Drug-use Guidance...

Substances Generally Recognized as Safe

The FDA has published in the Code of Federal Regulations (Title 21, Parts 182 and Part 582) an exceptionally long list of substances that are generally recognized as safe (GRAS) for their specific uses. For example: FDA regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use. As additional conditions for use of such substances, the FDA considers these to be GRAS substances only if they are made and used in accordance with good manufacturing or feeding practice, respectively.

Although this specific section (of the Code of Federal Regulations) refers to “substances” as opposed to “drugs,” any one of these listed GRAS substances could be defined (by CVM) as a drug based on the intended use of the substance. If the intended use of the substance is other than that listed in 21 CFR 182 or 21 CFR 582, it is no longer GRAS, and if it were to be used in a manner consistent with FDA’s definition of a drug, it would then be considered an unapproved drug and illegal to use. For example: eugenol, the primary ingredient of clove oil, is considered to be GRAS when used as a flavoring substance and adjuvant (21 CFR 582.60). However, clove oil, when used as an aesthetic on fish, is an unapproved drug and illegal to use.

A complete listing of all substances defined as GRAS by FDA can be found in both 21 CFR 182 and 21 CFR 582. The Code of Federal Regulations can be found and accessed at:

http://www.gpoaccess.gov/cfr/index.html