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

FDA Issues 13 Policy Memos on Flavored E-Cigarette Review Methods

Nov.22.2024
FDA Issues 13 Policy Memos on Flavored E-Cigarette Review Methods
FDA has released 13 additional regulatory science policy memos related to the review of premarket applications, detailing the processes and prioritization methods for filing and reviewing PMTAs for flavored e-cigarettes and other products, as well as the basis for specific actions related to environmental assessments.

On November 21st, U.S. Food and Drug Administration (FDA) released additional regulatory science policy memos concerning its review of premarket applications. These memos aim to provide clarity on the agency’s methods and processes for evaluating applications.

 

The release includes thirteen memos developed between 2020 and 2023 and details FDA's approach to filing and reviewing PMTAs for flavored e-cigarettes and other products, including the criteria for prioritization. The memos also outline the agency's rationale for actions related to environmental assessments.

 

The memos posted today include:

 

  • Feb. 20, 2020: To Support the Efficient Filing Review of Premarket Tobacco Product Applications (PMTAs)

 

  • June 30, 2021: Updated Prioritization of PMTA Filing Reviews (includes an addendum from July 28, 2021)

 

  • Jan. 21, 2022: Filing Prioritization for PMTAs Received between Sep. 10, 2020, to Nov. 3, 2021 (with an addendum from Feb. 28, 2022)

 

  • July 9, 2021: ENDS Containing Non-Tobacco Flavored E-Liquid: Approach to PMTAs Not in Substantive Scientific Review (Phase III) (and five addendums from July 28, 2021, Aug. 18, 2021, Nov. 22, 2022, Dec. 7, 2022, and April 27, 2023) 

 

  • July 16, 2020: Environmental Assessment Criteria to Support Refuse to Accept or Refuse to File Actions on Premarket Applications (with an addendum from May 27, 2021)

 

FDA notes that these science policy memos provide snapshots of its perspectives at specific times. Consequently, the information may evolve with changes in policies, regulatory frameworks, or regulatory science.  

 

FDA reviews tobacco product applications based on the specific facts provided in each submission, with findings documented accordingly. As such, the regulatory science policy memos are not intended to serve as tools, guides, or manuals for preparing or submitting applications to FDA.

 

To support applicants seeking to market new tobacco products, FDA has issued final regulations, including the PMTA final rule. This rule specifies the required content, format, and review procedures for PMTAs and is supplemented by additional guidance documents. FDA also offers resources such as webinars and application tips, which are regularly updated on the CTP's website and social media platforms.

 

In April 2024, FDA resumed the publication of regulatory science policy memos. With the latest batch released today, the agency has published four sets of memos this year, totaling 26 memos in 2024.

 

#North America#United States#Open system e-cigarettes#Regulation
China Tobacco Regulation Shift：Policy Updates and Market Impact
China Tobacco Regulation Shift：Policy Updates and Market Impact
Glas, the FDA, and the Future of Flavored ENDS
Glas, the FDA, and the Future of Flavored ENDS
Japan to Raise Tobacco Taxes and Corporate Income Tax From April 1 to Help Fund Defense Spending
Japan to Raise Tobacco Taxes and Corporate Income Tax From April 1 to Help Fund Defense Spending
Japan will raise tobacco product taxes and corporate income tax from April 1 as part of a package of levies to help fund a five-year defense spending increase totaling JPY 43 trillion. Tobacco taxes will be raised in two stages, with the first increase taking effect on April 1 and the second in October, while personal income tax is planned to rise in January.
Mar.27 by 2FIRSTS.ai
Russia May Allow Regions to Introduce Experimental Vape Sales Bans
Russia May Allow Regions to Introduce Experimental Vape Sales Bans
Russia’s government commission on legislative activity has approved second-reading amendments to a bill on licensing trade in tobacco and nicotine-containing products that would allow Russian regions to introduce experimental bans on vape sales.
Mar.31 by 2FIRSTS.ai
FDA Authorizes Glas Vape but Flavor Hopes Fall Short
FDA Authorizes Glas Vape but Flavor Hopes Fall Short
The FDA has added Glas products to its authorized electronic nicotine delivery systems (ENDS) list, granting Marketing Granted Orders (MGOs) to the Glas G DEVICE and a BLONDE TOBACCO pod. The decision expands the number of FDA-authorized ENDS products to 41, marking the first new authorization since Juul’s approvals in July 2025. However, widely anticipated non-tobacco flavored products were not approved.
Mar.13
France’s HAS to Address Role of E-Cigarettes in Updated Smoking-Cessation Guidelines, Tells 2Firsts
France’s HAS to Address Role of E-Cigarettes in Updated Smoking-Cessation Guidelines, Tells 2Firsts
2Firsts has learned that France’s national health authority, the Haute Autorité de Santé (HAS), confirmed the role of e-cigarettes will be addressed in updated national smoking-cessation guidelines expected by the end of 2026. HAS said the recommendations will focus on clinical and public-health considerations, will not set technical standards for vaping products, and that current studies are insufficient to clearly assess risks and benefits across different product categories.
Mar.10
Azerbaijan Amends Administrative Offenses Code to Penalize E-Cigarette Violations
Azerbaijan Amends Administrative Offenses Code to Penalize E-Cigarette Violations
Azerbaijan has established fines for the import, export, production and sale of e-cigarettes. Under amendments to the Administrative Offenses Code approved by President Ilham Aliyev, using e-cigarettes in places prohibited by the law “On the Restriction of Tobacco Product Use,” including streets and other public areas, will result in a fine of 30 manat.
Mar.16 by 2FIRSTS.ai
Thailand’s National Health Commission Office Reviews Two Years of E-Cigarette Control Efforts and Plans Further Recommendations
Thailand’s National Health Commission Office Reviews Two Years of E-Cigarette Control Efforts and Plans Further Recommendations
Thailand’s National Health Commission Office and partner agencies held a public policy forum on March 13 to review results from the past two years of efforts to protect children and youth from e-cigarettes and to prepare recommendations for submission to the National Health Commission.
Mar.17 by 2FIRSTS.ai
Related Topics
HEADLINE News Regulation
Related Read
Japan to Raise Tobacco Taxes and Corporate Income Tax From April 1 to Help Fund Defense Spending
Japan to Raise Tobacco Taxes and Corporate Income Tax From April 1 to Help Fund Defense Spending
2FIRSTS.ai
Russia May Allow Regions to Introduce Experimental Vape Sales Bans
Russia May Allow Regions to Introduce Experimental Vape Sales Bans
2FIRSTS.ai
FDA Authorizes Glas Vape but Flavor Hopes Fall Short
FDA Authorizes Glas Vape but Flavor Hopes Fall Short
France’s HAS to Address Role of E-Cigarettes in Updated Smoking-Cessation Guidelines, Tells 2Firsts
France’s HAS to Address Role of E-Cigarettes in Updated Smoking-Cessation Guidelines, Tells 2Firsts
Azerbaijan Amends Administrative Offenses Code to Penalize E-Cigarette Violations
Azerbaijan Amends Administrative Offenses Code to Penalize E-Cigarette Violations
2FIRSTS.ai
Thailand’s National Health Commission Office Reviews Two Years of E-Cigarette Control Efforts and Plans Further Recommendations
Thailand’s National Health Commission Office Reviews Two Years of E-Cigarette Control Efforts and Plans Further Recommendations
2FIRSTS.ai
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