## Facts

- A trade association representing frozen food manufacturers challenged FDA regulations governing labeling of certain nonstandardized foods.
- The regulations set “common or usual names” for (1) seafood cocktails and (2) frozen “heat and serve” dinners.
- The rules conditioned use of those product names on meeting specified compositional and labeling/ingredient-disclosure requirements.
- The association argued the FDA exceeded statutory authority by using “common or usual name” regulations as a substitute for formal standards of identity, and also alleged the rules were arbitrary, unsupported by the record, and unconstitutional under the First Amendment.
- The case was decided on cross-motions for summary judgment.

## Issues

1. Whether the FDCA authorizes the FDA to define, by regulation, “common or usual names” for nonstandardized foods and impose related labeling conditions.
2. Whether the regulations were invalid because they effectively created standards of identity without using the FDCA’s more formal procedures applicable to standards of identity.
3. Whether the regulations were arbitrary or capricious under the APA due to inadequate record support.
4. Whether conditioning use of product names on compliance with disclosure and composition-related requirements violated the First Amendment.

## Decision

- The court granted summary judgment for the government and upheld the regulations.
- The court held the FDA acted within its statutory authority to implement the FDCA’s nonstandardized-food labeling requirements, including defining “common or usual names.”
- The court rejected the claim that the rules were de facto standards of identity requiring heightened procedures, concluding they operated as naming and labeling controls for nonstandardized foods.
- The court found the regulations were supported by the administrative record and were not arbitrary or capricious.
- The court held the regulations did not violate the First Amendment because they served the governmental interest in accurate, non-misleading labeling and did not bar truthful communication outside the regulated naming framework.

## Legal Principles

- The FDCA permits the FDA to implement the “common or usual name” requirement for nonstandardized foods through generally applicable regulations adopted under the agency’s rulemaking authority.
- Regulations defining “common or usual names” may include reasonable conditions and disclosures to prevent misleading labeling and consumer deception.
- Naming-and-labeling regulations for nonstandardized foods are distinct from standards of identity; they need not follow the FDCA’s more formal procedures applicable to standards of identity unless they purport to establish such standards.
- Under APA review, food-labeling regulations are sustained when reasonably explained and supported by the administrative record.
- Labeling rules that condition use of particular commercial terms to prevent deception and require factual disclosures are consistent with constitutional limits on regulation of commercial speech.

## Conclusion

The court upheld FDA regulations defining “common or usual names” for certain nonstandardized foods and tying those names to disclosure and compositional conditions, holding the FDA acted within statutory authority, used proper procedures, built adequate record support, and imposed permissible limits aimed at preventing misleading labeling.


Am. Frozen Food Inst. v. Mathews, 413 F. Supp. 548 (D.D.C. 1976)