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Citing Flaws, IDFA Urges FDA to Withdraw Guidance on Clinical Trials

Apr 16, 2014

In comments submitted last week, IDFA urged the Food and Drug Administration to withdraw its final guidance on clinical research studies involving foods. The guidance currently requires studies involving conventional foods to comply with onerous investigational new drug (IND) requirements, which are designed to protect human research subjects. IDFA believes the new requirements are unnecessary, fall outside of FDA’s statutory authority and ultimately will discourage food companies from sponsoring important studies regarding the health benefits of food.

According to the guidance, a conventional food product that offers more than taste, aroma or nutritive value would be considered a drug because FDA says the primary purpose for consuming it would change. IDFA challenged this definition of food, saying it is unnecessarily restrictive and conflicts with case law.

Yogurt a Prime Example

Yogurt with probiotics is a prime example. Consumption has more than doubled between 2001 and 2011, and consumers say they choose yogurt because it’s nutritious and has added health benefits. The 2010 Dietary Guidelines Advisory Committee also recognized that “gut microbiota play a role in health” and encouraged the consumption of foods containing probiotics, while saying sufficient evidence doesn’t exist to support specific recommendations for probiotic intake.

IDFA believes the committee’s statement underscores the need for further research on the benefits of probiotics. At a minimum, IDFA urged FDA to include a list of examples of food research, such as studies involving probiotics in yogurt, that would be exempt from complying with IND requirements.

“If lawfully marketed drugs are exempt from the IND requirements, we cannot understand the agency position that lawfully marketed foods – with a risk profile that is dramatically lower than drugs – must be subject to these requirements. As with certain lawfully marketed drugs, IRB [Institutional Review Board] review and informed consent are sufficient to protect participants in clinical studies involving food,” the comments said.

Read the comments here.

For more information, contact John Allan, IDFA vice president of regulatory affairs, at

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