On September 6, the FDA submitted for comment a Draft Guidance entitled, “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials: Guidance for Industry.” The document addresses how to list the quantity of probiotic ingredients on dietary supplement product labels. Current FDA regulations require listing dietary ingredients, including probiotics, by metric weight such as milligrams.
The World Health Organization (WHO) has established a definition of probiotics as, “live microorganisms which, when consumed in adequate amounts, confer a health benefit on the host.” The FDA defines a live microbial as, “a single-celled prokaryotic or eukaryotic microorganism that is intended to be viable at the point of ingestion.” Measuring in milligrams does not differentiate between viable and non-viable cells. Therefore, it does not provide any indication of therapeutic efficacy or strength of the probiotic ingredient(s).
The International Probiotics Association (IPA) attempted to reconcile this issue in January 2016 by submitting a Citizen Petition asking the FDA to amend the existing regulation to require listing the quantitative number of probiotics in dietary supplements on product labels as Colony Forming Units (CFU) instead of milligrams. The petition cited CFUs as the best available metric for indicating the number of viable cells. The IPA pointed out that the FDA had previously allowed CFUs as a measurement metric for various New Dietary Ingredient (NDI) notifications as well as for applications for Generally Regarded as Safe (GRAS) designations. Also, other countries such as Italy and Canada utilize CFUs as the measure of probiotic ingredients on supplement labels.
The FDA produced the Draft Guidance to provide bioth the current regulatory standing on the subject and serve as a response to IPA’s Citizen Petition. The Guidance stops short of mandating CFUs on labels but does allow firms to declare, in the Supplement Facts label of products containing probiotics, the number of live microbials in CFUs, provided they meet the following conditions:
- The quantity is first listed in terms of weight;
- The quantity in CFUs is expressed in a manner that is clearly separate and readily distinguishable from the weight, e.g., as a parenthetical or in a subset line;
- The declaration of quantity in CFUs is formatted in clear terms that can easily be understood by a common reader, e.g., 10 billion or 300* (where the unit that “*” is intended to represent, such as million or billion, is a typical measurement of CFUs and is clearly indicated elsewhere in the Supplement Facts label);
- The declaration of quantity in CFUs is accurate and not misleading, and does not render misleading other aspects of the Supplement Facts label, or other aspects of the product label;
- The declaration of quantity in CFUs measures only live microbial ingredients and does not include inactive, dead, or nonviable organisms;
- Live microbial dietary ingredients in a proprietary blend are listed in descending order of predominance by weight; and
- The product label otherwise complies with all applicable laws and regulations.
- According to the Draft Guidance, “While (the FDA) currently believes that CFUs provide a useful description of the quantity of live microbial dietary ingredients, we are aware that researchers are currently evaluating other methods and units of measure for live microbial dietary ingredients and that such alternative methods have the potential to more accurately and more efficiently quantify the number of viable cells in a product at a future time. Therefore, at this time, we intend to continue monitoring the development of new technologies and their potential impact on the use of other units of measure on the Supplement Facts label before deciding whether to engage in rulemaking to revise the Supplement Facts regulations.”
The FDA accepted comments on the Draft Guidance until November 6th and is expected to issue a Final Guidance in the near future.
To view the Guidance Document Click Here