Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials


How to Comment

Submit either electronic or written comments on the draft guidance by November 6, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Submit Comments Online
Submit electronic comments on to docket folder FDA-2011-D-0376.

Submit Written Comments
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2011-D-0376.

Contains Nonbinding Recommendations 

Draft– Not for Implementation

This guidance is being distributed for comment purposes only.

September 2018

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.  

Download the Draft Guidance 

Page Last Updated: 09/15/2018
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