FDA OK With Probiotic Weight CFUs In Supplement Facts Labels, For Now
This article was originally published in The Rose Sheet
Until CFSAN decides whether to engage in a rulemaking to amend FDA's supplement labeling regulation, it intends "to exercise enforcement discretion for those firms that choose to declare the quantitative amount of live microbial ingredients in the Supplement Facts label by CFUs in addition to weight," according to draft guidance.
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FDA has heard from some manufacturers that additional time is needed to meet all of the requirements, “especially during the COVID-19 pandemic.” Prior to the pandemic, agency announced enforcement discretion during 2020 for compliance by firms with more than $10m in annual sales.
Council for Responsible Nutrition, Consumer Healthcare Products Association and Natural Products Association urge FDA to allow colony forming units on probiotic product labels while nixing current labeling regulation’s allowance of metric weight, as the measurement does not reflect live microbials.
FDA's regulatory pathway "for development of probiotic drugs is reasonably clear. But the road to develop probiotic foods, supplements or microbiome-based dietary strategies to compensate for deficient microbiota is less so," says the International Scientific Association for Probiotics and Prebiotics. FDA's Center for Biologics Evaluation and Research is conducting Sept. 17 workshop to exchange information with the scientific community about the clinical, manufacturing and regulatory considerations associated with live microbiome-based products administered to treat a disease.