For those of you who lived the late 80’s, you should remember the oat bran fiasco, a classic example of “good science goes fad.”
For those of you who lived the late 80’s, you should remember the oat bran fiasco, a classic example of “good science goes fad.” To jog your memory, after scientific research was published linking oat bran consumption to heart health, this ingredient propelled to the top of the food chain by a combination of media hype and over-zealous, irresponsible food companies that added oat bran to otherwise unhealthy products and marketed them as miracle foods.
The science surrounding oat bran and its ability to reduce the risk of coronary heart disease is sound. In fact, FDA eventually authorized a health claim on this relationship. But because today’s labeling laws and health claim approval process did not enter the food formulating world until 1993, regulating its use got out of control in the 80’s. Even since the Nutrition Labeling and Education Act went into effect, there remain questionable areas when it comes to using and marketing certain food ingredients. One such example is probiotics.
As someone who lived the late 80’s - big hair, neon nail polish and oat bran everything - I see similarities between oat bran and probiotics. I fear that the good science supporting true probiotics will be tainted by bandwagon hoppers who turn probiotics into a fad. All fads eventually go bad. Fortunately, oat bran recovered…and even more fortunately, big hair and neon nail polish did not.
Processors must remember that even though there are not any probiotic-specific regulations, scientific authorities have established a definition. Probiotics are defined as being live cultures that, when consumed in sufficient quantities, can provide health benefits to the individual. Further, there are four key criteria to this definition, according to the International Scientific Association for Probiotics and Prebiotics (ISAPP). These are:
• A probiotic must be alive when administered;
• A probiotic must have undergone controlled evaluation to document health benefits in the target host;
• A probiotic must be a taxonomically defined microbe or combination of microbes (genus, species and strain level); and
• A probiotic must be safe for its intended use.
In efforts to continue with the good science, and to keep probiotics off the oat bran track, this past June, the University of Maryland School of Law hosted the first of a series of multidisciplinary meetings that are part of a Human Microbiome Project ELSI (Ethical, Legal, Social Implications) grant to study federal regulation of probiotics. Participants in the conference included members of academia and the scientific research, business, legal and federal regulatory communities, and included two ISAPP board members, Gregor Reid and Mary Ellen Sanders.
“The National Institutes of Health funding provided a wonderful opportunity for experts from diverse backgrounds to come together and discuss a field that has been growing in importance exponentially,” says Reid, a past president of ISAPP. “Unlike perhaps any other product, a probiotic can fit into all the product categories - food, supplement, drug, medical device and cosmetic - set up by FDA. Hopefully, the workshops will lead to not only questioning and challenging the current administrative set up, but also recommending changes that can be implemented in ways that help government, consumers and manufacturers.”
Sanders, ISAPP’s executive director, adds, “Regulatory issues are critical to the probiotic field.” She explains that 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 when taking 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.
“Although FDA should be lauded for its concern about safe use of these products in vulnerable populations, their use to reduce the risk of acute diseases or to provide a safe option for dietary management of certain symptoms might be areas that this University of Maryland project can challenge FDA to address,” Sanders concludes.
Probiotics have the potential to positively impact health and wellness for generations. If regulations are put in place for the proper marketing of true probiotic-enhanced foods and beverages, it would disqualify the abusers and prevent good science from going fad.
