FEELM Issues Press Statement on FDA’s First Vaping Product Authorization
FEELM made the following statement regarding the FDA’s first vaping product authorization:
On Oct 12, 2021, the U.S Food and Drug Administration (FDA) has granted marketing orders for Vuse Solo, closed electronic nicotine delivery system (ENDS) and accompanying tobacco-flavored e-liquid pods of R.J.Reynolds Vapor, allowing the products to be legally sold in the United States. It is the first set of ENDS products authorized by the FDA through the Premarket Tobacco Product Application (PMTA), marking a milestone for the global vaping regulations. It sends a positive message to the global atomization industry for it is the first time that a vaping product is authorized by a health regulator, indicating that FDA has embraced vaping’s potential to improve public health.
The scientific data submitted by R.J.Reynolds Vapor has demonstrated the health benefits of Vuse tobacco-flavored ENDS. According to FDA, “under the PMTA pathway, manufacturers must demonstrate to the agency that marketing of the new tobacco product would be appropriate for the protection of the public health. “
Remarkably, the authorization only applies to the tobacco-flavored cartridge and FDA has simultaneously issued marketing denial orders (MDOs) for other flavors submitted under Vuse Solo. It could represent a direction of vaping regulations of FDA and other regulators: ENDS products shall be only used as a tool to help smoking cessation while preventing a new generation of nicotine addiction. Since the U.S federal flavor ban went into effective in February 2020, it has been clear that FDA is highly concerned with the alleged association between youth vaping and flavors.
Meanwhile, Vuse Alto, another flagship product of R.J.Reynolds Vapor is awaiting further review from FDA. In September 2020, the company has completed the PMTA submissions of Vuse Alto, which is powered by FEELM ceramic coil. The authorization of Vuse Solo by FDA is a sign of more authorizations of ENDS products to come.
Vuse has become the fastest-growing vapor brand. It has accounted for over 26% market share in the top five markets, being the market leader in Canada, the UK, France and Germany. In the U.S, e-cig category volume growth slightly decelerates while Vuse continues to outperform in 2021, making it the second largest and fastest-growing market player in this country. As the industry’s first vapor brand authorized by FDA, Vuse is expected to continue its growth momentum by virtue of its first-mover advantage and its industry-leading ceramic coil.
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