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New FDA Guidance Has Broad Implications for Nutrition Research

Nov 20, 2013

New final guidance issued this fall by the Food and Drug Administration will have broad and possibly negative implications for nutrition research and the food industry, IDFA has learned. According to an upcoming article by Roger Clemens, a leading food scientist and adjunct professor at the University of Southern California, the guidance effectively mandates drug research standards for food studies.

The “Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND” significantly changed the scope from the 2010 draft IND guidance that did not address foods. The new guidance now requires a wide range of studies, including investigations establishing relationships between foods and structure/function or health outcomes, to obtain an Investigational New Drug application from FDA.

What Does This Mean for Food Companies?

“The potential impact is significant, ranging from adding new regulatory barriers and increased costs for product development to stifling U.S. research and innovation and incentivizing its movement abroad,” Clemens said. “There is growing support within the food industry, among many scientific organizations and leading clinical investigators from academic institutions that urges withdrawal of this new Guidance until there is an adequate opportunity for its open review and discussion of alternatives.”

Clemens said many unanswered questions remain, including whether the guidance conflicts with the Good Manufacturing Practice (GMP) standard for studies of foods. It’s also unclear how it will affect research relating to functional foods and products that include probiotics.

IDFA will work with partners in the food industry and academia to seek clarification on these questions, among others. Members with an interest in this topic are encouraged to contact Cary Frye, IDFA vice president of regulatory and scientific affairs, at or (202) 220-3543.

The article will appear online on December 10 and later next month in Food Technology, a monthly magazine published by the Institute of Food Technologists. IDFA members may read the e-publication version of “A Major Obstacle in the Path of Clinical Nutrition Research."

Roger Clemens

Dr. Clemens is chief scientific officer of Horn Company, a distributor of specialty ingredients, raw materials and chemicals for use in a wide variety of industries. He also serves as adjunct professor of pharmacology and pharmaceutical sciences within the USC School of Pharmacy. Clemens served on the U.S. Department of Agriculture’s 2010 Dietary Guidelines Advisory Committee with primary responsibilities in food safety, and dietary lipids and health.

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