Small Firms Get Year Reprieve From Compliance With US FDA’s Supplement Facts Label Changes
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.
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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.
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amount of live microbial ingredients in the Supplement Facts label by CFUs in addition to weight," according to draft guidance.
FDA’s final rule updating Nutrition Facts labels will have a far-reaching impact on products beyond labeling. The requirements also will change nutrient daily values, potentially affecting product claims and the way in which consumers perceive products, say food consultants during an FDLI webinar.