IFT comments to the FDA on Clinical Investigators, Sponsors, and Institutional Review Boards: Investigational New Drug Applications (IND)

November 26, 2013

IFT submitted joint comments (American Academy of Pediatrics, American Society for Nutrition, American Society for Parenteral and Enteral Nutrition, International Life Sciences Institute North America, International Scientific Association for Probiotics and Prebiotics, North American Society for Pediatric Gastroenterology, Hepatology and Nutrition), to the U.S. Food and Drug Administration (FDA) expressing concern that the food and nutrition research community was not given an opportunity to review and provide input on guidance related to “Conventional Food and Studies Intended to Support a Health Claim” before the final IND guidance was issued.  The FDA released final guidance in September on “Clinical Investigators, Sponsors, and Institutional Review Boards (IRBs): Investigational New Drug Applications (INDs)” which will impact food and nutrition research.  The organizations request that the FDA reevaluate and reissue this section of the guidance with an opportunity for interested parties to provide comment, and finally revise this portion of the guidance so that additional clarity is provided on the rationale behind when an IND is required for human research on foods, nutrients and dietary supplements. The guidance presents multiple concerns for the food and nutrition research community, including many potential unintended consequences which are expressed in the comments.

Click here for the joint comments. (PDF)

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