Will E-Cigarette Regulation Evolve in Pace With New Products?

The response to a new form of coronavirus shows how public health authorities can respond extremely rapidly to emerging threats to health. But what if the threat is not from a microorganism spread by droplets or mosquitoes but rather a product spread by global corporations that have the power, often hidden from view, to influence policy, something that traditional disease vectors lack?¹

Since beginning to treat e-cigarettes as tobacco products rather than medicines in 2016, the Food and Drug Administration (FDA) has had extensive powers to reduce their availability to young people and to require manufacturers to obtain premarketing approval on grounds of safety. Only the first of these powers was enacted. A bewildering array of new products entered the market, and a new generation of young people was becoming addicted to nicotine.² Decades of progress in tobacco control were being reversed.

Meanwhile, the FDA delayed acting on product safety. Eventually, in July 2019, it was forced to act. A US district court ordered the agency to implement its approval procedures with respect to any “new” tobacco products marketed since 2007. Applications were required to be filed by May 12, 2020, but products could remain on the market for up to a year while the FDA processed the data submitted by manufacturers for the approval procedure.

As the accompanying editorial by Zeller describes (p. 772), the FDA has decided to prioritize its actions. The first products assessed will be flavored, cartridge-based products (except for those with tobacco or menthol flavors); products for which the manufacturer has failed to take action to prevent access by minors; and products whose marketing is targeted at or likely to increase use by minors.³

Obviously, from a public health perspective, any measure that addresses the growing concerns about the safety of these products is welcome. Yet e-cigarettes, similar to microorganisms, are constantly evolving. When a new antibiotic is introduced, there will often be bacteria that are resistant, giving them a competitive advantage. Soon they take over. In these circumstances, it is difficult to see why a regulator would leave open any loopholes. However, this is exactly what the FDA has done.

Some existing e-cigarettes possess many features that make them attractive to young people, such as ease of concealment, yet apparently fall outside the FDA’s priorities. These include products with refillable pods rather than prefilled cartridges, such as Suorin, and self-contained disposable products, such as puff bars. Proving that a manufacturer has failed to act to reduce use among young people will be very difficult. And why exempt menthol flavoring, given its attraction to young people?⁴

The FDA does recognize this challenge, noting that it is “continuously evaluating new information and adjusting its enforcement priorities.”^3(p23) Yet, given the likelihood that the agency will always be several steps behind an industry that has demonstrated remarkable ingenuity in attracting new users, surely the obvious solution is to reverse the burden of proof and apply the precautionary principle. This underpins the regulations the FDA seems so reluctant to enforce. Given growing evidence that flavorings contribute substantially to the tissue damage associated with e-cigarettes,^4,5 coupled with how they are being used to attract young people⁶ and the vast resources that manufacturers are deploying to defend them, a continuing delay in banning them until they are shown to be safe seems very difficult to justify.