After Criticism, FDA Pledges to Revamp Its Tobacco Division

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The U.S. Food and Drug Administration’s heavily criticized 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 Dr. Robert Califf said in an agency news release. “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 anti-tobacco 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 FDA’s new 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 said.

While public health groups want more aggressive regulation, tobacco companies argue that the FDA won’t approve new alternatives that may help adults quit smoking, the AP reported.

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.

“Unfortunately, the tobacco industry has fought the agency on many of the science-based actions we’ve taken, putting profits over public health,” King said.

More information

The U.S. Centers for Disease Control and Prevention has more on e-cigarettes.

SOURCE: Associated Press

Source: HealthDay

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