FDA Issues Draft Guidance on the Labeling of Dietary Supplements Containing Live Microbials

September 6, 2018

The U.S. Food and Drug Administration today issued draft guidance to advise firms that manufacture, market, or distribute dietary supplements that contain live microbial ingredients of the conditions under which we intend to exercise enforcement discretion to allow firms to declare, in the Supplement Facts label, the quantity of live microbials in colony forming units (CFUs), in addition to the quantitative amount by weight required by regulation.

We believe that CFUs provide a useful description of the quantity of live microbial dietary ingredients. Allowing firms to declare the CFUs within the Supplement Facts label will help consumers more readily identify the amount of living microorganisms for each product and more easily compare products.

The FDA also issued a response to a citizen petition from the International Probiotics Association requesting that we amend 21 CFR 101.36 to allow probiotic ingredients to be labeled by CFUs instead of by weight. FDA denied the request to amend our regulations, in order to allow for further evaluation of methods to enumerate live microbials. In the meantime, we believe that the draft guidance regarding our intent to exercise enforcement discretion will allow consumers and health care professionals to benefit from the declaration of live microbials in CFUs in addition to weight in the Supplement Facts label.

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