FDA Halts Marketing of Two Vuse Menthol E-Cigarette Products

The agency says the products do not meet public safety standards.

On January 24, the US Food and Drug Administration issued marketing denial orders (MDOs) for two R.J. Reynolds Vapor Company menthol-flavored e-cigarette products. The products included in the MDOs are the Vuse Ciro Cartridge Menthol 1.5% and the Vuse Vibe Tank Menthol 3.0%.

The FDA says the company must stop marketing these products or could risk enforcement action. In addition, the agency intends to ensure distributors and retailers comply with the orders.

However, the company may submit new applications to address their product’s deficiencies highlighted in the MDOs.

According to the press release, after reviewing the company’s premarket tobacco product applications (PMTAs), the agency determined that the applications did not provide sufficient evidence to demonstrate that the sale of the products would be appropriate for the protection of public health. Meeting this requirement is the applicable standard mandated by the 2009 Family Smoking Prevention and Tobacco Control Act.

The FDA states that non-tobacco flavored vape products, such as menthol-flavored products, have been associated with an increased risk of use by young people. In contrast, tobacco-flavored e-cigarettes do not pose the same use risk among youth.

“Given these existing differences in youth risk,” the agency states, “applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes products.”

Despite this recent denial order, the FDA has reviewed and authorized the marketing of 23 tobacco-flavored e-cigarette products and devices in the US, including other R.J. Reynolds Vapor Company products.