LawFlash

FDA: Probiotic Products Can Use CFUs on Supplement Facts Panel

September 10, 2018

In a draft guidance document, the US Food and Drug Administration stated that in certain cases, it will allow probiotic products to use colony-forming units to quantify live microbial ingredients on the Supplement Facts panel, noting that this measurement tool is useful to consumers.

On September 6, the US Food and Drug Administration (FDA) issued a draft guidance document stating its intention to exercise enforcement discretion for certain probiotic products that declare the quantitative amount of live microbial ingredients on the Supplement Facts panel in terms of colony-forming units (CFUs). The agency states in the draft guidance that CFUs provide a useful description of the quantity of live microbial dietary ingredients, and use of that measurement on the Supplement Facts panel will help consumers identify the amount of living microorganisms in each product and make comparisons across dietary supplement products. Accordingly, while FDA considers whether to conduct rulemaking to formally change the unit of measure, it will allow the use of CFUs in certain cases.

The Draft Guidance

The term “probiotic” is not defined in FDA regulations, but is used to describe dietary supplement products that contain live microbial dietary ingredients. Currently, dietary supplement ingredients can only be quantified by weight on the Supplement Facts panel pursuant to 21 CFR § 101.36(b)(3). However, FDA notes that measuring live microbial dietary ingredients by weight may be inaccurate or confusing to consumers. For example, the weight of a microbial dietary ingredient includes both live and dead microorganisms. Additionally, live microorganisms die over time, and therefore the labeled weight of the microbial ingredient may not reflect its number of live microorganisms throughout the shelf life of the product.

CFUs, which are not a weight measurement, provide a description of the quantity of live microbial dietary ingredients, and according to FDA, “CFU is currently the mostly widely recognized measure of live microbials used by FDA and foreign governmental organizations.” FDA states in the draft guidance that researchers are also evaluating other units of measure for live microbial dietary ingredients that may more accurately and efficiently quantify the number of viable cells.

Until FDA decides whether to engage in rulemaking to amend 21 CFR § 101.36, it intends to allow firms to declare the quantitative amount of live microbial ingredients on the Supplement Facts label by CFUs, 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 on 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.
  • The product label otherwise complies with all applicable laws and regulations.

Takeaways

FDA recognizes that CFU measurements are the more common method used by consumers to assess probiotic products, and so will now allow their use. Current good manufacturing practice documents will be necessary to support the CFU label claims. Manufacturers of probiotics and other dietary supplements should consider submitting comments to FDA to further inform the agency’s view of measuring live microbial ingredients in probiotics, including whether the stated amount is intended to last during the expected shelf life of the product.

FDA is accepting comments on its draft guidance through October 3, 2018.

Contacts

If you have any questions on the issues discussed in this LawFlash, or would like assistance drafting a comment for submission to FDA, please contact either of the following Morgan Lewis lawyers:

Washington, DC
Kathleen Sanzo
Hilary Lewis