FDA rescinds ban on Juul products

(The Hill) – The Food and Drug Administration (FDA) announced it was rescinding its order to ban the sale of Juul electronic cigarettes, or 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 at the time the company had failed to prove keeping its products on the market “would be appropriate for the protection of the public health.”

Juul products have been available for purchase since then, as the agency paused its ban later that same year, citing the need for additional review. Juul also sued the FDA for not disclosing documents that the agency said supported the decision to ban Juul products.

Juul products are displayed at a smoke shop in New York, on Dec. 20, 2018. Embattled vaping company Juul Labs announced layoffs Thursday, Nov. 10, 2022, as the company tries to weather growing setbacks to its electronic cigarette business, including lawsuits, government bans and increasing competition. (AP Photo/Seth Wenig)

“Today, the FDA rescinded the MDOs issued in June 2022 to JUUL Labs, Inc. This action is being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant,” the FDA said in a statement Thursday.

“Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied,” said the agency. “Rescission 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 a marketing authorization for JUUL products,” said the company.

“We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate 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 youth. The 2023 National Youth Tobacco Survey released in November found that tobacco use decreased in 2023 among high school students and rose among middle schoolers. E-cigarettes remained the most popular product for the 10th year in a row among this cohort, while cigarette and cigar use reached an all-time low.