The FDA regulates the e-cigarette as stated earlier in the previous posts, this is because its a device that uses chemicals that is heated into a vapor and delivers to the human body via the lungs. This respiratory delivery system is a known drug delivery pathway such as for example using Albuterol as a steroid for patients that have Asthma. This e-cigarette is closely compared to a Nebulizer which heats up saline into a mist form and is combined with the drug for inhalation. In 2016 the FDA has extended their rule on CTP’s regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco product. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories.

If an e-cigarette would be used as a drug delivery medical device it would in fact be considered a class III device, this is due to the fact that it would have to undergo clinical trials to test whether it can be used to vaporize the drug and used for proper distribution in the human body, in terms of targeting the lungs, it is a known fact that it will but it all depends on the drug’s application that will be used for testing and their intended use. Overall i believe that regular cigarettes should be regulated just as any human consumption product is. As mentioned before by the previous participant, the different flavors of e-cigarette are also regulated, which would mean that e-cigarettes are also considered a combination product.