Major Medical, Scientific, and Food Associations Object to FDA IND Guidance

By Wes Siegner –

The following organizations filed joint comments on November 26, 2013 voicing strong opposition to the food provisions of FDA’s final IND Guidance and requesting that FDA reopen the comment period to permit comment on the food provisions of the guidance, which FDA has now done:

• American Academy of Pediatrics
• American Society for Nutrition
• American Society for Parenteral and Enteral Nutrition
• Institute of Food Technologists
• International Life Sciences Institute North America
• International Scientific Association for Probiotics and Prebiotics
• North American Society for Pediatric Gastroenterology, Hepatology and Nutrition

We have previously posted on this guidance, its implications for foods, medical foods, and cosmetics, and FDA’s decision to reopen the comment period for this guidance (here, here, and here).  Comments are due April 9, 2014.