A little more than a month after industry trade associations requested an extension, the U.S. Food and Drug Administration (FDA) today announced it will extend the New Dietary Ingredients (NDIs) guidance comment period an additional 60 days to Dec. 2, 2011.
The extension exceeds the 45-day extension request submitted Aug. 3 by the Council for Responsible Nutrition (CRN), the American Herbal Products Association (AHPA), the Natural Products Association (NPA), the United Natural Products Alliance (UNPA) and the Consumer Healthcare Products Association (CHPA). Calls for extensions on the comment period came almost immediately after the document was first released in early July.
"We are pleased with the additional time," said John Gay, executive director and CEO of the NPA. "We would have been ready to submit our comments by October 1, but this extension will ensure that the comments will be the best that they can be."
Gay said he wasn't surprised to receive the extension. "It seemed like a reasonable request and was in the interest of the FDA to make sure they get the best comments possible."
In its extension notice, FDA writes that "the extension allows adequate time for interested persons to submit comments without significantly delaying action by the agency."
Industry hopeful that FDA is willing to listen
"Hopefully, this is an indication of the reasonableness of ongoing dialogue," said Len Monheit, director of the Supply Network of New Hope Natural Media. "As FDA goes through the comments they are receiving, hopefully there will be a loop back into industry to really assess the impacts of the guidance."
Scott Steinford, president of the ingredient company ZMC-USA, said he hopes ingredient manufacturers will use the extra time to craft their own comments for FDA on the NDI guidance. "Ingredient manufacturers to date have tended to be somewhat silent in this discussion," he said.
One message Steinford urges ingredient companies to convey to the agency is that ingredient manufacturers—not finished product manufacturers—bear the onerous task of demonstrating ingredient safety. "We are the ones that need to be held responsible for safety," Steinford said. "Without that, ingredient manufacturers will be impacted whether they believe it or not."
What will happen with the NDI guidance after the comment period ends is uncertain. FDA is not obligated to revise the guidance nor to issue it in a final form, one of the key ways in which a guidance document differs from a formal rule making procedure. And there is a precedent: An FDA guidance seeking to distinguish liquid dietary supplements from beverages has languished in draft form since it was introduced in 2009.
To submit electronic or written comments, the guidance can be accessed at FDA.gov: "Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues".
Additional reporting by Carlotta Mast