Separate submissions from the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the Consumer Healthcare Products Association (CHPA), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA) have been sent to the FDA requesting specific clarification on NDI ingredient identity.
The groups note that FDA's rule on NDI notifications, as codified in 21 CFR 190.6, does not specifically state what information should be provided to the agency on the identity of the ingredient that is the subject of an NDI notification. Yet the most common objection communicated by FDA in its responses to NDI notifications is that the agency "is unable to establish the identity" of the dietary ingredient that is the subject of the notification.
"This is clearly an area in which guidance is needed by the regulated supplement industry," said Michael McGuffin, AHPA president. "We are therefore requesting that FDA prioritize its attention to this specific issue and provide the industry with clarity on this matter."
Revised draft guidance
Speaking at the SupplySide Marketplace event in New York last week, Daniel Fabricant, PhD, director of FDA's Division of Dietary Supplement Program, confirmed that, “FDA is planning to issue revised draft guidance with additional Q&A”.
The request from the five trade associations was made to FDA to urge the agency to address the issue of ingredient identity separately and not wait until a comprehensive second draft is released.
Guidance
"Reviewing the NDI notifications submitted to date indicates that FDA often cites absence of clear information on ingredient identity," said Loren Israelsen, UNPA's executive director.
"Guidance from FDA should therefore more closely focus on information that is needed to provide an accurate description of an ingredient that is the subject of an NDI notification. In fact, this is what the associations had anticipated the June 2011 draft guidance would comprise."
Steve Mister, president and CEO of CRN added that other issues raised by FDA's 2011 draft NDI guidance continue to cause concern to the supplement industry.
"We will continue our active dialogue with FDA until each of these is resolved. But in the meantime, it benefits both the industry and FDA to move forward on the topics where there is agreement. 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,” added Mister.
"These new comments offer FDA a blueprint of what the associations and our members think should be included in NDI notifications to clearly establish the identity of these ingredients," added John Shaw, NPA's executive director and CEO.
Scott Melville, president and CEO of CHPA, urged FDA to consider these additional comments and release a new draft guidance on the notification issue.
"We must continue our discussions about what demonstrates whether an ingredient is grandfathered under the law, what constitutes chemical alteration of an old ingredient, and other matters. However, there's no need to hold up guidance on this issue while we continue discussions on the meaning of the statute in other areas."