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GUIDANCE DOCUMENT

Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages January 2014

Final
Docket Number:
FDA-2009-D-0542
Issued by:
Guidance Issuing Office
Office of Dietary Supplement Programs

We are issuing this guidance to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage. This guidance describes the factors that distinguish liquid products that are dietary supplements from those that are conventional foods.  Further, this guidance reminds manufacturers and distributors of dietary supplements and beverages about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding their respective ingredients and labeling.

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 dietary supplements and beverages.

Download the Guidance


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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