The Global Health Center, headed by William Powderly, MD, is working with the Center for Gut Microbiome and Nutrition Research, directed by Jeffrey Gordon, MD, and a multidisciplinary team of Washington University faculty, staff, and trainees in a gut microbiome initiative designed to address a range of scientific, regulatory, ethical, social, cultural, and policy considerations that underpin the development of next generation nutribiotics for childhood undernutrition.
Team members Jonathan M. Green, MD, MBA, Associate Director of the Global Health Center; Michael J. Barratt, PhD, Executive Director of the Center for Gut Microbiome and Nutrition Research; Michael Kinch, PhD, Associate Vice Chancellor and Director at the Center for Research Innovation in Business; and Jeffrey I. Gordon, MD, the Dr. Robert J. Glaser Distinguished University Professor, are all authors on a paper recently published in Science discussing how microbiota-directed food might fit within the current Food and Drug Administration (FDA) regulatory framework.
Research continues to show that gut microbiota is an important determinant of healthy growth and of our metabolic, physiologic, immune, and perhaps neurologic phenotypes, thus it is a logical target for intervention. Microbiota directed foods (MDFs) are designed to specifically alter the structure or function of the gut microbiome, with the goal of improving a person’s health. The development and use of MDFs as either a preventative or therapeutic approach raises the question as to how MDFs should be regulated. This will affect innovation incentives, product quality, consumer access, and public health. Given that the regulations predate our recognition of the key role of the microbiome in health and disease, it is perhaps not surprising that MDFs do not fit cleanly into the existing regulatory paradigm.
The U.S. FDA regulations provide for a number of distinct categories under which an MDF might be classified, such as a conventional food, medical food, dietary supplement or even as a drug. Each has specific criteria, and the classification determines what sort of health claims can be made and the level of evidence required to support such a claim. For example, a claim that an MDF can prevent the development of diabetes might result in the MDF being classified as a drug. In contrast, a claim that the MDF promotes a healthy metabolism might be allowable for a conventional food or dietary supplement. While this may seem a somewhat esoteric concern, it will have a profound impact on the costs of development and subsequent availability of an MDF.
Dr. Green believes that MDFs should be subject to the minimum regulatory burden consistent with safe use of the product. Given the potential profound impact that these may have on a number of diseases, including the global problem of undernutrition, over-regulation may adversely affect the development of a safe and effective treatment.