FEELM Issues Press Statement on FDA’s First Vaping Product Authorization

Rhea-AI Summary

On October 12, 2021, the FDA authorized the marketing of Vuse Solo, the first vaping product to receive approval through the Premarket Tobacco Product Application (PMTA). This milestone signifies FDA’s acceptance of vaping's potential public health benefits. However, other flavor variants submitted by R.J. Reynolds were denied, reflecting the agency's focus on preventing youth nicotine addiction. With a market share exceeding 26% in key markets, Vuse is positioned as a leading vapor brand, expected to maintain growth due to its first-mover advantage and innovative ceramic coil technology.

Positive

• FDA authorized Vuse Solo, marking the first vaping product approval under PMTA.
• Vuse holds over 26% market share in major markets, leading in Canada, UK, France, and Germany.
• Vuse's innovative ceramic coil technology positions it competitively in the market.

Negative

• FDA denied marketing for other flavors of Vuse Solo, indicating regulatory challenges.
• The authorization may limit flavored ENDS products, affecting future offerings.

SHENZHEN, China--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211021006142/en/

Media:

FEELM

feelm@smoorecig.com

Frankie Chen, (+86)13530848319, frankie.chen@smoorecig.com

Source: FEELM

FAQ

What was the significance of the FDA's authorization for Vuse Solo on October 12, 2021?

The FDA's authorization marked the first approval of a vaping product under the Premarket Tobacco Product Application (PMTA), indicating acceptance of vaping's potential health benefits.

What market share does Vuse hold in the vaping industry?

Vuse accounts for over 26% market share in top markets, being the leader in Canada, the UK, France, and Germany.

What flavors were denied by the FDA for Vuse products?

The FDA issued marketing denial orders (MDOs) for all flavors of Vuse Solo except for the tobacco-flavored cartridge.

What is the expected impact of Vuse Solo's FDA authorization on the vaping market?

Vuse Solo's FDA approval is expected to drive growth for Vuse, leveraging its first-mover advantage in the vaping market.