Placing the Legal Vape Market in the Hands of Big Tobacco

The US Food and Drug Administration’s (FDA’s) new guidance on its enforcement policies for Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) is really two documents. The first polices the present; the second promotes a dystopian future in which the number of safer alternatives to smoking available to consumers will be drastically reduced, leaving those that remain overwhelmingly under the control of the same companies that continue to profit from combustible tobacco cigarettes.

The initial three enforcement priorities for ENDS are (1) flavored, cartridge-based ENDS products (except for tobacco- or menthol-flavored products); (2) all other ENDS products for which the manufacturer failed to take (or is failing to take) adequate measures to prevent minors’ access; and (3) any ENDS products targeted to, or whose marketing is likely to promote use by, minors.

In all three cases, monitoring their effectiveness over time would be valuable, although more clarity on what constitutes “adequate measures” and “likely to promote use” would be needed to do so. In particular, the heated controversy over flavor restrictions means their actual effects on uptake of e-cigarettes by youths and, critically, adult smokers, should be carefully examined.

Unfortunately, it will be difficult to obtain meaningful results before the regulatory doomsday clock hits zero and the fourth enforcement priority kicks in.

In addition, FDA intends to prioritize enforcement of any ENDS product that is offered for sale in the United States after May 12, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application).^1(p11)

The market that emerges under such enforcement is likely to dismay ENDS proponents and opponents alike. Currently, there are millions of ENDS products legally on sale in the United States. As of the writing of this comment, only three applications for new tobacco products have been approved (Philip Morris Products SA, IQOS tobacco-heating system holder and charger and tobacco sticks, three varieties; Swedish Match North America, Inc., snus smokeless tobacco, eight varieties; 22nd Century Group Inc., very low nicotine cigarettes, two varieties), none of them for vapor products.² As a consequence, as of May 12, 2020, the vast majority, at minimum, of vapor products currently being used in place of lethal cigarettes by millions of Americans will become illegal.

Given the lack of clear FDA standards for approval, it is possible that no e-cigarette or vapor product will ultimately survive the “vapocalypse.” Alternatively, the legal vape market will be left overwhelmingly in the hands of Big Tobacco companies that can afford to undertake the costly and uncertain FDA premarket application process yet paradoxically have the least interest in reducing cigarette smoking.

How this guidance will further the FDA’s role of promoting public health and consumer protection also remains murky. The guidelines not only acknowledge that most reports of injury and death implicate THC (tetrahydrocannabinol, the principal psychoactive constituent of cannabis) vaping products that contain vitamin E acetate but recognize that such nontobacco products fall outside their scope. Nevertheless, they still attempt to use these same injuries and deaths to justify regulation of e-cigarettes, contributing to the dangerous conflation of these two unrelated product categories in the eyes of the public.

At the same time, they fail to balance the potential risks of ENDS currently sold through legal channels against the more relevant risks of pushing consumers toward the unregulated black market of emerging products such as puff bars, or the deadly combustible cigarettes that ENDS can help make obsolete. Exactly zero brands of combustible cigarettes currently sold legally in the United States will become illegal on May 12, 2020, the same day the vast majority of demonstrably safer alternatives are outlawed. Enforcement that protects incumbent tobacco companies by “grandfathering in” their indisputably deadly products—while making it prohibitively difficult for independent manufacturers to legally market newer, less harmful alternatives—not only hurts consumers today but inhibits innovation of future products that could be even more effective at halting the ongoing public health crisis of combustible tobacco use.

Note. At the time this comment went to press, the deadline for submitting a premarket application has been extended for many e-cigarettes, cigars, and other new tobacco products to September 9, 2020, in response to the COVID-19 pandemic.