For years, FDA has allowed the vast majority of e-cigarettes to stay on the market even though none of them have the premarket tobacco product application (PMTA) orders they need to be sold legally. But all that is changing. Following a court ruling, FDA must issue PMTA orders by September 9, pro or con, for every e-cigarette brand or variant that has applied to stay on the market and take any not receiving permissive orders off the market.
So, the big questions are whether FDA will issue PMTA orders to allow the continued marketing of any e-cigarettes, and if so, what restrictions and requirements FDA might put on the permitted e-cigarettes, their flavors, and their marketing.
Juul in the Spotlight
One of the first PMTA orders FDA issues will likely be for Juul's e-cigarettes. Juul has applied to market e-cigarettes in just two flavors, tobacco and menthol, and with two different nicotine strengths. Juul says its application includes data-driven ways the company will address possible underage use of its e-cigarettes -- but what those are has not been made public.
Many blame Juul's aggressive marketing of multi-flavored versions of its especially addictive e-cigarettes for the sharp rise in youth e-cigarette use. North Carolina recently settled its lawsuit against Juul for $40 million, and a number of other lawsuits against Juul are pending. Before that, following bad publicity and pressure from FDA, Juul stopped all television, print, and digital advertising of its e-cigarettes, and then stopped selling flavors other than tobacco or menthol. Largely because of the rise in youth use, in January 2020 FDA initiated an enforcement action to remove any Juul-type cartridge-based e-cigarettes from the U.S. market if they had any flavors other than tobacco or menthol.
Similarly, FDA's ruling on Juul will establish a framework for FDA's PMTA decisions for all other e-cigarettes.
What Factors Play Into the PMTA?
FDA can allow an e-cigarette's marketing only if it finds that doing so is "appropriate for the protection of the public health" -- i.e., will reduce overall tobacco-related harms. If e-cigarette use is less harmful than smoking, the only sure way e-cigarettes can reduce health harms and risks is if smokers who would not have otherwise quit smoking switch entirely to using e-cigarettes. Or if youths who would otherwise have become addicted smokers become regular e-cigarette users instead.
Any other regular use of e-cigarettes will increase health harms. Most clearly, any use by youth or adults who would not otherwise use any tobacco product will increase overall harms (especially if it later evolves into smoking). And any e-cigarette use by smokers that stops or delays their smoking cessation or quitting all tobacco-nicotine use will also increase overall health harms.
So, to let any e-cigarettes stay on the market, FDA has to determine that the harm reductions from their future use as a complete substitute for traditional cigarette smoking by those who would otherwise smoke will be larger than the new health harms potentially caused by e-cigarettes.
So far, e-cigarette use among youth who would not otherwise smoke appears to be much more common than otherwise smokers using only e-cigarettes. It remains unclear whether smoker e-cigarette use will end up accelerating and increasing smoking cessation or reducing or delaying it. Accordingly, it might seem quite difficult for FDA to find that it is "appropriate for the protection of the public health" to allow any e-cigarettes to stay on the market.
However, in any PMTA orders to allow e-cigarette marketing, FDA has the power to include any restrictions and requirements on their labeling, packaging, marketing, and sale that would increase their harm-reducing potential or reduce any collateral risks or harms. For example, in the PMTA order allowing Philip Morris' "heat-not-burn" IQOS cigarette on the market, FDA stated that it may not be advertised or sold via any electronic media without strict age and ID verification to prevent youth exposure or purchases. FDA will likely place that same requirement on any e-cigarettes it allows to be marketed -- but FDA could include much more to protect public health.
For example, FDA could prohibit any e-cigarettes with any added flavors other than tobacco and menthol (the only flavors now allowed for cigarettes). Or could allow only tobacco and unflavored versions, and use other measures, instead of flavors, to prompt smokers to switch. FDA could further prevent youth use by allowing e-cigarette sales only in stores that do not allow youth, such as adult-only vape shops or tobacconists. FDA could also allow e-cigarette advertising only via direct communications to pre-verified adult smokers, and prohibit the sale of cheaper, disposable e-cigarettes, which tend to be used more by youth than by smokers trying to switch.
To try to ensure that e-cigarettes are used only in harm-reducing ways, FDA could require that e-cigarette labeling, package inserts, and ads explain how to use them to reduce health harms and how all other uses increase health harms and risks.
Putting such restrictions and requirements in any e-cigarette PMTA orders FDA issues would directly prevent and reduce future harm-increasing uses, especially among youth. But the e-cigarettes would still be readily available to adult smokers as a presumably less-harmful alternative. And FDA could put parallel restrictions on cigarettes and other smoked tobacco products to reduce smoking even more.
In the few PMTA orders FDA has already issued to allow the marketing of other types of tobacco products, FDA failed to include numerous measures that would have better protected the public health. However, the public health risks from the marketing and sale of e-cigarettes are clearly much larger, which could prompt FDA to act more responsibly this time. Also, FDA's failure to comply with applicable laws to protect the public health more effectively in its prior PMTA orders is now a matter of public record, making FDA vulnerable to corrective lawsuits. That should make continued FDA PMTA failures less likely. It is also possible that some e-cigarette manufacturers have proposed certain product and marketing restrictions and requirements in their applications in order to increase their chances that FDA will find it appropriate for the protection of the public health to issue orders allowing their marketing.
Is It Really About Public Health?
What FDA actually ends up doing could, unfortunately, depend largely on a range of political and bureaucratic factors, rather than on what's best for the public health. Since the 2009 Tobacco Control Act gave FDA extensive powers to regulate tobacco products, FDA has never received the White House support it needs to take strong, effective action to sharply reduce the many deaths and harms caused by smoking. With luck, the Biden administration will support FDA more than the Trump or Obama administrations did. One key indicator of whether that is happening is if the PMTA orders FDA issues for Juul and other e-cigarettes are clearly designed to effectively protect and promote public health, and are also supplemented with strong new FDA rules to directly prevent and reduce smoking.
Eric N. Lindblom, JD, a former official at FDA's Center for Tobacco Products, is now an independent legal and policy consultant on tobacco control and other public health matters, and a senior scholar at Georgetown Law's O'Neill Institute for National & Global Health Law.
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