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TPSAC Meetings on MRTP Applications

The following information provides a brief overview of the Tobacco Products Scientific Advisory Committee (TPSAC) and TPSAC meetings on modified risk tobacco product (MRTP) applications, the public’s role at TPSAC meetings, and important dates related to the September 2018 TPSAC meeting to discuss MRTP applications submitted by R.J. Reynolds Tobacco Company for six Camel Snus smokeless tobacco products.

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 the 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 the meeting. The FDA intends to post the materials for the September 2018 TPSAC meeting to the FDA website on September 11, 2018.

During this upcoming meeting, representatives from R.J. Reynolds Tobacco Company and FDA’s Center for Tobacco Products’ Office of Science will present information about the company’s MRTP applications currently under FDA scientific review. TPSAC members may then discuss available scientific evidence related to issues and questions posed by FDA about the applications. 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.

How Can Public Comments be Presented to TPSAC?

Public comments have an important role in the MRTP review process, and the FDA recognizes that TPSAC meetings provide the public with an opportunity to present information to TPSAC members.

Please refer to the Federal Register notice for instructions on how to submit public comments to TPSAC. Requests to present an oral comment at the September 2018 meeting must be received by Aug. 16, 2018. Written comments related to the TPSAC meeting must be received by Aug. 29, 2018.

These deadlines apply only to the TPSAC meeting and do not apply to the public docket for R.J. Reynolds Tobacco Company MRTP applications. There is currently no deadline for public comments on these applications.

Read the Notice