AHPA, Other Supplement Groups Seek FDA Guidance on NDIs

WASHINGTONUnder federal law, manufacturers and distributors who want to market dietary supplements containing "new dietary ingredients" (NDIs) must notify FDA.

But the industry is seeking clarity on the information that must be included to identify new ingredients. Five trade groups have asked the FDA for revised draft guidance.

"This is clearly an area in which guidance is needed by the regulated supplement industry," Michael McGuffin, president of the American Herbal Products Association (APHA), said in a statement Monday. "We are therefore requesting that FDA prioritize its attention to this specific issue and provide the industry with clarity on this matter."

APHA noted four other trade organizations also have requested revised guidance on NDIs: the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the Natural Products Association and the United Natural Products Alliance.

According to the groups, FDA's current rule on NDI notifications doesn't specify what information should be disclosed to the agency on the identity of a new ingredient.

Federal law defines an NDI as a dietary ingredient that was not marketed in this country before Oct. 15, 1994, coinciding with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) 

In July 2011, FDA issued draft guidance on NDIs. Supplement firms still have questions and concerns about the regulations.

After reviewing hundreds of NDI notifications that have been submitted to FDA since 1995, AHPA has discovered the agency's most common objection to the notices is that it "'is unable to establish the identity' of the dietary ingredient that is the subject of the notification," the trade group stated in comments filed last month with FDA.

"What constitutes an adequate description of the ingredient in an NDI notification is one of those issues where the trade associations and FDA are likely to agree," Steve Mister, president and CEO of the Council for Responsible Nutrition, said in a statement Monday.

FDA last year disclosed it would issue new guidance on NDIs, according to AHPA. Previously, in a letter to FDA Commissioner Margaret Hamburg, U.S. Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) urged the agency to withdraw its draft guidance. Hatch and Harkin, who fostered passage of DSHEA, argued the guidance undermines the law, imposing undue burdens on manufacturers.

Other than an exception related to conventional food, supplement distributors and manufacturers must submit an NDI 75 days before introducing it into interstate commerce. Among other details, the notification must provide a history of use or other evidence showing the new ingredient will be reasonably expected to be safe under its labeled conditions of use.