Tobacco Products: FDA Should Monitor Timeliness of Application Reviews

Filed 1h ago · Via GAO · The Buffoon Desk

THIS STORY IS SCORED

Dvorak Polka

Kevin MacLeod · incompetech.com · CC BY 4.0

Photo: Public Record Office of Northern Ireland · No restrictions · via Wikimedia Commons

A GAO report finds FDA received over 25 million tobacco product applications in 2020-2021 after its oversight expanded to cover all tobacco products, up from about 1,000 annually in 2018-2019, creating a massive backlog.

FDA has since cleared most applications but nearly 132,000 remained unreviewed as of December 2025, with average review time across 2018-2025 running 507 days against stated goals of 7 to 180 days per phase.

The agency's data system isn't built to track the scientific-review phase at all, so FDA cannot measure whether it's meeting its own timeliness goals there; GAO recommends it start collecting that data, and HHS agreed.

The full dispatch is available from the source below.

✒ FROM THE EDITORIAL DESK

An agency that sets a goal and then builds a system incapable of checking whether it met the goal isn't managing a backlog, it's managing the appearance of one. Over five hundred days average review time is already a long wait for an answer about what's legally for sale; not even knowing how slow the slowest part is makes it worse. Agreeing with the recommendation is the easy part, actually building the tracking is the part that counts.

Source: Read the original at GAO → Scored: Dvorak Polka · Kevin MacLeod · CC BY 4.0

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