## Facts

- Consumers brought a putative class action alleging Trader Joe’s deceptively labeled certain food products under the FDCA’s misbranding provisions and parallel California consumer-protection statutes incorporating federal standards.
- A central challenge targeted Trader Joe’s use of the term “soymilk” on soy-based beverages.
- Plaintiffs claimed “soymilk” improperly used a standardized term (“milk”) and was misleading because consumers might believe the product contained cow’s milk or had comparable nutrition.
- Plaintiffs relied on FDA’s regulatory definition (standard of identity) for “milk” as a cow-derived lacteal secretion and cited FDA warning letters suggesting “soy milk” may be misbranded.
- Trader Joe’s moved to dismiss under Rule 12(b)(6).

## Issues

1. Whether labeling a soy-based beverage as “soymilk” violates 21 U.S.C. § 343(g) by purportedly representing the product as standardized “milk” without meeting the federal standard of identity.
2. Whether “soymilk” is misleading under 21 U.S.C. § 343(a) and parallel California statutes because reasonable consumers might think it contains cow’s milk or implies nutritional equivalence to cow’s milk.
3. What legal weight, if any, FDA warning letters have in interpreting FDCA misbranding requirements.

## Decision

- The court granted the motion to dismiss the “soymilk” claims and dismissed them without leave to amend.
- The court held “soymilk” does not violate § 343(g) because a compound name using “milk” does not, by itself, mean the product purports to be standardized dairy milk.
- The court held “soymilk” is not misleading as a matter of law under § 343(a) because no reasonable consumer would think it contains cow’s milk or promises the same nutritional profile.
- The court declined to treat FDA warning letters as controlling or binding interpretations of the FDCA.

## Legal Principles

- Under § 343(g), the question is whether the product purports to be the standardized food; inclusion of a standardized term within a compound product name is not enough when context clearly signals a different product.
- Under § 343(a) and California “reasonable consumer” standards, a label is not actionable when its plain meaning and common usage make the product’s nature clear and do not imply the alleged attributes.
- FDA warning letters are informal, nonfinal agency communications that do not have the force of law and generally do not warrant deference as authoritative statutory or regulatory interpretations.
- Common usage and ordinary consumer understanding may inform whether labeling “purports to be” a standardized food or is likely to mislead.

## Conclusion

The court dismissed the challenge to Trader Joe’s “soymilk” labeling, concluding that the term neither represents the product as standardized dairy milk nor misleads reasonable consumers into believing it contains cow’s milk or has equivalent nutrition, and that FDA warning letters did not control the analysis.


Gitson v. Trader Joe’s Co., No. 13-cv-01333-VC, 2015 WL 9121232 (N.D. Cal. Dec. 1, 2015)