Fixing the federal policy on e-cigs will save lives
Unless something changes soon, the doomsday clock will strike midnight on the e-cigarette industry. Thanks to regulations finalized in August 2016 by the Food and Drug Administration (FDA), manufacturers of e-cigarettes and nicotine vapor products now have less than two years to complete an expensive and arduous application process to keep their products on the market. Unable to shoulder the costs, many mom and pop vape shops are already starting to shutter. Thousands more are likely to close soon.
Meanwhile, smokers and former smokers who rely on e-cigarettes as smoking-cessation tools or lower-risk alternatives will soon encounter limited options and increased costs. In all likelihood, many probably will be driven back to combustible cigarettes. This would be a real shame, since e-cigarettes are at least 95 percent less harmful than combustible alternatives and smoking-related illness is a leading cause of preventable death in America.
There has been a lot of talk about the need to amend the FDA rules in order to save the vapor product industry from death-by-red-tape and ensure consumers continue to have access to nicotine-delivery alternatives. In particular, many groups advocate changing the predicate date (the date by which products must have already existed on the market in order to be “grandfathered in”) to avoid the long and expensive application process. The date currently is set as Feb. 15, 2007, thanks to the Tobacco Control Act of 2009. Critics rightly point out that nearly all e-cigarette products have been introduced since that date, and that the hurdles established by the FDA process will be nearly impossible for all but the largest e-cigarette companies to meet.
But while fixing the predicate date is an essential first step to save the industry from impending death, it’s simply not enough. For example, instituting any grandfather date—even an updated one—still privileges existing products and restricts entry into the marketplace in the future, thereby stifling innovation.
Beyond that, the FDA’s deeming regulations are not the only culprit preventing us from realizing the full public health and economic benefits e-cigarettes could provide. There are in fact numerous failures in federal policy, all of which contribute to a climate actively hostile to tobacco harm reduction.
There are other things federal lawmakers and regulators can do to work toward a more sensible tobacco policy aside from the bandaid fix of repealing the deeming regulations. To start, they should embrace a “harm reduction” approach for nicotine products across federal agencies. Our current public health approach promotes abstinence, but some nicotine products are lower risk than others. Agencies like the FDA, Centers for Disease Control and Prevention (CDC), National Institutes of Health and Office of the Surgeon General should recognize the principle of relative risk and embed it in their services. The constructive role regulators could take is to set product standards to ensure that products are safe without stifling innovation.
Relative risk also should be incorporated into labeling rules and public health campaigns. Agencies like the CDC, FDA, and Office of the Surgeon General have all promulgated public health campaigns with misleading information about the risks of e-cigarettes. This has led to a great deal of misinformation among the public. Americans should have honest information about relative risks, so that they can make informed decisions. This also means e-cigarette and vapor product manufacturers should have permission to indicate on their packaging that their products are less harmful than traditional cigarettes.
With a Republican-controlled Congress and administration, many are hopeful we will soon see the end of the FDA’s deeming regulations. Such a reversal would grant a lifeline to the e-cigarette industry, though the path toward a more sensible tobacco control policy will have just begun. To fully realize e-cigarettes’ potential to improve public health, a reorientation of policy across agencies and a change in the national discussion over tobacco control is necessary.
E-cigarettes are the most innovative and promising smoking-cessation technology ever created, but right now, the government is standing in the way of progress. If federal lawmakers really want to reduce the burden of tobacco-related deaths and illnesses, it’s time for them to step into reality and catch up to speed.
Image by Leszek Glasner
