American Herbal Product Association (AHPA) President Michael McGuffin discussed how marketers of new dietary ingredients (NDIs) can successfully meet NDI notification requirements at the American Conference Institute's (ACI's) second annual Legal, Regulatory and Compliance Forum on Dietary Supplements and Nutritionals held in New York.
McGuffin's presentation was part of a three-person panel, "Strategies for Filing NDI Notifications with No FDA Objections - Try and Try Again," presented with Ashish Talati (Amin Talati LLC) and Claire Kruger, Ph.D., DABT (Spherix Consulting).
"There is a false impression in the supplement industry that the NDI notification system is a bound-to-fail effort for most companies," McGuffin said. "In fact, more than half of submissions that are in full compliance with the current NDI regulations are filed by FDA without substantive objections on the initial submission, and this rate increases with attentive resubmissions when needed."
Using data derived from the AHPA NDI Database, McGuffin demonstrated that companies can effectively navigate the NDI notification system by avoiding common pitfalls and persistently addressing specific concerns identified by the Food and Drug Administration (FDA) in reviewing notifications. The AHPA NDI Database is a subscription-based repository of the more than 700 NDI notifications that have been submitted to FDA since 1995.
To reduce the chances of FDA objections to an NDI notification, McGuffin advised companies to:
• Accurately and completely describe the NDI;
• Create an informative narrative that clearly associates the NDI to the evidence submitted;
• Comply with all regulatory details (per 21 CFR 190.6);
• Avoid making drug claims in NDI notifications;
• Be prepared to document pre-IND marketing and conformity with the statutory definition of a dietary ingredient (per 21 U.S.C. 321(ff)(1));
• Get good legal and scientific advice; and
• Address FDA's identified concerns in initial notifications in follow-up resubmission.
"At some point FDA will reissue its draft guidance on NDI notifications and AHPA will continue to be vigilant in resisting any attempts by the agency to use this guidance to reinterpret DSHEA," added McGuffin. "In the meantime, there are significant resources available to assist marketers of NDI's to successfully navigate the maze of NDI regulations."