## Facts

- The FDA issued regulations classifying vitamin A products exceeding 10,000 IU per dosage unit and vitamin D products exceeding 400 IU per dosage unit as “drugs” and limiting them to prescription-only distribution.
- The regulations relied on findings that high-dose vitamins A and D were commonly used for therapeutic purposes, could be toxic at those levels, and lacked additional nutritional value at such doses.
- A trade association of vitamin producers and a manufacturer sued federal health and FDA officials seeking declaratory and injunctive relief to invalidate the regulations.
- The district court initially denied preliminary relief; later it upheld the regulations under the APA.
- On an earlier appeal, the court of appeals ordered further proceedings akin to an Overton Park–style inquiry to clarify the agency’s reasoning.
- After additional proceedings and record development on remand, the district court again upheld the regulations; plaintiffs appealed.

## Issues

1. Whether the FDA’s classification of high-dose vitamins A and D as “drugs” and restriction to prescription-only status was arbitrary or capricious under the APA.
2. Whether the FDA reasonably determined that these high-dose vitamin products fell within the FDCA definition of “drug” based on intended use and effects.
3. Whether the FDA had an adequate evidentiary basis to require prescription dispensing for these products due to toxicity and the need for medical supervision.

## Decision

- The court of appeals affirmed the judgment upholding the regulations.
- Applying APA review, the court held the agency considered relevant factors and articulated a rational basis supported by the administrative record as clarified on remand.
- The court upheld the FDA’s determination that high-dose vitamins A and D qualified as “drugs” because their dosage levels and marketing/consumer use showed therapeutic intent and physiological effects beyond ordinary nutrition.
- The court upheld prescription-only status because the record supported findings of potential toxicity, cumulative risk, and the need for physician supervision.
- The court rejected claims that different treatment of other vitamins (such as vitamin C) rendered the regulations invalid, finding differing toxicity and risk profiles could justify different regulatory choices.

## Legal Principles

- Under APA § 706(2)(A), a court performs a searching review of the record to ensure reasoned decision-making but may not substitute its policy judgment for the agency’s.
- Under the FDCA, “drug” status turns substantially on intended use and claimed or demonstrated effects, not solely on whether a product is commonly described as a food or supplement.
- Under the FDCA prescription provisions, a product may be limited to prescription distribution when toxicity or potential harmful effects make it unsafe for self-administration without practitioner supervision.
- When scientific evidence is complex or disputed, an agency’s technical judgments are upheld if the record shows consideration of relevant factors and a rational connection between evidence and decision.

## Conclusion

The court sustained FDA regulations treating high-dose vitamins A and D as prescription drugs, holding that the agency’s determinations regarding intended therapeutic use, toxicity, and the need for medical supervision were adequately explained and supported by the administrative record and therefore not arbitrary or capricious under the APA.


Nat’l Nutritional Foods Ass’n v. Mathews, 557 F.2d 325 (2d Cir. 1977)