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GUIDANCE DOCUMENT

Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials September 2018

Draft

Not for implementation. Contains non-binding recommendations.

Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials

Docket Number:
FDA-2011-D-0376
Issued by:
Guidance Issuing Office
Office of Dietary Supplement Programs

The purpose of this guidance is to advise firms that manufacture, market, or distribute dietary supplements of our intent to exercise enforcement discretion with respect to the declaration of live microbial quantity in colony forming units (CFUs), in addition to the quantitative amount by weight declaration required by regulation, within the Supplement Facts label of dietary supplements containing live microbials, provided that certain conditions are met.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our 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 FDA guidances means that something is suggested or recommended, but not required.  

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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:

Division of Dockets Management (HFA- 305)
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-2011-D-0376.