The FDA's marketing denial order (MDO) for Vuse Vibe menthol vape refills was granted a stay by a federal court in January. R.J. Reynolds Vapor Company, the manufacturer, will be permitted to keep selling the goods until the Fifth Circuit Court of Appeals rules on the company's request for a review of the MDO.
Sales of the goods have not yet been halted since Reynolds was granted a temporary stay of the MDO as soon as the denial was made. For menthol refills for the Vuse Ciro and Vuse Vibe devices, the MDO was applicable. The FDA gave the Ciro and Vibe, together with their tobacco-flavored refills, marketing authorization in May 2022. R.J. Reynolds has given up on promoting the Ciro menthol MDO since it is no longer selling the Vuse Ciro.
The FDA Center for Tobacco Products was sharply criticized in today's unanimous decision by a three-judge panel of the Fifth Circuit for the CTP's unexpected policy changes pertaining to flavored vaping products and marketing strategies meant to discourage underage usage.
The court further observed that the CTP's position on menthol vapes abruptly changed after Director Brian King joined the organization in July of last year. According to internal FDA documents that Filter reporter Alex Norcia received in December, the CTP Office of Science changed its mind about other menthol product applications due to pressure from the CTP director's office. This information was used in the verdict.
Reynolds "easily met its burden," according to the Fifth Circuit panel, and the case is likely to succeed on its merits. Judge Edith Jones, who penned the vehement dissent in the same court when Triton Distribution's petition for review was denied in July, also wrote the ruling. (The manufacturer is currently requesting a rare en banc rehearing in the Triton case, which is currently being reargued before the Fifth Circuit.)
Reynolds was granted a temporary stay by the same court on Monday in connection with an MDO regarding refills for Vuse Solo menthol. Reynolds has submitted a move for a stay of proceedings pending review as well as a petition for review of the Vuse Solo denial, similar to the January MDO.
