FDA Intends to Allow Alternate Live Microbe Quantity Listing on Supplement Facts Labels

The Food and Drug Administration issued a new draft guidance document announcing the agency’s intent to let dietary supplement manufacturers with live microbial ingredients to list the quantity of those ingredients in “colony forming units” (CFUs) on revised supplement facts labels soon set to take effect. For supplements containing live microbials, such as probiotics, labels may include a declaration of live microbial quantity in CFUs alongside the quantitative amount by weight already required on the labels, provided the weight is listed first, the CFU quantity is listed separately, in clear terms and accurately, and the CFU amount online includes live microbes and not dead or inactive organisms, among other conditions, FDA said. New supplement facts labels are required beginning in 2020 for most manufacturers, and in 2021 for small businesses (see 1805030053). Comments on the draft are due Nov. 6.