Replies to post #50230 on 22nd Century Group Inc (XXII)

[Bubbster]

What Does TPSAC Do?

Generally, the role of TPSAC is to review and evaluate scientific issues, including safety, dependence, and health issues, relating to tobacco products and provide advice, information, and recommendations to the FDA.

What is TPSAC’s Role in the MRTP Application Review Process?
By law, the FDA must refer MRTP applications to TPSAC, and TPSAC must report its recommendations on the applications. In providing their recommendations, TPSAC members may not necessarily read the entirety of the applications.
The FDA reviews and makes the determination as to whether to authorize an MRTP, and is not required to follow TPSAC recommendations, including votes. However, the FDA takes into consideration TPSAC members’ insights, along with public comments and other information made available to the agency, before making a determination on any MRTP application.

What Happens at TPSAC Meetings on MRTP Applications?
Before a meeting, TPSAC members receive materials prepared by the FDA and the company that provide context to inform TPSAC members’ discussion, including with respect to specific issues and questions from FDA staff that arose during the agency’s scientific review of the MRTP applications. The FDA intends to post all materials provided to TPSAC (redacted in accordance with applicable laws) on the agency’s website two days before a TPSAC meeting.

During a TPSAC meeting, representatives from the company and FDA’s Center for Tobacco Products present information about the company’s MRTP application(s) currently under FDA substantive review. TPSAC members may then discuss available scientific evidence related to issues and questions posed by FDA about the application(s). During this discussion, TPSAC voting members may vote on specific issues and questions or other topics arising during the committee’s discussion.
TPSAC meetings also include time for in-person public comments. Members of the public may attend TPSAC meetings or watch the live webcast.
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