The FDA has recently passed sweeping regulations, which classifies and then regulates electronic cigarettes as “tobacco products” in the same manner as traditional cigarettes. Though the agency reasons that unknowing adults and children may easily turn to e-cigarettes without fully understanding the potential health effects, there is a lack of conclusive evidence in this field to justify such a comprehensive regulatory scheme. Through the far-reaching “Deeming Rule,” e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market. The channels by which the FDA proposes manufacturers and retailers gain permission from the agency to sell their products on the market in the first place threaten to put them out of business completely. Courts read a cost-benefit analysis into their interpretation of the Administrative Procedure Act, and the FDA has failed to conduct a fair and full cost-benefit analysis before the passage of the new Deeming Rule. By violating the Administrative Procedure Act, consumers are unable to turn to a safe alternative to traditional cigarettes, and manufacturers are unfairly put out of business. Instead of heavily regulating an entire industry with such limited research to support it, the FDA should step out and cease regulation until adequate research has been conducted. If the agency is unwilling to completely delay the regulation, weakening the burdensome approval process and stringent requirements until more research is completed would allow companies to still supply the market while protecting consumers.
Lauren H. Greenberg,
The “Deeming Rule”: The FDA’s Destruction of the Vaping Industry,
83 Brook. L. Rev.
Available at: https://brooklynworks.brooklaw.edu/blr/vol83/iss2/20