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  • dag56 replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago

    As thuytienlecao mentioned above, the FDA currently regulates the electronic cigarette due to it containing tobacco products (nicotine) which is a controlled substance. This electronic device is also very different when compared to normal cigarettes due to its lack of some ingredients and over concentration of others. E-cigarettes do lack a lot of the harmful ingredients conventional cigarettes have such as tar, however, some also have a much higher nicotine concentration making them debatably more dangerous due to growing cultural trends. Therefore, I believe that they should definitely have different regulations from their ‘organic’ counterparts.

    Lastly, an electronic cigarette is simply a device that delivers a drug (nicotine) to the body and therefore should be in consideration for class III combination device. In addition, I believe that each company SHOULD require a full clinical trial for each model released due to each model possibly having a different mechanism of action. This is because different variations of the device could deliver different amounts of the drug into the body in addition to each flavor on the market reacting differently with the body/ device. In my opinion, overregulation of inherent non-medicinal products can’t hurt, under-regulation can.

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