December 1, 2012 (updated October 19, 2013)
According to authorities in the European Union (EU), the term “probiotic” is an implied claim (European Commission 2007) With the exception of yogurt cultures improving lactose digestion in lactose intolerant people, no probiotic claims have been approved in the EU.
There are many confounding factors contributing to this state of affairs: lack of clear direction on what research is required (Guarner et al. 2011; Sanders, et al. 2011), exclusion of well-conducted studies because they studied patient (not healthy) populations or disease outcomes, difficulty in defining physiological benefits with healthy study subjects, and existence of studies that do not substantiate the physiological benefit (i.e., null studies). Some believe that the standard of evidence required by EU authorities is unrealistic for foods. However, as regulatory expectations become clearer and as assessors become more knowledgeable, I expect that specific probiotic claims are likely to be approved in the EU. Until that time, the word ‘probiotic’ and descriptors such as “live active cultures” or “active bacteria” have been banned for foods by some member states (Ireland and Sweden). Other countries may follow.
A probiotic is a live microorganism, which when administered in adequate amounts, confers a health benefit on the host (WHO/FAO, 2001; Sanders, 2009). If you accept this definition of a probiotic, then the logical conclusion is that if a health benefit has not been established, then use of the term “probiotic” is not appropriate. Recent regulatory action in Europe is internally consistent with this logic. There is little doubt about the physiological effects of some probiotics. But the conduct of appropriately designed studies and the generation of consistent evidence for specific effects that will be suitably convincing to regulators must be developed before claims will be approved.
Guarner F, Sanders ME, Gibson G, Klaenhammer T, Cabana M, Scott K, et al. Probiotic and prebiotic claims in Europe: seeking a clear roadmap. Br J Nutr. 2011:1-3. Epub 2011/07/09.
Sanders ME, Heimbach JT, Pot B, Tancredi DJ, Lenoir-Wijnkoop I, Lahteenmaki-Uutela A, et al. Health claims substantiation for probiotic and prebiotic products. Gut Microbes. 2011;2(3):127-33.
WHO/FAO (World Health Organization and Food and Agricultural Organization of the United Nations). Health and Nutritional Properties of Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria. 2001.
Sanders ME. How do we know when something called “probiotic” is really a probiotic? A Guideline for consumers and health care professionals. Functional Food Rev. 2009;1:3-12.