The FDA held a public meeting, Development of a List of Dietary Ingredients that Pre-Date the Dietary Supplement Health and Education Act of 1994 (DSHEA), to discuss the development of a list of pre-DSHEA dietary ingredients.
October 3, 2017
8:00am – 5:00pm
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 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.
For more information about the meeting, see the Federal Register notice and the additional links provided below.
- Meeting Agenda (PDF: 126KB)
- Recording of the Meeting Morning Session
- Recording of the Meeting Afternoon Session
- Meeting Transcript (PDF: 453KB)
- Panel 1 Presentations: What Evidence is Necessary to Show that an Ingredient was Marketed Before October 15, 1994?
- Panel 2 Presentations: What Process Should Be Used to Develop the List of Pre-DSHEA Ingredients?
The FDA accepted public comments September 6, 2017 through December 4, 2017. View comments submitted electronically on regulations.gov in docket folder 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- Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Draft Guidance for Industry
- Federal Register Notice for the Draft Guidance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