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

PMI Expands Its Second Global and First Asian Business Services Hub in the Philippines, Serving 160 Markets and Scaling Up AI Capabilities

PMI Expands Its Second Global and First Asian Business Services Hub in the Philippines, Serving 160 Markets and Scaling Up AI Capabilities

Philip Morris International's PMI Business Solutions Philippines has expanded its global business services hub in Makati and plans to add more than 80 positions. Established in 2021 primarily to provide finance and IT support to about 20 markets, the center now employs 519 professionals delivering roughly 600 services across 160 markets. Its functions now span finance, human resources, IT, commercial operations, data analytics, supply chain and project management. PMI says the hub's next phase will focus on AI-enabled and higher-value work. The company did not disclose the size or investment cost of the expansion.

UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax

UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax

The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Ahead of implementation, DOJO, PIXL and Hayati have introduced or been reported to be adding lower-capacity tiers alongside larger products. DOJO has added a 6ml BLAST7K Fresh below its 10ml BLAST10K Fresh, PIXL offers both a 12ml 8000 and a 6ml 5K, while retailer Ninja Vapes says Hayati is preparing a 7ml 4K alongside its existing 12ml 6K. The pattern points to a growing lower-capacity tier in the UK market, although the brands have not all explicitly linked the changes to the new duty.

Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1

Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1

Australia's Therapeutic Goods Administration published a final decision on September 25 to classify 6-methylnicotine as a Schedule 9 prohibited substance under the Poisons Standard, effective October 1, 2026. TGA said the chemical has been reported in e-cigarette liquids sold in Australia and marketed as nicotine-free or nicotine alternatives, while evidence also indicates its use in preparations such as oral pouches. The government originally proposed a Schedule 7 classification but ultimately adopted the stricter Schedule 9 designation, citing acute toxicity, dependence risk, use in unapproved consumer products and misleading marketing.

Sep.29 by 2Firsts Perspectives

Imperial Brands Acquires Helwit Owner Yoik Group for SEK 515 Million, More Than Doubling Swedish Nicotine Pouch Share

Imperial Brands Acquires Helwit Owner Yoik Group for SEK 515 Million, More Than Doubling Swedish Nicotine Pouch Share

Imperial Brands has agreed to acquire 100% of Swedish modern oral nicotine company Yoik Group AB for an initial SEK515 million, equivalent to about US$53.9 million, plus a deferred payment linked to performance over the next two years. Yoik owns nicotine pouch brand Helwit, which held about 3.4% of Sweden’s modern oral nicotine market over the past 12 months. Imperial says the acquisition will more than double its existing share of the Swedish market. Helwit is also sold elsewhere in the Nordics, through European online channels and in selected UK retail outlets.

Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria

Philip Morris Malaysia Again Meets Religious Authority Over Cigarette Alternatives as Perlis Mufti Responds on Halal Criteria

Philip Morris Malaysia Managing Director Naeem Shahab Khan met Perlis Mufti Mohd Asri Zainul Abidin on September 17 and presented the company's shift from conventional cigarettes toward alternative products. The mufti said a product could be considered halal if it is clean, its side effects are not harmful or can be controlled, and it does not involve excessive waste. His remarks did not mention IQOS or any other specific PMI product and did not amount to a new product-specific religious ruling. It was at least the second publicly reported engagement between Philip Morris Malaysia and a Malaysian religious institution over cigarette alternatives within six months.

Sep.18 by 2Firsts Perspectives

China Tobacco Hubei explores staged nicotine pouch delivery, using dynamic membranes to slow early release and gradient particles to sustain later delivery

China Tobacco Hubei explores staged nicotine pouch delivery, using dynamic membranes to slow early release and gradient particles to sustain later delivery

China Tobacco Hubei Industrial Co., Ltd. disclosed several oral nicotine-related patent applications in August 2026, including two that approach staged nicotine release from different directions. One uses a high-viscosity membrane that forms inside the pouch after contact with saliva to slow rapid early release, while the other uses gradient particles with a faster-disintegrating outer layer and a slower core to create a fast-to-sustained release profile. Together, the filings explore how nicotine pouches could balance initial delivery with release later in use.

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