## Facts

- Two trade associations representing manufacturers and sellers of protein supplements challenged FDA labeling regulations aimed at products marketed for weight loss and capable of serving as the sole or primary calorie source.
- FDA acted after reports of serious adverse health events, including deaths, associated with very-low-calorie liquid protein diets.
- The regulations required prominent warning statements on covered products to address health risks and prevent misleading impressions about safety.
- FDA issued the regulations under the FDCA’s general misbranding provision, § 403(a), using informal notice-and-comment procedures.
- Plaintiffs contended FDA instead had to proceed under § 403(j) (foods for special dietary use), which—through § 701(e)—would require a formal, on-the-record hearing.
- Plaintiffs also alleged FDA relied on advice from an improperly constituted physician group in violation of the Federal Advisory Committee Act (FACA).
- The district court denied injunctive relief and dismissed the complaint; plaintiffs appealed.

## Issues

1. Whether FDA was required to use FDCA § 403(j) and § 701(e) formal hearing procedures, rather than § 403(a) notice-and-comment rulemaking, to impose warning-label requirements on protein weight-loss products.
2. Whether FDA’s consultation with a group of physicians triggered FACA requirements and, if so, whether any noncompliance invalidated the regulations.
3. Whether plaintiffs were entitled to injunctive or declaratory relief preventing enforcement of the warning-label regulations.

## Decision

- The Second Circuit affirmed the district court’s denial of relief.
- The court held FDA could proceed under § 403(a) and use informal notice-and-comment rulemaking; a formal evidentiary hearing was not required.
- The court rejected the FACA challenge as a basis to set aside the regulations.
- Because FDA acted within statutory authority and employed adequate procedures, injunctive relief was properly denied.

## Legal Principles

- When statutory provisions overlap, an agency may select a reasonable source of authority unless Congress clearly mandates an exclusive procedure for the action taken.
- Formal, trial-type rulemaking procedures are not presumed; they are required only when the governing statute clearly imposes them.
- Warning-label requirements aimed at preventing misleading labeling and addressing health risks can fall within a general misbranding authority.
- FACA does not automatically apply to ad hoc expert consultations; even where procedural flaws are alleged, invalidation of a rule generally requires a showing that the defect materially affected the rulemaking or prejudiced challengers, especially when the rule rests on an independent notice-and-comment record.

## Conclusion

The Second Circuit upheld FDA warning-label regulations for protein-based weight-loss products, concluding FDA permissibly relied on the FDCA’s general misbranding authority and informal rulemaking procedures and that alleged FACA violations did not justify enjoining or vacating the rules.


Nat’l Nutritional Foods Ass’n v. Califano, 603 F.2d 327 (2d Cir. 1979)