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# Probiotic CFU Enforcement Discretion
- URL: https://www.fdaweb.com/probiotic-cfu-enforcement-discretion/
- Published: 2018-09-06T12:00:00.000Z
- Updated: 2026-09-15T00:30:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142277

FDA has issued a draft guidance, *Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials*, to advise firms that manufacture, market, or distribute dietary supplements of the agency’s intent to exercise enforcement discretion about the declaration of live microbial quantity in colony forming units (CFUs) in addition to the quantitative amount by weight declaration required by regulation in the Supplemental Facts label if certain conditions are met. The [document](https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM619529.pdf?ref=fdaweb.com) says that many supplements marketed as probiotics include claims that the live microbial ingredient, formulated in adequate amounts, will confer a health benefit on consumers. It says that a CFU is a measurement of viable microbial cells that are capable of replicating on agar plates and forming colonies that are counted. Existing law permits dietary supplements to contain information about the quantitative amount of live microbial ingredients in CFUs in areas of the supplement label outside of the Supplement Facts label. Within the Supplement Facts label itself, however, those ingredients can be quantified only by weight.

FDA says that CFUs is the most widely recognized measure of live microbials used by FDA and foreign governmental organizations. It says that allowing firms to declare live microbial quantity in terms of CFUs would permit consumers to more readily identify the amount of viable microorganisms for each product and more easily compare products without searching through various parts of the product label.