Will Pending Regs Reign in the Growing e-Cig Industry?

While the popularity of e-cigarettes has grown exponentially, so has the uncertainty about how federal agencies will regulate the product, what the effects of using the cigarette replacement products are, and, in turn, what the future e-cigarette industry will look like. These topics are at the heart of the discussion in a Health Affairs Health Policy Brief released by the Robert Wood Johnson Foundation, which opined that the finalization of pending regulations proposed by the FDA could have a profound effect on the future of the booming industry.


In April 2014, the FDA issued a Proposed rule detailing how it plans to regulate e-cigarettes. Specifically, the proposal included a ban on e-cigarette sales to children and teens under 18 years of age and other constraints. The Family Smoking Prevention and Control Act of 2009 (FSPCA) gave authority to the FDA to regulate cigarettes as well as the tobacco in cigarettes and “to ‘deem’ other products that meet the statutory definition of tobacco…as subject to its regulatory oversight.” The April Proposed rule was a first step in the “deeming” authority process under the FSPCA. Comments on the Proposed rule will be received by the FDA until August 8, 2014, and the report noted that a potential extension to that submission date followed by many months of deliberation and final rule tweaking by the FDA is expected.


In addition to the uncertainty associated with the future of the regulations and their issuance date, the report discussed the questions that have been posed in regard to the role of e-cigarettes as a cigarette replacement and the safety risks associated with the products. The report noted that “scores of studies are currently under way” to consider these types of questions: “What is the efficacy of e-cigarettes as a smoking cessation device? Will they encourage more conventional tobacco smoking or less? And what is the safety of the vapor itself for users and people around them?” So far, according to the report, while some completed studies have indicated e-cigarettes may be used as a tool to help smokers quit, the policy brief described the overall evidence on that front as “contradictory.”


Despite the ongoing debate and the unknown content of the final federal regulations for e-cigarettes, the report announced that it was “likely that one or more e-cigarette makers might soon try to market their product as an approved smoking cessation device.” At the same time, the report noted the likelihood of the e-cigarette industry beginning to use the same tactics used in the early, unregulated days of the tobacco industry. Indeed, the report emphasized that tobacco companies have already entered the e-cigarette market, as the three largest tobacco companies have either acquired an e-cigarette company or developed their own product. In closing, the report forecasts the near future of the industry as such: “Until the FDA issues its final rule, possibly not until next year, and then decides whether or not it will regulate e-cigarette advertising, expect to see a market that harkens back to advertising techniques once common with tobacco cigarettes, using cartoons and celebrities and loaded language.”