ABSTRACT
In pertinent part, section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FDC Act), 21 U.S.C. § 321(g)(1), states:
The term “drug” means… (B) articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease…; and (C) articles (other than food) intended to affect the structure or any
function of the body….
