By law, the FDA must refer MRTP applications to TPSAC, and TPSAC must report its recommendations on the applications. The FDA reviews and makes the determination as to whether to authorize an MRTP, and 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.
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