NDIs, Adulteration on AHPA's Radar

While notification to FDA of new dietary ingredients (NDIs) has been a requirement since the passage of the Dietary Supplement Health & Education Act (DSHEA), many companies continue to struggle to understand the process. Virgo Publishing's Jon Benninger spoke with Michael McGuffin, president of the American Herbal Products Association (AHPA), during SupplySide West in October 2010 regarding NDIs and other hot industry issues, after McGuffin spoke on a panel about NDIs.

Specific to the NDI notification process, McGuffin reminded industry that the requirement is notification with convincing information; companies can continue to market even if the agency disagrees with the notification, although the agency has been forthcoming with suggestions to improve notifications to get to a preferred "no questions" outcome. Regardless of whether FDA issues a planned guidance on the topic, McGuffin said the existing records hold great information for companies to learn from.

McGuffin and Benninger also chatted on the topic of adulterated products "masquerading" as dietary supplementsa distinction McGuffin called out, as products containing unlabeled pharmaceutical ingredients are not legally dietary supplements. McGuffin added the problem is not just a U.S. issue, but one that spans international borders. As such, McGuffin shared steps AHPA is taking to help bring the issue into focus around the globe.