American e-cigarette maker Juul Labs announced Thursday that it has received approval from the U.S. Food and Drug Administration (FDA) to sell several products in the United States, including the device itself and menthol pods.
"Following a rigorous evaluation of the data, the FDA has determined that an MGO (authorization for sale, editor's note) for the Juul system is 'appropriate for the protection of public health,' the standard required for authorization," the company said in a statement, adding that it had provided more than 110 scientific studies as part of the applications filed in 2020.
The company hit a rough patch when U.S. health officials banned the sale of its products in the United States in June 2022, a decision later temporarily lifted under conditions by an appeals court.
These products were therefore able to remain on the market while the FDA conducted an in-depth study to assess their impact, a Juul spokesperson explained to AFP.
This review is now complete and they are now fully "cleared by the FDA," he noted.
A spokeswoman for the Ministry of Health said the authorization issued Thursday covered five products: the device itself and four capsules, two flavors (Virginia tobacco and menthol) in two nicotine dosages each (3% and 5%).
Calling the green light "an important milestone for the company and for consumers," Juul said in its statement that it allows it to submit marketing applications for its new system, the Juul2, and for additional flavors.
According to a Juul spokesperson, this has already been done for the new device and for the new Virginia tobacco and menthol pods, which are currently under review by the FDA.
– Anti-smoking –
Their possible commercialization in the United States, particularly the timing, will depend on the decision of this body, he added.
Menthol is one of the most sought-after flavors. Menthol cigarettes are considered a gateway to smoking, particularly encouraging young people to start smoking.
"The FDA determined that the evidence provided by the company (...) demonstrated that these specific products met the legal criteria (...) for marketing these products in the United States," the ministry spokeswoman added.
According to her, the data – including from a two-year cohort study – showed "a high rate of adults" completely abandoning traditional cigarettes to switch to Juul products (Virginia tobacco or menthol).
But, she cautioned, a sales authorization does not mean that these products are safe or that they are approved by the FDA, which will "closely monitor compliance with the rigorous restrictions to limit the exposure of young people to marketing operations."
Juul agreed in April 2023 to pay $462 million to six US states and the capital Washington for targeting young people, and also submitted to marketing restrictions.
A few months earlier, it had agreed to pay $438.5 million to 34 US states or territories.
Several thousand complaints had been filed against him.
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