The anti-competitive aspects of the law not only arose because it grandfathered existing drugs and imposed costly new regulatory hurdles to introduction of new drugs, but also because the law defined the term drug in a way that excluded competition. The Food Drug and Cosmetic Act defined the term drug based on intended use, not on therapeutic composition. A drug was not something that was used to cure disease but rather anything intended for such use. Consequently, an orange would become a drug under this definition if it was intended for use in mitigating the effects of a cold. Sell it for its nutritive value and taste, and the law would allow it as a food without requiring FDA pre-approval. Sell it as a way to help lessen the length or severity of a cold, and the FDA would declare it a drug, bar it from sale, and prosecute those who sold it for putting in commerce contraband (an unapproved new drug). In this way, the FDA not only protected big pharmaceutical interests from competition within the drug industry (by erecting a byzantine set of regulatory barriers that imposed enormous costs on anyone who dared seek drug approval), not only by granting synthetic drugs monopoly patent protection, but also granting drug companies with FDA approved drugs a monopoly on therapeutic claims.
