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  • jr377 replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 7 years ago

    Technically, the FDA regulates all nicotine products including cigarettes and e-cigs. I however, don’t believe that they should be classified as a class III medical device. Regulation has a tendency to kill small businesses, because it only takes one law and now you produce illegal goods. Dr. Simon was right when he said that larger companies can weather out the storm because they can afford to. Small businesses go bankrupt because they don’t have the capital. If you regulate e-cigs it will be harder to create health studies to see whether or not e-cigs are better than normal tobacco products. That is why the FDA created the current rules they have, which are across the tobacco-related products board. Tobacco products are harmful, but they aren’t banned. People have the freedom to still use them, as long as they obey the laws on the books. If you wish to say that e-cigs are drug delivery devices, then so are all tobacco products, because they all deliver nicotine and other chemicals. For now, more studies are needed on safety before such a regulatory judgement call is made.

    [1] https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm506676.htm