Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
The purpose of the meeting is to give interested stakeholders an opportunity to discuss issues related to FDA’s future development of such a list. In August 2016, FDA published a revised draft guidance for industry entitled, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications). In the revised draft guidance, we stated our willingness to compile an authoritative list of pre-October 15, 1994 dietary ingredients based on independent and verifiable data to be supplied by industry. Although we are aware that several trade associations and industry groups have independently developed their own unofficial lists of ingredients that they believe were marketed before October 15, 1994 (sometimes referred to as “grandfathered” or “old” dietary ingredients), we are unable to verify the accuracy of those lists and therefore have never recognized or sanctioned any of them. We also have never compiled our own list.
An authoritative list would provide benefits to both industry and FDA. By providing clarity as to which ingredients do not require notifications, it would alleviate the burden on industry of preparing and submitting unnecessary notifications. Similarly, by eliminating unnecessary notifications, an authoritative list would enable us to more efficiently use our limited resources to review notifications for truly “new” ingredients. In addition, an authoritative list would allow us to better focus our enforcement efforts in alignment with our strategic priorities of consumer safety, product integrity, and accurate information.
For more information about the meeting, as well as how to participate in the meeting or submit written comments afterwards, see the Federal Register notice. For general questions about the meeting or to request special accommodations due to a disability, contact Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, phone: 240-402-1731, email: Juanita.Yates@fda.hhs.gov.
Registration is now closed for this event.
Participants are encouraged to arrive via Metro, parking is limited.
From the Metro:
Take the Green line in the direction of Greenbelt. Exit Metro at the College Park Metro Station. The Harvey Wiley Building is the four story building directly across the Parking Lot from the Front of the Metro Station (not the side where the U.S. Post Office is located).
Instructions for gaining entrance into the FDA/CFSAN Building:
! You must have some form of Photo Identification
Below is a list of properties convenient to the FDA facility in College Park, MD. The sleeping room rate and availability at each property cannot be guaranteed, and guests should contact the properties directly for more information.
6400 Ivy Lane
Greenbelt, Maryland 20770
The Marriott Inn & Conference Center, University of Maryland University College
3501 University Blvd, East
Hyattsville, Maryland 20783
Holiday Inn Hotel Washington, DC – Greenbelt, MD
7200 Hanover Drive
Greenbelt, MD 20770
Hilton Garden Inn Washington DC/Greenbelt
7810 Walker Drive
Greenbelt, Maryland 20770