Less Mumbo Jumbo? FDA Unexpectedly Reopens Comment Period on Guidance Requiring INDs for Basic Food ResearchJanuary 21, 2014
By Wes Siegner –
On September 18, we alerted food researchers that FDA had added new language to a final IND guidance that would require FDA approval of an investigational new drug application (IND) for many food studies now conducted without the burden of filing an IND, and for most, if not all, clinical studies intended to support the benefits of any medical food. Our September 18 blogpost warned that a new section that FDA had added, without any advance notice, to the final guidance had the potential to severely restrict the growing field of research into the positive health effects of a variety of food and food ingredients.
The negative effects of FDA’s growing tendency to regulate food research under the onerous drug regime by requiring INDs was a key topic that was addressed by an NIH-funded University of Maryland study conducted from 2010 to 2012. The University of Maryland convened a multidisciplinary Working Group, of which I was a member, to make recommendations for more efficient regulation of the promising area of probiotics. The journal Science published the final White Paper produced from this study in October 2013 (see here). "Probiotics: Finding the Right Regulatory Balance," Science 18 October 2013: Vol. 342 no. 6156 pp. 314-315. Clinical researchers who participated in this study related experiences where FDA as a matter of routine required costly and lengthy safety studies in human subjects under INDs for probiotics, even where that probiotic had been consumed safely for decades or even centuries. One of the many important conclusions that the Probiotics Working Group reached was a simple and elegant solution to the IND dilemma that FDA’s final IND guidance illustrates – “If proposed research is to investigate non-drug claims for a food or dietary supplement, an IND should not be required even if the researchers use a disease endpoint.” Working Group White Paper, page 31 (Recommendations). This solution appropriately focuses on the final intended use of the product and avoids needless regulatory interference with the study of safe food products and ingredients.
FDA has now granted researchers and others an important potential reprieve by reopening the comment period to the final guidance. The new comment period, applicable to research on both food and cosmetic products, is 60 days from publication in the Federal Register. Although comment periods for guidance are flexible, it is recommended that comments be submitted within the allotted 60 days to maximize the chance that they will be factored into any decision to revise the guidance. It is important that any researchers, Universities, or businesses planning to conduct clinical studies in the future into the health benefits of foods and food ingredients push FDA to revise the final guidance to avoid an IND requirement for studies that are intended to support claims for foods, including medical foods, foods for special dietary use, and dietary supplements.