What Statutory Definitions Might Apply?
To understand how the Act or the PHS Act might apply to CAM products, we begin by understanding the Act’s statutory definitions or, in the case of the PHS Act, our authority regarding biological products. • “Drug” and “New Drug” Section 201(g)(1) of the Act (21 U.S.C. 321(g)(1)) defines the term “drug,” in relevant part, to mean: (A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). Section 201(p) of the Act (21 U.S.C. 321(p)) defines the term “new drug” to mean: (1) Any drug (except a new animal drug or
