Premarket Notification for New Dietary Ingredients: A Leading Manufacturer's Perspective
April 21, 2005
New products are the lifeblood of most industries, and dietary supplements are no exception. Innovative new products often contain new ingredients, and as such, it’s essential to develop a workable system for introducing products that contain what are known as new dietary ingredients (NDIs). Currently, FDA (Rockville, MD) is focusing on a provision in the Dietary Supplement Health and Education Act (DSHEA) that outlines an NDI evaluation process. FDA posed several questions in the October 20, 2004, Federal Register and has asked industry and others to comment.