FDA Tobacco Unit Overloaded and Lacking Direction, Panel Says

TUESDAY, Dec. 20, 2022 (HealthDay News) — The U.S. Food and Drug Administration tobacco unit is “reactive and overwhelmed,” an expert panel reviewing its work reported Monday. In addition, the panel blamed inconsistent FDA regulation efforts for the spread of unauthorized e-cigarettes that are appealing to teens, among other problems.

Commissioned by FDA Chief Robert Califf, M.D., this summer, the review was done by a panel convened by the Reagan-Udall Foundation. The Reagan-Udall Foundation is a nonprofit that was established to work on FDA issues. It is funded by the FDA and industry, the Associated Press reported.

“This work is particularly critical as we focus on preventing initiation, while also helping people quit, especially the deadliest form of tobacco use, combustible tobacco products,” Califf said in a news release announcing the release of the report. “Despite meaningful declines in cigarette use over the past several decades, nearly 500,000 Americans still die every year from cigarette smoking. Additionally, with more than 3 million youth reporting current use of a tobacco product in 2022, and e-cigarettes being the most used product, we risk another generation becoming addicted to these products.” Califf added that he plans to review the recommendations and develop an action plan by February.

In the report, the experts recommended agency leaders set clear objectives and expectations to prevent more “detrimental” effects on the FDA work and staff morale. “Something is wrong if FDA can be given these amazing powers in 2009 and here we are at the end of 2022 and it has yet to take actions that would take a bite out of smoking,” Eric Lindblom told the AP. He is a lawyer at the Georgetown University O’Neill Institute and previously worked at the FDA tobacco center.

“The agency must do a better job of setting forth clear policies to protect kids, while also helping adults who can’t or won’t quit smoking,” Cliff Douglas, who leads the University of Michigan Tobacco Research Network, told the AP.

The agency also is undergoing “near constant litigation,” according to the panel. Lawsuits have increased as the FDA has missed deadlines to review millions of e-cigarette applications, the AP reported. The agency needs more money to handle the workload.