Special edition: Pre- and Probiotics

Stakeholders urge FDA to stick to CFUs, dump weight requirement on probiotics labels

By Hank Schultz contact

- Last updated on GMT

Stakeholders urge FDA to stick to CFUs, dump weight requirement on probiotics labels
FDA’s draft guidance on the labeling of products containing live microorganisms is a step in the right direction but does not go far enough, stakeholders say.

To sum up the comments of stakeholders:  Microbial ingredients should be labeled in terms of CFUs, not milligrams, and when ranking multiple strains in a blend by quantity, this should be done on a CFU basis as well.

FDA recently put out a draft guidance for industry on the labeling of products that contain live microorganisms. The goal of the guidance was to deal with the issue of federal requirements that mandate that individual components of a product ought to be specified and ranked by weight. 

Viability is the key, not weight

This makes sense for many ingredients and provides useful information for consumers.  More vitamin C by weight has more activity than a lesser amount, for example.  A greater weight of dietary fiber will provide a correspondingly greater functional effect in the gut, and so forth.

But the issue with probiotics is different.  The question here is what is the potential of these ingredients, not necessarily how much they weigh, and the two do not necessarily always strictly correspond to each other.

For microbial ingredients, the issue is how much of the total consists of viable units, and thus the industry has settled on the standard of counting individual viable cells, or colony forming units (CFUs).  So an ingredient that is specified as 10 billion CFUs is a more significant portion of a whole blend than might be one that is specified as 1 billion CFUs, regardless of what the two ingredients might weigh.

 At the moment, many probiotic products are already labeled in this way, and are, strictly speaking, could be said to not be in compliance with the letter of federal labeling law. FDA signaled in its draft guidance​ a willingness to afford some flexibility on this topic.

But the draft guidance dose not go far enough, in the opinion of groups that have submitted comments to the agency.  While the agency agrees CFUs should appear on the labels, it still says that milligrams should be quoted, too.

Andrea Wong, PhD, chief science officer of the Council for Responsible Nutrition, said the issue is one that has been on the table for a long time.

“This is something that we have been working on for a number of years. Starting back in 2014, we commented on the issue when we submitted comments on FDA’s rule for proposed changes to nutrition labeling,”​ Wong told NutraIngredients-USA.

Giving consumers the most accurate information

CRN filed comments to the federal docket, along with the International Probiotics Association and the Natural Products Association.  In its comments, CRN noted that measuring the total weight would include dead cells along with live ones, and so might misinform the consumer.

“CRN has advocated for the acceptance of CFUs as the unit of measure for live microbials for labeling purposes for several years. We are encouraged by FDA’s willingness to recognize that declaration of live microbial dietary ingredient quantity in CFUs would give consumers the most accurate information about the amount of viable microorganisms present in a product throughout shelf life,”​ CRN commented.

Flexibility inherent in law

IPA noted that it its view, labeling only with CFUs can be interpreted as already complying with the law.  In IPA’s view, federal law speaks of denoting the ‘quantity’ of an ingredient, and does not specify that to mean ‘weight.’ In the case of microbial ingredients, ‘quantity’ is best expressed as CFUs, the organization said. 

IPA also noted that federal law has already signaled some flexibility for labeling, when it said, “It is not possible to specify appropriate ingredients for every other dietary ingredient.”

Expectation of viability

NPA noted that most probiotic manufacturers are using CFUs on their labels.  Using metric weights could actually misinform consumers, the organization argued.

NPA noted that the “reasonable consumer” has an expectation that microbial ingredients in probiotics are alive and that CFUs are widely accepted in the scientific community and are consistent with international accepted definitions of probiotics as live microorganisms.

Wong said that CFUs are the industry accepted standard for quantifying the amount of live microorganisms in a probiotic product.  But new techniques are coming online, and may have to accounted for in future labeling policy revisions.

“Flow cytometry is one method that has been worked on , but it’s not quite ready for prime time,”​ she said.

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