On October 30, 2015, the U.S. Food and Drug Administration (FDA) announced that it is staying select parts of a final Guidance on Investigational New Drug (IND) applications as it pertains to conventional foods and studies intended to support health claims. The partial stay is intended to encourage scientific research to explore the relationship between diet and health.
The Guidance was originally issued in 2013 to clarify when researchers or sponsors need to file IND applications before conducting human research studies. The stay allows researchers and sponsors of studies intended to support a new or expanded health claim to carry out research without obtaining an IND. For example, stay of guidance would allow research to demonstrate that a cereal reduces cholesterol to occur without submitting an IND application. However, the stay of the health claim subsection does not apply to clinical studies that include people with altered immune systems, or people with serious, life-threatening medical conditions, or children under one year of age. Similarly, research studies of non-nutritional effects of conventional foods on the structure or function of the body do not require an IND while the stay is in effect.
The stay does not affect the FDA’s position on dietary supplements, which requires (under part 312) an IND for clinical investigations intended to evaluate the dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease.
For assistance in ensuring compliance with federal regulations surrounding clinical trials, including the Investigational New Drug (IND), New Drug Application (NDA), and Institutional Review Board (IRB) process, contact Frier Levitt.
