Dr. Michael Pesko Discusses New FDA Regulations of Electronic Nicotine Delivery Systems
The US Food and Drug Administration (FDA) recently issued new regulations for electronic nicotine delivery systems (ENDS) including vaporizers and e-cigarettes. The regulations will raise the purchasing age of ENDS to 18 years to align with cigarettes, require all ENDS manufacturers to submit chemical and manufacturing information for FDA review, which will result in new warning labels.
Dr. Michael Pesko has recently been awarded a CHERISH Pilot Grant to examine data from the National Center for Health Statistics to explore the impact of non-financial incentives such as minimum purchasing age, on ENDS use and important health outcomes. Dr. Pesko has previously published several studies examining the potential effects of financial incentives and non-financial incentives of ENDS regulations on ENDS use in adolescents and adults.
Dr. Pesko, in one of your recently published studies you measured the reactions of current and former cigarette smokers to different warning labels proposed for the ENDS packaging, flavor regulations and options as well as the effect of pricing on purchasing behavior.
How do the new proposed labels from the FDA compare to those you studied? And consequently what effect do you think the new labels will have on purchasing or smoking behaviors?
The warning label that we used in a discrete choice experiment read: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” The recently-enacted rule uses the same warning label, but removes the section that explains that nicotine is “derived from tobacco.” In our discrete choice experiment, we found that this warning label was associated with a small decrease in the propensity to switch from cigarettes to vaping products among adult smokers, compared to the counterfactual of the vaping product having no label. However, many vaping manufacturers were previously voluntarily including similar warning labels on their products, so it seems unlikely to me that the new warning label will have much of an effect on vaping product purchasing overall.
The new proposed regulations also require that ENDS manufacturers submit chemical and manufacturing information for review.
Do you think that disclosing this information will cause ENDS manufacturers to change their products? Could this information influence purchasing or smoking behaviors in adults or adolescents?
I think that the new disclosure requirements will reduce incidents of vaping products being poorly manufactured in ways that lead to explosions of the vaping devices or toxicants unnecessarily seeping into the devices. I think that this is a useful law to battle misperceptions that vaping products are just as dangerous as cigarettes. If this misperception is challenged by producing devices that are safer, this could encourage more cigarette smokers to try to quit with vaping devices.
One unintended effect of this regulation is that it may cause consolidation in the vaping industry, as many smaller manufacturers may not be able to pay the costly disclosure requirements of the FDA and will either close or merge. This will likely lead to less competition in the vaping industry, less variety of vaping products, and higher prices. This is obviously a non-trivial cost of the regulation.
According to one of your studies, in 2014, 80% of the states in the US have minimum legal purchasing restrictions and 10% of those states with minimum legal purchasing ages have set this age at 19.
The FDA has now proposed a national minimum purchasing age of 18. In your study you suggest a potential increase in cigarette use following ENDS age purchasing restrictions. Do you think we will see an increase in adolescent cigarette use or marijuana use in response to the new FDA regulation on minimum age for ENDS purchase?
I don’t suspect we will see an increase in cigarette use because almost all states had e-cigarette purchasing laws in place by the time the FDA rule came into effect. However, states have the option to increase their tobacco purchasing ages to higher than 18, which many states are already doing. If states increase their purchasing ages for both cigarettes and vaping products to 21, I suspect that we will see a corresponding increase in cigarette use among 18-20 year olds because there is no extra incentive to use vaping devices to quit or reduce regular cigarette consumption. Without commenting on the merits of raising the cigarette purchasing age to 21, my research suggests it would be better to increase the purchasing age to 21 only for cigarettes, and leave the purchasing age for e-cigarettes at 18.
My research has found no evidence of substitution between e-cigarettes and marijuana, but more research is clearly needed in this area. Some people may vape instead of using marijuana, and others may now use marijuana more regularly because many vaping devices can vaporize marijuana so that it can be consumed more discretely.