New Draft Guidance for Probiotic Labeling Could Yield Inaccurate Product Labels

Washington, D.C., September 20, 2018—In response to the draft guidance “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials,” issued by FDA, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:

Statement by Andrea Wong, Ph.D., vice president, scientific & regulatory affairs, CRN: 

Andrea Wong.jpg“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However, the Draft Guidance states that the label must also list the quantitative amount by weight, as is required by current regulation applicable generally to other dietary supplements,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 A dual listing of ingredient quantity in weight and CFUs, as proposed by the Draft Guidance, presents conflicting product information on the label and puts responsible industry members in an untenable position.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 CRN intends to submit comments on the Draft Guidance and encourages industry members to voice their concerns as well.”

Note to EditorThe Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit Follow us on Twitter @CRN_SupplementsFacebook, and LinkedIn.