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

FDA Releases Additional Regulatory Science Policy Memoranda on PMTA

Regulations by 2FIRSTS.ai
May.15.2024
FDA Releases Additional Regulatory Science Policy Memoranda on PMTA
FDA announces new regulatory science policy memoranda focusing on premarket tobacco product application (PMTA) review roles, responsibilities, and processes.

According to the US Food and Drug Administration (FDA), on May 14th, the FDA released an additional regulatory science policy memorandum focusing on internal roles, responsibilities, and processes related to the Pre-Market Tobacco Product Application (PMTA) review.

 

The five memorandums released this time were completed between 2020 and 2022.

 

These memoranda describe the internal roles and responsibilities for reviewing scientific disciplines and marketing information. One memorandum also discusses the FDA's approach to acceptance and filing reviews in development, including prioritizing certain non-tobacco nicotine product applications received before November 4, 2021.

 

These 5 memos include:

 

August 3, 2020: Guidelines for the review and evaluation of marketing plans for the Office of Health Communication and Education March 4, 2021: Clarification on harmful and potentially harmful constituents (HPHC), aerosol and smoke production, and Biomarkers of Exposure (BOE) data in relation to the Premarket Tobacco Product Application (PMTA) review responsibilities of the Division of Individual Health Science (DIHS), Division of Product Science (DPS), and Division of Non-Clinical Science (DNCS) March 30, 2022: Clarification of PMTA review responsibilities between the Division of Population Health Science and Division of Individual Health Science May 2, 2022: Supplementary explanation of guidelines for the review and evaluation of marketing information for PMTA from the Office of Health Communication and Education June 1, 2022: Implementation of new PMTA acceptance and filing review processes in accordance with the new requirements of 21 CFR 1114.

 

Furthermore, the memorandum to be released should not be used as a tool, guide, or manual for preparing applications or submissions to the FDA. For applicants seeking to sell new tobacco products, the FDA has already issued final regulations, such as the PMTA Final Rule, which describe the required content, format, and review process for PMTAs, as well as guidance documents.

 

References:
[1] FDA Posts Additional Regulatory Science Policy Memos
Also Read:
[1] John Verbeten Appointed Compliance Office Director by FDA-CTP in 2024
[2] FDA to Host Webinar Celebrating 10th Anniversary of "The Real Cost" Campaign
[3] Consumers and Advocates Welcome FDA-CTP's Health Findings
[4] FDA Issues Warnings to 14 Online Retailers for Unauthorized E-Cigarettes
[5] FDA and DOJ Seize $700k Worth of Illegal E-Cigarettes
[6] FDA Issues MDO on 65 "MNGO Disposable Stick" Vapes of Shenzhen YIBAI Technology
[7] Second Lawsuit Filed Against FDA for Failing to Ban Menthol Cigarettes
#North America#United States#Regulation#FDA#Heated 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
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden's Public Health Agency has found ingredient labels on ZYN nicotine pouches sold by Philip Morris International subsidiary Swedish Match to be noncompliant, according to Dagens industri. The products' packaging listed 10 to 13 ingredients, compared with 11 to 42 in regulatory submissions, with multiple flavoring ingredients grouped under the generic term "aromer." The agency ordered corrective action, warning of a conditional penalty of SEK 2 million per month for noncompliance. The order applies only to products manufactured after the decision becomes legally effective and does not require recalls. Swedish Match disputes the agency's interpretation and plans to appeal.
PMI
Oct.22
PMI Launches Fourth IQOS Convenience-Store Discount of 2026 for Black Friday in Japan, Cutting ILUMA i ONE to About $19 After Ploom AURA Fell to About $9
PMI Launches Fourth IQOS Convenience-Store Discount of 2026 for Black Friday in Japan, Cutting ILUMA i ONE to About $19 After Ploom AURA Fell to About $9
Philip Morris Japan launched its fourth confirmed nationwide convenience-store discount campaign for IQOS ILUMA i devices in 2026 on October 26, cutting three models by as much as ¥2,000, or about $12.70. The campaign began one day after JT ended a promotion that reduced Ploom AURA to ¥1,480, or about $9.40. JT says Ploom's share of Japan's heated-products category rose from 10.9% in January 2024 to 18.3% in June 2026, a gain of 7.4 percentage points, while PMI says IQOS still held about 68% category share in the third quarter. At the same time, Japan's two-stage heated-tobacco tax adjustment has pushed stick prices higher, leaving device discounts as an increasingly important tool for lowering the upfront cost of customer acquisition.
Market
Oct.28
2Firsts Data｜China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
2Firsts Data｜China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
China exported $979 million of vape-related products in August 2026, up 3.3% from a year earlier but down 6.4% from July. The UK replaced the U.S. as the main source of growth: UK-bound shipments jumped 51.4% to a 2026 high of $177 million, while exports to the U.S. fell 12.4% to $339 million. Shipments to markets outside the U.S. increased 14.2%, broadening growth beyond the market that had driven July’s rebound.
News
Sep.23 by 2Firsts Perspectives
Product | KT&G Launches lil HYBRID 3.0 Misty Rosé Edition II in South Korea With Two Pink Finishes at 88,000 Won
Product | KT&G Launches lil HYBRID 3.0 Misty Rosé Edition II in South Korea With Two Pink Finishes at 88,000 Won
South Korean tobacco company KT&G launched the limited-edition lil HYBRID 3.0 Misty Rosé Edition II on September 30, 2026, following the original Misty Rosé Edition introduced in November 2025. The new release comes in two pink finishes, Bloom Rosé and Viva Rosé, each priced at 88,000 won. Both versions initially went on sale through the lil Store online shop and lil MINIMALIUM flagship stores. From October 7, Bloom Rosé became available at approximately 1,500 lil Station retail outlets nationwide. The release retains the existing lil HYBRID 3.0 hybrid heated tobacco platform, with changes focused on exterior design and distribution.
product
Oct.10
Product | KUMI SCENIC 50K Offers Nicotine and 6-Methyl Nicotine Versions as 6-MN Products Appear in Multiple U.S. State Directories, With Louisiana Listing FDA Exemption
Product | KUMI SCENIC 50K Offers Nicotine and 6-Methyl Nicotine Versions as 6-MN Products Appear in Multiple U.S. State Directories, With Louisiana Listing FDA Exemption
An October 2026 review of U.S. state vapor product directories found KUMI 6 SCENIC 50K listed in Louisiana and Nebraska. Louisiana classifies 20 related product entries as “FDA EXEMPTION.” The SCENIC platform is marketed in both conventional nicotine-salt and NoNic6 formulations, each advertised with 22mL e-liquid capacity and up to 50,000 puffs. U.S. wholesaler Midwest Goods listed both versions in August 2025 with a suggested retail price of $19.99 each. The NoNic6 version is associated with 6-methylnicotine and is also marketed by some distributors as “nicotine-free.”
product
Oct.27
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
Related Topics
News Regulation
Related Read
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
PMI Launches Fourth IQOS Convenience-Store Discount of 2026 for Black Friday in Japan, Cutting ILUMA i ONE to About $19 After Ploom AURA Fell to About $9
PMI Launches Fourth IQOS Convenience-Store Discount of 2026 for Black Friday in Japan, Cutting ILUMA i ONE to About $19 After Ploom AURA Fell to About $9
2Firsts Data｜China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
2Firsts Data｜China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
2Firsts Perspectives
Product | KT&G Launches lil HYBRID 3.0 Misty Rosé Edition II in South Korea With Two Pink Finishes at 88,000 Won
Product | KT&G Launches lil HYBRID 3.0 Misty Rosé Edition II in South Korea With Two Pink Finishes at 88,000 Won
Product | KUMI SCENIC 50K Offers Nicotine and 6-Methyl Nicotine Versions as 6-MN Products Appear in Multiple U.S. State Directories, With Louisiana Listing FDA Exemption
Product | KUMI SCENIC 50K Offers Nicotine and 6-Methyl Nicotine Versions as 6-MN Products Appear in Multiple U.S. State Directories, With Louisiana Listing FDA Exemption
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
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