Some ingredients that have big market shares and lots of research backing activity, such as curcuminoids or omega-3s, can fly under the radar in terms of the claims implied in their very names. To date regulators have not linked these ingredient names to implied claims for fighting inflammation or lessening heart disease risk.
The name’s a claim
Not so for probiotics. Consumers increasingly know what probiotics do, and regulators in Europe have gone so far as to say the word can no longer be used on labels because the very name implies a gut health claim. And the expert panel of the European Food Safety Authority (EFSA) ruled some years ago that there is insufficient evidence to support those claims.
While the same regulatory regime does not obtain in the United States, an expert who will take part in a panel in tomorrow’s free online event said companies still need to be aware that these names imply a certain activity, and those companies better have evidence lined up to back that activity.
“Prebiotics and probiotics—these are both claims,” attorney Ivan Wasserman told NutraIngredients-USA. Wasserman is a partner in the firm Amin Talati Upadhye.
The definition for both of these terms speaks of health benefits to the consumers. It’s either about directly supplying a beneficial microorganism or fostering the growth of beneficial microorganisms in the gut, but in both cases, the goal is to confer a health benefit to the host. So Wasserman said the same strictures that would apply to any claim—making sure the science matches the language—would apply here.
In the case of express claims used in marketing language and on labels, Wasserman said basic guidelines about structure/function claims apply. In the probiotics space the amont of backing these must have has been elucidated by the court decision in teh Bayer/Phillips Colon Health case, but Wasserman said there is still a lot of confusion about the decision did and didn’t do. The decision struck down the hard and fast rule that two randomized, placebo-controlled trials are always necessary to make a claim. But it didn’t open up some sort door to the Wild West of claims, Wasserman said.
“What didn’t come out of the Bayer case is this notion that you no longer need science,” he said. “You still need ‘competent and reliable’ evidence to support a digestive health claim just like any other claim.”
Wasserman said some of the good things that came out of the ruling was the recognition that many claims for support9ing digestive health did in fact fall into structure/function territory and were not implied disease claims. The court also ruled that there was little evidence to support the idea that different strains of probiotics, which may have been studied in isolation, would somehow provoke an antagonistic effect when administered together. So marketers of multispecies products could still rely on these isolation studies for scientific backing.
Wasserman will join three other panelists—Anthony Thomas, PhD, science director for Jarrow Formulas, Matthew A. Roberts, PhD, chief quality officer at Pharmavite and George Paraskevakos, executive director of the International Probiotics Association.
The event, which begins at 11:30 AM Eastern time tomorrow, Nov. 15, will also include presentations by Anurag Pande, PhD, of Sabinsa Corporation, Samantha Ford, of AIDP Inc. and Dr. Gregor Reid, PhD, director of the Canadian R&D Centre for Human Microbiome and Probiotics and the Lawson Research Institute.
For more information and to register for the FREE event, click here.