E-cigarettes could one day be regulated as an over-the-counter drug.
FDA Commissioner Scott Gottlieb said Wednesday the agency 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.
"Right now, we're looking very actively at could we bring e-cigarettes into the over-the-counter regulatory pathway, which would give us many more tools to look at both safety and benefit, and study whether or not an e-cigarette actually does promote smoking cessation and also give us many more tools to actually study the toxicology associated with it and see what effects it might have on the lung," he said in an interview with Meg Tirrell at CNBC's "Healthy Returns" conference.
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.
A group of public health advocates and pediatricians sued the FDA on Tuesday for delaying regulation of e-cigarettes and some tobacco products.
Gottlieb said the groups waited until he acted on the parts of his overhaul they liked, then sued for the parts they didn't.
"If you're in favor of getting adults to quit smoking you can't turn a blind eye to the people who want to get access to nicotine," he said.
"At the very time I am trying to take nicotine out of combustible tobacco, I don't want to be sweeping the market of products that provide an alternative to smokers who want to get access to nicotine," Gottlieb said.
Driving the FDA's policies is the idea tobacco products exist on the so-called continuum of risk, where conventional cigarettes are the most harmful and other nicotine products are potentially less risky. Adopting the ideology has required the agency to balance persuading adult smokers to quit conventional cigarettes without enticing adolescents and teens.
Media reports have chronicled how kids are embracing e-cigarettes, especially the brand JUUL. Gottlieb said the FDA is aware of the problem with JUUL and other products, and the agency will take enforcement action against companies that are unlawfully marketing to kids.