Vaping giant Juul wins key regulatory battle in US
The US Food and Drug Administration (FDA) had originally banned the vapes as Juul did not prove its products would be 'appropriate for the protection of the public health', although this measure was suspended after two weeks to conduct a scientific review.
On Thursday, Juul Labs said that the FDA had officially authorised it to market its vaping system and refill capsules. The decision means Juul can continue to sell products that have been on the US market.
The well-known e-cigarette brand was available on the Irish market for only two years after being launched in 2019. Juul Labs exited several European markets at the end of 2020.
Its products were authorised for sale in the US as the benefits for smoking cessation were 'sufficient to outweigh the risks of the product,' including to anyone not using tobacco products.
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Juul markets its products as providing a public health benefit because they can shift smokers away from cigarettes closely linked to deadly illnesses.
But the company has been criticised for its marketing practices, agreeing to pay $438.5m (€375.93m) in a 2022 settlement with 34 US states to resolve accusations of marketing to underage smokers.
Juul won the new marketing granting orders (MGO) after submitting more than 110 scientific studies to the agency, it said in a statement.
'Following rigorous evaluation of the data, FDA decided that an MGO for the Juul System was 'appropriate for the protection of public health' – the standard required by statute for authorisation,' Juul said.
However, a spokesperson for the US Department of Health and Human Services said its decision 'does not mean these tobacco products are safe, nor are they 'FDA approved''.
The Department also indicated it will continue to monitor Juul's compliance with youth marketing restrictions.
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