The five associations representing the dietary supplement industry have requested that FDA issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus on the information to be included to identify the new dietary ingredient.
The request, made by 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), was made in the form of comments submitted by AHPA to FDA on April 27 and joined by CRN, CHPA, NPA and UNPA in separate submissions.
The groups noted 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.”
Earlier comments submitted by each of the trade associations to FDA’s June 2011 draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, were generally critical. In June 2012, FDA informed the associations that the agency was planning to promulgate revised draft NDI guidance and would permit additional input from the industry on these topics.
“Other issues raised by FDA’s 2011 draft NDI guidance are still concerning to the supplement industry,” said Steve Mister, president and CEO of CRN. “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.”
“Reviewing the NDI notifications submitted to date indicates that FDA often cites absence of clear information on ingredient identity,” noted 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.”
“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.
“We urge FDA to consider these additional comments and release a new draft guidance on the notification issue,” commented Scott Melville, president and CEO of CHPA. “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.”