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FDA Shifts To CFU Labeling for Supplements, Still Comes Up Short According to Experts

Category: Educational Articles

In September 2018, the FDA issued a draft guidance on how to label supplements containing live microbials. The announcement presents the organization’s “intent to exercise enforcement discretion to allow supplement companies to use colony forming units (CFUs) when declaring the quantity of live microbials on a Supplement Facts Label.”

 Why the Guidance Was Issued

The new guidance comes in response to a widespread disagreement over the use of the weight of ingredients versus colony forming units (CFUs). The new guidance does allow manufacturers to incorporate CFUs; however, weight must still be included on the label, and listed in order of predominance by mass quantity.

Despite the fact that the FDA believes “CFUs provide a useful description of the quantity of live microbial dietary ingredients,” it rejected a petition from the International Probiotics Association to list ingredients only by CFUs rather than weight. While disappointed that the FDA denied the petition, the IPA still considers the new guidance a victory in promoting the use of CFUs. Although weight, which has proven to be an inaccurate way to measure microbials, will continue to be a requirement, the addition of CFUs in live microbial labeling provides consumers with more information to choose the best product for them.

FDA Will Allow CFU Labeling, But Supplements Must Meet 7 Requirements

 The FDA will permit CFU labeling of microbial dietary ingredients provided the following requirements are met:

  1. The quantity is first listed in terms of weight.
  2. 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.
  3. The declaration of the 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 is a typical measurement of CFUs, and is clearly indicated elsewhere in the Supplement Facts label).
  4. The declaration of quantity in CFUs is accurate and not misleading, does not render misleading other aspects of the Supplement Facts label, or other aspects of the product label.
  5. The declaration of quantity in CFUs measures only live microbial ingredients and does not include inactive, dead, or nonviable organisms.
  6. Live microbial dietary ingredients in a proprietary blend are listed in descending order of predominance by weight; and
  7. The product label otherwise complies with all applicable laws and regulations.

 Scientists Prefer CFUs to Measure Live Microbials

CFUs are the scientifically accepted unit of measurement for probiotics. Rather than painstakingly counting every cell individually under a microscope, scientists dilute a sample of microbes and spread it across a Petri plate, allowing them to count groups of microbes, called colonies, with the naked eye. However, each CFU doesn’t necessarily correspond to a single microbe. But if the cells stick together in lumps or chains, the CFU instead refers to these groupings. Each colony is assumed to have grown from a single colony-forming unit, or CFU.

 CRN Commends Guidance but Has Reservations

Another group advocating for CFU usage is the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry. While the news of the draft guidance was indeed hopeful, they worry it doesn’t go far enough. Like the IPA, CRN’s main concern is that weight, which must still be included in labeling, isn’t an accurate measurement for determining live microbial counts in products.

CRN thinks the FDA is heading in the right direction but cautions that a “dual listing of ingredient quantity in weight and CFUs presents conflicting product labeling information and puts responsible industry members in an untenable position.”

Why This Matters to Supplement Companies

 At present, the FDA is garnering much feedback on their draft guidance, opinions which may alter their current stance that weight must be included in supplement labeling. Deerland Probiotics & Enzymes wants to ensure that the industry stays abreast of regulatory changes. By subscribing to our blog, Digestible, you can remain current with market trends and regulatory developments that affect how the supplements you sell must be labeled, and the best way to communicate any changes with your customers.

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About The Expert
Hope Hanley
Vice President of Quality & Regulatory Affairs, Deerland Enzymes & Probiotics

Hope has more than 10 years of experience as VP of Quality and Regulatory Affairs with Deerland Probiotics & Enzymes.

Hope Hanley

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