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
Product | Japan Tobacco Expands Nordic Spirit Nicotine Pouch Range to Eight SKUs in Japan, Launches Melon Variant and Broadens Mint Retail Distribution
Product | Japan Tobacco Expands Nordic Spirit Nicotine Pouch Range to Eight SKUs in Japan, Launches Melon Variant and Broadens Mint Retail Distribution
Japan Tobacco Inc. (JT) launched Nordic Spirit Rich Melon Medium through selected tobacco retailers in Japan on November 2, 2026, while expanding physical retail distribution for three existing mint products previously sold through the CLUB JT online store. The melon launch brings Nordic Spirit's Japanese portfolio to eight SKUs. All four products are manufactured in Sweden, contain a standard 14 pouches per can and retail for ¥500 including tax. Since introducing Nordic Spirit in Japan in March, JT has expanded the brand's product lineup and distribution through its online store, convenience stores and selected tobacco retailers.
product
Nov.04
Special report｜Indonesia's Vape Industry Has 200 Manufacturers and $1.7 Billion in Investment. Could a Regulatory Divide Derail Its Rise as the World's No. 2 Manufacturing Hub After Shenzhen?
Special report｜Indonesia's Vape Industry Has 200 Manufacturers and $1.7 Billion in Investment. Could a Regulatory Divide Derail Its Rise as the World's No. 2 Manufacturing Hub After Shenzhen?
Indonesia's Ministry of Industry said at a November 3, 2026, policy forum that the country has about 200 electronic cigarette companies, Rp31 trillion (approximately $1.71 billion) in cumulative industry investment and around 100,000 jobs across the supply chain. The National Narcotics Agency is seeking a comprehensive ban on vape use and circulation, while the industry ministry favors tighter import, product-standard and distribution controls. Indonesia exported approximately $518 million in vaping products in 2025, and Chinese manufacturers including Smoore, GEEKVAPE and Jinjia Group have established local operations. An international logistics specialist interviewed by 2Firsts said more Chinese vape companies began production in Indonesia from the second half of 2025, accompanied by increased shipments of manufacturing equipment and investment in logistics facilities. The regulatory debate comes as Indonesia expands its role in international vaping manufacturing.
Special Report
Nov.05
Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping
Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping
The Philippines’ Bureau of Internal Revenue is intensifying enforcement against illicit vape and tobacco products ahead of the Christmas shopping season, directing regional and enforcement offices to strengthen monitoring of production sites, warehouses, distribution channels and retail outlets. The BIR destroyed 240,550 illicit vape products in August with an estimated tax liability of about PHP1.53 billion. A nationwide tax-compliance operation in July also inspected 3,590 businesses involved in tobacco and vapor products.
Regulations
Sep.17 by 2Firsts Perspectives
Special Report｜Virginia Vape Directory Shows Contrast Between Vuse and JUUL Pod Systems and CrossBar 20K, Loon Flavored Disposables
Special Report｜Virginia Vape Directory Shows Contrast Between Vuse and JUUL Pod Systems and CrossBar 20K, Loon Flavored Disposables
A 2Firsts analysis of Virginia's liquid nicotine and vapor product certification directory identified 213 product records from 15 manufacturers. Companies associated with BAT, Altria, Imperial Brands, JTI and JUUL account for 127 entries. The directory also includes independent brands CrossBar 20K, Loon and Breeze. CrossBar advertises a 13mL disposable capable of up to 20,000 puffs, while Loon has 16 disposable entries featuring fruit, cooling and beverage-related flavors. Of all records, 120 are labeled as under FDA PMTA review. Virginia introduced revised penalties on October 1, 2026, including a minimum first-violation civil penalty of $5,000 per unlisted product, alongside new retail tobacco permitting requirements.
Regulations
Oct.30
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
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Pennsylvania begins enforcing its electronic nicotine delivery system (ENDS) directory restrictions on October 19, 2026. The October 18 directory contained 163 product records from seven manufacturers, including Vuse, JUUL, NJOY, Logic and Naked 100. Geek Bar, RAZ and Lost Mary were absent. BAT, Altria, Japan Tobacco and JUUL collectively accounted for 112 records, or 68.7%, while Imperial Brands' blu had no listings. The directory included 15 disposable vape records, 40 bottled e-liquids and 10 products labeled 0mg, but no open-system refillable devices. Twenty-two manufacturer certifications remained under review. Four Logic models corresponding to Smoore's pending records were listed under the brand owner, while LYCO, OXBAR and Boulder/Rock had no approved directory entries.
Regulations
Oct.19
Related Topics
News Regulation
Related Read
Product | Japan Tobacco Expands Nordic Spirit Nicotine Pouch Range to Eight SKUs in Japan, Launches Melon Variant and Broadens Mint Retail Distribution
Product | Japan Tobacco Expands Nordic Spirit Nicotine Pouch Range to Eight SKUs in Japan, Launches Melon Variant and Broadens Mint Retail Distribution
Special report｜Indonesia's Vape Industry Has 200 Manufacturers and $1.7 Billion in Investment. Could a Regulatory Divide Derail Its Rise as the World's No. 2 Manufacturing Hub After Shenzhen?
Special report｜Indonesia's Vape Industry Has 200 Manufacturers and $1.7 Billion in Investment. Could a Regulatory Divide Derail Its Rise as the World's No. 2 Manufacturing Hub After Shenzhen?
Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping
Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping
2Firsts Perspectives
Special Report｜Virginia Vape Directory Shows Contrast Between Vuse and JUUL Pod Systems and CrossBar 20K, Loon Flavored Disposables
Special Report｜Virginia Vape Directory Shows Contrast Between Vuse and JUUL Pod Systems and CrossBar 20K, Loon Flavored Disposables
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
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
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