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On June 6th, the American e-cigarette brand JUUL issued a statement announcing that the U.S. FDA has rescinded its Marketing Denial Orders (MDOs) for JUUL products scheduled for June 2022, and will reevaluate JUUL's application through the scientific review process.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

References:

[1] JUUL LABS STATEMENT ON THE FDA’S RESCISSION OF ITS 2022 MARKETING DENIAL ORDERS

Also Read:

[1] Colorado Department of Justice Allocates $20M for Youth Mental Health

[2] Colorado Schools Receive $11.4 Million Settlement from Juul

[3] Tucson Unified School District Receives $7 Million Settlement Funds from JUUL

[4] Wisconsin Health Department Funds Anti-Smoking E-Cigarette Initiative

#North America #United States #Legislation #Open system e-cigarettes #FDA #Product

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

PMI's ZYN Launches Low-Nicotine Product Promotion in UK and Philippines

Philip Morris International's ZYN launches "X-Low" low nicotine pouches targeting adult users seeking lower intake or smoke-free options.

Dec.09 by 2FIRSTS.ai

South Korea Plans Unified Regulation for Synthetic and Look-Alike Nicotine Products

South Korea Parliament discusses including "nicotine" in Tobacco Business Act; synthetic nicotine testing method established, awaiting legislation approval.

Oct.22 by 2FIRSTS.ai

Cambodia MoT warns: Businesses using vaping and shisha will have their operating licences revoked

Cambodia’s Ministry of Tourism has issued a new directive prohibiting all tourism service establishments from possessing, selling, importing, storing, or advertising e-cigarettes and shisha-related products. Violators will face written warnings, suspension of operations, or even revocation of their tourism business licenses. The measure is part of a nationwide ban enacted under Sub-Decree No. 02 BB, issued by the Royal Government on October 21.

Nov.21 by 2FIRSTS.ai

Philip Morris Korea Launches New TEREA Packaging for IQOS ILUMA to Mark Third Anniversary

Philip Morris Korea has announced a new packaging design for TEREA, the dedicated tobacco stick brand for its heat-not-burn device IQOS ILUMA, to celebrate the third anniversary of its launch in South Korea. The newly designed products are now available at nine IQOS flagship stores and major convenience stores across the country.