The petition (docket number FDA-2016-P-3968) states: “The amendment to the regulations [21 C.F.R. § 101.36] requested here would help ensure that consumers have the most useful, relevant information with respect to the amount of probiotic ingredients in dietary supplements.”
Colony forming units (CFUs) are calculated from probiotic plate counts, a technique that was developed at the start of the 20th Century. Plate counts are still the gold standard for quantifying viable cells.
Currently, the regulations require the labeling of probiotics by weight per serving (usually in milligrams for probiotics) to give consumers the information they need to evaluate how much “effective” ingredient is in a product. While such an approach may work for vitamins, minerals, fatty acids, botanicals and other dietary ingredients, probiotics are very different.
Dr David Keller, VP of Scientific Operations for Ganeden and a member of the IPA Regulatory Affairs Committee Americas, explained: “According to the World Health Organization (WHO), probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Since they are live microorganisms they are very unique from other dietary ingredients.
“While milligrams (mg) is a meaningful unit of measurement for most dietary ingredients, Colony Forming Units (CFU) is the appropriate unit of measurement for probiotics. The number of mgs of a probiotic has no correlation to the number of CFUs. For example, two products could each contain 50mg of a probiotic, but have very different CFU counts. Efficacy of individual strains are based on clinical data specific to that strain, and have historically, and continue to be reported in CFU.
“The goal of this citizen’s petition is to increase transparency in the probiotic market, by labeling products with a meaningful unit of measure. This change will allow all stakeholders to identify the amount of probiotic in each product, and be able to correlate that with what is required for an efficacious amount, as well as accurately compare different product inclusion levels.”
The petition also notes that other government agencies around the world already specifically recommend labeling in CFUs, including Health Canada, the Ministry of Health in Italy, while GRAS notifications and dossiers also state CFUs.
George Paraskevakos, IPA’s executive director, told us: ““We are hoping that the entire probiotic industry comments and supports IPA’s citizens petition. Labelling in CFU is very significant to our sector in every way and the time has come that we address this with all the stakeholders involved in the probiotic market.”
The comment period is open until May 17, 2017.