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 Series of Internal Memos on Tobacco Product Review Policies

Regulations by 2FIRSTS.ai
Apr.07.2024
FDA Releases Series of Internal Memos on Tobacco Product Review Policies
FDA releases internal science review policy memoranda regarding tobacco product premarket review process, enhancing transparency and commitment to stakeholders.

According to a report dated April 2, 2024, the U.S. Food and Drug Administration (FDA) recently released a series of internal scientific review policy memoranda, which reflect the FDA's internal viewpoints on certain issues in the pre-market review process for tobacco products. This move validates the commitment of the Center for Tobacco Products (CTP) to publish scientific policy memoranda and review guidance, in response to the feedback from the Reagan-Udall Foundation's 2022 operational assessment of the center.

 

The Director of the FDA Center for Tobacco Products, Dr. Brian King, stated:

 

We have received clear feedback from stakeholders that we have the opportunity to increase transparency of the center. In line with this commitment, the FDA is making public previous internal memos to further clarify the pre-review process. We plan to continue releasing such memos in a timely manner.

 

These memos provide additional transparency on the considerations of standard scientific disciplines when reviewing tobacco product applications. These memos are part of the FDA's planned release, and are the first batch to be released. This release includes six memos covering tobacco product application plans from 2019 to 2023, as well as chemical and toxicological topics involved in the review process. Generally, scientific policy memos reflect the center's internal thinking on a specific topic at a particular time. Therefore, the information contained in the memos may change, for example, due to policy changes, regulatory frameworks, or changes in standard scientific practice.

 

The memorandum released today is as follows:

 

Chemistry

  1. During the product review process before listing, attention should be paid to the filling material, cigarette paper, and adhesive of cigars, as well as the tobacco-specific nitrosamines (TSNA) in mainstream cigarette smoke. 
  2. The evaluation of chemical ingredients in e-liquid manufacturing, responsibilities in the PMTA and MRTPA review programs. 
  3. The review of smokeless tobacco products and other oral tobacco products in pre-market tobacco applications are recommended. 
  4. Methods for evaluating the differences in nicotine release characteristics, as well as assessing extractables and leachables in tobacco product applications, are also important aspects of toxicology.

 

Toxicology

 

The use of reference values for normalizing the levels of harmful and potentially harmful constituents (HPHC) in new and comparator products in ENDS PMTAs for toxicological assessments of inhaled tobacco products.

 

The release of these memos is a specific action taken in response to the sixth recommendation of the Reagan-Udall Foundation's evaluation of the CTP operations. For more information on how the FDA is addressing the RUF evaluation and the newly released memos, visit the FDA's official website.

 

Also Read:
[1] FDA Cracks down on Selling Flavored ZYN Products, 41 Physical Retailers Fined
[2] South Carolina Senators Pass Bill to Restrict E-cigarette Sales
[3] Second Lawsuit Filed Against FDA for Failure to Ban Menthol Tobacco
[4] Kentucky State E-cigarette Bill Officially Passed with Amendments
#North America#United States#Traditional tobacco#Regulation#FDA#Product

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
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s state of Victoria has activated new powers allowing Tobacco Licensing Victoria and police to shut premises suspected of selling, supplying or possessing illicit tobacco for up to 90 days. Longer closures can be ordered by a magistrates’ court. Businesses subject to closure orders must generally cease all trading and will be placed on a public list. Breaching a closure order can carry penalties of up to A$2.5 million and 20 years in prison.
Sep.10
2Firsts First Look｜China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
2Firsts First Look｜China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
China's Ministry of Finance and State Taxation Administration announced on October 12, 2026, that value-added tax (VAT) export rebates for vape devices, nicotine and its salts, and certain non-combustible inhalation products will be eliminated from April 1, 2027. The measure adds four tobacco- and nicotine-related customs codes, including 8543400010, which covers vape devices and qualifying empty pods. China previously eliminated rebates for nicotine-containing vaping products and devices under code 8543400090 in April 2026. According to industry classification information held by 2Firsts, the latter currently corresponds to heated tobacco devices. Export excise tax refund and exemption arrangements will remain unchanged.
Special Report
Oct.12
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
American Vapor Manufacturers (AVM) and Altria subsidiaries Helix Innovations and NJOY filed separate motions on October 7, 2026, seeking to intervene on the FDA's side in a lawsuit challenging its enforcement guidance for certain e-cigarette and nicotine pouch products with pending premarket tobacco product applications (PMTAs). Seven public health and tobacco-control organizations, including the Campaign for Tobacco-Free Kids, sued the agency in July to overturn the policy. AVM argues that vacating the guidance could disrupt orders, inventory, retail distribution and investments in regulatory submissions.
Regulations
Oct.09
U.S. Rep. Krishnamoorthi Questions FDA Over Planned PMTA Rewrite, Seeks Communications With Altria and Reynolds
U.S. Rep. Krishnamoorthi Questions FDA Over Planned PMTA Rewrite, Seeks Communications With Altria and Reynolds
U.S. Rep. Raja Krishnamoorthi on Oct. 6 questioned the FDA over its plan to reassess and potentially replace the 2021 PMTA regulatory framework, asking the agency to identify provisions it may change or eliminate, state whether current scientific evidentiary standards will be maintained, and disclose communications with Altria, Reynolds and other parties challenging the rule. Krishnamoorthi led a congressional investigation into JUUL and youth vaping in 2019 and has since remained active on e-cigarette regulation and enforcement.
Regulations
Oct.08
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain's cigarette volumes declined 5.2% year over year in August 2026, according to government data cited by UBS and reported by Investing.com on October 7. British American Tobacco's volumes fell 14.5%, followed by Imperial Brands at 8.8%, Philip Morris International at 6.6% and Japan Tobacco at 4.6%. JTI was the only one of the four companies to gain cigarette market share, rising six basis points to 26.7%. In France, official customs data showed an unadjusted 3.7% decline in cigarette deliveries. Adjusting for the difference in delivery days produces a decline of approximately 8.3%, consistent with the UBS figure. The bank also estimated the earnings exposure of major tobacco companies to both markets.
Market
Oct.13
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona's First Things First is pushing for an excise tax equal to 50% of the retail price of vaping products, estimating that the measure could generate about $100 million annually. The agency says its tobacco-tax revenue has fallen 47% from 2008 levels. Arizona has attempted to broaden its nicotine tax base in each of the past two years: a 2025 bill proposed a 50% wholesale-price tax, while a 2026 measure shifted to a 50% retail-price tax covering alternative nicotine products and vapor products. Separately, the state enacted HB 4001 this year to establish a new licensing and sales framework for alternative nicotine products.
Sep.21
Related Topics
News Regulation
Related Read
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
2Firsts First Look｜China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
2Firsts First Look｜China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
U.S. Rep. Krishnamoorthi Questions FDA Over Planned PMTA Rewrite, Seeks Communications With Altria and Reynolds
U.S. Rep. Krishnamoorthi Questions FDA Over Planned PMTA Rewrite, Seeks Communications With Altria and Reynolds
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
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