The Natural Products Association (NPA), Washington, D.C., has submitted extensive comments to FDA in response to the agency’s draft guidance on New Dietary Ingredients (NDIs).   
 
“In this draft guidance, FDA significantly oversteps the authority given to it by Congress in DSHEA,” said NPA executive director and CEO John Gay. “Therefore, a substantial rewrite of the guidance is necessary.”
 
“Congress set appropriate parameters regarding the safety of new dietary ingredients, and NPA supports those safety measures. Unfortunately, this draft guidance goes well beyond what was envisioned by Congress,” said NPA vice president for Scientific and Regulatory Affairs Dr. Cara Welch. “To cite just one example, the draft guidance sets up a de facto food additive safety standard, which directly contravenes the intent of Congress in DSHEA.”
 
Added Mr. Gay, “Through DSHEA, Congress envisioned a system that would allow products already on the market to remain available to the consumer while creating a reasonable mechanism for new ingredients to enter the market. The draft guidance does neither. Rather, it proposes an NDI process that would result in dampened innovation, more expensive and fewer products and excessive paperwork, robbing the industry and FDA of scarce resources. The overall impact would be felt by customers, retailers, and suppliers alike, hitting small businesses especially hard.”
 
“The industry needs clarity for the rules governing the NDI process, but those rules must be consistent with DSHEA. Our comments provide the FDA with the information needed to achieve that goal, and NPA stands ready to work with the FDA on this important task,” said Mr. Gay.