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msc52njit-edu replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 6 years, 10 months ago
Yes, the FDA currently regulates e-cigarettes as well as all tobacco products. May 5, 2016 was when the FDA ruled on electronic cigarettes.
https://changelabsolutions.org/does-fda-regulate-e-cigarettes
https://www.federalregister.gov/documents/2016/05/10/2016-10685/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-theI do think that e-cigarettes and regular cigarettes should be regulated differently. The e-cigarette is a mixture of chemicals that contains similar chemicals to a normal but does not have the same side effects on the individuals health. Also, since it has the ability to be highly addictive, very easy to use and very easy to attain, just as normal cigarettes are, I do not think there should be different regulations from normal cigarettes. Both products should contain warning labels regarding the health risk and the addiction risk, and should be treated and regulated the same.
The FDA does regulate cigarettes as it affects the packing, labeling and distribution.
https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm482563.htmI think that e-cigarettes are a new device that delivers a new form of drug that they should be regulated as a class II medical device and should have to go through clinical trials. Nicotine is a highly addictive substance and if a company is claiming that the device to be used to help people stop smoking then there must be more research involved that proves it will actually help people stop smoking. Inhaling a mixture of chemicals can have different, negative effects on the lungs that the company should know does not harm the individual, before it claims it is a safe alternative to smoking normal cigarettes. Individuals use to not have a clear understanding of the health effects of smoking because there was no intensive research and trials. E-cigarettes can be the same way but it is the FDA’s obligation to regulate and force clinical trials to ensure that this product that has reached millions of users, a lot of them underage, is safe for use and will not cause any long term health effects. Since E-cigarettes are so new there is not too much data on long term effects from consistent use, which is why the FDA must classify E-cigarettes as a class II device. It is a combination device that combines different chemicals, it is new to the market, it is highly addictive, and it can pose a serious risk to our generation and youth.