This time, the FDA has rejected two menthol refills for the Vuse Solo, another menthol-flavored vaping product. The Solo vaping device and its refills with a tobacco flavor were the first to be approved for sale by the FDA in 2021. The Solo is an outdated cigalike-style vape that uses screw-on prefilled cartomizer refills and is powered by a battery fashioned like a cigarette.
The FDA stated in a news release that because menthol e-cigarettes "have a known and substantial risk with regard to youth appeal, uptake and use," they did not fulfill the agency's "appropriate for the protection of public health" threshold.
The FDA has issued marketing denial orders (MDOs) for millions of flavored e-liquids and pre-filled devices since it started rejecting premarket tobacco applications (PMTAs) in August 2021. However, the majority of menthol products were not reviewed until after Brian King was named director of the FDA's Center for Tobacco Products last summer.
There were rumors that the FDA will approve certain menthol products as safer substitutes for those who smoke the agency's planned ban on menthol cigarettes. But since King took office, the FDA has rejected requests for menthol refills for a number of previously approved mass-market vaping products, starting with the Logic Pro and Logic Power refills.
The Third Circuit Court of Appeals granted Logic a temporary stay of the denial order after Logic promptly challenged the FDA decision in court. The CTP director's office (both before and after King took over) exerted pressure on the CTP Office of Science to deny Logic's menthol refills after the science office first recommended authorization, according to CTP papers uncovered during Logic's case.
The Vuse Ciro and Vuse Vibe were two previously approved Vuse devices. In January, the government issued MDOs for menthol refills. The Fifth Circuit Court of Appeals granted Vuse producer R.J. Reynolds a temporary stay of the marketing denial order (MDO) one day after it was issued.
Reynolds will most likely challenge the Vuse Solo menthol MDO in court because it contradicts the menthol denials made by Ciro and Vibe. Reynolds most likely worries about a future denial order for the Vuse Alto and its menthol refills, even if none of the three approved Vuse products are particularly well-liked. In contrast to the other three Vuse products, the Alto leads the vaping products market in the convenience store/gas station category. The FDA is still reviewing the Alto PMTA.
The FDA falsely claims in its news release that Vuse is the “second most common brand youth e-cigarette users reported 'usually' using” based on data from the National teenage Tobacco Survey. The FDA is aware that the three Vuse products that are permitted by the agency—as well as their menthol refills—are not well-liked by consumers of any age. The widely used Vuse Alto is mostly mentioned in the NYTS data.
Recently, R.J. Reynolds requested that the FDA take action against the widely used disposable vapes that presently rule the c-store and gas station vape markets.
