The US Food and Drug Administration (FDA) has issued marketing denial orders for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company, a subsidiary of British American Tobacco (BAT), under its Vuse brand.
This is the second instance of the agency banning e-cigarette products based on the flavour, following the marketing denial orders for menthol-flavoured products by Logic Technology Development, a subsidiary of JTI, in October last year.
The products affected include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.
The FDA said the applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.
“It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard,” said Brian King, director of the FDA’s Center for Tobacco Products.
BAT said the company is disappointed with the FDA decision, adding that Reynolds will seek a stay of enforcement immediately and pursue other appropriate avenues to allow Vuse to continue offering its products without interruption.
“We believe that menthol vapour products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health. Reynolds will challenge the denials,” a BAT spokesperson said.
“We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”
The company must not market or distribute these products in the US, but they may resubmit applications or submit new applications to address the deficiencies.
The FDA noted that existing evidence demonstrates a ‘known and substantial risk with regard to youth appeal, uptake and use’ with respect to non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes. In contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk.
Given these existing differences in youth risk, 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.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices.
