GAO Urges FDA Tobacco Monitoring

In 2016, the FDA expanded its authority to oversee all tobacco products, including millions of e-cigarettes already on the market.

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

As of December 31, 2025, almost 132 thousand applications remained without a completed review.

From calendar year 2018 to 2025, the FDA took an average of 507 days to complete its review of tobacco product applications.

The FDA has goals for each phase of the review process, ranging from 7 to 180 days.

For the screening phase, the FDA did not meet its goals, although it has made progress toward them.

However, the FDA’s data system was not designed to track steps in the last phase of review.

Thus, it does not collect the data necessary to monitor whether it is meeting its goals.

In September 2025, the agency created a pilot program aimed at streamlining the review process for nicotine pouches.