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On June 6th, the American e-cigarette brand JUUL issued a statement announcing that the U.S. FDA has rescinded its Marketing Denial Orders (MDOs) for JUUL products scheduled for June 2022, and will reevaluate JUUL's application through the scientific review process.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

Indiana Halts Sales of Elf Bar, Lost Mary, MR FOG and iJOY Vapes Under Foreign-Adversary Rules; Some Products Return After Compliance Filings
Indiana Halts Sales of Elf Bar, Lost Mary, MR FOG and iJOY Vapes Under Foreign-Adversary Rules; Some Products Return After Compliance Filings
Indiana's Alcohol and Tobacco Commission (ATC) ordered tobacco certificate holders in September to remove certain vaping products marketed under Elf Bar, Lost Mary, MR FOG, iJOY and other brands from inventory under the state's foreign-adversary product law. The agency later listed 257 MR FOG products and 77 Lost Mary product entries as lawful for sale. The Lost Mary revision expressly stated that compliance evidence had been received for 20 additional products. 2Firsts compliance expert Kurt said potential filings could include e-liquid and ingredient-origin records, U.S. nicotine-analog supply-chain documentation and FDA premarket application status.
Regulations
Oct.08
Athletes Back Skoka's $21.5 Million Nicotine Pouch Venture: Can Its Consumer Health Founder Make an FDA-Focused Strategy Pay Off?
Athletes Back Skoka's $21.5 Million Nicotine Pouch Venture: Can Its Consumer Health Founder Make an FDA-Focused Strategy Pay Off?
U.S. nicotine pouch startup Skoka Inc. has raised $21.5 million and committed $15 million to an FDA regulatory and scientific research program. Founder Dan Aziz previously built dietary supplement brand Premama, which was acquired by Dr. Reddy's Laboratories in 2023. Skoka is combining proprietary formulations, ingredient transparency and equity investment from professional athletes. The company submitted a bundled PMTA covering 55 products on October 1, 2026. Aziz said Skoka declined an opportunity to enter retail in 2025, prioritizing product research and regulatory submissions instead. It now targets a U.S. retail launch in 2027, subject to FDA requirements. Its products have not received marketing authorization.
Business
Nov.04
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin's electronic vaping device directory has been fully enforced for more than a year, and local vape retailers say the reduced range of eligible products has contributed to declining sales, store closures and layoffs. Johnny Vapes owner Ben Hall said he has closed four of seven locations and cut about 70% of his staff. State law bars the sale of vaping devices not listed on the Wisconsin Department of Revenue directory and allows penalties of $1,000 per day for each unlisted device sold or offered for sale. In April 2026, the U.S. Court of Appeals for the Seventh Circuit allowed enforcement of the law to continue.
Regulations
Oct.10
UK HMRC Launches Vape Duty Stamps on October 1, Ushering in Supply-Chain Traceability as Chinese Exporters Face New Compliance Hurdles
UK HMRC Launches Vape Duty Stamps on October 1, Ushering in Supply-Chain Traceability as Chinese Exporters Face New Compliance Hurdles
HM Revenue & Customs put the UK's Vaping Products Duty and Vaping Duty Stamps Scheme into effect on October 1. All vaping liquids manufactured in or imported into the UK are now subject to duty at £2.20 per 10ml, regardless of nicotine content. The stamp regime will introduce digital functionality designed to provide traceability throughout the supply chain, with approved manufacturers, importers and warehousekeepers required to report product movements and retailers and consumers eventually able to scan stamps to verify authenticity. China exported $177 million of vape-related products to the UK in August, up 51.4% year over year, increasing the significance of the new compliance regime for China's Shenzhen-centered vape supply chain.
Regulations
Oct.04
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
German prosecutors and customs authorities are conducting a criminal investigation into an alleged cross-border organised vape network. Authorities say that between January 2024 and March 2025, four employees of an unnamed Chinese e-cigarette manufacturer allegedly built a network of sales agents and wholesalers that brought more than 7.6 million nicotine disposable vapes into Germany, causing an estimated €33.3 million in excise-tax losses. The manufacturer has not been named. Some products visible in enforcement images have packaging resembling products from FUMOT’s portfolio. European regulatory records from 2024, FUMOT’s public overseas-sales materials and records involving German vape importer and distribution company Zamu-Pro GmbH also show FUMOT/RandM products and German distribution activity during the period covered by the investigation.
Sep.21
STIIIZY Redesign Fails to Escape PAX Labs Patent Import Ban as Section 337 Case Also Involves China ALD
STIIIZY Redesign Fails to Escape PAX Labs Patent Import Ban as Section 337 Case Also Involves China ALD
U.S. Customs and Border Protection ruled that STIIIZY had not shown that the redesigned cannabis-vape products covered by its latest request fall outside an ITC limited exclusion order tied to PAX Labs patents. CBP accepted some of STIIIZY’s claim-construction and non-infringement arguments, but the company did not address two additional claims in the same patent. Earlier STIIIZY redesigned cartridges and certain associated components imported with them had received separate CBP clearance.
Sep.16