FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products.” E-cigarettes are included in the category of ENDS — Electronic Nicotine Delivery Systems — products that use a liquid containing nicotine and varying amounts of flavor, glycerin, propylene glycol and other ingredients. This liquid is heated into an aerosol that users then smoke. It is often referred to as “vaping.”

The question whether e-cigarettes are safer alternatives to regular cigarettes is in itself an answer to whether it should be classified as a Class III device. However, there is not much research available into the long term effects on ENDS on adults. Also, due to increasing trend children have been adopting e-cigarettes. There is hardly any substantial data of the effects on children to address this issue completely. There is a speculation that since ENDS products contain nicotine, not only it is addictive but also can adverse effects on development of brain of a child. The FDA regulation on this will have a positive effect on these companies who have false claims on the quantity of Nicotine. Needless to say that FDA needs to conduct more research and more data from these companies to classify this device properly. But in order to do a heavy screening needs to be conducted by FDA to put these products out in the market.

Reference: http://www.cnn.com/2016/05/06/opinions/fda-electronic-cigarettes-caudle/index.html