Recently, the FDA issued marketing denial orders (MDO’s) upon two products from Vuse Solo brand. Vuse is the second most popular brand of electronic cigarettes that young people “usually” use, according to the 2022 National Youth Tobacco Survey (NYTS). Specifically, these MDO’s were placed upon two menthol e-cigarette products, banning R.J. Reynolds Vapor Company from marketing or distributing these products within the United States. These products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2. Upon reviewing the company’s premarket tobacco product applications (PMTAs), a public health standard that considers the product’s risks and benefits, the FDA decided that marketing these products would not be appropriate for protection of public health. More specifically, the applicant’s evidence did not show that its menthol-flavored e-cigarettes are better for adult smokers than tobacco-flavored e-cigarettes.

However, now the federal Fifth Court has granted a stay, allowing the products to remain – provisionally – in the marketplace. More than 30 companies have challenged the FDA’s denials in court, many of which have led to temporary stays. Reynolds stated that they are “pleased” with the stay and “remain confident in the quality of all of Reynolds’ applications”.

Regulation based on youth appeal

The NYTS shows there is an increased youth appeal and use within non-tobacco-flavored e-cigarettes, including menthol-flavored. Tobacco-flavored e-cigarettes, on the other hand, are not as popular with young people and do not carry the same level of risk. Therefore, applicants must provide solid proof that using their menthol-flavored e-cigarette products is likely to promote complete switching or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes. The applicant did not sufficiently provide this evidence.

Which products have been approved and why?

This is one of a number of steps the FDA has taken to ensure that any tobacco products sold in the United States are subjected to a scientific evaluation before being granted marketing authorizations. Only 23 tobacco-flavored e-cigarette products and devices have been approved by the FDA so far, making them the only e-cigarettes that can legally be sold or distributed in the United States at this time; this includes the Vuse Solo electronic cigarette and two tobacco-flavored e-liquid cartridges that come with it. The agency has turned down marketing applications for millions of products that didn’t meet the minimum requirements of the guidance.

So will the FDA approve any menthol or other flavors in the future? Stay tuned.

Scott Mayo

Client Program Manager, III