Industry urges FDA to clarify new dietary ingredient notification regulations
SILVER SPRING, Md. — The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient 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, the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the Natural Products Association and the United Natural Products Alliance, 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 note that FDA’s rule on NDI notifications 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,” stated Michael McGuffin, AHPA president. “We are therefore requesting that the 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Earlier comments submitted by each of the trade associations to the FDA’s June 2011 draft guidance, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," generally were critical. In June 2012, the 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 the FDA’s 2011 draft NDI guidance are still concerning to the supplement industry,” noted Steve Mister, president and CEO of CRN. “We will continue our active dialogue with the 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 the FDA are likely to agree.”
One of the bigger issues includes which supplements have been grandfathered under the regulation, and subsequently don't need an NDI, and which haven't. “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," acknowledged Scott Melville, CHPA president and CEO. "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.”