FDA Bans Sales of Vuse Menthol, Mixed-Berry E-Cigarettes

R.J. Reynolds seeks a stay of enforcement as it challenges the denials.

October 13, 2023

The U.S. Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Company for six flavored e-cigarette products under its Vuse Alto brand, which is one of the best-selling vapor brands in the country.

The company must not market or distribute these products in the United States, the FDA said. The denial includes three menthol-flavored and three mixed-berry products, with each flavor offered in three nicotine strengths.

According to the FDA, Reynolds failed to demonstrate that permitting marketing of the products would be appropriate for public health.

British American Tobacco (BAT), of which R.J. Reynolds Vapor Co. is an indirect subsidiary, said in a statement that the company “will immediately challenge the FDA-issued marketing denial orders (MDOs) seeking a stay of enforcement.”

“This decision flies in the face of proven science and is contrary to the FDA’s stated goal of reducing the health effects of tobacco use,” said Kingsley Wheaton, chief strategy officer and growth officer, BAT. “This disappointing decision would harm, not benefit, public health. We believe appropriately regulated flavored vaping products—including menthol—are critical in supporting adult smokers migrating from combustible cigarettes.”

Wheaton also called the decision arbitrary, stating that the sole ground for the decision was “the absence of long-term consumer switching data for these products. This is a capricious decision, considering a year-long data package was presented at the Food and Drug Law Institute’s Tobacco and Nicotine Regulatory Product Science Symposium … with FDA in attendance. We will publish a summary of these data on our website in the coming days.”

Wheaton also said, “Central to the efficacy of any regulated market is the rule of law—where good behavior is encouraged and bad behavior punished. Without a properly functioning regulatory regime, illicit markets grow that endanger the public, irresponsible players flourish, responsible players are penalized, the purposes of the underlying regulations are undermined and consequently adult smokers who would like to transition to reduced risk products are let down.”

In September, the FDA fined retailers for selling what it deemed youth-appealing e-cigarettes.