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
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Shenzhen SKE Technology has launched the FRESA PRO in the United States, a high-capacity rechargeable disposable vape featuring Fresh Lock electromagnetic valve supply control technology. The device combines a claimed capacity of up to 40,000 puffs, dual mesh coils, dual output modes and a transparent tank design. The launch reflects the high-capacity disposable vape segment’s shift from puff-count competition toward improved e-liquid management and device-level experience.
Aug.03
From Nicotine Salts to Cocrystals: China’s Shenzhen Huabao institute explores a more stable form for sustained nicotine release
From Nicotine Salts to Cocrystals: China’s Shenzhen Huabao institute explores a more stable form for sustained nicotine release
China-based Shenzhen Huabao Collaborative Innovation Technology Research Institute Co., Ltd. has filed a patent application for a nicotine-ascorbic acid cocrystal, exploring a new solid-state form of nicotine. The patent proposes applications across e-liquids, heated tobacco sticks, oral tobacco, chewing tobacco and snuff. In nicotine pouch tests disclosed in the filing, cocrystal formulations showed less than a 6% decline in nicotine content after three months of accelerated storage and a release profile combining early-stage release with sustained delivery over 60 minutes. The filing reflects exploration of nicotine forms beyond conventional nicotine base and nicotine salts.
Aug.13
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
A new expert paper in JAMA urges U.S. clinicians to include nicotine e-cigarettes in smoking-cessation discussions, citing higher quit rates than nicotine replacement therapy. It also stresses that products must deliver enough nicotine to replace cigarettes, dual use should be brief, and complete switching is the goal. 2Firsts argues the recommendations matter beyond clinics: public-health professionals should reassess relative risk, regulators should preserve sufficient product appeal for adult smokers, and manufacturers should focus on helping users quit cigarettes more sustainably.
SCIENCE
Aug.03 by 2Firsts Perspectives
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.
Aug.13
$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
An Illinois court ordered three companies tied to Posh vapes to pay $20 million and permanently restricted the sale, marketing and distribution in Illinois of products lacking required FDA authorization. The consent order also imposes downstream distributor controls, age-verification measures and social-media marketing limits, creating a new state-level compliance benchmark for disposable vape businesses.
Regulations
Aug.05
U.S. FDA: Youth E-Cigarette Prevention Campaign Prevented About 444,000 Initiations and Reduced Illegal Vape Sales
U.S. FDA: Youth E-Cigarette Prevention Campaign Prevented About 444,000 Initiations and Reduced Illegal Vape Sales
The U.S. Food and Drug Administration (FDA) said its youth e-cigarette prevention campaign, “The Real Cost,” prevented about 444,000 U.S. youth from starting e-cigarette use between 2023 and 2024 and blocked more than $42 million in unauthorized e-cigarette sales that would have been used by youth.
Market
Jun.25
Related Topics
News Regulation
Related Read
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
Product | SKE Launches FRESA PRO in the U.S., Introducing Fresh Lock Technology for E-Liquid Management in High-Capacity Vapes
From Nicotine Salts to Cocrystals: China’s Shenzhen Huabao institute explores a more stable form for sustained nicotine release
From Nicotine Salts to Cocrystals: China’s Shenzhen Huabao institute explores a more stable form for sustained nicotine release
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
Science | International Experts Propose a New Smoking Cessation Pathway, Citing Higher Quit Rates With E-Cigarettes Than Nicotine Replacement Therapy
2Firsts Perspectives
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
U.S. FDA: Youth E-Cigarette Prevention Campaign Prevented About 444,000 Initiations and Reduced Illegal Vape Sales
U.S. FDA: Youth E-Cigarette Prevention Campaign Prevented About 444,000 Initiations and Reduced Illegal Vape Sales
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