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GUIDANCE DOCUMENT

Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements January 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0542
Issued by:
Guidance Issuing Office
Human Foods Program

We are issuing this guidance for two purposes.  The first purpose of the guidance is to remind manufacturers and distributors of conventional foods about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding substances added to conventional foods, including beverages.  “Substance” is defined in FDA’s food additive regulations to include foods and food components consisting of one or more ingredients (21 CFR 170.3(g)).  Thus, a “substance” for purposes of the regulations and this guidance may be a food (e.g., an apple) that can be eaten on its own as well as used as an ingredient in other foods, or it may be a food that is used only as a component of other foods (e.g., flour).  A second purpose of the guidance is to remind dietary supplement manufacturers and distributors that the same requirements apply to certain substances that are added to dietary supplements -- namely, those that are not dietary ingredients as defined in section 201(ff)(1) of the FD&C Act (21 U.S.C. § 321(ff)(1)).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word “should” in Agency guidance means that something is suggested or recommended, but not required.

In this guidance, “we” refers to FDA and “you” refers to manufacturers and distributors of foods, including beverages and, where applicable, dietary supplements (see Section III.B).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0542.

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