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New Draft Guidance for Probiotic Labeling Could Yield Inaccurate Product Labels, CRN Says


The U.S. Food and Drug Administration (FDA) recently released a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials” to advise firms that manufacture, market or distribute dietary supplements that contain live microbial ingredients of the conditions under which the FDA intends to exercise enforcement discretion to allow firms to declare in the Supplement Facts label the quantity of live microbials in colony-forming units (CFUs), in addition to the quantitative amount by weight required by regulation.

Non-GMO Project

FDA said it believes that CFUs provide a useful description of the quantity of live microbial dietary ingredients. Allowing firms to declare the CFUs within the Supplement Facts label will help consumers more readily identify the amount of living microorganisms for each product and more easily compare products.

The FDA also issued a response to a citizen petition from the International Probiotics Association requesting that it amend 21 CFR 101.36 to allow probiotic ingredients to be labeled by CFUs instead of by weight. FDA denied the request to amend its regulations in order to allow for further evaluation of methods to enumerate live microbials. In the meantime, the FDA said that the draft guidance regarding the intent to exercise enforcement discretion will allow consumers and health care professionals to benefit from the declaration of live microbials in CFUs in addition to weight in the Supplement Facts label.

In response, Andrea Wong, PhD, vice president, scientific & regulatory affairs for the Council for Responsible Nutrition (CRN) released the following statement:

“CRN commends FDA’s announcement of its 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. We are encouraged by FDA’s receptiveness to collaborate with industry to provide consumers with meaningful label information to inform their purchase decisions.

“However, the Draft Guidance states that the label must also list the quantitative amount by weight, as is required by current regulation applicable generally to other dietary supplements,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. CRN cautions that weight does not correlate with the number of viable microorganisms in a product. Therefore, it is not possible to accurately declare quantity in both weight and CFUs on a consistent basis. 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.”

For more information, visit www.crnusa.org.