National Nutritional Foods Ass'n v. Mathews
557 F.2d 325 (1977)
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Rule of Law:
The Food and Drug Administration (FDA) cannot classify a substance as a "drug" under the Federal Food, Drug and Cosmetic Act based solely on its potential for toxicity or evidence of consumer use for therapeutic purposes. The classification must be based on objective evidence of the vendor's intent to market the product for the diagnosis, cure, mitigation, treatment, or prevention of disease.
Facts:
- The Food and Drug Administration (FDA) promulgated regulations classifying Vitamin A preparations over 10,000 IU and Vitamin D preparations over 400 IU as 'drugs'.
- These regulations restricted the sale of these high-potency vitamins to prescription only.
- The FDA's rationale for the classification included the products' lack of nutritional usefulness at these levels, their potential for toxicity, and widespread promotion and use by the public for therapeutic purposes.
- National Nutritional Foods Association and other vendors (plaintiffs) market and label these high-potency vitamins as 'dietary supplements'.
- There was no evidence in the administrative record that the manufacturers or vendors themselves promoted the products for therapeutic uses through labeling, advertising, or other materials.
- The evidence of therapeutic promotion relied upon by the FDA came from medical and popular literature, as well as from comments submitted by consumers, none of which were attributed to the vendors.
- Vitamins A and D are listed in the official United States Pharmacopoeia (USP) and National Formulary (NF), which are compendia of drugs.
Procedural Posture:
- National Nutritional Foods Association and other producers sued the FDA in the U.S. District Court for the Southern District of New York, seeking to invalidate new regulations.
- The district court denied the plaintiffs' motion for a preliminary injunction.
- The plaintiffs (as appellants) appealed the denial to the U.S. Court of Appeals for the Second Circuit, which affirmed the district court's decision.
- The case returned to the district court, which then dismissed the complaint on the merits, upholding the regulations.
- The plaintiffs (as appellants) appealed the dismissal to the U.S. Court of Appeals for the Second Circuit.
- The Court of Appeals remanded the case to the district court for a hearing on the rationality of the FDA Commissioner's decision.
- On remand, the district court again upheld the regulations and dismissed the action.
- The plaintiffs (as appellants) appealed that dismissal to the U.S. Court of Appeals for the Second Circuit, which is the subject of the present opinion.
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Issue:
Does the FDA act arbitrarily and capriciously, and not in accordance with law, when it classifies high-potency Vitamin A and D preparations as 'drugs' based on their potential for toxicity and widespread consumer therapeutic use, rather than on evidence of the vendors' intended therapeutic purpose?
Opinions:
Majority - Robert P. Anderson, Circuit Judge
Yes, the FDA's regulations are arbitrary and capricious and not in accordance with law. The statutory definition of a 'drug' under § 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act hinges on the vendor's intended use of the article for therapeutic purposes. The court reasoned that this intent must be determined from objective evidence, such as the vendor's own labeling, advertising, and promotional materials. The FDA improperly relied on factors like potential toxicity, lack of nutritional value, and third-party or consumer use for therapeutic purposes, which do not establish the vendor's intent. Furthermore, mere inclusion of a substance in the United States Pharmacopoeia (USP) or National Formulary (NF) under § 201(g)(1)(A) is insufficient to classify it as a drug, as this would grant the FDA overly broad power to regulate common items like salt and olive oil, which are also listed. Because the FDA failed to provide evidence of the vendors' therapeutic intent and relied on irrelevant factors, its classification was contrary to the statute and must be invalidated.
Analysis:
This decision significantly curtails the FDA's authority to regulate dietary supplements as drugs. It solidifies the 'intended use' doctrine, clarifying that the focus must be on the manufacturer's or vendor's objective claims, not on consumer behavior or a product's inherent properties like toxicity. This ruling created a higher bar for the FDA to reclassify supplements, thereby protecting the supplement industry from drug-level regulation unless they make explicit disease-related claims. The case reinforces the principle that an administrative agency's actions must be strictly grounded in statutory definitions and cannot be justified by general public health concerns that fall outside that legal framework.
