Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Search

FDA to Launch Next Generation CTP Portal Next Year

Regulations by 2FIRSTS.ai
Jul.16.2024
FDA to Launch Next Generation CTP Portal Next Year
FDA to launch new CTP portal for tobacco product applications next year, streamlining submission process for SE and PMTA reports.

On July 15th, the Center for Tobacco Products (CTP) of the US Food and Drug Administration (FDA) published two notices in the Federal Register, stating their plans to launch a new generation CTP web portal next year for the submission of certain new tobacco product applications.


The purpose of this improvement is:


Integration of major Substantial Equivalence (SE) reports and Premarket Tobacco Product Applications (PMTAs), previously submitted amendments, and general correspondence into one system; introducing a more efficient submission process by eliminating the need for multiple tools (including consolidating PDF editing software, FDA's eSubmitter desktop tool, and FDA's CTP Portal web application into one place); providing tools to expedite data entry, guide applicants to relevant sections, and verify that all necessary data has been provided. No action is required for current users of any CTP system for these improvements in the works. Existing CTP Portal accounts and any pending or ongoing applications will automatically migrate to the new CTP Portal Next Generation. CTP will provide additional communication and support before the changes take effect.


As part of submitting SE reports and PMTAs in the CTP Portal Next Generation, applicants will need to enter certain information on the applicable forms. Therefore, two Federal Register notices (one regarding SE, one regarding PMTA) announced today are seeking public input on entering this information.


The public comment period will begin on July 16 and end on September 14 at 11:59 PM (Eastern Time).


References:
[1] FDA Plans to Launch Updated Submission Portal for New Tobacco Product Applications in 2025
Also Read:
[1] United States Senators Urge DOJ and FDA for E-cigarette Enforcement
[2] FDA Reissues Swedish Match MRTP Application for Public Comment
[3] FDA Updates Modified Risk Tobacco Product Orders for Swedish Match USA
[4] US Supreme Court Overturns Precedent, Impacting E-Cigarette Industry and FDA
#North America#United States#Market#FDA#Tobacco products

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

China Tobacco Regulation Shift：Policy Updates and Market Impact
China Tobacco Regulation Shift：Policy Updates and Market Impact
Yinghe-Controlled Vape Maker SKE Ordered to Post £569,039 Security as It Pursues Crystal Bar Design Infringement Case in UK
Yinghe-Controlled Vape Maker SKE Ordered to Post £569,039 Security as It Pursues Crystal Bar Design Infringement Case in UK
The UK High Court has ordered Chinese vape manufacturer Shenzhen SKE Technology to provide £569,039 ($776,000) in security for costs in its design infringement proceedings against Vapepen London and other defendants over its Crystal Bar vape product. The court did not accept the defendants’ main argument that recovering costs from a China-based company would face significant enforcement obstacles, but found that SKE had not sufficiently disclosed its own financial position. The order is procedural and does not determine the underlying infringement claims.
News
Aug.21
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
The FDA has authorized four additional on! nicotine pouches, bringing the U.S. total to 30. The decision marks another outcome of the agency’s nicotine pouch review pilot, whose communication and review practices are now being applied more broadly across the category. It also extends Helix’s authorized portfolio from on! PLUS to the earlier on! line. Yet all FDA-authorized nicotine pouches still come from subsidiaries of PMI or Altria, underscoring how concentrated U.S. regulatory access remains.
Aug.05
BAT's VELO Partners With McLaren F1 Team for Global Fan Campaign to Expand Nicotine Pouch Brand Reach
BAT's VELO Partners With McLaren F1 Team for Global Fan Campaign to Expand Nicotine Pouch Brand Reach
BAT-owned nicotine pouch brand VELO and the McLaren Mastercard Formula 1 Team have launched a global fan engagement campaign offering motorsport enthusiasts opportunities to win exclusive team-related experiences. The initiative aims to connect racing culture, fan interaction and VELO’s brand experience across global markets. The partnership reflects BAT’s broader strategy of expanding modern nicotine product brands beyond traditional tobacco categories through lifestyle and cultural marketing.
Jul.23
BAT Calls for Retailer Input in Future Nicotine Regulations
BAT Calls for Retailer Input in Future Nicotine Regulations
British American Tobacco (BAT) has called for stronger retailer involvement in shaping future nicotine product regulations in the UK, arguing that frontline market feedback should be considered during policy development. BAT said retailers provide direct insight into consumer behavior, market changes and regulatory implementation challenges. The comments come as the UK nicotine market undergoes regulatory changes, including the disposable vape ban, Vaping Products Duty and efforts to address illicit vape sales.
Jul.29
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Mesa Underwriters Specialty Insurance Company has asked a federal court in Washington to declare that it has no duty to defend or indemnify vape distributor i5 Distribution in a product liability case involving an Elf Bar BC5000. The plaintiff alleges that the disposable vape caught fire and exploded in his pocket, causing severe burns and ultimately requiring an above-the-knee amputation of his left leg. MUSIC is relying on a tobacco, nicotine or nicotine replacement products exclusion and a premises limitation endorsement. The court has not ruled on the coverage dispute.
News
Sep.10
China’s Zhengzhou Tobacco Research Institute develops end-to-end heated tobacco analysis to trace aerosol compound origins
China’s Zhengzhou Tobacco Research Institute develops end-to-end heated tobacco analysis to trace aerosol compound origins
The Zhengzhou Tobacco Research Institute of China National Tobacco Corporation has filed a patent application for an end-to-end method to analyze the migration and transformation of chemical compounds in heated tobacco products. Using GC-Orbitrap/MS non-targeted analysis, the method compares tobacco substrate and aerosol samples to distinguish compounds transferred directly from the substrate from those newly formed during heating, while also calculating transfer rates. In an example involving nine heated tobacco products, the patent identified 17 newly formed thermal decomposition compounds and 38 transferred compounds.
Aug.13
Related Topics
HEADLINE News Regulation
Related Read
Yinghe-Controlled Vape Maker SKE Ordered to Post £569,039 Security as It Pursues Crystal Bar Design Infringement Case in UK
Yinghe-Controlled Vape Maker SKE Ordered to Post £569,039 Security as It Pursues Crystal Bar Design Infringement Case in UK
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
BAT's VELO Partners With McLaren F1 Team for Global Fan Campaign to Expand Nicotine Pouch Brand Reach
BAT's VELO Partners With McLaren F1 Team for Global Fan Campaign to Expand Nicotine Pouch Brand Reach
BAT Calls for Retailer Input in Future Nicotine Regulations
BAT Calls for Retailer Input in Future Nicotine Regulations
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
China’s Zhengzhou Tobacco Research Institute develops end-to-end heated tobacco analysis to trace aerosol compound origins
China’s Zhengzhou Tobacco Research Institute develops end-to-end heated tobacco analysis to trace aerosol compound origins
FOLLOW US ON SOCIAL MEDIA
Contact: info@2firsts.com
Stay up to date.
Submit your email to receive weekly newsletter on the most relevant news of the e-cigarette industry.
© 2026 2FIRSTS. All Right Reserved.
2FIRSTS is only accessible to industry practitioners, researchers, media and other professionals. Access by minors is prohibited.
This website provides services to users outside the Chinese mainland.
English
English
中文