Some vapers and business owners were surprised to see an FDA announcement that a recent rule had been withdrawn. Some mistakenly believed that the deeming rule itself had been withdrawn, and that rumor spread.
The Food and Drug Administration (FDA) published in the Federal Register of August 8, 2016, a direct final rule regarding procedures for refusing to accept premarket tobacco product submissions. The comment period closed October 24, 2016. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. FDA will consider the comments we received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (August 8, 2016).
The announcement referred to a rule regarding the submission and acceptance of premarket tobacco applications (PMTA), after public comments challenging its legal basis. The comments came from Altria Client Services, the legal and regulatory compliance arm of Altria, which owns Philip Morris USA, manufacturer of Marlboro cigarettes.
The explanation for what happened is fairly technical — and not especially interesting — but essentially the rule that was withdrawn would have allowed the FDA to refuse applications and force the submission to be redone from scratch, rather than allowing a simple amendment to the existing PMTA.
The rule change will have no effect on the PMTA process for independent vape companies. As American Vaping Association president Gregory Conley pointed out, “This is about procedure for those who actually can afford to file PMTA’s. If you are in the 99-plus percent that don’t have millions of dollars sitting around, this doesn’t impact you.”