The Food and Drug Administration (FDA) has announced that it is rescinding its order banning the sale of Juul e-cigarettes in light of new case law.
About two years ago, the FDA banned Juul from selling and marketing its e-cigarette products, saying the company had failed at the time to prove that keeping its products on the market would be “appropriate for the protection of public health'.
Juul products have been on sale ever since, as the agency paused sales later that same year due to the need for additional review. Juul also sued the FDA for failing to make public documents that the agency said supported the decision to ban Juul products.
“Today, the FDA revoked the MDOs issued to JUUL Labs, Inc. in June 2022. had been issued. This action is being taken in part as a result of the new case law, as well as the FDA's review of the information provided by the applicant,” the FDA said in a statement Thursday.
“The revocation of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied,” the agency said. “Withdrawal of the MDOs returns the applications to pending status, under substantive review by the FDA.”
Juul welcomed the news in a statement released shortly after the FDA's decision was announced.
“We appreciate the FDA's decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue marketing authorization for JUUL products” , the company said.
“We remain confident in the quality and content of our applications and believe that a full assessment of the science and evidence will demonstrate that our products meet the regulatory standard of being suitable for the protection of public health.”
When the FDA issued its ban in 2022, officials cited the role Juul played in increasing tobacco use among young people. The 2023 National Youth Tobacco Survey, released in November, found that tobacco use decreased among high school students and increased among high school students in 2023. E-cigarettes remained the most popular product among this cohort for the tenth year in a row, while cigarette and cigar use reached an all-time low.
