After Criticism, FDA Pledges to Revamp Its Tobacco Division

MONDAY, Feb. 27, 2023 (HealthDay News) -- The heavily criticized U.S. Food and Drug Administration tobacco program promised changes on Friday, including a five-year strategic plan to better outline priorities.

"As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle," FDA Commissioner Robert Califf, M.D., said in a statement. "Our ability to keep pace with these changes will depend on immediate, short-term, and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products."

The agency has faced criticism from antitobacco advocates, the industry, and lawmakers for its past work in cigarette and vaping regulation, the Associated Press reported. An external review commissioned last summer released a report in December that called the FDA "reactive and overwhelmed." Its workforce was struggling to manage tobacco and largely unauthorized e-cigarettes, the report stated.

The new FDA strategic plan is expected to outline efforts on e-cigarettes, as well as to be more transparent about FDA decisions, such as mass rejection of applications from e-cigarette makers.

Regulators would like to "better communicate" with companies about how the FDA makes decisions, said Brian King, tobacco chief for the agency. "Some things will take longer than others, but we're committed to getting everything done that we've outlined as expeditiously as possible," King told the AP. The FDA will also meet with the U.S. Department of Justice on efforts to crack down on the fruit- and candy-flavored e-cigarettes that appeal to teens, King added.

Hundreds of warning letters to vaping retailers and e-cigarette manufacturers are sometimes ignored, the FDA noted. King said the FDA relies on the Justice Department on when to bring on lawsuits. The two agencies have announced lawsuits and fines in recent months. "Those are the first of their kind, and I hope they're a wake-up call to industry that if you are violating the law we are going to use the full portfolio of our enforcement activities to ensure that you comply," King told the AP.

Associated Press Article