Bottom line up front#
The week’s biggest story was the US FDA confirming (30 Sept) that it will pursue rulemaking to replace the 2021 PMTA framework. A GAO audit published days later showed why: 131,915 applications were still unresolved at the end of 2025, waiting an average of 1,266 days. In Europe, the UK’s vaping duty and duty-stamp scheme went live on 1 October, Germany’s four-year tax rise moved through parliament, and the EU Tobacco Products Directive revision drew more criticism over the evidence it relies on.
Coverage window: 27 September – 4 October 2026. Items outside the window were excluded.
United States#
FDA confirms it will pursue a new PMTA rulemaking (30 Sept)#
- The FDA said it will “evaluate changes to the premarket tobacco product application regulatory framework, including initiating new rulemaking” that could replace the 2021 PMTA rule.
- Stated reasons: experience administering the 2021 rule, growth of illicit and unregulated markets, the pace of new product introductions, and recent litigation.
- Applications continue to be processed under current rules in the meantime.
- CTP Director Bret Koplow said the agency is moving away from “one-size-fits-all” approaches and developing a supplemental PMTA pathway, so manufacturers can modify authorized products without restarting full reviews.
- The announcement does not say what the replacement framework will look like.
- Reason’s coverage reports roughly 130,000 pending applications as of March 2026, and cites a company whose flavored pouch applications took 321 days just to be accepted for review.
Earlier reports of faster flavored-vape and pouch reviews (1 Oct)#
It has been reported that the administration is preparing changes to speed reviews of flavored vapes and nicotine pouches. This rests on a 24 September Tobacco Reporter summary of Wall Street Journal coverage, which Reuters could not independently verify. An HHS spokesperson cited three goals: keeping nicotine from minors, removing counterfeit vapes, and giving adult smokers alternatives. The official FDA announcement of 30 September now confirms the direction of travel.
GAO audit: 131,915 applications pending, average wait 1,266 days (reported 3 Oct)#
- GAO found 131,915 unresolved applications as of 31 December 2025, with an average wait of 1,266 days.
- It also found that FDA “lacks the data needed to systematically determine whether scientific reviews meet applicable timelines.”
- HHS agreed to upgrade tracking across all three premarket pathways.
- Accelerated PMTA screening fell from 845 days (2022) to 156 days (2025).
- Lessons from the nicotine pouch pilot have been applied to e-cigarette reviews since April 2026.
- The legacy eSubmitter system is replaced by CTP Portal NextGen on 14 November 2026.
Litigation over the FDA’s enforcement policy (2 Oct)#
A company producing e-cigarette liquids is seeking to intervene in a lawsuit brought in July by public health groups, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics and the American Cancer Society. The suit challenges the FDA’s 8 May guidance letting certain unauthorized vapes and nicotine pouches stay on the market while their PMTAs are pending. The groups argue the FDA has no authority to create such a “safe harbor.” Schwartz says overturning it could force its products off the market, even though it separately sued the FDA in November 2025 over review delays.
Other FDA items#
- Transparency Roadmap (3 Oct): The FDA’s new roadmap does not commit to expanded disclosure of PMTA records, deficiency letters or marketing denial orders. It focuses mainly on drugs and biologics.
- Registration form (29–30 Sept): The FDA introduced a redesigned, unified establishment registration and product listing form.
State rules: Pennsylvania and Virginia#
- Pennsylvania (Act 57): Enforcement of the state vape directory starts 19 October. Unlisted products can be seized, with fines up to $1,500 per day per unlisted product. One retailer said 97% of its vapes are not on the list, and only about 39 e-cigarettes from a handful of brands qualify statewide.
- Virginia: A retail permit requirement for vape sellers began on 1 October. More than 3,000 businesses applied in September alone. Fees are $300 or $400, and civil fines for selling unlisted products start at $5,000.
Market data: pouches growing as cigarettes decline (2–3 Oct)#
NACS research shows convenience-store cigarette dollar sales down 2.5% over 52 weeks. The “smokeless tobacco alternatives” subcategory, which includes nicotine pouches, rose 22.4% in dollar sales and 15.2% in units.
United Kingdom#
Vaping Products Duty and duty stamps began 1 October#
- The duty is £2.20 per 10ml of vaping liquid, charged to manufacturers, importers and warehousekeepers. Whether the cost reaches consumers is a commercial decision.
- Transitional (non-digital) stamps are allowed until 31 December 2026. Digital stamps are required on new products from 1 January 2027. A grace period for eligible unstamped stock runs to 31 March 2027.
- Tobacco duty also rose by £2.20 per 100 cigarettes or 50g, which the government says preserves the incentive to switch to vaping.
- Expected revenue is over £550 million a year by 2030–31, with an enforcement cost of £30 million a year through 2028–29.
- China’s vape exports to the UK are reported to have reached $177 million in August 2026 (+51.4% year on year).
- Treasury minister James Murray said the measures help “get illicit vapes off high streets.”. It will probably cause the exact opposite: an exacerbation of the illicit market.
European Union and Europe#
Germany: four-year tax rise advances (reported 2 Oct)#
After its first reading on 24 September, the Bundestag sent the bill to committee (Finance Committee leads). - Vape liquid: €0.32/mL now, rising by €0.01 a year to €0.36/mL in 2030. - Cigarettes: from about 20.27 to 28.77 cents per stick by 2030. - Heated tobacco: from 16.65 to 23.12 cents per stick. - The government projects an average 20-cigarette pack rising from €8.05 to about €11.36, and extra revenue of €756 million in 2027 rising to €3.59 billion a year by 2030.
Germany: €33 million vape tax-evasion case (28 Sept)#
Customs executed 13 arrest warrants over the alleged smuggling of more than 7.6 million disposable vapes from China (Jan 2024 – Mar 2025), involving about €33.3 million in unpaid excise tax. 23 suspects are named, and about 600,000 vapes were seized.
Belgium: illicit-market survey (30 Sept)#
An industry-commissioned survey of 2,800 discarded packs in 18 cities found 50.6% were foreign-market or counterfeit (46% foreign, 4.6% counterfeit), up from 44.4% in March 2026. Bulgaria was the largest source (30%). The survey cannot tell legal cross-border purchases from illicit trade, and it was commissioned by the industry.
EU Tobacco Products Directive revision: criticism over evidence (3 Oct)#
Euro Weekly News reports that more than 100 scientists and public-health experts wrote to Commission President von der Leyen claiming “131 relevant scientific studies had been left out of the analysis.” The revision targets e-cigarettes, heated tobacco and nicotine pouches. Harm-reduction advocates say combustion, not nicotine, causes most harm. Public-health groups counter that tighter rules are needed to limit youth uptake. The article also cites €12.8 million a year of EU funding to nine Brussels-based tobacco-control groups. Note: the letter’s own date was not confirmed; only the article date (3 Oct) is verified.
Asia and global advocacy#
- 9th Summit on Tobacco Harm Reduction (virtual, 28–30 Sept): In coverage dated 4 Oct, experts including Dr Mohsin Wali and Prof. Neal Benowitz argued that smokers need clinical cessation support alongside policy, and that “nicotine and cigarette smoking should not be treated as synonymous.”
- AFN26 announced (30 Sept): The Asia Forum on Nicotine takes place 16–17 October in Manila. The organizers state that eight of eleven ASEAN nations ban e-cigarettes or heated tobacco products.
What to watch next#
- Details and timing of the FDA’s PMTA rulemaking and the supplemental PMTA pathway.
- The outcome of the Schwartz intervention in the challenge to the FDA’s enforcement guidance.
- Pennsylvania’s directory enforcement on 19 October.
- AFN26 in Manila on 16–17 October.
- UK stamp deadlines on 31 December 2026, 1 January 2027 and 31 March 2027.
- German Finance Committee review of the tax bill.
Sources#
- FDA Makes Major PMTA Overhaul Official – Nicotine Insider (30 Sept)
- The FDA promises to streamline the dauntingly complex rules for approving nicotine products – Reason (30 Sept)
- Trump Administration Reportedly Plans Faster PMTA Reviews – Vaping360 (1 Oct)
- GAO Audit Finds Nearly 132,000 FDA Tobacco Applications Waiting an Average 1,266 Days – 2Firsts (3 Oct)
- Naked 100 Maker Seeks Role in FDA Vape Fight – Nicotine Insider (2 Oct)
- FDA Transparency Push Raises CTP Questions – Nicotine Insider (3 Oct)
- FDA Updates Tobacco Product Establishment Registration and Product Listing Form – FDA CTP Newsroom (29 Sept)
- FDA Unifies Tobacco Registration and Product Listing Form – 2Firsts (30 Sept)
- Oct. 19: Pennsylvania Vape Directory Takes Effect – Nicotine Insider (1 Oct)
- Pennsylvania Act 57’s Vape Sales Restrictions – Hoodline (3 Oct)
- Virginia Tobacco Retail Permit Takes Effect October 1 – 2Firsts (3 Oct)
- Cigarette Sales Fall as Smokeless Alternatives Gain in US Convenience Stores – 2Firsts interview (Oct 2–3)
- New Vaping Products Duty comes into effect – GOV.UK (1 Oct)
- Germany Advances Four-Year Tobacco and Vape Tax Increases – Vaping360 (2 Oct)
- German Customs Arrest 13 in €33 Million Vape Tax Case – Vaping360 (28 Sept)
- Belgian Survey Finds Half of Cigarette Packs Are Foreign or Counterfeit – Vaping360 (30 Sept)
- EU nicotine crackdown sparks warning that ex-smokers could be driven back to cigarettes – Euro Weekly News (3 Oct)
- PMI Drops Pouch Patent Amid BAT Challenge – Nicotine Insider (30 Sept)
- Imperial Adds ‘Red’ Blend to UK Paramount Range – Nicotine Insider (1 Oct)
- JTI Adds Southeast Asia’s First DIET Plant – Nicotine Insider (1 Oct)
- Helping smokers quit needs clinical support, policy support: Experts – Business Standard (4 Oct)
- Asia’s Nicotine Divide Goes Under the Microscope at AFN26 in Manila – GlobeNewswire (30 Sept)
