Reynolds Files for FDA Review of Vuse E-Cigarettes
Tobacco giant Reynolds submitted an application for some of its Vuse e-cigarettes to the FDA,seeking permission to keep its vaping products on the market.
The Reynolds filing, which totals more than 150,000 pages, gives it a jump on its two main rivals, Juul Labs Inc. and NJOY Holdings Inc. The FDA, which regulates tobacco, has given companies until May 2020 to submit any products they want to keep on store shelves after that date.
The reviews have taken on new importance as the FDA prepares to pull off the market all e-cigarettes other than those formulated to taste like tobacco in a move intended to curb a rise in teen vaping.
If that ban were implemented, manufacturers could bring sweet- and fruity-flavored products back on the market with FDA authorization. But first they must demonstrate to the agency that the products provide a net benefit to public health. The submissions must include clinical research and behavioral studies comparing the vaping products to traditional cigarettes and examining the potential risk of uptake by young people or nonsmokers.
The submission by Reynolds, the U.S. business unit of British American Tobacco PLC, covers a group of products in its Vuse Solo line of e-cigarettes, including several different flavors, company executives said. The Solo refill pods come in flavors such as melon, chai, mint and berry.
The company plans additional applications over the next several months. Reynolds has three other Vuse product lines including Alto, a rectangular vaporizer which the company is promoting as a competitor to market leader Juul.
Juul is still conducting clinical trials on its products, including mango, mint and menthol flavors, to gather information that it plans to submit to the FDA by May, according to people familiar with the matter. NJOY, the No. 2 player, is aiming to submit its application in January, according to a person familiar with the matter.
Juul last year voluntarily stopped selling its sweet and fruity flavors in bricks-and-mortar stores under pressure from regulators who blamed the startup for a rise in underage vaping. That created an opening for rivals.
Reynolds ran its first television ad for Vuse in March. In April, it put coupons for Vuse Alto on packs of Camel Crush cigarettes. Since July, the company has been selling deeply discounted Alto devices priced at 99 cents, not including refill pods. The pods come in menthol, mixed berry and tobacco flavors.
Vuse was an early entrant to the market but was eclipsed by Juul, which commands 67% of the U.S. retail market, according to Wells Fargo. Vuse accounts for 12% of e-cigarette sales, and NJOY 14%. Japan Tobacco Inc., whose Logic e-cigarettes represent 2% of the U.S. market, submitted an application to the FDA in August, a spokeswoman said.
NJOY also this year has made strong market share gains with a 99-cent promotion on its Ace vaping device. The company decided to wind down that promotion after the FDA in September announced its plan to pull most e-cigarettes off the market.
After a similar review process, the FDA earlier this year authorized a device called IQOS, which heats but doesn’t burn tobacco. Marlboro maker Altria Group Inc. launched the product in Atlanta this month in a partnership with Philip Morris International. Altria also has a 35% stake in Juul.
The reviews have taken on new importance as the FDA prepares to pull off the market all e-cigarettes other than those formulated to taste like tobacco in a move intended to curb a rise in teen vaping.
If that ban were implemented, manufacturers could bring sweet- and fruity-flavored products back on the market with FDA authorization. But first they must demonstrate to the agency that the products provide a net benefit to public health. The submissions must include clinical research and behavioral studies comparing the vaping products to traditional cigarettes and examining the potential risk of uptake by young people or nonsmokers.
The submission by Reynolds, the U.S. business unit of British American Tobacco PLC, covers a group of products in its Vuse Solo line of e-cigarettes, including several different flavors, company executives said. The Solo refill pods come in flavors such as melon, chai, mint and berry.
The company plans additional applications over the next several months. Reynolds has three other Vuse product lines including Alto, a rectangular vaporizer which the company is promoting as a competitor to market leader Juul.
Juul is still conducting clinical trials on its products, including mango, mint and menthol flavors, to gather information that it plans to submit to the FDA by May, according to people familiar with the matter. NJOY, the No. 2 player, is aiming to submit its application in January, according to a person familiar with the matter.
Juul last year voluntarily stopped selling its sweet and fruity flavors in bricks-and-mortar stores under pressure from regulators who blamed the startup for a rise in underage vaping. That created an opening for rivals.
Reynolds ran its first television ad for Vuse in March. In April, it put coupons for Vuse Alto on packs of Camel Crush cigarettes. Since July, the company has been selling deeply discounted Alto devices priced at 99 cents, not including refill pods. The pods come in menthol, mixed berry and tobacco flavors.
Vuse was an early entrant to the market but was eclipsed by Juul, which commands 67% of the U.S. retail market, according to Wells Fargo. Vuse accounts for 12% of e-cigarette sales, and NJOY 14%. Japan Tobacco Inc., whose Logic e-cigarettes represent 2% of the U.S. market, submitted an application to the FDA in August, a spokeswoman said.
NJOY also this year has made strong market share gains with a 99-cent promotion on its Ace vaping device. The company decided to wind down that promotion after the FDA in September announced its plan to pull most e-cigarettes off the market.
After a similar review process, the FDA earlier this year authorized a device called IQOS, which heats but doesn’t burn tobacco. Marlboro maker Altria Group Inc. launched the product in Atlanta this month in a partnership with Philip Morris International. Altria also has a 35% stake in Juul.
