How Should E-Cigarettes Be Regulated?
Public health excitement around e-cigarettes rests on their potential to significantly reduce harm compared to cigarettes. If the evidence does eventually show net benefits at the population level—i.e., that cigarette smokers will switch completely to e-cigs, that they do not lead to youth uptake of cigarettes and that any harm (both from using and from being exposed to someone using) is negligible—then we can consider marketing these products aggressively.
Until then, e-cigs should be subject to the same marketing and sales restrictions as cigarettes. In addition, use of e-cigs should be prohibited in indoor and outdoor public places where cigarettes are prohibited, and they should not be sold to minors unless prescribed by a health care provider.
The overwhelming preventable deaths come not from nicotine but from smoking tobacco, primarily cigarettes. The goal of regulation is harm minimization at individual and population levels: use e-cigs to speed the obsolescence of lethal combustibles, while keeping them away from youth.
Regulations must minimize individual harms while ensuring e-cigs are not sold or marketed to anyone under 18. Product standards can ensure quality controls, safe handling and accurate labeling, and child-resistant packaging. Comprehensive nicotine regulation is required to maximize benefits: fast track approval of use for harm reduction and smoking cessation to replace lethal cigarettes. Post-market surveillance should aggressively monitor unintended consequences and drive public education/ enforcement to counteract misleading beliefs and behaviors that slow rather than accelerate e-cigs’ beneficial impact.
E-cigarettes should be subject to the same basic requirements as cigarettes and other tobacco products. For example, e-cig manufacturers should be required to register with the FDA, provide ingredient information and obtain approval for new products. The FDA should also establish product standards, quality controls for manufacturing, contaminant limits and labeling requirements. The American Heart Association has also asked the FDA to require childproof packaging, restrict marketing to children, prohibit sales to youth and ban the use of candy and fruit flavors.
Elliott Antman, MD, is president of the American Heart Association and a Harvard Medical School professor.
Regulating in the absence of solid evidence is tough. E-cigarette regulation should not be undertaken without strengthening all aspects of cigarette regulations starting with taxes and better controls on youth access. E-cig regulations should focus on product safety, minimizing youth access and control of candy flavors. They should be framed to encourage harm reduction—switching from cigarettes to e-cigs reduces to almost zero the harm caused by tobacco—and be linked to strategic research evaluating impact. We need research that looks at the impact of e-cigs on the use of tobacco products, as well as on the impact of e-cig use on health outcomes.
Derek Yach, MPH ’85, MBChB, is senior vice president of the Vitality Group.
E-cigarettes present great potential for the reduction, and ultimate elimination, of cigarette smoking. The key to their success will be in how they are regulated. Federal regulation is necessary to prevent e-cigarettes from becoming gateway tools into tobacco use, particularly for adolescents, and to prevent dual use of e-cigarettes and tobacco cigarettes.
E-cigs should be regulated as novel nicotine delivery systems. While most of these regulations would align with current tobacco guidelines for packaging, labeling, sales, and advertisement, new regulations specific to e-cigs, such as prohibiting the sale of nicotine flavors targeted to children, are necessary too.
Kate Baquis is an MSPH candidate at the Bloomberg School and an associate at Avalere Health in Washington, D.C.