FDA's tobacco unit pledges reset after criticism
Food and Drug Administration officials on Friday pledged a reset in the agency's tobacco program, responding to criticisms that a lack of direction has hampered efforts to regulate cigarettes, vaping devices and related products.
The head of the agency's tobacco center promised to deliver a five-year strategic plan by year's end outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.
The announcement comes as the tobacco center is besieged by criticism from all sides — including lawmakers, anti-smoking advocates and tobacco companies.
FDA chief Dr. Robert Califf commissioned separate, external reviews of the agency's tobacco and food programs last summer, amid controversies in both units.
The blistering report on the tobacco program, issued in December, described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.
The report mainly channeled long-standing grievances from groups on opposing sides of the tobacco issue. Public health groups want the FDA to more aggressively police regular cigarettes and flavored ecigarettes that appeal to teenagers. Tobacco companies complain that the FDA is unwilling to approve new alternative products — including e-cigarettes — that might help adults quit smoking.
FDA's tobacco chief, Brian King, said Friday that regulators are looking at ways to “better communicate” with companies about how the FDA makes decisions. The agency is also working to streamline the review process, when possible.
“Some things will take longer than others, but we're committed to getting everything done that we've outlined as expeditiously as possible,” King said in an interview.
Vaping industry representatives said they were unimpressed by the FDA update, which they said would continue to result in denials for most vaping products.
“While the devil is in the details, nothing in today's announcement hinted at any material shift in FDA's perpetual attack on every nicotine-containing product,” said Tony Abboud of the Vapor Technology Association, in an emailed statement.
The FDA has OK'd a handful of tobacco-flavored e-cigarettes from several large companies. But many industry players are pushing for approval of menthol and other flavors.