Numbers confirm the trend. The Innova database of global new product introductions reports that in the fourth quarter of 2008, 31 new products carried the word. This rose dramatically to 71 in the first quarter of 2009, with a peak of 94 products carrying the word proven in the third quarter of 2009.
This trend started at a time when many European food marketers’ dossiers for health claims were rejected by the European Food Safety Authority. In the States, FDA started to clamp down, too.
According to Mary Ellen Sanders, executive director of the International Scientific Association for Probiotics and Prebiotics (ISAPP), a major issue surrounding the proper positioning of probiotics is the fact that “typically investigated endpoints in probiotic studies are considered to be ‘drug use’ endpoints by regulatory authorities,” she says. Examples include studies on prevention of allergy in children and managing intestinal discomfort while receiving antibiotics.
“Such scientifically proven benefits currently cannot be communicated on a probiotic food or dietary supplement in the States,” Sanders says. “FDA goes as far as saying that citing studies that show such effects on a product website constitutes illegal product labeling.”
There are some dairies that make statements associating probiotic intake with “balancing the digestive system” or “boosting natural defenses.” Such structure-function claims can be made, but very carefully, as there is a fine line to when a structure-function claim starts sounding like a health claim. And there are no approved health claims for probiotics in the United States. For example, balancing digestive system is acceptable, as is “helps keep you regular.” “Reduces constipation” crosses the line.
Other acceptable structure-function claims include: supports immune function; supports healthy intestinal balance; and promotes overall health. With structure/function claims, the “burden of proof” rests with manufacturers who must have appropriate scientific substantiation to make the claims. Most of the time, the clinical or scientific studies support a very specific endpoint, usually a drug-use endpoint (i.e., reduces constipation), and not one that proves a structure/function claim (i.e. helps keep you regular).
A few years back, Dannon Co., White Plains, N.Y., was faced with a class action suit alleging that the company’s studies failed to support its advertised claims that its products were clinically and scientifically proven to have health benefits other yogurts did not. The company’s settlement included eliminating some claims and rephrasing others.
So can probiotic-containing foods and beverages be described as “proven?” The answer is: not very easily according to current regulations.
Savvy marketers who want to stay off FDA’s radar are creating educational platforms and advertising campaigns that do not make or allude to any health claims. They rely on creative techniques to get the health and wellness benefit message to consumers.
“As a company, one of our key missions is to help improve people’s health by educating them about the benefits of probiotics,” says Teruo Tabuchi, executive vice president and COO of Yakult U.S.A. “We think that this campaign relays our message in a new, impactful way that we hope will make everybody smile.”
Rob Siltanen, S&P’s chairman and chief creative officer, says, “Research shows that while most Americans have heard about probiotics, they are not aware of their digestive health benefits. We specifically designed this campaign to help educate people about Yakult in a way that is as fun and flavorful as the product itself.”
While Yakult is currently celebrating its 75th anniversary and more than 28 million bottles are enjoyed daily around the world, the shot-sized probiotic powerhouse was not made available to the U.S. market until 2007. Official sales territories include California, Nevada, Arizona, Texas, Colorado and New Mexico, though smaller specialty grocers carry the product across the country and in Canada.
Yakult is one of the world’s leading probiotic beverages. It was created by microbiologist Minoru Shirota in 1935 in Japan to help people maintain good health. The company believes it markets a proven probiotic. The company is, however, wise enough to not dangle that descriptor in front of FDA.