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
UK Sets Oct. 29 Start for New Vape Retail Rules Covering Age Checks, Giveaways and Discounts
UK Sets Oct. 29 Start for New Vape Retail Rules Covering Age Checks, Giveaways and Discounts
The UK Department of Health and Social Care published new guidance on Aug. 11 outlining the next phase of retail rules under the Tobacco and Vapes Act 2026, which will take effect on Oct. 29, 2026. The measures extend the minimum age of sale of 18 to all vaping and consumer nicotine products and restrict proxy purchasing, promotional giveaways and substantial discounts. Relevant offences in England, Wales and Scotland may carry a £200 fixed penalty notice, while persistent offenders can face temporary sales bans.
Aug.12
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York State will extend its tobacco products tax to “alternative nicotine products,” including tobacco-free nicotine pouches, from September 1, 2026, at a rate of 75% of the wholesale price. Distributors, wholesalers and retailers must also inventory products held as of 11:59 p.m. on August 31 and pay a floor tax. Vapor products are excluded from the new category and remain subject to New York's separate 20% supplemental sales tax on the retail price.
Aug.26
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
Private antitrust litigation stemming from Altria's 2018 $12.8 billion investment for a 35% economic interest in JUUL is advancing before the U.S. Court of Appeals for the Ninth Circuit. Direct purchasers, indirect purchasers and indirect resellers of JUUL products filed answering briefs this week seeking to preserve class certifications granted by a California federal court in February. Altria and JUUL argue that individual consumers and large distributors differ too much in purchasing terms to remain in a single direct-purchaser class, while a separate dispute concerns whether California antitrust law can apply to indirect purchasers across 27 jurisdictions. A September trial has been put on hold during the appeal.
Sep.23
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
Ireland’s Vape Tax Raises €22 Million in Nine Months as Government Considers 2027 Budget Changes
Ireland’s Vape Tax Raises €22 Million in Nine Months as Government Considers 2027 Budget Changes
According to Irish media outlets Highland Radio and BreakingNews.ie, the Irish government is considering whether to adjust vape tax policy in the 2027 Budget. The tax has generated about €22 million ($24 million) in revenue during its first nine months. While no increase has been confirmed, the revenue performance could influence future fiscal discussions. Any tax rise could increase product costs and potentially affect retail prices.
Aug.12
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
Korea Customs Service has tightened import controls on nicotine-analog and nicotine-free e-cigarette liquids, placing the products under 100% document review and subjecting all e-cigarette liquid import declarations to pre-clearance ingredient analysis. As of September 20, 2026, South Korea had imported about 15 metric tons of nicotine-analog liquids, 99.99% from China, and about 316 metric tons of nicotine-free liquids, including roughly 315 metric tons, or 99.7%, from China. The measures follow South Korea's April expansion of its tobacco definition to include synthetic nicotine products and include new checks on Chinese manufacturing, transaction and export documentation.
Sep.24
Related Topics
News Regulation
Related Read
UK Sets Oct. 29 Start for New Vape Retail Rules Covering Age Checks, Giveaways and Discounts
UK Sets Oct. 29 Start for New Vape Retail Rules Covering Age Checks, Giveaways and Discounts
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
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
Ireland’s Vape Tax Raises €22 Million in Nine Months as Government Considers 2027 Budget Changes
Ireland’s Vape Tax Raises €22 Million in Nine Months as Government Considers 2027 Budget Changes
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
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