FDA Publishes Notice Reopening IND Guidance; Comment by 60 University-Based Nutrition Department Heads Voiced Strong Opposition to Guidance

By Wes Siegner –

On January 21 we posted on FDA’s unusual decision to reopen the comment period for the final guidance on INDs with respect to food and cosmetic research.  Subsequently we learned that 60 university department heads submitted a comment to FDA’s Final IND Guidance on November 6, 2013.  The comment vigorously opposed implementation of the guidance with respect to food research, and was likely a significant reason for FDA’s decision to reopen comment on a final guidance.   Today, FDA published a Federal Register Notice reopening the comment period on the IND Guidance for 60 days.

Quoting from the department heads’ comment:

Foods and drugs are statutorily defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Recommending a “drug-level” approach to research for foods through the filing of INDs:

• would have a paralyzing effect on clinical research in the U.S. and stifle innovation and product development;
• is unnecessarily burdensome to academic and organization institutional review boards; 
• is outside the scope of current laws/regulations and inconsistent with the FDA’s charter;
• contravenes the statutory and regulatory definition for foods; and
• represents the creation of regulatory guidance that was not developed through a transparent and open process.

For these reasons, we urge you to take immediate action to stop implementation of the new confusing and contradictory IND Guidance. 

The Department Heads urged FDA to open a dialogue with stakeholders to “review and consider the potential impact on the public, health care providers, academia, government and industry.”  It appears that FDA, in reopening the comment period, may have heeded this message.  Regardless, it is important, now that the comment period has been reopened, for others who are negatively impacted to submit comments on this guidance.