September 5, 2017
The U.S. Food and Drug Administration announced today a public meeting entitled “Development of a List of Dietary Ingredients that Pre-Date the Dietary Supplement Health and Education Act of 1994” (DSHEA). The public meeting will be held on October 3, 2017 from 8:00 a.m. until 5:00 p.m. at the CFSAN Wiley Auditorium, 5001 Campus Dr., College Park, MD 20740.
The purpose of the meeting is to give interested stakeholders an opportunity to discuss issues related to FDA’s planned development of a list of pre-DSHEA ingredients. Topics covered during the meeting will include what evidence is necessary to show that an ingredient was marketed before October 15, 1994, and what process should be used to develop the list. FDA invites interested parties to provide information, share perspectives, and raise issues specifically related to the evidence needed to demonstrate that an ingredient is pre-DSHEA and on the process by which ingredients should be added to the list. Parties who are unable to participate in person will be able to join the meeting via live webcast.
Public meeting attendees are encouraged to register online to attend the meeting in person or to participate via webcast.
For more information about the meeting, as well as instructions on registration and requesting to make an oral presentation, see the Federal Register notice about the meeting and the additional links provided below.
Public meeting attendees need to register to attend the meeting in person or online. Early registration is strongly recommended because seating is limited.
The FDA is accepting public comments on this meeting beginning on September 6, 2017. To submit comments to the docket electronically, visit http://www.regulations.gov and type FDA-2017-N-4625 in the search box.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2017-N-4625 on each page of your written comments. Comments will be accepted until December 4, 2017.
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Important Dates to Remember
- September 18, 2017 - Request to make an oral presentation
- September 18, 2017 - Request special accommodations due to disability
- September 25, 2017 - Registration Deadline
- October 3, 2017 - Public Meeting
- December 4, 2017 - Deadline to submit electronic or written comments to docket FDA-2017-N-4625
- Federal Register Notice Announcing the Public Meeting
- Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Draft Guidance for Industry
- Federal Register Notice for the Draft Guidance
- Background and Information about Submitting NDI Notifications
- Public Meeting page