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Special edition: Pre & Probiotics

Effort underway to better fit probiotics into regulatory structure

By Hank Schultz

21-Nov-2016
Last updated on 21-Nov-2016 at 17:35 GMT2016-11-21T17:35:30Z

©  iStock / Jezperklauzen
© iStock / Jezperklauzen

Regulatory definitions remain hazy for probiotics and prebiotics, but efforts are underway to further nail down where these ingredients fit within the overall structure that governs dietary supplements.

Regulatory questions occupied a significant portion of the recent Pre & Probiotics Forum hosted last week by NutraIngredients-USA. The online form was broadcast last week and can be heard on demand by clicking here .

What is a healthy gut?

Underlying this regulatory vagueness is the notion that for gut health ingredients generally there is not firm footing to point to for what companies ought to be shooting for in terms of health benefits.  Unlike cardiovascular health, where there are good biomarkers such as blood pressure or blood lipid levels, or even immune health where frequency of upper respiratory infections might act as a guide, there are currently no accepted biomarkers for gut health and no definition of what a healthy gut ought to look like. For a healthy gut, the situation roughly akin to questions of pornography and the First Amendment, when the late Supreme Court justice Potter Stewart famously wrote in a 1964 opinion that he couldn’t define obscenity but said “I know it when I see it.” 

Ivan Wasserman is an attorney who manages the Washington, DC office of the law firm Amin, Talati Upadhye.  Wasserman, who is also the counsel for the International Probiotics Association, was a participant on the panel as were George Paraskevakos, IPA executive director and Silvano Arnoldo, a probiotics industry consultant who has done a lot of work with Jarrow Formulas.

There is no real regulatory definition of probiotics, Wassermand said. Lacking a precise definition, these ingredients fall under the aegis of existing legislation, which is some ways is ill equipped to deal with these singular ingredients, Wasserman said. One conundrum in particular is the way in which these ingredients are called out on the label. 

“It’s fascinating to me what a big role that gut microbiome plays in our overall health. And with probiotics in particular are such a unique category of ingredients.  I mean, they’re not part of a rock, like calcium.  It’s a category of living microorganisms that are incredibly complex, but there are no unique regulations that apply to these unique ingredients.  The regulations that apply to vitamin C also apply these organisms and to the organism-feeding ingredients that are the probiotics,” Wasserman said.

Labeling confusion

Ivan Wasserman, Amin Talati & Upadhye, LLP

These regulations stumble when it comes to label callouts.  Dietary supplement labeling regulations use milligrams as the base measure, and while this requirement applies in principle to the labeling of probiotics, few companies comply with the letter of this law for a simple reason:  It makes no sense.

“The same regulations that apply to vitamin C also apply to these organisms and the organism-feeding ingredients that are the prebiotics. Because there are no special rules, the one rule applies that says all ingredients have to declared in milligrams.  This doesn’t make sense in the case of live organisms because dead organisms weigh something but if they confer no benefit they should not be included,” Wasserman said.

Wasserman and Paraskevakos noted that the vast majority of scientific studies on probiotic ingredients have for years used the measure of CFUs—or colony forming units—as the measure of how much probiotic ‘stuff’ they are dealing with.  Therefore it makes sense that callouts on labels ought to match what the science says.  At the moment, the only validated way of determining how many little beasties you have in your product is by plating them up and physically counting them.

“How can we determine if there is are live microorganisms in a product?  It is really only by counting them,” Arnoldo said.

Wasserman said IPA is in the process of assembling a citizen’s petition to ask FDA to make this change and to formally recognize current practice in labeling by allowing CFU counts as the accepted standard.

Caution on Bayer case

Matching claims with science is one reason for the CFU callouts, and Wasserman said it points to the importance of backing up claims on the label with available evidence.  On that note he cautioned the industry on reading too much into the outcome of the Bayer vs FTC case.  In that case, Bayer was taken to task by FTC over claims made on its Phillips Colon Health multi-species probiotic product for alleged violation of a previous consent decree that related to allowed health claims language. A judge sided with the company, but Wasserman said he disagreed that this was as big of a victory for the industry as some seem to have suggested .

“One judge in New Jersey decided that Bayer did not violate its consent order. The decision has been taken to stand for the proposition that you don’t need randomized controlled trials to make a health claim. I don’t read the case to mean that and FTC doesn’t read the case to mean that,” Wasserman said.

“Bayer had wonderful experts and a wonderful, robust internal program in place to review science before making claims and the judge gave a lot of weight to that. They had strain specific science, and these were very well categorized species of probiotics. Bayer however did not have a study on its finished product, but there was no evidence presented that could show that different probiotics could somehow counteract each other in the finished product,” he said.

Webinar on demand

NutraIngredients-USA's Pre & Probiotics webinar, which was sponsored by Prenexus Health, Sabinsa, Nebraska Cultures and Cargill, can be heard on demand by clicking here .

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