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Although an article may be recognized as a food, this does not preclude it from being regulated as a drug. The determination that an article is properly regulated as a drug, however, is not left to the commissioner's unbridled discretion to act to protect the public health but must be in accordance with the statutory definition. Toxicity is not included as an element in the statutory definition of a drug. It is relevant as a factor supporting the commissioner's classification under § 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.S. § 321(g)(1)(B), but only to the extent that it constitutes objective evidence of therapeutic intent.
Plaintiffs, producers and vendors of vitamin preparations, sought relief against regulations promulgated by defendant, Commissioner of the Food and Drug Administration, who classified preparations of Vitamins A and D in excess of 10,000 IU (international units) per dosage unit and 400 IU per dosage unit, respectively, as "drugs" under § 201(g)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(g)(1), and which restricted them to prescription sale under § 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1). 21 C.F.R. §§ 250.109 and 250.110 (1976). The district court upheld the regulations as not "arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law" under the standard of review prescribed by 5 U.S.C. § 706(2)(A). The plaintiffs sought review of the judgment.
Were the regulations in question arbitrary, capricious, and not in accordance with law?
The court reversed the decision dismissing plaintiffs’ action, holding that defendant Commissioner of the Food and Drug Administration singled out for drug classification items included in the United States Pharmacopoeia (USP) and National Formulary (NF) on the basis of factors, such as toxicity in this case, that were not relevant to the statutory criteria. The court noted that the defendant determined that plaintiffs indicated an intended therapeutic use for the vitamins. However, there was no evidence that plaintiffs represented that these products were effective in the cure or treatment of disease. They were sold as dietary supplements. In adopting these regulations, defendant did not cite the USP and NF; therefore, defendant was not entitled to rely upon them on appeal as the basis for his drug classification because it was sheer post hoc rationalization. The court thus remanded the case with directions to enter an order granting summary judgment in plaintiffs' favor declaring the regulations enacted by defendant, Commissioner of the Food and Drug Administration, invalid as arbitrary and capricious and not in accordance with law.