FDA Issues Sales Ban on Vuse Solo Menthol E-Cigarette Products

On March 17th, the US Food and Drug Administration (FDA) issued a ban on the sale of two menthol-flavored e-cigarette products from the Vuse Solo brand owned by Reynolds American Inc. The ban is applicable to "Vuse Replacement Cartridge Menthol 4.8% G1" and "Vuse Replacement Cartridge Menthol 4.8% G2".

Currently, Renault is not allowed to sell these products in the United States or they will face enforcement action from the FDA. However, the company can resubmit an application to address the product defects involved in the MDO constraints.

The FDA has requested that applicants disclose whether mint-flavored e-cigarettes are more beneficial compared to tobacco-flavored e-cigarettes.

The FDA evaluates tobacco products for public health standards before they can be marketed through a Pre-Market Tobacco Application (PMTA). Upon reviewing the company's PMTA, the FDA determined that the application lacked sufficient evidence to prove that allowing the product to be sold would be in the best interest of public health, as required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, the evidence presented by the applicant did not demonstrate that mint-flavored e-cigarettes were less harmful to the adult smoking population compared to tobacco-flavored e-cigarettes.

Existing evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), suggests that non-tobacco flavored e-cigarettes, including mint-flavored e-cigarettes, pose significant risks in terms of attraction, intake, and use among youths. In contrast, data indicates that tobacco-flavored e-cigarettes do not have the same appeal to young people and therefore do not pose the same risks. Given these existing differences in youth risks, the applicant needs to provide strong evidence to demonstrate that the use of their mint-flavored e-cigarette products can greatly reduce cigarette use among adult smokers compared to tobacco-flavored e-cigarettes.

According to data from The New York Times, Vuse is the second most popular brand among teenage e-cigarette users. The FDA aims to ensure not only that the manufacturers comply, but also that the distributors and retailers comply. Retailers who have any doubts about their inventory should contact Reynolds.

This is not the first action taken by the FDA.

This recent action is just one of many taken by the FDA to ensure that tobacco products sold in the United States undergo scientific review and receive PMTA approval. So far, the agency has received over 26 million PMTA applications and has made decisions on 99% of them. Currently, the FDA has approved 23 flavored electronic cigarettes for sale or distribution in the United States, which are the only ones allowed on the market legally.

The FDA has also rejected millions of non-compliant marketing applications, including 10 non-tobacco-flavored e-cigarette pods under the Vuse Solo brand. On January 24 of this year, the FDA also issued marketing bans (MODs) for two products by Reynolds American Inc., including the Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%.

In October 2022, the FDA issued an MDO (Modified Risk Order) for several mint-flavored e-cigarette products sold by Logic Technology Development. This was the first time the FDA had issued an MDO for products containing menthol after undergoing scientific review. However, a few days later, Logic received an order from the US Third Circuit Court of Appeals, which temporarily suspended the MDO's enforcement.

References:

The FDA has refused to allow two Vuse Solo menthol e-cigarette products to be marketed.

Related reading:

The FDA has announced that it has rendered decisions on 99% of the PMTA applications for electronic cigarettes, and intends to review the remaining popular products by the end of the year.

The FDA issues a marketing refusal order for two Vuse products.

Renault, a tobacco company owned by British American Tobacco, plans to appeal against the marketing ban imposed by the FDA.

The FDA has filed civil lawsuits and imposed fines against four electronic cigarette liquid manufacturers for the first time.

The FDA has scheduled a public hearing on April 12th to discuss the creation of new regulations for the manufacturing of tobacco products.