FDA Regulation of E-Cigarettes Creates New Opportunities
[Posted on: Thursday, November 12, 2015]

Since the passing of Tobacco Control Act in 2009, FDA has been actively and aggressively going after all tobacco products. Last week we discussed in details the actions FDA has taken to strictly regulate sale of tobacco products, primarily cigarettes. One thorn on FDA’s side has been e-cigarettes which currently FDA cannot regulate. In the 2009, FDA tried to seize e-cigarette products calling them “unregulated drug delivery” devices, but had to step back after courts refused to allow FDA jurisdiction over e-cigarettes. Since, 2011 FDA has been slowly building new rules to regulated e-cigarettes by reclassifying these as tobacco products bringing them under the Tobacco Control Act. It seems soon FDA will be able to regulate e-cigarettes as cigarettes requiring expensive market approval application. Some have predicted that this could be the end of e-cigarettes commercially in the US. However, there may a silver lining for the industry. Cancer caused by cigarettes is mostly linked to the tar and other by products of smoking. However, nicotine is not considered to be carcinogenic but addictive. Several smoking cessation products contain nicotine to help smokers get their nicotine cravings without the harmful smoke. By making e-cigarettes highly regulated, FDA will eventually make it hard to e-cigarettes to compete with cigarettes but e-cigarettes should any way never be compared to cigarettes; rather these products should be compared to smoking cessation products. The main concerns for e-cigarettes are solvents used and material for the pipe, which may get heated and release carcinogens. However, it is possible to design better quality e-cigarettes that avoid the risk but still provide nicotine, thereby acting as very effective smoking cessation products. With smoking cessation being a multi-billion dollar industry, it is time for e-cigarette manufactures to create better regulatory strategies to use FDA’s rules to their benefit and get access to a market much larger than e-cigarettes could ever be.