The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.

The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives said on September 23 that it has joined the interagency Trade Fraud Task Force to strengthen enforcement against illegal, misdeclared and smuggled vape and tobacco products. ATF will bring its authority under the Prevent All Cigarette Trafficking Act into the task force, including registration, reporting, shipping and record-inspection requirements covering interstate sales of electronic nicotine delivery systems. ATF said the move will strengthen its ability to trace illicit products from U.S. points of entry through domestic trafficking and distribution networks.

India's Ministry of Health and Family Welfare has directed states to step up enforcement against nicotine pouch sales, citing increased availability through online and offline channels and concern about nicotine exposure among children. Reuters reported that international brands including ZYN and White Fox are being sold in India. A study led by ICMR-NICPR found pouches in seven of 10 surveyed locations and identified 68 brands and 445 flavors online. Separately, India's Drugs Technical Advisory Board recommended in August that no new nicotine formulation be approved.

At the 2026 New Approaches Summit in New York, FDA Center for Tobacco Products Director Bret Koplow said the PMTA pathway is “predicated on tobacco harm reduction.” He outlined four CTP priorities: youth prevention, helping adults quit or switch to lower-risk products, improving relative-risk communication, and reducing unauthorized products. Koplow also addressed flavored e-cigarettes, public risk perceptions, industry credibility and efforts to make PMTA reviews more efficient and predictable.

Cliff Douglas, a veteran U.S. tobacco-control and public health policy figure, told NAS 2026 that the “continuum of risk” should play a central role in tobacco policy. He called for clearer market pathways, stronger risk communication, differentiated regulation and enforcement, and said possible FDA reforms to PMTA reviews could be a “welcome correction” if they create a more efficient, predictable route for scientifically substantiated lower-risk products. Read 2Firsts’ on-site coverage.