Five associations representing the dietary supplement industry have reportedly asked the Food and Drug Administration (FDA) to issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus on information to identify the new dietary ingredient.
Making the request were the American Herbal Products Association, Council for Responsible Nutrition, Consumer Healthcare Products Association, Natural Products Association, and United Natural Products Alliance.
Of particular concern to the groups is 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,” said AHPA President Michael McGuffin. “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Earlier comments submitted by each trade association to FDA’s June 2011 draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” were reportedly critical. In June 2012, FDA then informed the associations that the agency was planning to promulgate revised draft NDI guidance and would permit additional industry input.
“Other issues raised by FDA’s 2011 draft NDI guidance are still concerning to the supplement industry,” said Steve Mister president and CEO of the Council for Responsible Nutrition. “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.” See Council for Responsible Nutrition Press Release, May 6, 2013.