Food and dietary supplements companies have long claimed that probiotics in yogurt and other cultured dairy products improve digestion, boost immunity and confer other health benefits. Julian Mellentin, editor of the London-based food industry trade magazine New Nutrition Business, says consumers are increasingly buying into that concept. Aging populations and female consumers in particular are fueling much of the probiotic industry's growth, which is approaching $7 billion in Europe and $1.7 billion in the US, according to his analysis.
But regulatory authorities, particularly in Europe, have been thus far unimpressed with data put forth to support probiotic health claims. This year, the European Food Safety Authority (EFSA), a scientific advising body to the EU, rejected nearly every health claim put forward by the probiotics industry. In an e-mail, EFSA spokesperson Jan Op Gen Oorth wrote that the claims were rejected either because the microbes had not been sufficiently characterized, because the claimed effect was not considered beneficial (the EFSA panel opined that increasing numbers of bifidobacteria in the gut are not in themselves beneficial) or because human studies in support of the claims had not been made available. The EU stated that after December 14, 2012, food and nutritional supplements companies will no longer be allowed to communicate health benefits for their products on account of probiotic content.
Shelly Burgess, spokesperson with the US Food and Drug Administration (FDA), declined to comment on whether similar measures might be taken in the US. FDA regulates probiotics under the "generally recognized as safe" provision of the Food, Drug and Cosmetic Act. As long as a company sticks to nonspecific structure and/or function claims (that is, "improves digestive health"), it can sell the probiotics without regulatory worries. Trouble brews when companies start making more specific, drug-like claims that would otherwise require supporting evidence from human clinical trials.
