In a new comment letter to FDA, AGA commends FDA’s recent draft guidance — “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials” — clarifying the expectations of probiotics manufacturers who choose to specify the amount of a live microbial component in their product in colony forming units (CFUs).
Though manufacturers are not currently required to report CFUs, AGA feels strongly that all manufacturers of probiotic supplements should voluntarily report the composition of live microbials in their products as CFUs.
However, reporting CFUs alone provides insufficient information to consumers and health care professionals who may recommend probiotic supplements to their patients. In our comment letter, AGA encourages FDA to expand what information manufacturers are required to include. In addition to the conditions already outlined in FDA’s draft guidance, AGA recommends including the conditions of storage as well as an expiration or “use by” date.
We acknowledge that researchers are evaluating other methods and units of measure besides CFUs for not only live microbials but also microbial bioactivity. However, in the absence of a widely-accepted alternative, which may take several years to develop and adopt, AGA strongly encourages FDA and manufacturers to take the small step forward of using CFUs now rather than waiting for another solution to emerge.
Probiotics have been an important focus for the AGA Center for Gut Microbiome Research and Education due to the need for evidence-based guidance for health care providers and their patients. The center will continue to work to educate physicians, patients and industry on best practices to ensure safe use of probiotics.