Ready or Not, Here It Comes: The FDA’s Attempt to Regulate the E-Cigarette Industry

by Dylan Quinn, UMN Law Student, MJLST Staff

While the United States partial government shutdown created widespread uncertainty for federal employees and the monetary system, some are worried that the shutdown may cause the FDA to miss its self-imposed October 31, 2013 deadline for releasing the highly anticipated e-cigarette regulations. The FDA has already failed to meet its initial, self-imposed deadline of April 2013. While there are clearly no penalties for missing a self-imposed deadline, there are increasing external pressures that may force the FDA into action before the agency has a full grasp of the issues surrounding e-cigarettes.

It is estimated that e-cigarette sales in the U.S. will reach $1.7 Billion this year. E-cigarette use by students in middle and high school more than doubled from 2011 to 2012, according to the Centers for Disease Control and Prevention. They have become so popular that the use of the e-cigarette product has been coined, “vaping“.

While the FDA regulates e-cigarettes that are marketed for therapeutic purposes, it has made clear that it intends to treat e-cigarettes as a “tobacco product”, and establish regulatory control over the entire industry. However, by seemingly having this plan for years, the question arises of why the agency is on the brink of missing another deadline. The practical, and probable, answer is that the agency has no idea how to approach (or regulate) e-cigarettes.

Earlier this month the European Parliament took a “permissive approach” to e-cigarettes by shooting down proposals that called for strict regulation. European law makers seem to be influenced by the potential of e-cigarettes to be a healthy alternative to smoking, and are likely hesitant to place constraints on an industry that offers immense potential benefit to public health.

While the U.S. may benefit from taking the same approach, many think that the e-cigarettes are making nicotine addiction worse among youth, and there seems to be added pressure on the FDA to tightly regulate the industry. Just last month, Attorneys General from 41 states urged the FDA to issue the promised regulations, and there have been months of talks over a possible ban of online e-cigarette sales. However, the Obama Administration has just recently announced a significant funding program to operate 14 research centers focused on regulatory policy over tobacco products, and the FDA has expressly stated that more research is needed in regards to e-cigarettes.

There is no doubt that the public health impacts of e-cigarettes are not fully understood, and while this may not be a good enough reason to hold off strict regulation, the FDA may simply not know enough to effectively regulate the industry. Although continually missing deadlines, and gaining a better understanding, may lead to better regulation in the long run, the external pressures facing the FDA will not allow it to put off the regulations for much longer.