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

New Zealand Associate Health Minister Casey Costello Warns on Illicit Cigarettes as Legal Tobacco Sales Halve Over Decade

New Zealand Associate Health Minister Casey Costello Warns on Illicit Cigarettes as Legal Tobacco Sales Halve Over Decade

New Zealand Associate Health Minister Casey Costello said legal tobacco sales in the country have fallen by more than half over the past decade, with sales declining more than 20% in 2025 compared with the previous year. She warned that the decline may not fully reflect lower smoking rates, as increased availability of illicit cigarettes could also be contributing. The government said it would continue strengthening tobacco and vape retail enforcement while monitoring the impact of illicit tobacco on public health and tax revenue.

Product | JT Expands Vote-Winning EVO Cacao Mint Crystal to Nationwide Retail in Japan, Adds 22-Stick Limited Pack at Same Price

Product | JT Expands Vote-Winning EVO Cacao Mint Crystal to Nationwide Retail in Japan, Adds 22-Stick Limited Pack at Same Price

Japan Tobacco (JT) will expand EVO Cacao Mint Crystal from limited channels to nationwide retail in Japan from October 6, 2026. The Ploom tobacco stick ranked first in the brand's first consumer voting campaign for new tobacco-stick SKUs held earlier this year. JT will also introduce a limited 22-stick pack at the same JPY 620 price as the standard 20-stick pack. The capsule-format product combines menthol with sweet, bittersweet cacao notes and adds a berry nuance when the capsule is crushed.

U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking

U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking

A federal judge in Texas on Oct. 8 granted a joint request by the FDA and plaintiffs including Altria subsidiaries Helix Innovations and NJOY to stay litigation challenging the agency's 2021 PMTA rule. The court cited FDA's anticipated rulemaking concerning the regulation at issue. FDA announced on Sept. 28 that it intends to reassess the PMTA framework and could initiate new rulemaking to replace it. The parties must file a joint status report within 45 days and every 45 days thereafter. A motion by three Reynolds American companies to intervene remains pending.

Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches

Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches

Gallup’s 2026 Consumption Habits survey tracked nicotine pouch use for the first time. The survey found that 11% of U.S. adults reported smoking cigarettes in the past week, 9% reported vaping, and 4% reported using nicotine pouches. Cigarette smoking remained near Gallup’s long-term low, while adult vaping rates stayed relatively stable in recent years.

Aug.25 by 2Firsts Perspectives

Product | HQD SiSA 80K Enters the U.S. Market With a Hookah-Inspired Approach to the High-Capacity Disposable Segment

Product | HQD SiSA 80K Enters the U.S. Market With a Hookah-Inspired Approach to the High-Capacity Disposable Segment

The HQD SiSA 80K Hookah Disposable Vape has appeared across U.S. and cross-border online retail channels. The device comes prefilled with 28ml of e-liquid, uses a 5% nicotine salt configuration and carries a brand claim of up to 80,000 puffs. Beyond puff count, the product differentiates itself through hookah-inspired features including adjustable airflow, a flowing-water sound effect and flavor options associated with traditional hookah consumption.

Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow

Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow

French vaping company Kumulus Vape reported first-half 2026 revenue of €25.5 million, down 8.3% year over year, as its core B2B distribution business fell 11% to €21.6 million. B2C and store-network revenue rose 5.6% and 17.8%, respectively. Commercial margin increased to 26.3% from 21.7%, while net profit rose 24.1% to €0.8 million. The company attributed the profitability improvement to catalog optimization, logistics restructuring and the ramp-up of Labster, its in-house production unit for proprietary brands.

Sep.17 by 2Firsts Perspectives

Related Topics

HEADLINE News Regulation

Related Read

New Zealand Associate Health Minister Casey Costello Warns on Illicit Cigarettes as Legal Tobacco Sales Halve Over Decade

New Zealand Associate Health Minister Casey Costello Warns on Illicit Cigarettes as Legal Tobacco Sales Halve Over Decade

Product | JT Expands Vote-Winning EVO Cacao Mint Crystal to Nationwide Retail in Japan, Adds 22-Stick Limited Pack at Same Price

Product | JT Expands Vote-Winning EVO Cacao Mint Crystal to Nationwide Retail in Japan, Adds 22-Stick Limited Pack at Same Price

U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking

U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking

Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches

Gallup Tracks Nicotine Pouch Use for the First Time: 11% of U.S. Adults Smoke, 9% Vape and 4% Use Nicotine Pouches

2Firsts Perspectives

Product | HQD SiSA 80K Enters the U.S. Market With a Hookah-Inspired Approach to the High-Capacity Disposable Segment

Product | HQD SiSA 80K Enters the U.S. Market With a Hookah-Inspired Approach to the High-Capacity Disposable Segment

Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow

Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow

2Firsts Perspectives