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# FDA Denies Probiotics CFU Petition
- URL: https://www.fdaweb.com/fda-denies-probiotics-cfu-petition/
- Published: 2018-09-07T12:00:00.000Z
- Updated: 2026-09-15T00:30:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142295

FDA has denied, as “not appropriate at this time,” an International Probiotics Association 11/1/16 petition asking the agency to require that the quantitative amount of probiotic ingredients be declared in terms of colony forming units (CFUs). The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-3968-0137&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) notes issuance of a [draft guidance](https://www.fdaweb.com/probiotic-cfu-enforcement-discretion/) explaining FDA’s intent to exercise enforcement discretion with respect to declaration of live microbial quantity in CFUs in addition to the quantitative amount by weight within the Supplemental Facts label of dietary supplements containing live microbials, provided certain conditions are met.

“We agree with many of the assertions set forth in the petition and in comments submitted to the docket in support of the petition,” FDA says, “in particular, those comments regarding the potential benefit to consumers in knowing the quantity of probiotic ingredients in terms of CFUs. However, we are also mindful that researchers are in the process of evaluating other methods and units of measure for live microbial dietary ingredients, such as flow cytometry, and that these alternative methods have the potential to more accurately and more efficiently quantify the number of viable cells in a product at a future time. Therefore, at this point we intend to continue monitoring the development of new technologies and their potential impact on the use of other units of measure on the Supplement Facts label before deciding whether to engage in rulemaking to revise the Supplement Facts regulations.”