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:

• The quantity of the substance added to food must not exceed the amount reasonably required to accomplish the intended technical effect.
• Any substance intended for use in or as food must be of appropriate food grade and must be prepared and handled as a food ingredient.

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:

• The substance is not of a quality consistent with its use as food for human consumption, or
• The substance is not used in accordance with the principles of good manufacturing practices, i.e. is added in amounts in excess of that which is necessary to accomplish the effect for which the use of the substance is GRAS, or
• Where there are "specific limitations," the substance is not used for the specified technical effect or is used in excess of the "specific limitations" for which the use of the substance is GRAS.

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, 5/05
Updated: 11/29/05