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On June 6th, the American e-cigarette brand JUUL issued a statement announcing that the U.S. FDA has rescinded its Marketing Denial Orders (MDOs) for JUUL products scheduled for June 2022, and will reevaluate JUUL's application through the scientific review process.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

West Virginia Senate Backs Vape Tax Increase to Offset Income Tax Cut
West Virginia Senate Backs Vape Tax Increase to Offset Income Tax Cut
The West Virginia Senate approved a 10% personal income tax cut on February 22, 2026, with part of the revenue offset coming from increased excise taxes on vape and e-cigarette products.
News
Feb.23
Costa Rica’s Constitutional Court Rejects Challenge, New Vape Rules to Take Effect on August 6
Costa Rica’s Constitutional Court Rejects Challenge, New Vape Rules to Take Effect on August 6
Costa Rica’s Constitutional Court has rejected an injunction seeking to stop a new vape regulation from taking effect, ruling that there was no specific harm to constitutional rights. As a result, Technical Regulation RTCR 519-2025, promoted by the Health Ministry, will enter into force on August 6 as originally planned.
Mar.20 by 2FIRSTS.ai
Sesh Launches 200-Pouch Refill Bag, Expanding Retail Unit Size in U.S. Nicotine Pouch Market
Sesh Launches 200-Pouch Refill Bag, Expanding Retail Unit Size in U.S. Nicotine Pouch Market
According to a LinkedIn post published by Sesh CMO Josh Metz on February 25, 2026, Sesh Products has introduced a 200-pouch nicotine pouch refill bag sold with a reusable metal can. In a U.S. MO market dominated by 20-pouch plastic cans, the product offers a larger retail unit size. The company lists a standard price of USD 49.99, with a uniform 15% discount currently applied, bringing the price to USD 42.49.
Innovation
Feb.25
Philippine Customs Seizes Illegal Vape Products Worth Up to PHP 1.4 Billion in Navotas Warehouse
Philippine Customs Seizes Illegal Vape Products Worth Up to PHP 1.4 Billion in Navotas Warehouse
The Philippine Bureau of Customs seized illegal vape products worth an estimated PHP 1 billion to PHP 1.4 billion at a warehouse in Navotas City. Customs Commissioner Ariel Nepomuceno said the operation was the agency’s largest crackdown on illegal vape products since 2024.
Mar.23 by 2FIRSTS.ai
PMTA Manufacturing Panel Sees Small Firms Warn “Unknown Is Death” as FDA Defends Review Boundaries
PMTA Manufacturing Panel Sees Small Firms Warn “Unknown Is Death” as FDA Defends Review Boundaries
During FDA’s Feb 10 PMTA roundtable (manufacturing controls panel), small ENDS manufacturers warned that uncertainty in manufacturing expectations creates existential financial risk. FDA officials reiterated review flexibility is constrained by statutory and scientific boundaries. The panel debated testing standards, documentation requirements, open-system responsibility, supply chain changes, and software updates—highlighting unresolved PMTA challenges for small manufacturers.
Feb.11
FDA Outlines Manufacturing Requirements as Critical to ENDS PMTA Success
FDA Outlines Manufacturing Requirements as Critical to ENDS PMTA Success
FDA officials said manufacturing consistency is a core prerequisite for ENDS PMTA reviews, not a procedural formality. During its February 10, 2026 roundtable, the agency outlined expectations for quality management systems, manufacturing documentation, nicotine control, stability studies, and risk mitigation, emphasizing that robust manufacturing evidence underpins determinations of whether products are appropriate for the protection of public health.
Feb.11