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FDA issues guidance on disclosing amount of live microbial ingredients in supplements

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In draft guidance, FDA revealed plans to “exercise enforcement discretion” for companies that chose to declare on the Supplement Facts label the amount of live microbial ingredients based on colony forming units (CFUs), in addition to disclosing the quantitative amount of certain dietary ingredients based on their weight per FDA regulations.

FDA on Thursday recognized the benefits of disclosing on labels the number of live microbials in dietary supplements—an issue of interest to marketers of probiotics.

FDA stopped short of amending its labeling regulations, denying a request filed by the International Probiotics Association (IPA).

However, the agency revealed plans to “exercise enforcement discretion” for companies that chose to declare on the Supplement Facts label the amount of live microbial ingredients based on colony-forming units (CFUs), in addition to disclosing the quantitative amount of certain dietary ingredients based on their weight per FDA regulations.

“We believe that CFUs provide a useful description of the quantity of live microbial dietary ingredients,” FDA explained in a constituent update. “Allowing firms to declare the CFUs within the Supplement Facts label will help consumers more readily identify the amount of living microorganisms for each product and more easily compare products.”

Enforcement discretion

In draft guidance published Sept. 6, 2018, FDA said it intends to exercise its enforcement discretion, provided the following conditions are met:

• The quantity is first listed in terms of weight;

• The declaration of 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.

Benefits of disclosing CFUs

In 2016, IPA requested FDA amend its regulations to require that supplement labels disclose the amount of probiotic ingredients based on CFUs rather than by weight. The request was tied to the definition of probiotics per the World Health Organization (WHO): “Live microorganisms which when administered in adequate amounts confer a health benefit on the host.”

In its citizen petition, IPA explained, “Information about the weight of probiotics in a dietary supplement is irrelevant with respect to determining the amount of live, active organisms in the product.” The ingredient’s weight “does not indicate viability at all,” the petition continued. “Due to various cell concentrations of the probiotics, the same number of milligrams could represent very different CFU counts. Hence, declaring probiotic ingredients by weight does not provide consumers with relevant information on the amount of effective ingredient they are consuming in a dietary supplement.”

FDA acknowledged the myriad benefits of declaring on the Supplement Facts label live microbial quantity based on CFUs. Doing so, FDA said in the draft guidance, “would promote confidence that a particular dietary supplement product contains the labeled amount of live microbial ingredient, providing the specified number of viable microorganisms throughout the shelf life of the product.”

Nonetheless, FDA revealed plans 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.”

So that comments on the draft guidance are considered before the agency works on a final document, FDA advised interested parties to comment within 60 days of publication in the Federal Register. While FDA publicly released the draft guidance today, it is not scheduled to be published until Friday, Sept. 7.

IPA Responds

George Paraskevakos, executive director of IPA, suggested that FDA’s action would benefit industry and consumers by “allowing for the communication of useful and important information for probiotic supplements.”

“This ties the published science and research to the most used and internationally recognized measure for probiotics that is CFUs,” he said in an email to Natural Products INSIDER.

Despite FDA denying IPA’s petition, Paraskevakos considered the outcome a “victory.”

He recognized instances in which companies disclose probiotics based on milligrams. Disclosing CFUs, as well as the weight of ingredients, on the Supplement Facts label “now allows for the accurate reporting of the majority of probiotic supplements in the market,” he noted.

Concluded Paraskevakos: “That being said, we also know there are new techniques and methods currently being researched for probiotic counts, which will bring on a new discussion regarding future amendments and regulation changes on how to count these friendly and beneficial bacteria.”


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