The Public Health Cost of FDA’s Tobacco Review Delays

When avoidable delays in reviewing cigarette alternatives prolong smoking, they cost lives. Quitting reduces the risk of premature death, while continuing to smoke sustains exposure to the hazards responsible for smoking-related disease. Because cigarette smoking and secondhand smoke cause more than 480,000 deaths annually in the United States, the years-long delay documented in a September 2026 report from the Government Accountability Office (GAO) warrants scrutiny as a public health problem—not just a burden on manufacturers.

The GAO report documents prolonged waits and gaps in the ability of the Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) to track scientific reviews. As of Dec. 31, 2025, 131,915 tobacco-product applications submitted between 2018 and 2025 remained without completed reviews. Spanning multiple tobacco review pathways rather than reduced-risk products alone, these applications had been pending for an average of 1,266 days. While the report establishes administrative failures only, evidence on smoking cessation and consumer responses to restrictions on e-cigarettes give us a reason to examine what these delays could mean for adults trying to leave cigarettes behind.

Many adults need more support making the transition from cigarettes. The Center for Disease Control (CDC)’s analysis of 2022 national survey data found that roughly two-thirds of adults who smoked wanted to quit and more than half had tried in the past year, while fewer than one in 10 had recently succeeded. Counseling and FDA-approved cessation medications are options; however, access to lower-risk alternatives can complement these approaches for adults who would otherwise continue smoking.

The distinction between smoking and other nicotine use matters because cigarettes burn tobacco. The CTP recognizes that noncombustible products like e-cigarettes and nicotine pouches generally carry lower health risks than cigarettes. Switching completely can reduce exposure to harmful chemicals, although these products are not totally risk-free. Prolonged dual use can sustain substantial harm, and those who do not use tobacco products should not start.

A 2025 Cochrane review found high-certainty evidence that nicotine e-cigarettes help more people stop smoking for at least six months than nicotine replacement therapy, such as patches or gum. Its estimates suggest that eight to 11 of every 100 people using nicotine e-cigarettes might quit compared with six using nicotine replacement therapy. But while that finding supports another route away from smoking, it does not establish that every vaping product is equally effective. Larger, longer studies remain necessary to assess safety more fully.

Leaving cigarettes behind can change a person’s health trajectory. A large U.S. study found that adults who quit smoking at ages 45 to 54 gained about six years of life compared with those who continued. The CDC also reports that coughing and shortness of breath decrease within months of quitting, while heart attack risk drops sharply within one to two years.

Evidence from restrictions on e-cigarette access provides an indirect warning about substitution. A 2024 study compared tobacco-use trends among adults aged 18 to 29 across states. Most state flavor restrictions examined were associated with less daily vaping but more daily cigarette smoking, with the main estimate showing a 2.2-percentage-point increase in daily smoking relative to comparison trends. Maryland’s narrower policy did not show the same smoking increase. A separate retail-sales study found that flavor restrictions were associated with reduced e-cigarette sales and increased cigarette sales. Because these studies concern sales restrictions rather than delayed CTP reviews, they cannot tell us how many adults in the backlog kept smoking. However, they do support a plausible concern: Limiting useful alternatives may shift some consumption toward cigarettes rather than eliminating nicotine use.

Further complicating the connection between review timing and actual access, some products awaiting decision are already being sold without authorization. When a product ultimately meets the FDA standard, avoidable delay postpones authorization. Whether that also postpones an adult’s complete switch depends on availability, preferences, and behavior. The CTP must evaluate population-wide risks and benefits, including effects on youth and non-smokers. Timeliness should mean faster, scientifically sound authorizations and denials. The GAO recommends collecting the data needed to monitor scientific-review timelines, and the Department of Health and Human Services agrees. Better measurement would help determine whether reforms shorten waits without weakening scrutiny.

The unresolved public health question is what happens to adults who smoke while potentially useful alternatives await decisions. The CTP’s public health responsibility includes the risk of leaving potential benefits unresolved for years. A review system intended to protect health should account for both the risks of authorizing a product and the potential benefits lost through avoidable delays. While faster, scientifically sound decisions should help protect youth and non-smokers, they should also provide timely opportunities for adults to leave cigarettes behind.