- As a general matter, human clinical research studies to evaluate the therapeutic benefits of a substance are subject to FDA’s Investigational New Drug Application (IND) process. In September 2013, FDA issued a final guidance document regarding how to determine whether and which human research studies can be conducted without an IND.
- On October 30, 2015, FDA announced its decision to stay portions of the IND guidance that address conventional foods (related to the study of non-nutritional consumption benefits) and studies intended to support health claims. The stay of the health claims subsection does not apply to clinical studies that include children under one year of age, people with altered immune systems, or people with serious or life-threatening medical conditions. FDA has posted a revised copy of the final guidance on its website, indicating clearly those portions subject to the stay.
- While the partial stay is in effect, researchers who seek to conduct studies to support a new or expanded health claim conducted in healthy individuals over one year of age do not need to obtain an IND. Similarly, researchers who intend to study non-nutritional effects of conventional foods on the structure or function of the body do not need to obtain an IND. Overall, the stay gives the industry greater flexibility to conduct research on the beneficial effects of food substances. According to FDA, the partial stay will serve to encourage scientific research into the relationship between diet and health while the Agency considers comments received in response to the final guidance.