A report published on September 30, 2026, by the Government Accountability Office (GAO) reveals that the U.S. Food and Drug Administration (FDA) continues to struggle with review backlogs for Tobacco Harm Reduction (THR) applications. These persistent delays prevent regulated, reduced-risk alternatives from entering the market while hampering efforts to control illegal sales.
When the FDA asserted regulatory authority over e-cigarettes and alternative nicotine products in 2020, the agency received roughly 25 million applications across 2020 and 2021. Although staff processed the bulk of these filings, the GAO confirmed that 132,000 applications remained unreviewed as of December 31, 2025.
Staggering Backlogs and 507-Day Review Timelines
The report highlighted severe administrative bottlenecks. From 2018 to 2025, the average review duration for a single tobacco or THR product reached 507 days. During this period, the agency missed its initial screening phase targets and failed to collect adequate tracking data to manage review times.
The watchdog agency concluded that faster application processing would create regulatory clarity by differentiating legally authorized products from unauthorized imports. This transparency is necessary to help adult consumers choose authorized alternatives and assist law enforcement in removing illicit items from store shelves.
Market Clarity and Public Health Impact
Advocacy groups such as Citizens Against Government Waste emphasize that administrative paralysis directly undermines harm reduction goals. By streamlining scientific reviews as recommended by the GAO, federal regulators can expand legitimate access to smoke-free options for adults looking to replace combustible cigarettes.
Implementing the GAO recommendations offers a pathway to resolve application backlogs. Clearing delays will ensure that safer alternatives can compete fairly within a regulated domestic market.
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