The FDA’s Center for Tobacco Products Ignores the Science of Tobacco Harm Reduction
A recent article in The New England Journal of Medicine (NEJM) titled “Electronic Nicotine-Delivery Systems for Smoking Cessation” details a four-year study on electronic nicotine-delivery systems (ENDS). The study shows new evidence that ENDS products are an effective tobacco harm reduction tool, and is supported by medical professionals; yet as evidence grows, the U.S. Food and Drug Administration (FDA) continues to limit access to new ENDS products.
In the NEJM article, all 1,246 participants were adults who smoked at least five cigarettes per day and were interested in quitting. None had used e-cigarettes or nicotine-replacement therapy in the three months prior to enrollment in the study. Participants were randomly assigned to the experimental group (those who received ENDS, also referred to as e-cigarettes or vapes) or the control group (those who received money to purchase nicotine replacement therapy patches). Both groups received the same smoking cessation counseling.
Each participant responded to a series of questionnaires and underwent several clinical tests at the beginning of the study and at a six-month follow-up visit. Among participants who received ENDS, nearly 30 percent reported (and were verified to be) abstaining from tobacco smoking, whereas only 16 percent of those who used nicotine replacement therapy were smoke-free. Additionally, 60 percent of those in the experimental group were considered “tobacco abstainers,” reporting no tobacco cigarette use in the seven days prior to their six-month visit, whereas only 39 percent of those in the control group attained that level of abstinence.
These data add to the growing literature regarding the utility of ENDS products as tools to help people switch from combustible cigarettes to reduced-risk products (RRPs). However, other features of this clinical trial should also be considered when evaluating its outcomes. First, participants in the experimental group received open-system (rechargeable, refillable) ENDS devices, which are more difficult to use than closed-system (disposable) ENDS. Second, those who received ENDS products chose between 24 different e-liquids with a combination of six flavors (two tobacco, one menthol, three fruit) and four nicotine concentrations (19.6 mg, 11 mg, 6 mg, 0 mg), which they could order throughout the study based on their needs and preferences. Finally, all participants were tracked regarding potential health concerns over the six-month period. Only 4 percent of those who received ENDS products experienced a serious adverse event, whereas 5 percent of those who used nicotine replacement therapy experienced such an event. The occurrence rate of any adverse event was also similar across both groups. Safety data did not generate any significant concerns associated with the use of ENDS products.
Given the study’s success, the NEJM published commentary from Dr. Nancy Rigotti, director of the Tobacco Research and Treatment Center at Massachusetts General Hospital, alongside it. Rigotti states that the medical community should “acknowledge this progress and add e-cigarettes to the smoking-cessation toolkit” and that “the burden of tobacco-related diseases is too big for potential solutions such as e-cigarettes to be ignored.” These statements represent a tectonic shift in the academic medicine community toward providing those who smoke with clear guidance on the efficacy and safety of ENDS products.
As evidence grows for the utility of ENDS and other potentially life-saving alternative products, the FDA’s Center for Tobacco Products (CTP) continues to limit Americans’ access to these products. Though the CTP has received millions of applications for ENDS products, it has only allowed a few to be marketed legally in the United States. Of those that have received marketing clearance, only older closed systems have been approved—with tobacco as the only permitted flavor.
The CTP should act now to revise its processes and procedures and open the ENDS marketplace to products with varied characteristics (e.g., format, flavor, nicotine level) so that those interested in alternative nicotine products can access them. A diverse range of ENDS products available to those who smoke and want to quit is critical to reducing the health burdens associated with smoking. Continued delay by the CTP will only lead to more unnecessary deaths and disease in the United States.
The science is clear, and the evidence must not be ignored: Reduced-risk products save lives.