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cy268 replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 8 years ago
I don’t think e-cigarettes should be classified as a Class III medical or drug delivery device. From this week’s module, in order for a device to be considered as a medical device, the manufacturer first needs to make a claim that his device would have medical benefits. Although e-cigarette companies advertise that e-cigarettes help cessation from smoking, they have not yet filed a claim with the FDA suggesting it as a drug delivery device or a medical device that delivers therapeutic benefits.
E-cigarette brands make unvalidated claims their product helps people quit smoking
Nicotine from e-cigs activates the same reward pathways in the brain that recreational drugs do. If the question: if e-cigs help smokers break their habits or not, then I think that irrespective of type of substances inhaled through each of these devices the end effect is the same. The regular smoker who receives say 70% of the desired effect from cigarettes, e-cigs give him about 30%. As long as e-cig companies take advantage of the loopholes in the FDA policies, use of these devices will continue. But one cannot argue that banning or tight regulation of e-cigs will not only make people resort to regular (more harmful) cigarettes again but also create a larger demand in the black market for e-cigs which is again hard to regulate.