The big picture#
This was a week in which the United States moved further and faster toward a risk-proportionate regulatory posture than at any point so far this year, while India moved sharply in the opposite direction on nicotine pouches. Reporting emerged that the FDA is preparing to revisit the core 2021 rule governing premarket tobacco applications, CTP Director Bret Koplow’s harm-reduction framing continued to shape coverage of the agency, and a Senate confirmation hearing put flavored-vape policy back in the spotlight. Meanwhile, India ordered a nationwide crackdown on nicotine pouches, Canada’s health minister rebuffed industry calls to loosen pouch rules, and Philip Morris International expanded heated-tobacco access in the Gulf. A new Scotland-based study added fresh data on the comparative effectiveness of quitting aids.
United States: FDA reportedly preparing a major PMTA overhaul#
FDA plans to revisit the 2021 PMTA rule. The Wall Street Journal reported on September 23 that the Trump administration is preparing to change the regulatory process to make it faster and easier for qualifying tobacco products to win marketing authorization — potentially including a revision of the FDA’s 2021 final rule governing premarket tobacco product applications (PMTAs). Coverage on September 24 said the changes under consideration include simplifying certain scientific-study requirements and accelerating review timelines for e-cigarettes and nicotine pouches. The reported move closely tracks comments CTP Director Bret Koplow made earlier this month at the Global Tobacco & Nicotine Forum, where he said the agency should not take a “one-size-fits-all approach” and described a pilot program that lets the FDA rely on prior reviews when authorizing minor changes to already-approved products. Koplow has also said the FDA had cut its applications backlog by roughly 70% in 2025, and that helping smokers switch completely to lower-risk products is now one of CTP’s three core priorities. An industry regulatory-affairs executive called an overhaul “necessary,” noting the FDA has never once met the statutory deadline for reviewing non-combustible products.
FDA nominee questioned on flavored vapes at Senate hearing. Dr. Heidi Overton, President Trump’s nominee to lead the FDA, faced questions from Sen. Susan Collins (R-Maine) on September 24 about recent authorizations of fruit-flavored vaping products, with Collins warning they could set back progress on youth e-cigarette use. Overton said the administration shares the goal of protecting children from flavored vapes but noted that the approvals in question had the backing of FDA scientists because the products helped adult smokers switch away from cigarettes.
Source: The Hill, “Trump FDA pick dodges vaccine, abortion questions at Senate confirmation hearing” (Sept 24, 2026)
Manufacturer of low-nicotine combustible cigarettes presses for a nicotine cap alongside the PMTA changes. On September 24–25, 22nd Century Group publicly urged HHS Secretary Robert F. Kennedy Jr., the acting FDA commissioner and CTP Director Koplow to finalize the long-pending proposed rule capping nicotine yield in cigarettes at 0.70 mg per gram of tobacco — a level the company says is too low to create or sustain addiction. The company, which holds the only FDA-authorized reduced-nicotine combustible cigarette in the US, argued that the reported acceleration of vape and pouch authorizations “addresses only part of the continuum of risk” and should be paired with action on combustible nicotine limits.
Nicotine pouches: India cracks down, Canada holds the line#
India orders states to crack down on nicotine pouches. India’s Ministry of Health and Family Welfare wrote to all states on September 19 — reported widely on September 25 — directing them to enforce against the sale of nicotine pouches, which it says are addictive, pose independent health risks, and have not been shown to be effective smoking-cessation aids. The letter followed minutes, published September 16, of a meeting in which India’s Drugs Technical Advisory Board recommended that “no new nicotine formulation be approved henceforth in the public interest,” rejecting applications to market 2 mg, 4 mg and 6 mg pouch products. India’s National Tobacco Control Programme had opposed the applications; the pouches remain unapproved drugs under Indian law, distinct from FDA-authorized nicotine gums and patches, which continue to be permitted for cessation. India banned e-cigarettes outright in 2019 and, according to Reuters, records 1.35 million tobacco-related deaths a year. While India is cracking down pouches, local toxic oral products remain in the market, resulting in India having the highest death rates from oral cancer globally.
Source: Reuters, “India orders crackdown on nicotine pouches, citing health risks” (Sept 25, 2026)
Canada’s health minister rebuffs calls to loosen pouch rules. Federal Health Minister Marjorie Michel said on September 23 that she is “not considering” changes to Canada’s rules restricting nicotine-pouch sales, which currently confine the products to pharmacy shelves and limit approval to a single brand since 2024. The comment came the same week that Physicians for a Smoke-Free Canada, the Quebec Coalition for Tobacco Control and Action on Smoking and Health Canada urged Ottawa to resist industry lobbying, citing research suggesting pouch use is rising among young Canadians, and called for a broader nicotine strategy that also tackles illicit vape and pouch sales through stronger enforcement.
Source: CTV News, “Amid campaigns to loosen nicotine pouch rules, Canada’s health minister responds” (Sept 23, 2026)
Heated tobacco: new product launched in Kuwait#
A new HTP was launched in Kuwait on September 22, a compact heated-tobacco device which offers up to 28 uses per charge. The launch is aimed at adult smokers who would otherwise continue smoking. The move extends the heated-tobacco category’s reach in a Gulf region where, as noted in prior coverage, Kuwait’s incoming 2027 regulations are expected to keep legal pathways open for vaping and heated tobacco while tightening rules specifically on non-medicinal nicotine pouches.
Europe: the Swedish clock is still running#
There was no fresh Council-level movement this week on the stalled EU Tobacco Taxation Directive, which was pushed from October to a November ECOFIN vote earlier this month specifically to give Sweden time to form a government after its September 13 election. That process reached its final stretch during this window: Social Democrat leader Magdalena Andersson, tasked with assembling a center-left coalition, has until September 28 to report back to parliament’s speaker, after which — if she fails — center-right leader Ulf Kristersson would get a turn. Whichever government emerges will inherit Sweden’s position as the directive’s principal holdout, having resisted EU-wide minimum excise rates on nicotine pouches that industry estimates suggest could raise Swedish pouch taxes several-fold.
Science: a fresh look at what actually helps smokers quit#
A population-based study of Scottish quit attempts, published September 24 in the International Journal of Public Health, asked former and current smokers to rate, in retrospect, how helpful various products were during their most recent quit attempt. Varenicline was rated most helpful (67.5% of respondents), followed closely by e-cigarettes or vaping devices (63.0%) — both well ahead of nicotine gum, which scored lowest. Among the roughly 2,810 respondents with complete data, e-cigarette use alone (25.2%) and nicotine-patch use alone (21.4%) were the two most common quitting patterns. The gap between former and current smokers’ ratings was largest for e-cigarettes, a pattern the authors note is consistent with other retrospective-helpfulness research on cessation aids.
Source: Journal of Public Health, “Retrospective self-attributed helpfulness of smoking cessation products used in the most recent quit attempt: a population-based study in Scotland” (published Sept 24, 2026)
Quick-reference timeline#
| Date | Development |
|---|---|
| Sept 19 | India’s Ministry of Health writes to all states ordering enforcement against nicotine pouch sales (reported Sept 25). |
| Sept 22 | A new heated-tobacco device release in Kuwait. |
| Sept 23 | Canada’s federal health minister says she is not considering loosening nicotine-pouch sale restrictions. |
| Sept 23 | Wall Street Journal reports the FDA is preparing to speed up authorizations for vapes and nicotine pouches. |
| Sept 24 | FDA nominee Dr. Heidi Overton faces Senate questions on flavored-vape authorizations. |
| Sept 24 | Scotland-based study on retrospective helpfulness of smoking-cessation products published. |
| Sept 24–25 | Reporting details the FDA’s reported PMTA overhaul; low-nicotine cigarette manufacturer urges HHS/FDA to also finalize the reduced-nicotine-content standard. |
| Sept 25 | Reuters reports India’s nicotine-pouch crackdown letter and Drugs Technical Advisory Board recommendation in full. |
This roundup draws on reporting from Nicotine Insider, The Wall Street Journal, The Hill, GlobeNewswire, Reuters, CTV News, Times Kuwait, and the International Journal of Public Health, among others, current as of September 26, 2026. The EU tobacco-tax file and the FDA’s reported PMTA overhaul remained developing stories as of the end of this window and are worth revisiting next week.
