584 F.Supp.3d 806
N.D. Cal.2022Background
- Plaintiffs sued Kashi under state consumer-protection and tort law, alleging front-of-pack protein claims (e.g., “11g Protein”) are misleading.
- Kashi calculates those figures using the FDA-permitted nitrogen-content method (nitrogen × 6.25) and does not adjust the front-of-pack number for protein digestibility.
- FDA regulations require grams of protein on the Nutrition Facts label and expressly permit the nitrogen method; when nutrient claims appear outside the Nutrition Facts label, manufacturers must include a digestibility-adjusted protein Percent Daily Value in the Nutrition Facts.
- Plaintiffs contend the nitrogen method overstates usable protein and that unadjusted front claims mislead consumers.
- Court held that because the nitrogen-content method and unadjusted protein figures are authorized by FDA regulations and guidance, the front-of-pack statements are not “false or misleading” under the FDCA regulatory scheme.
- Result: motion to dismiss granted; plaintiffs’ state-law claims are preempted by federal law; dismissal with prejudice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a front-of-pack protein amount calculated by the nitrogen method is “false or misleading” under 21 C.F.R. §101.13(i)(3) | Nitrogen method overstates protein; not adjusted for digestibility, so front claim misleads consumers | FDA authorizes the nitrogen method and does not require digestibility adjustment for the stated grams | Not misleading under the regulation; FDA authorization forecloses finding it false or misleading |
| Whether unadjusted front-of-pack protein claims must be corrected or barred when not quality-adjusted | Front claims should be corrected or removed because consumers will assume digestible protein equals stated grams | Regulations require a digestibility-adjusted %DV in Nutrition Facts when front claims are made, but do not bar unadjusted gram statements outside Nutrition Facts | Requiring the %DV provides additional consumer information; unadjusted gram statements are not inherently misleading |
| Whether Ninth Circuit precedent (Reid/Hawkins) mandates a different outcome | Reid and Hawkins show nutrition-label facts aren’t a license to repeat claims elsewhere | Those cases involved objectively false “no trans fat” claims and are distinguishable | Court distinguishes them; precedent does not control here |
Key Cases Cited
- Reid v. Johnson & Johnson, 780 F.3d 952 (9th Cir. 2015) (recognizes that repeating nutrition-label facts elsewhere can still be misleading in some circumstances)
- Hawkins v. Kroger Co., 906 F.3d 763 (9th Cir. 2018) (discusses FDCA preemption and false nutrient claims context)
- United Savings Ass'n of Texas v. Timbers of Inwood Forest Assocs., Ltd., 484 U.S. 365 (U.S. 1988) (statutory scheme clarifies ambiguous provisions)
- Skidmore v. Swift & Co., 323 U.S. 134 (U.S. 1944) (agency guidance may carry persuasive weight)
- MGIC Indemnity Corp. v. Weisman, 803 F.2d 500 (9th Cir. 1986) (judicial notice of public records)