Cigarette Makers Frustrated As Product Approvals Stall
It's been only a few years since Congress granted the federal government the power to approve how tobacco products are made and sold in the U.S.
The Food and Drug Administration's new Center for Tobacco Products, established under a 2009 law that gives the agency jurisdiction over tobacco, must review all new cigarettes or smokeless tobacco, as well as any changes to existing brands.
But the agency has yet to clear any products under the new system, and some cigarette makers are frustrated by the backlog of applications.
The FDA typically evaluates new drugs and other products with a "safe and effective" standard. But Lawrence Deyton, the Center for Tobacco Products' director, says that standard "doesn't work for tobacco products."
FDA Would 'Rather Get It Right Than Get It Fast'
It's Deyton's job to figure out how a public health agency will regulate a consumer product that has proved to be addictive and deadly. Because there's no safe way to smoke, Deyton says, the FDA is using what's called a "population health" standard to evaluate tobacco.
"I sort of think of it as a ceiling of harm," Deyton says. "Things will get no worse, and any changes or new products that come on the market have to be appropriate for the protection of public health, or raise no different questions of public health."
Tobacco companies have not yet asked the agency to approve any new products, but they have submitted more than 3,500 applications for changes to existing brands — changes the companies say are so minor, they don't raise any of those "different questions."
The FDA has not approved any of the applications, some pending for more than a year and a half.
Deyton says the applications are getting the appropriate scientific scrutiny and that he would "rather get it right than get it fast."
The Two-Way
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