FLER at APE

A U.S. Government Accountability Office audit found that 131,915 tobacco product applications submitted to the FDA since 2018 remained without a final review as of December 31, 2025, with pending applications waiting an average of 1,266 days. GAO also found FDA lacks the data needed to systematically determine whether scientific reviews meet applicable timelines. HHS agreed to upgrade the agency's tracking systems. At the same time, FDA has begun applying lessons from its nicotine pouch PMTA pilot to e-cigarette reviews, while changes to enforcement policy and electronic submissions are making the specific stage of a PMTA increasingly relevant to market access.

DOJO officially launched the BLAST7K Fresh on September 17, 2026, introducing a UK-market prefilled pod product with 6ml of e-liquid and a manufacturer-rated capacity of up to 7,000 puffs. The device features a 1000mAh rechargeable battery, the INSTA-JUICED structure and COREX BLAST dual-mesh technology, while retaining compatibility with existing BLAST pods. The launch comes less than two weeks before the UK's Vaping Products Duty takes effect on October 1. At the new duty rate, 6ml of vaping liquid would correspond to £1.32 in VPD. DOJO has not stated that the product's 6ml format was designed in response to the new duty.

A decade-long study published in The Lancet Regional Health – Western Pacific found that heated tobacco product use in Japan increased from 0.1% in 2015 to 14.9% in 2025, although growth slowed after 2018. Switching from conventional cigarettes remained an important source of HTP uptake, while the contribution from previously non-current users increased. Approximately 56% of HTP users also smoked conventional cigarettes in 2025. Separate industry data show that Japan's heated tobacco sales reached 73.4 billion units in fiscal 2025, approaching conventional cigarette sales of 78.2 billion units.

The National Association of Tobacco Outlets is calling for more FDA marketing authorizations, greater transparency in the PMTA process and continued enforcement against unauthorized e-cigarettes, even as its executive director, David Spross, points to recent regulatory developments as signs of progress. At the state level, excise taxes, flavor restrictions and vapor product directories remain major issues for tobacco retailers. By August 2026, 17 states had enacted laws establishing state-managed e-cigarette directories or similar systems.

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.

U.S. nicotine pouch startup Skoka Inc. has raised $21.5 million and committed $15 million to an FDA regulatory and scientific research program. Founder Dan Aziz previously built dietary supplement brand Premama, which was acquired by Dr. Reddy's Laboratories in 2023. Skoka is combining proprietary formulations, ingredient transparency and equity investment from professional athletes. The company submitted a bundled PMTA covering 55 products on October 1, 2026. Aziz said Skoka declined an opportunity to enter retail in 2025, prioritizing product research and regulatory submissions instead. It now targets a U.S. retail launch in 2027, subject to FDA requirements. Its products have not received marketing authorization.