October 20, 2019

October 18, 2019

Subscribe to Latest Legal News and Analysis

Stakeholder Comments Reflect Discontent with FDA’s Draft Guidance for Quantitative Labeling of Supplements Containing Live Microbials

FDA’s regulation on nutrition labeling of dietary supplements requires that dietary ingredients for which a Reference Daily Intake (RDI) or Daily Reference Value (DRV) has not been established must be listed inside the Supplement Facts label along with their quantitative amount by weight per serving in metric units, as described in 21 CFR 101.36(b)(3).  For microbial ingredients in probiotic products, the weight of the cellular mass (which can include dead and injured cells) does not necessarily correlate with the number of viable microorganisms in the product.

In finalizing its May 2016 amendment of the labeling regulations for conventional foods and dietary supplements, FDA declined a request to “permit the use of additional units of measure for dietary ingredients to allow for use of more appropriate units of measure when metric weight is not the most accurate way to express the quantity of the dietary ingredient,” and cited the need for more time to evaluate the matter.  FDA subsequently received a citizen petition from the International Probiotics Association (IPA) requesting that the permitted unit for reporting live microbials be changed from weight to colony forming units (CFUs) in the regulation.

As reported here, FDA’s September 2018 draft guidance (Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials) reflected FDA’s decision to delay acting on IPA’s petition, and announced conditions under which the agency would in the interim exercise enforcement discretion for the declaration of the quantity of live microbials in CFUs in addition to weight.  FDA received 1,958 comments on the draft guidance before the comment period closed on November 6, 2018.  The Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and other stakeholder groups argue that requiring companies to list both the quantitative amount as weight (in mg) and as CFUs will present information on product labels in a way that is potentially misleading and will likely result in consumer confusion.  IPA further asserts that labeling only CFUs complies with the law because the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)) requires labeling to include the quantity of a nutrient but does not prescribe any specific unit of measure.

Since comments on IPA’s petition reflect wide – but not unanimous – industry support for mandatory listing of CFUs for microbial ingredients, and new methods for quantifying live microbes – including flow cytometry – are still in the research phase, we are convinced that FDA will not promulgate a regulation on listing CFUs at this juncture and is also very unlikely to revise its current enforcement policy to drop the requirement for listing the weight of microbial ingredients.

© 2019 Keller and Heckman LLP


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...