Oct. 16 update
The Fifth Circuit Court of Appeals has temporarily stayed the FDA marketing denial order (MDO) issued Oct. 12 for Vuse Alto menthol pods, allowing R.J. Reynolds to continue selling the product while the company pursues a full stay and appeal of the denial order.
R.J. Reynolds and two related businesses appealed the FDA's marketing denial order to the Fifth Circuit Court on Oct. 12---the same day it was issued. Reynolds asks the court to stay the order and prevent the FDA from enforcing it.
The FDA has rejected marketing applications for menthol-flavored refill pods for the Vuse Alto—the most popular flavor made for the Alto, which is the single most popular vaping device sold in the convenience store vape market. The Vuse Alto device and tobacco-flavored pods remain under review by the agency.
Marketing denial orders (MDOs) were issued for six Alto refill pods: both menthol and mixed berry flavors, each sold in three different nicotine strengths. Vuse manufacturer R.J. Reynolds must remove the popular menthol pods from store shelves immediately, or face FDA enforcement. The mixed berry products have been off the U.S. market since January 2020, when the FDA announced it would prioritize enforcement against pod-based vape products in flavors other than tobacco and menthol.
“Today’s actions are among many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency,” said the FDA in a press release. “The FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.”
In January, the FDA rejected the premarket tobacco application (PMTA) submitted by Reynolds for menthol Vuse Solo refills. Two months later, the agency also issued an MDO for Vuse Vibe and Ciro menthol refills.
Reynolds challenged the previous MDOs, and both have been stayed by the Fifth Circuit Court of Appeals. The company is expected to challenge the flavored Alto denials too.
While Reynolds fights the FDA’s actions against its menthol vaping products, the company has asked the agency to crack down on popular flavored disposable vapes, which have become the tobacco company’s biggest competitor for vape sales.
Since the FDA granted itself authority to regulate nicotine vaping products in 2016, the agency has only authorized the sale of seven e-liquid vaping devices (one of which is no longer being sold). All of the FDA-authorized products are manufactured by three Big Tobacco-owned companies: Logic, NJOY and Vuse.