JUUL Submits a New Application to the FDA for a Next-Generation Vapor Products

Business by Jacky Yin
Jul.20.2023
JUUL Submits a New Application to the FDA for a Next-Generation Vapor Products
JUUL made a press release that it has submitted a Pre-Market Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for a next-generation of vapor. The company's submission includes comprehensive science and evidence for the new device and the new tobacco-flavoured cartridges, which have a nicotine concentration of 18 mg/mL, as well as information on innovative data-driven technologies used to restrict underage use.

Special Announcement:
This article is only for industry professional internal research and exchange, no brand, or product recommendation; minors are prohibited from reading.

 

JUUL's chief product officer, Kirk Phelps, made a statement:

"Our company DNA is product innovation. With our next-generation platform, we have designed a technological solution for two public-health problems: improving adult-smoker switching from combustible cigarettes and restricting underage access to vapor products. This is only the beginning of new tech being developed and refined for the U.S. market and abroad to eliminate combustible cigarettes and combat underage use."

 

Launching as early as 2021 in the UK, this latest e-cigarette platform, called the JUUL2 System, is said to offer a better experience for adult smokers, employing a unique authentication technology to tackle illegal products and featuring age verification technology.

 

JUUL已向FDA提交新一代电子烟产品申请 将继续对FDA进行行政上诉
JUUL2 picture | JUUL

 

Based on feedback from adult smokers, features of the next generation platform include:

  • A more consistent vapor experience that better competes with combustible cigarettes
  • A Bluetooth-enabled device with a larger, long-lasting battery and a “smart light system” that communicates battery life and e-liquid level to the user
  • Newly-designed, tamper-resistant pods that enable improved aerosol delivery
  • An innovative heating element that improves product performance and temperature-control precision
  • A unique Pod ID chip that, among other tech capabilities, prevents the use of illicit counterfeit and compatible pods with the next-generation device
  • A mobile and web-based app that enables age-verification technology, including device-locking, and real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections

JUUL describes that initial behavioral research with the new platform in the UK has shown compelling switching and use among adult smokers. Six months after purchasing the product, more than 32 percent of JUUL2 System users had completely given up combustible tobacco.

And while the JUUL System, as currently sold, has successfully converted more than 2 million adult U.S. smokers, the company hopes to bring this new technology to the more than 28 million adults in the U.S. who continue to use combustible tobacco, a leading cause of preventable death.


Additionally, the company is continuing its administrative appeal of the FDA's decision to approve the JUUL System and believes that the product will not be subject to political interference under decisions of science and evidence, and that the product will receive marketing authorization.

Finally, JUUL has attached its submitted PMTA, but none of its products have yet passed the review application.

 

JUUL Submits a New Application to the FDA for a Next-Generation Vapor Products
JUUL's PMTA submissions | JUUL

 

Reference:

【1】A TECHNOLOGICAL SOLUTION FOR PUBLIC-HEALTH PROBLEMS: JUUL LABS SUBMITS THE FIRST PMTA FOR ITS NEXT-GENERATION PLATFORM TO IMPROVE ADULT-SMOKER SWITCHING AND RESTRICT UNDERAGE ACCESS

*The content excerpted or reproduced in this article comes from a third-party, and the copyright belongs to the original media and author. If any infringement is found, please contact us to delete it. Any entity or individual wishing to forward the information, please contact the original author and refrain from forwarding directly from here.

Charlie’s Plans Q3 2026 Pilot of America’s First Age-Gated Flavored Disposable Vape
Charlie’s Plans Q3 2026 Pilot of America’s First Age-Gated Flavored Disposable Vape
U.S. vape company Charlie’s Holdings announced plans to pilot its age-gated flavored disposable vape products in hundreds of retail stores during the third quarter of 2026. The company said the products will utilize AI- and blockchain-powered age-verification technology designed to address FDA concerns over youth access and potentially create a new compliance pathway for flavored vape products.
Jun.15
U.S. Military Nicotine Policy Sparks Debate as Nicotine Pouches Enter Discussion
U.S. Military Nicotine Policy Sparks Debate as Nicotine Pouches Enter Discussion
An opinion article published by Stars and Stripes argued that the Pentagon’s January nicotine clinical guidelines overemphasize abstinence, fail to reflect the reality that about 30% of active-duty personnel use nicotine, and do not address nicotine pouches as potential harm-reduction products.
Industry Insight
Jun.08
Oral Thin-Film Technology Firm CTT Pharma Eyes U.S. Nicotine Product Trials
Oral Thin-Film Technology Firm CTT Pharma Eyes U.S. Nicotine Product Trials
CTT Pharmaceutical Holdings said it has signed a letter of intent with a U.S. company to conduct clinical trials and testing for several potential nicotine products using its patented oral thin-film technology.
Jun.18
FDA Warns Retailers Over Unauthorized Nicotine Pouches Resembling Candy and Everyday Products
FDA Warns Retailers Over Unauthorized Nicotine Pouches Resembling Candy and Everyday Products
The FDA issued warning letters to eight retailers selling unauthorized nicotine pouches and dissolvable tobacco products resembling candy, breath strips and cough drops. The action highlights rising scrutiny of packaging, youth appeal and accidental ingestion risks, as the agency clarifies enforcement priorities for unauthorized ENDS and nicotine pouch products while maintaining PMTA as the legal market pathway.
Special Report
May.21
AP Questions FDA Rationale as Glas Fruit-Flavored Vapes Won Authorization Without Added Cessation Benefit
AP Questions FDA Rationale as Glas Fruit-Flavored Vapes Won Authorization Without Added Cessation Benefit
The U.S. Food and Drug Administration (FDA) recently authorized two fruit-flavored vaping products from Glas, but a newly released agency memo shows the products did not demonstrate greater smoking-cessation benefits than tobacco-flavored e-cigarettes. The Associated Press said the findings are likely to raise further questions about the FDA’s regulatory rationale and standards for flavored vaping products.
Jun.12
 FDA Begins Review of 22nd Century’s VLN MRTP Renewal Applications
FDA Begins Review of 22nd Century’s VLN MRTP Renewal Applications
The U.S. Food and Drug Administration (FDA) has initiated scientific review of renewal applications for 22nd Century Group’s VLN reduced-nicotine cigarettes under the Modified Risk Tobacco Product (MRTP) pathway, with current authorizations set to expire in December 2026.
News
May.13