## Facts

- The Federal Food, Drug, and Cosmetic Act (FDCA) deems a food “misbranded” if it is an “imitation” of another food unless the label prominently states “imitation” followed by the name of the food imitated.
- The FDCA did not define “imitation,” and prior case law discussed multiple possible characteristics (e.g., resemblance and marketing features) without a fixed regulatory definition.
- After notice-and-comment rulemaking, the FDA issued a regulation defining an “imitation food” as one that (1) is a substitute for and resembles another food and (2) is nutritionally inferior to that food.
- The regulation defined “nutritionally inferior” by measurable reductions in specified essential nutrients (including protein and listed vitamins/minerals) meeting a set threshold tied to the Required Daily Allowance.
- Under the regulation, a substitute food that resembles another food but is not nutritionally inferior need not be labeled “imitation,” but must bear a common/usual name or descriptive term.
- The Federation of Homemakers, a consumer organization, sued federal officials to enjoin enforcement of the regulation, arguing it conflicted with the FDCA and was arbitrary and capricious.
- The district court upheld the regulation on summary judgment, and the Federation appealed.

## Issues

1. Whether the FDA’s nutrient-based definition of “imitation” is consistent with FDCA § 403(c) and congressional intent despite the statute’s lack of a definition and prior judicial statements favoring ordinary English usage.
2. Whether the regulation is arbitrary and capricious under administrative law principles because it ties “imitation” labeling to nutritional inferiority rather than broader similarity factors.

## Decision

- The D.C. Circuit affirmed the district court’s judgment and upheld the regulation.
- The court held the regulation was consistent with the FDCA’s objectives and a reasonable exercise of the FDA’s regulatory authority.
- The court rejected the claim that prior judicial discussions of “imitation” foreclosed the FDA from adopting an administrable definition through rulemaking.
- The court found the FDA’s use of a nutritional-inferiority threshold to trigger “imitation” labeling was rational and not arbitrary and capricious.

## Legal Principles

- When Congress leaves a statutory term undefined, an agency may supply a reasonable definition by regulation so long as it fits the statute’s purposes and remains within delegated authority.
- FDCA § 403(c) permits the FDA to define “imitation” in a way that emphasizes consumer protection and avoids misleading labeling; “imitation” need not turn solely on lay impressions of resemblance.
- A regulation adopted through notice-and-comment that uses objective, measurable criteria (here, nutritional inferiority) to implement a misbranding provision is likely to survive arbitrary-and-capricious review if the agency’s choice is rational and explained.
- Foods that resemble and substitute for another food but are not nutritionally inferior may be marketed without the “imitation” label if labeled accurately with an appropriate common/usual name or descriptive term.

## Conclusion

The court sustained the FDA’s regulatory choice to require “imitation” labeling only for substitute foods that resemble another food and are nutritionally inferior, concluding the rule reasonably implemented the FDCA’s misbranding prohibition and was not arbitrary and capricious.


Fed’n of Homemakers v. Schmidt, 539 F.2d 740 (D.C. Cir. 1976)