- Public health authorities worldwide have long known and publicized the health risks associated with smoking and tobacco use. Smoking still remains the leading cause of preventable death in the United States. As FDA prepares to publish its “Deeming Regulation” — which is expected to capture e-cigarettes and e-liquid that contain tobacco-derived nicotine as regulated tobacco products under the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act — stakeholders have been concerned that the proposed “one-size-fits-all” approach to tobacco product regulation would effectively destroy the growing e-vapor industry, despite mounting evidence that these products are substantially less harmful than traditional combustible tobacco, like cigarettes.
- In late April 2016, the Royal College of Physicians (RCP) — Britain’s professional association dedicated to setting and improving medical standards — issued a groundbreaking report lauding the benefits of e-cigarettes as safer alternatives to smoked tobacco. The 200-page report summarizes the science, public policy, regulation, and ethical issues related to e-cigarettes and concludes that vaping is not a “gateway” to smoking. On the contrary, “the available evidence to date indicates that e-cigarettes are being used almost exclusively as safer alternatives to smoked tobacco, by confirmed smokers who are trying to reduce harm to themselves or others from smoking, or to quit smoking completely.” The report estimates that e-cigarettes are only 5% as harmful as traditional cigarettes and that long-term effects of nicotine from vaping are likely to be minimal. The report concludes that it is in the interest of public health to “promote the use of e-cigarettes, NRT [nicotine replacement therapy] and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK.”
- The RCP report has garnered widespread media coverage and has been met with controversial reactions in the United States. In response to the report, a spokesman for the Centers for Disease Control (CDC) reiterated the Agency’s contrary position that no conclusive scientific evidence supports the use of e-cigarettes as a safe and effective cessation tool at the population level. Particularly because the RCP issued the original groundbreaking report on the dangers of smoking in 1962 (in advance of the American Surgeon General’s 1964 report that linked smoking to cancer), it will be virtually impossible to ignore their latest statement of policy on this subject. It remains to be seen whether American and other global public health officials ultimately may follow suit and revise their policies with respect to the potential benefits of e-cigarette use.
Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice; for more information about this practice area in general, click here.