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Topline

The Food and Drug Administration rescinded its marketing ban on Juul Lab’s e-cigarette products Thursday—placing them back under scientific review—nearly two years after ordering a ban that was halted pending the company’s appeal.

Key Facts

The agency rescinded its marketing denial orders for the e-cigarette maker’s products after further review of information provided by Juul—as well as new case law.

Juul Lab’s products have returned to pending status and undergo review by the FDA, though no timeline has been provided and it noted agency regulations “significantly limit” what it can disclose regarding pending applications—Forbes has reached out to the agency for more information.

Juul Labs told Forbes in a statement that it appreciates the decision and looks forward to working with the agency, going on to say it remains confident in its applications and believes 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.”

The e-cigarette maker confirmed that its e-cigarette device and 5.0% and 3.0% nicotine pods in two flavors (Virginia Tobacco and Menthol) will remain on the market during the review process.

Key Background

Juul’s e-cigarette was introduced in 2015 and quickly rose in popularity, especially among teens and young adults. In November 2018, in response to the influx of youth using the e-cigarettes, Juul pulled most of its flavored pods from stores, leaving only its mint, menthol and tobacco flavors—though it discontinued its mint pods the following year ahead of a federal ban on most flavored e-cigarettes. After years of regulatory scrutiny, the FDA then issued a ban on Juul’s e-cigarette products on the U.S. market on June 23, 2022—which was temporarily halted by an appeals court the following day and the FDA issued a stay on the ban that July.

Tangent

In late April, the Biden administration once again delayed its proposed menthol cigarettes ban. Health and Human Services Secretary Xavier Becerra said the proposal “will take significantly more time” given the amount of public feedback.

Surprising Fact

E-cigarettes were the most popular tobacco product for the 10th year in a row for youth using such products, according to the FDA’s 2023 National Youth Tobacco Survey, published in November.

Further Reading

FDA Rescinds Juul Ban, Opening Door for Federal Clearance (The Wall Street Journal)

FDA Bans Juul E-Cigarettes From U.S. Market (Forbes)

Appeals Court Halts Ban On Juul Vaping Products—For Now (Forbes)

Biden Administration Again Delays Proposed Menthol Cigarettes Ban (Forbes)

Timeline: Significant events in the history of Juul (Reuters)



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