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FDA Stays Parts of Guidance on Clinical Research Involving Foods

Nov 04, 2015

In response to stakeholder comments, including those from IDFA, the Food and Drug Administration is staying select parts of its final guidance on Investigational New Drug (IND) applications. The guidance was issued in 2013 to guide clinical research studies, including those involving food.

IDFA and several other trade associations submitted comments in 2014 that pushed back against the guidance, saying it was overly burdensome and fundamentally flawed. IDFA’s comments outlined how the guidance could negatively affect parts of the dairy industry, particularly yogurt producers. 

The guidance would require studies involving conventional foods to comply with onerous investigational new drug (IND) requirements, which are designed to protect human research subjects. According to the original guidance, a product could be regulated as a drug, and thus be required to go through the IND process, merely because of the conditions studied in a clinical investigation, regardless of the actual claims made in marketing the product to consumers. In its comments, IDFA said the new requirements were unnecessary and would discourage food companies from sponsoring important studies regarding the health benefits of food.

Conventional Foods and Health Claims

FDA is staying part of the final guidance to allow for further consideration of issues raised by the comments. This stay essentially means that particular provisions of a rule or guidance are not in effect and enforced by FDA pending a future decision by the agency on whether to remove, modify or maintain the stayed provisions. 

Specifically, the agency is staying parts of the subsection on conventional foods and all of the subsection on studies intended to support health claims, with one exception: the stay of the health claim subsection does not apply to clinical studies that include children under a year of age, people with altered immune systems or people with serious or life-threatening medical conditions. The stays affect parts of subsection VI.D.

While the partial stay is in effect, researchers and sponsors of studies that are intended to support a new or expanded health claim and conducted in healthy individuals over 12 months of age do not need to obtain an IND. Researchers and sponsors of studies regarding non-nutritional effects of conventional foods on the structure or function of the body also do not need to obtain an IND while the stay is in effect.

FDA has republished the final guidance with the stayed portions clearly identified to avoid confusion about which parts of the guidance are stayed and which are still in effect.   

Members with questions may contact John Allan, IDFA vice president of regulatory affairs and international standards, at jallan@idfa.org.

 
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