FDA published a final rule on May 27, 2016 (“Food Labeling: Revision of the Nutrition and Supplement Facts Label”) which updated the requirements for Nutrition and Supplement Facts labels.  For more see the Daily Intake blog posts here and here.   In the preamble to the rule (81 FR 33742, 33933), FDA addressed a comment suggesting that the rule should “permit the use of additional units of measure for dietary ingredients to allow for use of more appropriate measure when metric weight is not the most accurate way to express the quantity of the dietary ingredient”.  The comment suggested that Colony Forming Units (CFUs) and enzyme assay units (e.g. HUT, PC, SU, and ALU) would be appropriate for probiotics and enzymes respectively.  FDA declined to make the proposed change, stating “[w]e need to fully evaluate each unit of measure for dietary ingredients to determine if it is appropriate for use on the Supplement Facts label” and to determine whether there would be any other implications.  FDA further indicated that it planned to “issue information related to this subject at a later date.”  FDA subsequently received a citizen petition from the International Probiotics Association requesting that the permitted unit for reporting live microbials be changed from weight to CFUs in the regulation.

In today’s Federal Register, FDA announced the availability of Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.  Having had a chance to consider the issue further, including via the review of submitted comments relating to the International Probiotics Association citizen petition, FDA is announcing its intent to exercise enforcement discretion for the declaration of the quantity of live microbials in CFUs in the Supplement Facts label for dietary supplements under certain conditions.  The conditions are:

• The quantity must first be listed in terms of weight;

• The quantity in CFUs must be “expressed in a manner that is clearly separate and readily distinguishable from the weight”;

• The declaration of quantity in CFUs must be formatted in terms that can clearly be understood by a common reader;

• The declaration of quantity in CFUs is accurate and does not render any other aspects of the remainder of the Supplement Facts label or the remainder of the label false or misleading;

• The declaration of quantity of CFUs only measures live microbials; and

• The product label otherwise complies with all applicable laws and regulations.

FDA determined that, under the conditions listed above, permitting the additional declaration on the Supplement Facts label of CFUs of live microbials would enable consumers to more easily compare dietary supplements and would provide consumers increased confidence that dietary supplement products contain the labeled amount of live microbial ingredients.

FDA is aware that researchers are evaluating methods and units that might be a more efficient or accurate means of quantifying the number of viable cells in a product.  FDA indicates in the draft guidance that it intends to monitor the development of new technologies before deciding to engage in rulemaking to modify the regulation.  However, because companies are in the process of preparing new labels to comply with the Nutrition and Supplement Facts Label Final Rule in advance of the January 1, 2020 (manufacturers with $10 million or more in annual food sales) or January 1, 2021 (manufacturers with less than $10 million in annual food sales) compliance date, FDA intends to exercise enforcement discretion until it decides whether to engage in rulemaking.