On October 30, 2015, the Food and Drug Administration (FDA) announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards (IRBs) entitled “Investigational New Drug Applications – Determining Whether Human Research Studies Can Be Conducted Without an IND.” The stay is related to portions of the guidance pertaining to foods and was effective on the date of the publication of the notice in the Federal Register. The FDA will accept comments on the guidance at any time. 

The original guidance expanded the scope of conventional food products and dietary supplements that are subject to the Investigational New Drug Application (IND) requirements. The newly issued stay applies to parts of the guidance related to studies on conventional foods as well as the subsection of the guidance on studies intended to support health claims. However, the stay related to studies intended to support a health claim does not apply to clinical investigations intended to evaluate whether a food substance may reduce the risk of a disease in individuals less than 12 months of age, those with altered immune systems, and those with serious or life-threatening medical conditions (hereinafter collectively referenced as “vulnerable individuals”). 

As a result of the stay, FDA will not require an IND for clinical studies on conventional foods or dietary supplements that are intended to evaluate whether the food or supplement will reduce the risk of a disease or that are intended to support a new or expanded health claim, if the studies are conducted in a population that does not include specified vulnerable individuals. Additionally, the FDA will not require an IND for clinical studies intended to evaluate a non-nutritional effect of a conventional food on the structure or function of the body. Consistent with the final guidance issued in 2013, the FDA will not require an IND for clinical studies designed to evaluate: (1) the nutritional effects of a conventional food, (2) a dietary supplement’s effect on the structure or function of the body, or (3) the relationship between a conventional food or dietary supplement and reduced risk of disease, if there is already an authorized health claim for the substance-disease relationship. 

Except as specified above, the FDA will require an IND for clinical studies evaluating the ability of a conventional food or dietary supplement to diagnose, cure, mitigate, treat, or prevent disease. Additionally, the FDA will require an IND for studies designed to evaluate whether a food or dietary supplement reduces the risk of a disease, is intended to support a new or expanded health claim and is conducted in a population that includes specified vulnerable individuals. 

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The Food and Drug Administration Announces a Stay Related to IND Guidance