E-cigarettes could one day be regulated as an over-the-counter drug. FDA is considering this option. The agency is re-evaluating and modernizing its approach to the development and regulation of nicotine replacement therapy products to assist smokers in quitting. This includes systems that go beyond nicotine gum, patches and lozenges, which have traditionally been used.
The FDA will soon put out guidance documents that address toxicology of e-cigarettes and what additional endpoints it could use to allow products to claim they aid in smoking cessation and smoking reduction, he said.
Under Gottlieb, the FDA unveiled a sweeping plan to overhaul tobacco regulation last summer.
Since then, the agency has moved to lower the amount of nicotine in cigarettes to minimally or nonaddictive levels. It has requested more information on the role flavors, including menthol, play in attracting people to cigarettes and alternatives like e-cigarettes. It is also reconsidering how it should regulate premium cigars.
