SILVER SPRING, Md. -- Another line of products from a major tobacco manufacturer—in this case, R.J. Reynolds Tobacco Co. and six of its snus products—is about to go before a U.S. Food and Drug Administration (FDA) review committee, which will help determine what claims the company can make in terms of the products being reduced or “modified” risk to consumers, the agency announced.
The FDA issued what it calls a Federal Register notice announcing that its Tobacco Products Scientific Advisory Committee (TPSAC) will review six of Reynolds’ snus products from Sept. 13-14 at the FDA’s White Oak campus in Silver Spring, Md.
The committee will discuss scientific issues related to the company’s modified-risk tobacco product (MRTP) applications for the Camel Snus smokeless tobacco products, which are currently under scientific review by the FDA. These products include:
Camel Snus Frost
Camel Snus Frost Large
Camel Snus Mellow
Camel Snus Mint
Camel Snus Robust
Camel Snus Winterchill
On Dec. 18, 2017, the FDA filed for substantive, scientific review of six MRTP applications from Winston-Salem, N.C.-based Reynolds for those products. In issuing its notice, the FDA also outlined the role of TPSAC in a Q&A format. Here's a look at that breakdown ...
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. It 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, in this case Reynolds, that inform TPSAC members’ discussion, including 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 Sept. 11, 2018.
During this upcoming meeting, representatives from Reynolds and the 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, the agency said, and the FDA recognizes that TPSAC meetings provide the public with an opportunity to present information to TPSAC members.
The agency asked that the public refers 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. Written comments related to the TPSAC meeting must be received by Aug. 29.
These deadlines apply only to the TPSAC meeting and do not apply to the public docket for Reynolds’ MRTP applications. There is currently no deadline for public comments on these applications.