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ala26 replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
I do not think e-cigs should be classified as a class III medical device due to the lack of studies regarding it’s safety. Also, class III devices are classified as devices that have a high risk to the user. I think classifying e-sigs as class III would be too much. In 2016, FDA apparently required that e-cigs would go through the FDA approval process as regular smokes. I believe currently they require an “a nicotine warning label” that must appear on all tobacco products including e-cigs.
E-cigs are known to be less harmful to a person’s health rather than regular cigars or cigarettes. E-sigs contain fewer toxins but do still deliver harmful chemicals. So I think it would be best to currently regulate the age e-sigs can be sold too. I think for now, we should only sell e-cigs to 18 years and above. We need further studies to prove e-sigs should be regulated like normal cigarettes before taking action.