Fifth Circuit Slams FDA, Stays Vuse Vibe Menthol Denial

A federal court has granted a stay of the marketing denial order (MDO) issued by the FDA in January for Vuse Vibe menthol vape refills. The manufacturer, R.J. Reynolds Vapor Company, will be able to continue selling the products until the company’s petition for review of the MDO is decided by the Fifth Circuit Court of Appeals.

Reynolds had received a temporary stay of the MDO immediately after the denial was issued, so sales of the products have so far not been interrupted. The MDO applied to menthol refills for the Vuse Ciro and Vuse Vibe devices. The Ciro and Vibe, and their tobacco-flavored refills, received marketing authorization from the FDA in May 2022. R.J. Reynolds no longer sells the Vuse Ciro, so has abandoned its appeal of the Ciro menthol MDO.

Today's unanimous ruling by a three-judge panel of the Fifth Circuit included pointed criticism of the FDA Center for Tobacco Products for the CTP's unannounced policy shifts regarding flavored vaping products and marketing plans intended to reduce youth use.

Worth noting that the Fifth Circuit states that FDA should have considered evidence of benefits to "adult and youth cigarette smokers alike who switched to menthol Vuse."

CTP has long had an (informal?) policy that switching by youth is never beneficial. pic.twitter.com/0T8kYKINxj

— Gregory Conley (@GregTHR) March 23, 2023

The court also noted that CTP Director Brian King’s arrival at the agency last July precipitated a sudden change in the CTP’s attitude toward menthol vapes. The ruling quoted internal FDA documents obtained last December by Filter reporter Alex Norcia, which showed the CTP Office of Science reversed itself on other menthol product applications after being pressured by the CTP director’s office.

The Fifth Circuit panel found that Reynolds “easily met its burden,” and is likely to prevail on the merits of the case. The ruling was written by Judge Edith Jones, who also wrote the blistering dissent in the same court’s rejection of Triton Distribution’s petition for review last July. (The Triton case is now being reargued before the Fifth Circuit after the court granted the manufacturer a rare en banc rehearing.)

The same court granted Reynolds a temporary stay on Monday in a separate appeal of an MDO for Vuse Solo menthol refills. As with the January MDO, Reynolds has filed a petition for review of the Vuse Solo denial, and a motion for a stay pending review.