The e-cigarette maker, Juul Labs Inc, seeks FDA approval for its next-generation vaporizer, already available in the U.K. and Canada. The company is waiting for word on whether its current products can stay on the market.
Earlier this year, Altria Group Inc MO divested Juul Labs recording a loss of at least $12.5 billion. Altria acquired a 35% stake in Juul Labs for $12.8 billion in 2018.
The new device boasts age-verification features and prevents the use of unauthorized refill cartridges. The FDA application includes one flavor, Virginia Tobacco, with a nicotine concentration of 18 mg per mL, similar to the levels sold in the U.K. and Canada.
Juul aims to address past FDA technical issues that led to a market ban on its existing products.
Juul Labs claims the new vaporizer poses fewer health risks and hopes it will appeal to adult smokers seeking safer alternatives, Wall Street Journal reported.
However, Juul hasn't decided whether to market the device under its current brand or a new name.
All e-cigarette manufacturers must submit new products for FDA review. Juul presented scientific research demonstrating reduced carcinogen exposure compared to cigarettes and emphasizing the benefits for adult smokers while addressing concerns about nicotine addiction among youth.
Juul continues researching additional flavors like menthol, taking steps to prevent underage access. The company adopts a "shots-on-goal" approach, presenting various products to regulators for potential approval.
The new device incorporates better temperature controls to minimize toxic substances and utilizes an app for usage tracking.
Juul's latest research showed a significant portion of smokers switching to the new device in the U.K. market. While Juul's popularity among young people has declined, disposable brands like Elf Bar have gained traction among youth vapers.
In April, Juul Labs agreed to pay $462 million to six states and the District of Columbia for its role in the youth vaping surge.
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