Updated: 2005-11-29
BACKGROUND:
Section 409 of the Federal Food, Drug, and Cosmetic Act provides that a substance added to food is unsafe unless the substance conforms to the terms of an exemption for investigational use, or unless the substance is in conformance with a regulation describing the conditions under which the substance may be safely used or unless the substance is generally recognized as safe (GRAS). Although it is impractical to list all substances that are GRAS, FDA has identified numerous substances which, when used for their specified uses and in accordance with good manufacturing practice, are GRAS. See 21 CFR Part 182, 184 and 186. According to 21 CFR 182.1(b), the following good manufacturing practices are applicable to GRAS substances:
Routine FDA investigational work and consumer or trade complaints often reveal that industry does not always observe these good manufacturing practices.
POLICY:
Although a regulation may exist authorizing the use of a GRAS substance, the addition of a GRAS substance to a food may cause that food to be adulterated when it can be established that:
If one or more of the above can be demonstrated, recommend appropriate regulatory action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605).
*Material between asterisks is new or revised.*
Issued: 6/1/86
Revised: 3/95, 8/96, 5/2005