## Facts

- The FDA promulgated regulations governing vitamin and mineral preparations under the Federal Food, Drug, and Cosmetic Act (FDCA), including rules tied to “foods for special dietary use” and labeling requirements.
- Trade associations and a manufacturer of vitamin/mineral supplements, plus a physician in a parallel petition, sought judicial review to invalidate portions of the regulations.
- The dispute followed extended FDA rulemaking efforts and earlier litigation concerning FDA regulation of vitamin/mineral products.
- In 1976, Congress amended the FDCA to limit FDA authority to restrict the potency of vitamins and minerals in dietary supplements, subject to exceptions for products intended for children under 12, pregnant or lactating women, or where safety concerns justified restrictions.
- Petitioners argued the regulations exceeded FDA authority or conflicted with the FDCA as amended, including by operating as potency limits.
- The FDA maintained the rules were proper consumer-protection measures, especially through labeling and special-dietary-use controls.

## Issues

1. Whether the 1976 FDCA amendments curtailed FDA authority to impose, directly or indirectly, broad potency limits on vitamin and mineral supplements for adults.
2. Whether specific FDA regulations on special dietary use and labeling were within the FDCA’s grant of authority and consistent with Congress’s 1976 policy choice.
3. Whether challenged provisions were unlawful under administrative law review because they conflicted with the statute or exceeded delegated authority.

## Decision

- The court granted the petitions in part and denied them in part.
- The court held that, after the 1976 amendments, FDA could not maintain regulatory provisions that effectively imposed potency ceilings beyond the statute’s limited exceptions.
- The court upheld FDA authority to regulate labeling and certain aspects of foods for special dietary use, so long as those requirements did not function as prohibited potency restrictions.
- The court set aside or required revision of regulatory provisions that conflicted with the amended FDCA, while leaving in place provisions consistent with FDA’s misbranding and labeling authority.

## Legal Principles

- When Congress limits an agency’s regulatory power through statutory amendment, agency rules that conflict with that limitation are invalid, even if the agency invokes general regulatory authority.
- Under the FDCA as amended in 1976, FDA authority to restrict vitamin and mineral potency in dietary supplements is limited to specified contexts (children under 12, pregnant or lactating women, and safety-based restrictions).
- FDA retains authority to require truthful, non-misleading labeling and to regulate products as foods for special dietary use, but it may not use labeling or classification rules as a disguised means of imposing barred potency controls.
- Judicial deference to agency interpretation does not extend to regulations that cannot be reconciled with clear statutory text and congressional policy.

## Conclusion

The Second Circuit enforced Congress’s 1976 decision to curtail FDA’s broad control over vitamin and mineral potency, while preserving FDA’s power to regulate labeling and special-dietary-use aspects that protect consumers without recreating prohibited potency ceilings.


Nat'l Nutritional Foods Ass'n v. Kennedy, 572 F.2d 377 (2d Cir. 1978)