Using the FDA’s current regulatory framework for tobacco products, implemented under the Family Smoking Prevention and Tobacco Control Act, there are some areas of the electronic cigarette industry that may face regulation under current law.
The most damaging potential regulation would require electronic cigarette companies to comply with the current substantial equivalence determinations governing cigarette companies. Essentially, this regulation would require all electronic cigarette companies that began operating after 2007 to have their products taken off the market until they demonstrate that they are in compliance with FDA regulations and are substantially equivalent to the other electronic cigarette products offered in the marketplace.
Given that almost every electronic cigarette company entered the market after 2007, and the notoriously slow process of obtaining equivalency status, complying with this requirement could result in a large time gap in which many electronic cigarette brands would not be available to the public.
If any kind of equivalency regulation is enforced or proposed, electronic cigarette companies should retain experienced counsel to begin the regulatory compliance and equivalency process as soon as possible.
It is also likely that the FDA will propose advertising and marketing restrictions on electronic cigarette companies. As of right now, electronic cigarette companies face little-to-no regulations governing how they market their product(s). Some of the larger electronic cigarette companies are even starting to run major celebrity-endorsed television commercials reminiscent of the cigarette commercials that aired in the 1970s and 1980s, before these practices came under governmental regulation.
Electronic cigarette companies must become intimately familiar with the advertising and marketing laws regulating their industry or risk facing potential class action lawsuits and investigations by the Federal Trade Commission and state attorneys general.
It should be noted that the announcement of proposed regulations does not necessarily mean that such regulations will be immediately passed into law, as-is. There will likely be a lengthy public discussion and comment period, which will delay the final draft of the bill from being presented to Congress for a vote. The foregoing notwithstanding, it is a best practice to plan a course of action early and retain experienced counsel to help navigate the murky regulatory climate.