Dive Brief:
- Juul has been granted marketing approval for five e-cigarette products, the U.S. Food and Drug Administration announced Thursday.
- The approved products include Juul’s e-cigarette device as well as Virginia tobacco and menthol-flavored Juul pods in 3% and 5% nicotine concentration varieties.
- This announcement reverses an earlier decision from the FDA, which denied Juul’s application in June 2022.
Dive Insight:
Juul can now market and sell these five items in the U.S. The FDA reached its decision after Juul submitted additional data, including a two-year-long study focused on whether Juul products can help consumers quit regular cigarettes, according to the announcement.
After the FDA denied Juul’s application in June 2022, Juul filed a lawsuit in response, prompting an appeals court judge to issue a stay. The FDA issued its own administrative stay in July 2022 for “additional review.” It later rescinded the marketing denial as it re-evaluated the e-cigarette company’s data.
“Following an extensive scientific review, the FDA determined that evidence provided by the company – including new information the company submitted in response to a deficiency letter from the FDA – demonstrates that these specific products meet the legal standard set by the 2009 Family Smoking Prevention and Tobacco Control Act,” the FDA noted in its announcement.
Juul now joins RJ Reynolds’ Vuse, Altria’s Njoy and Japan Tobacco’s Logic as the only e-cigarette products allowed to be marketed to customers in the U.S.
Juul said in a statement that the FDA’s approval “marks an important milestone” that lets the company look ahead at what’s next.
“Today’s authorization of the JUUL System, including the market-leading tobacco-flavored vapor product in the U.S., enables us to submit applications with updates to the device and pod hardware with the goal of improving the user experience,” the company said.
Marketing approval may provide a boost to Juul’s sales, since the company can now begin advertising and using other promotions. Juul is currently third in U.S. sales among e-cigarette companies, behind Njoy and Geek Bar maker Guangdong Qisitech, according to a report from Goldman Sachs. That same report noted that Juul’s sales have declined by over 14% in the past year.
Two other companies — Triton Distribution and Vapetasia — also filed suit to get their applications reconsidered. However, a Supreme Court ruling earlier this year found no improprieties in the FDA’s denial.
