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CABI U.S. Government Accountability Office · Audits

Tobacco Products: FDA Should Monitor Timeliness of Application Reviews

What GAO Found In 2016, the Food and Drug Administration (FDA) expanded its authority to oversee all tobacco products, including millions of e-cigarettes that were already on the market. In response, it received a surge of applications from manufacturers in 2020 for products seeking authorization to remain on the market legally. Specifically, it received over 25 million applications in 2020 and 2021, compared to just over 1 thousand applications in 2018 and 2019. This led to a backlog of applications. While FDA has since reviewed most of the applications submitted during this period, almost 132 thousand remained without a completed review as of December 31, 2025. (See figure.) Figure: FDA T.

CW Reported by Claire Walsh

Tobacco Products: FDA Should Monitor Timeliness of Application Reviews.

The item is dated Thu, 01 Oct 2026 07:23:55 -0400.

TeamCog is carrying it as a audits report from GAO reports and testimonies RSS.

What GAO Found In 2016, the Food and Drug Administration (FDA) expanded its authority to oversee all tobacco products, including millions of e-cigarettes that were already on the market.

In response, it received a surge of applications from manufacturers in 2020 for products seeking authorization to remain on the market legally.

Specifically, it received over 25 million applications in 2020 and 2021, compared to just over 1 thousand applications in 2018 and 2019.

This led to a backlog of applications.

While FDA has since reviewed most of the applications submitted during this period, almost 132 thousand remained without a completed review as of December 31, 2025. (See figure.) Figure: FDA T…

Official Source

GAO reports and testimonies RSS. Accessed 2026-10-01T15:00:02.348Z.