E-cigarettes could one day be regulated as an over-the-counter drug.
FDA Commissioner Scott Gottlieb said Wednesday the agency is actually considering This kind of option. The agency is actually re-evaluating along with modernizing its approach to the development along with regulation of nicotine replacement therapy products to assist smokers in quitting. This kind of includes systems in which go beyond nicotine gum, patches along with lozenges, which have traditionally been used.
“Right currently, we’re looking very actively at could we bring e-cigarettes into the over-the-counter regulatory pathway, which could give us many more tools to look at both safety along with benefit, along with study whether or not an e-cigarette actually does promote smoking cessation along with also give us many more tools to actually study the toxicology associated with the item along with see what effects the item 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 in which address toxicology of e-cigarettes along with what additional endpoints the item could use to allow products to claim they aid in smoking cessation along with 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. the item has requested more information on the role flavors, including menthol, play in attracting people to cigarettes along with alternatives like e-cigarettes. the item is actually also reconsidering how the item should regulate premium cigars.
A group of public health advocates along with pediatricians sued the FDA on Tuesday for delaying regulation of e-cigarettes along with 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 in which provide an alternative to smokers who want to get access to nicotine,” Gottlieb said.
Driving the FDA’s policies is actually the idea tobacco products exist on the so-called continuum of risk, where conventional cigarettes are the most harmful along with additional 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 along with teens.
Media reports have chronicled how kids are embracing e-cigarettes, especially the brand JUUL. Gottlieb said the FDA is actually aware of the problem with JUUL along with additional products, along with the agency will take enforcement action against companies in which are unlawfully marketing to kids.