MRTP applications meeting

| June 22, 2018

The US Food and Drug Administration has issued a Federal Register notice announcing a meeting of its Tobacco Products Scientific Advisory Committee (TPSAC) to discuss scientific issues related to the modified risk tobacco product (MRTP) applications submitted by R.J. Reynolds Tobacco Company for six Camel Snus smokeless tobacco products, which are currently under scientific review by the FDA.

The meeting is scheduled for September 13-14 at the FDA’s White Oak campus.

The role of the 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.

By law, the FDA must refer MRTP applications to the TPSAC, and the 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.

Before the meeting, TPSAC members receive materials prepared by the FDA and the company that provide context to inform TPSAC members’ discussions, including those materials that relate to specific issues and questions from FDA staff that arose during the agency’s scientific review of the MRTP applications.

The FDA posts all materials provided to the TPSAC (redacted in accordance with applicable laws) on the agency’s website two days before the relevant meeting; so the agency intends to post the materials for the September TPSAC meeting on the FDA website on September 11.

During the upcoming meeting, representatives from R.J. Reynolds Tobacco Company 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 on other topics arising during the committee’s discussion.

TPSAC meetings include also time for in-person public comments; and instructions on how to submit public comments to the TPSAC are to be found on the Federal Register notice.

Requests to present an oral comment at the September meeting must be received by August 16, while written comments related to the meeting must be received by August 29.

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.

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Category: Breaking News, Harm reduction, OTP, Regulation, Science, Technology

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