gram claims reflect that authorized measurement	Claims not "false" under FDCA because regs authorize the nitrogen method and plaintiffs did not allege the gram values misreported the nitrogen‑measured protein
Whether front‑label protein claims are "misleading" by implying all grams are nutritionally equivalent when protein quality is low	Gram claims imply consumers will receive all nutritive benefits; this misleads average consumers	The regulatory scheme addresses quality: if a protein claim is made outside the NFP, PDCAAS‑adjusted %DV must appear in the NFP	Protein claims can be misleading if the NFP omits the PDCAAS‑adjusted %DV, but plaintiffs did not allege such omission here
Whether plaintiffs’ state‑law consumer‑protection claims are preempted by the FDCA/NLEA	State claims enforce consumer protection against misleading labels and should be permitted	Federal regs expressly preempt state requirements that are not identical; regs authorize the challenged quantitative protein claims subject to the trigger	State‑law claims that would impose different labeling requirements are expressly preempted; dismissal affirmed
Role and weight of FDA guidance/agency interpretation (e.g., memo, FAQ)	FDA materials caution that protein quantity alone can mislead and support plaintiffs' view	Agency guidance and FAQ clarify that gram claims calculated under §101.9(c)(7) comply when the PDCAAS %DV appears in the NFP	Court found the agency guidance persuasive (Skidmore deference) and supportive of the view that gram claims are authorized when the trigger provision is satisfied

Key Cases Cited

Hawkins v. Kroger Co., 906 F.3d 763 (9th Cir. 2018) (express‑preemption analysis of food labeling claims)
Reid v. Johnson & Johnson, 780 F.3d 952 (9th Cir. 2015) (preemption turns on whether federal regulations authorize statements)
Durnford v. MusclePharm Corp., 907 F.3d 595 (9th Cir. 2018) (nitrogen method as agency‑authorized proxy for protein content)
Williams v. Gerber Prods. Co., 552 F.3d 934 (9th Cir. 2008) (reasonable‑consumer standard in consumer‑fraud context; state law)
Bell v. Publix Super Markets, Inc., 982 F.3d 468 (7th Cir. 2020) (distinguishing preempted federal labeling from voluntary front‑label modifiers)
Kisor v. Wilkie, 139 S. Ct. 2400 (2019) (limits and standards for deference to agency interpretations)
Skidmore v. Swift & Co., 323 U.S. 134 (1944) (weight to give agency interpretations depends on persuasiveness)