Probiotic labeling debate: FDA live microbials draft guidance “misses the mark,” says US supplements trade body 

25 Sep 2018 --- The recently posted US FDA draft guidance on the declaration of live microbial quantity in colony forming units (CFUs) in dietary supplements “misses the mark” and could “yield inaccurate product labels,” according to the Council for Responsible Nutrition (CRN), the US trade association for the dietary supplement and functional food industry. Many dietary supplements that are described as “probiotics” contain live microbial ingredients. The FDA guidance concludes that “consumers would benefit from permitting the label of dietary supplement products to accurately represent the quantity of live microbial dietary ingredients in the Supplement Facts label in terms of CFUs.”

However, CRN notes in a statement on its website that accurately declaring quantity in both weight and CFUs on a consistent basis is not possible. Moreover, listing the weight of probiotic contents does not provide consumers with useful information for comparing probiotic products and making purchasing decisions.

By issuing the guidance, entitled Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials, the FDA is seeking to advise “firms that manufacture, market, or distribute dietary supplements of our intent to exercise enforcement discretion with respect to the declaration of live microbial quantity in colony forming units (CFUs), in addition to the quantitative amount by weight declaration required by regulation, within the Supplement Facts label of dietary supplements containing live microbials, provided that certain conditions are met.”

The guidance documents do not establish legally enforceable responsibilities.

However, the agency body notes that the guidance describes its current thinking on the topic and should be viewed as recommendations.

In response to the draft guidance, which was posted last week, Andrea Wong, Ph.D., Vice President, Scientific & Regulatory Affairs, CRN, comments that the trade association commends FDA’s intent to exercise enforcement discretion to allow supplement companies to use colony forming units (CFUs) when declaring the quantity of live microbials on a Supplement Facts Label.

“CFU is the scientifically accepted unit of measure for probiotics, and labeling live microbial dietary ingredients in CFUs gives consumers the best information possible when it comes to the viable microorganisms present in the product throughout shelf-life,” comments Wong. “We are encouraged by FDA’s receptiveness to collaborate with industry to provide consumers with meaningful label information to inform their purchase decisions.”

However, she notes, the draft guidance states that the label must also list the quantitative amount by weight, as is required by current regulation applicable generally to other dietary supplements, in addition to an expression of CFUs, and still requires listing in order of predominance by weight.

“To that extent, FDA’s guidance missed the mark," she says.

Weight does not correlate with the number of viable microorganisms in a product, and it is therefore not possible to accurately declare quantity in both weight and CFUs on a consistent basis, she puts forward.

“Listing the weight of probiotic contents does not provide consumers with useful information for comparing probiotic products and making buying decisions. A dual listing of ingredient quantity in weight and CFUs, as proposed by the Draft Guidance, presents conflicting product information on the label and puts responsible industry members in an untenable position.”

“CRN has advocated for the acceptance of CFUs as the unit of measure for probiotics over the past several years and will continue to engage with FDA on this important issue. CRN intends to submit comments on the Draft Guidance and encourages industry members to voice their concerns as well,” Wong adds in the statement.

By Lucy Gunn

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