Federal Court Grants Stay on Marketing Denial Order for Menthol Vapes

R.J. Reynolds Vapor Company had been worried about the marketing denial order (MDO) that the FDA had issued for Vuse Vibe menthol vape refills back in January. It meant that the company wouldn't be able to sell its products anymore. However, Reynolds received a temporary stay of the MDO right after it was issued, so sales of the products had been unaffected until now.

This week, the company received some good news when a federal court granted a stay of the MDO. This means that Reynolds can continue to sell the menthol refills until the company's petition for review of the MDO is decided by the Fifth Circuit Court of Appeals.

The MDO had only applied to menthol refills for the Vuse Ciro and Vuse Vibe devices. The Ciro and Vibe, along with their tobacco-flavored refills, had received marketing authorization from the FDA in May 2022. Reynolds no longer sells the Vuse Ciro, so the company has abandoned its appeal of the Ciro menthol MDO.

The recent ruling by the three-judge panel of the Fifth Circuit was unanimous and critical of the FDA Center for Tobacco Products (CTP). The panel noted that the CTP had unannounced policy shifts regarding flavored vaping products and marketing plans intended to reduce youth use. The court also mentioned that the sudden change in the CTP's attitude toward menthol vapes coincided with the arrival of CTP Director Brian King at the agency last July.

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

Reynolds also received 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. The company is optimistic that it will be able to continue to sell its products and is awaiting the outcome of its petitions.