Probiotics marketing races ahead of the science

Probiotics have become almost a household word. Ten years ago the idea that bacteria could be good for you just didn't register in mainstream America. Today — with successful products such as Activia Yogurt and the Align dietary supplement — and the advertising that accompanies them — the concept of probiotics has arrived in the consciousness of US consumers. This reality intersects with a scientific undertaking called the human microbiome project. This $115 million research initiative funded by the US National Institutes of Health aims to identify and characterize the microbes associated with humans, and to determine their role in health and disease. This is a global research priority, and one that will provide an invaluable scientific foundation for further developments in the probiotic field. It's an exciting time for probiotics.

But even as consumers embrace the concept of probiotics, there are serious challenges associated with their emergence into prime time. Probiotics once flew below the regulatory radar (a 1990 Office of Dietary Supplements survey of 3,000 dietary-supplements products did not include a single probiotic product), but recently the FDA and FTC have targeted probiotic companies through warning letters and initiation of investigations into claims, respectively. A marketplace once characterized by undefined products touting claims rooted in unsubstantiated hypotheses, products today are expected to be identified to the strain level and substantiated by well-controlled, published, strain-specific human studies.

And these issues are not unique to the United States. Europe, Canada, India and other regions globally are specifically addressing issues surrounding the science and marketing of probiotic products. For example, in Europe, where all claims related to health benefits of foods must be approved by the European Food Safety Authority, close to 100 claims for probiotic health benefits have been denied.

This situation has caused a bit of a tumult among researchers, regulatory authorities and companies marketing the products. Over the past 20 years, the pace of mechanistic and clinical research on probiotics has accelerated greatly. According to the PubMed bibliographic database, the number of human clinical trials on probiotics published in the past 10 years has increased 20-fold. However, translating this emerging science into health-benefit claims that are meaningful to the consumer, accurately reflect the science, and satisfy regulatory authorities is a challenging undertaking with high stakes.