JUUL Receives FDA Approval to Resume Product Sales

Regulations by 2FIRSTS.ai
Jun.07.2024
JUUL Receives FDA Approval to Resume Product Sales
Juul, US e-cigarette brand, welcomed FDA's decision to revoke sales refusal order and initiate scientific review process on June 6.

On June 6th, the American e-cigarette brand JUUL issued a statement announcing that the U.S. FDA has rescinded its Marketing Denial Orders (MDOs) for JUUL products scheduled for June 2022, and will reevaluate JUUL's application through the scientific review process. (See news article: American FDA revokes 2022 Marketing Denial Orders for JUUL products, restarts review process)

JUUL Receives FDA Approval to Resume Product Sales
Translation: JUUL Statement | Image source: JUUL Official Website

 

JUUL expressed the following viewpoints in their statement:

 

JUUL appreciates the FDA's decision and looks forward to re-establishing contact with the agency to seek market approval for JUUL products through a scientific and evidence-based process. 

JUUL is confident in the quality and substance of their application, believing that a comprehensive review of the science and evidence will demonstrate that JUUL products meet the safety standards required to protect public health. 

During this review period, JUUL devices and Virginia Tobacco and Mint JUULpods with 5.0% and 3.0% nicotine concentration will continue to be sold on the market.

 

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

Acting CTP Director Says FDA Cut Premarket Tobacco Application Backlog by About 70% Over the Past Year
Acting CTP Director Says FDA Cut Premarket Tobacco Application Backlog by About 70% Over the Past Year
FDA Center for Tobacco Products Acting Director Bret Koplow said at the American Tobacco and Nicotine Forum that the agency has reduced its premarket tobacco application backlog by about 70% over the past year and eliminated the acceptance queue. He said FDA has reviewed about 27 million applications, but only a small number have been authorized, mainly because most submissions lacked the scientific data needed to demonstrate public health benefits.
Apr.23 by 2FIRSTS.ai
Philip Morris Ukraine Says Ukraine’s Flavored Vape Ban Still Lacks Effective Enforcement
Philip Morris Ukraine Says Ukraine’s Flavored Vape Ban Still Lacks Effective Enforcement
Mikhail Polyakov, deputy general director for corporate affairs at Philip Morris Ukraine, said Ukraine’s ban on flavored and aromatic additives for e-cigarettes, in force since July 11, 2024, has not worked in practice because compliance is not being enforced.
Mar.17 by 2FIRSTS.ai
Japan to Raise Tobacco Taxes and Corporate Income Tax From April 1 to Help Fund Defense Spending
Japan to Raise Tobacco Taxes and Corporate Income Tax From April 1 to Help Fund Defense Spending
Japan will raise tobacco product taxes and corporate income tax from April 1 as part of a package of levies to help fund a five-year defense spending increase totaling JPY 43 trillion. Tobacco taxes will be raised in two stages, with the first increase taking effect on April 1 and the second in October, while personal income tax is planned to rise in January.
Mar.27 by 2FIRSTS.ai
Philip Morris Ukraine Says It Will Invest Another USD 10.00 Million in ZYN Nicotine Pouches This Year
Philip Morris Ukraine Says It Will Invest Another USD 10.00 Million in ZYN Nicotine Pouches This Year
Philip Morris said that after investing USD 5.00 million last year to promote its ZYN nicotine pouch brand in Ukraine, it plans to invest another USD 10.00 million this year to develop the nicotine pouch category and launch a new ZYN line.
Apr.08 by 2FIRSTS.ai
York Traders Could Face Fines of Up to GBP 200 Under New Illegal Vape Enforcement Plans
York Traders Could Face Fines of Up to GBP 200 Under New Illegal Vape Enforcement Plans
City of York Council is considering new plans that would allow fines of up to GBP 200.00 (approximately USD 260.00) for traders caught selling illegal single-use vapes.
Apr.09 by 2FIRSTS.ai
French Anti-Tobacco Group Contre-Feu Calls for Plain Packaging Across All Vaping Products
French Anti-Tobacco Group Contre-Feu Calls for Plain Packaging Across All Vaping Products
French anti-tobacco group Contre-Feu said in a statement released on April 14 that e-cigarette manufacturers are encouraging nicotine dependence among young people through targeted marketing and called for concrete measures to protect minors. The group asked for plain packaging for all vaping products, strict regulation of flavor names, and a ban on online sales.
Apr.15 by 2FIRSTS.ai