U.S. FDA Issues Draft Guidance on Labeling Policy for Supplements Containing Live Microbials

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September 26, 2018Patricia IscaroBlog

On 7 September 2018 the U.S. Food and Drug Administration (FDA) announced the availability of a guidance for industry entitled "Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials" (Guidance). Comments will be accepted until 6 November 2018.

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The focus of the draft Guidance is on live microbial dietary ingredients in dietary supplements. The goal of the Guidance is to advise manufacturers, marketers or distributors of dietary supplements on FDA's intent to exercise enforcement discretion in cases where a company decides to include the live microbial quantity in colony forming units (CFUs), in addition to the quantitative amount by weight declaration which is required by regulation, within the Supplement Facts label on dietary supplements containing live microbials.

According to the FDA's 2016 draft guidance entitled "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Draft Guidance for Industry," a live microbial is a single-celled prokaryotic or eukaryotic microorganism that is intended to be viable at the point of ingestion. Many dietary supplements that are described as “probiotics” contain live microbial ingredients. According to the Federal Food, Drug, and Cosmetic Act (FD&C Act) or the Public Health Service Act (PHSA), "probiotics" are not defined as a regulatory product category, and products that may be considered to be “probiotics” may be foods, drugs, and/or biologics under the FD&C Act and/or PHSA.


A dietary supplement is considered misbranded under the FD&C Act if the presentation of the nutrition information does not include the quantity of each dietary ingredient (or of a proprietary blend of such ingredients) per serving. For additional information on the labeling of dietary supplements, please see the 3E Monitor article "U.S. FDA Finalizes Supplement Facts Label Requirements." The FDA has extended compliance dates for the Supplement Facts label to January 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply (until 1 January 2021).

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Although FDA's draft guidance documents are recommendations and do not establish legally enforceable responsibilities, the guidance is geared to help manufacturers, marketers and distributors of dietary supplements to label their products properly. These parties as well as interested stakeholders may submit comments electronically until 6 November 2018. Written comments may be submitted to the Dockets Management Staff (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. FDA's draft guidance documents do not establish legally enforceable responsibilities but rather FDA recommendations.