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

    FDA considers e-cigarette just like a regular cigarette. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories. However, the FDA’s Center for Drug Evaluation and Research maintains its authority to regulate electronic smoking devices as drugs or devices if the devices are marketed for therapeutic purposes. Even though the FDA now regulates electronic smoking devices, local and state governments may still adopt laws regulating electronic smoking devices, including restrictions on their sale or use.
    I think that e-cigarettes should be treated differently by the FDA; FDA should allow more of the e-cigarettes, so that people go toward e-cigarettes rather than regular cigarettes. Since e-cigarettes have much less tobacco than a regular cigarettes then using them would reduce the use of tobacco, which is the goal of the FDA.
    Yes, e-cigarettes are a drug delivery device and yes they have nicotine, however, they should be classified as medical devices since they are electronic devices which makes them a combination device.