FDA Reconsiders Probiotic Labeling

Washington, DC — The Food and Drug Administration (FDA) has issued a draft for new guidance allowing probiotics to be measured in colony forming units (CFUs) on the Supplement Facts Label, although it is neither required nor a replacement for the weight of the probiotics.

A CFU is a bacterium that is living and capable of reproducing in order to form more bacteria like it—in other words, a unit of bacteria which is capable of forming a colony. Integral to the definition of CFU is that the bacteria must be alive, and therefore capable of conferring health benefits onto the person eating it.

Measuring the amount of bacteria in a food in terms of weight, on the other hand, also measures dead or inactive bacteria, which are useless. Therefore, two different brands of yogurt, for instance, could have 50mg of probiotics, but wildly different CFUs.

Andrea Wong, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), released a statement applauding the FDA’s decision and requesting further action.

She points out that “listing the weight of probiotic contents does not provide consumers with useful information for comparing probiotic products and making buying decisions.” Not to mention that “a dual listing of ingredient quantity in weight and CFUs presents conflicting product information.” And, of course, the fact that it is not a requirement to list the CFUs at all lends itself to confusion. Thus, while this is a step in the right direction, it’s not yet the end of the road.

The CRN intends to continue to engage with the FDA on this issue, and to submit comments on the Draft Guidance.

In the official draft guidance, the FDA says that “researchers are currently evaluating other methods and units of measure for live microbial dietary ingredients,” and that these methods might be more accurate and efficient than CFUs. They do not, therefore, intend to change the rules when they might end up changing the rules again in the near future.

Comments must be posted by 11:59 PM Eastern time on Nov. 6.

The guidance can be found here: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm619524.htm

Comments can be submitted here: https://www.regulations.gov/comment?D=FDA-2011-D-0376-2015