Section 409 of the Federal Food, Drug, and Cosmetic Act authorizes the establishment of conditions for the safe use of food additives. Conditions may include the maximum quantity of such additive which may be used, or permitted to remain, in or on such food, and any directions, or other labeling requirements, deemed necessary to assure the safe use of the additive.
Many substances that have approved food additive uses also have various non-food uses. The label of these substances must have directions necessary to assure safe use in accordance with the applicable food additive regulation.
Food grade chemicals sold as such and recommended or intended to be used in or on foods, must have labeling that includes directions for safe use, and any specific limitation listed in any regulation governing the use of the chemical as a food additive. If there are no such limitations, the labeling must include information concerning the levels of the chemical that may be used in a manner consistent with good manufacturing practices. Products that do not have such labeling may be deemed misbranded under 403(a)(1) and section 201(n) of the FD&C Act.
Revised: 3/95, 8/96
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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Rockville, MD 20852
All comments should be identified with the title of the guidance.