Unintended consequences of the FDA’s e-cigarette regulations

Earlier this year, the Food and Drug Administration (FDA) finalized a rule that extended the agency’s authority to regulate electronic cigarettes and related vapor products as tobacco products. However, these products do not actually contain tobacco.

In so doing, FDA started the clock ticking toward August 8, 2018, the date on which e-cigarettes, e-liquids and other related newly deemed tobacco products that do not have FDA approval to remain on the market can no longer be legally sold.

E-cigarette products can only stay on the market after this ‘predicate date’ if a manufacturer undertakes a package of research that is required by FDA to consider granting approval for a product to stay on the market.

{mosads}Experts have estimated that undertaking this research package to a good standard could cost a manufacturer at least $3 million per product it wishes to keep on the market. In other words, if an e-liquid manufacturer wants to sell four different flavors of e-liquid, the manufacturer would have to pay in the region of $12 million to conduct or commission research on those four products, none of which guarantees FDA will grant approval for any of the four liquids.

Some of the major companies will be able to shoulder this financial burden, but it is highly likely that the vast majority of small and independent manufacturers will not, and so, will be put out of business.

What, then, will people who currently use e-cigarettes do if, on August 8th 2018, their preferred products are no longer legally available to buy. My research team at the Centre for Substance Use Research (CSUR) recently asked this question to more than 9,000 US-based e-cigarette users, and the results should give FDA cause for alarm.

First, 8,451 current e-cigarette users who were also former cigarette smokers were asked what they would likely do if, as a consequence of the Deeming Rule, the e-cigarette products they use right now were taken off the market. Approximately 73 percent of the vaping former smokers indicated they would ‘bulk buy’/stock up on their preferred products before the rule was implemented.

Nearly 70 percent indicated they would start to source their e-cigarettes and e-liquids from a non-licensed vendor, and so fuel a black market trade in e-cigarettes. In addition, 66 percent of vaping former smokers said they would likely start to import e-cigarettes from overseas, and 65percent  said they would start making and mixing their own e-liquids at home — in other words, they would become not merely a consumer, but also a manufacturer of e-cigarette products.

It is very likely that each of these intended responses to FDA’s regulations would pose much greater risks to the health of consumers than are being posed by the e-cigarette products that are currently being sold in stores across the US. These unintended consequences — in particular, driving consumers to an underground ‘black market’ trade in e-cigarette products of dubious manufacturing standards and unknowable toxicity — would both undermine FDA’s ability to assess the population health impact of its own rule, and undermine the FDA’s stated mission of improving and protecting the health of Americans.

In contrast to the high rate at which our respondents indicated their intention to continue using e-cigarettes and supplies that will not be purchased from licensed vendors, only 17.5 percent  of vaping former smokers said they will continue to buy e-cigarette products that have been FDA-approved and only 6.2 percent  said they would stop using e-cigarettes altogether.

And then came a particularly worrying finding —15 percent  of the respondents, who have already successfully quit smoking, said they would likely start smoking again if they could no longer legally buy their preferred e-cigarette products.

The FDA has indicated that the goal of the new regulations is to protect Americans from tobacco-related disease and death. Yet by rationalizing current users’ decisions to circumvent the rule by turning to black market e-cigarettes, or going back to smoking tobacco, the regulations risk creating harm where little, if any, currently exists for consumers.

By beginning to buy e-cigarettes ‘off the books’ from black market traders, consumers will become effectively invisible to legitimate vendors and to health and regulatory authorities that wish to monitor use of e-cigarettes in the population. They will be entirely visible, however, to black market traders who will inevitably begin to offer these consumers more than just illegal e-cigarettes.

Even if a small proportion of the individuals we surveyed become motivated to source e-cigarettes from the black market, the FDA’s ability to monitor the prevalence, quantity, and frequency of e-cigarette use post-implementation of its regulations, and to estimate the health risks associated with the use of black market products, would be significantly undermined.

Since their publication, the FDA’s ‘deeming’ regulations of e-cigarettes have been criticized on several grounds by many health and harm reduction scientists, including by Dr. Michael Siegel, a professor in the Department of Community Health Sciences at the Boston University School of Public Health.

Dr. Siegel, who has 25 years of experience in the field of tobacco control, has noted as recently as this month that the FDA’s deeming rule actually prohibits manufacturers from making safety improvements to an e-cigarette if they do not undergo the multi-year, multi-million dollar approval process, “even if [the manufacturer] becomes aware of severe and potentially life-threatening product defects.”

Our research provides another important angle to this criticism. It is vitally important that the FDA and policy makers recognize the harms that would potentially be caused if, after August 8th, 2018, the vast majority of current e-cigarette users sampled, who may represent millions more, act on their expressed intentions to pursue ways to continue using e-cigarette products after they have been banned from the licit market.

There is a clear need for the FDA to monitor the impact of these rules to identify whether these adverse effects are occurring and, if they are, to consider reconfiguring the regulations. One way to do this would be to allow currently marketed e-cigarettes and e-liquids to continue to be the subject of a lighter form of regulatory assessment, while imposing stricter regulatory requirements on any new products that a manufacturer seeks to bring to market.

We agree with FDA that manufacturers should be required to conduct research on the products they wish to market, and that the quality of this research should be assessed to determine whether the introduction of a product into the market is likely to cause more harm than benefit to the public’ health.

We, along with the vast majority of e-cigarette manufacturers and consumers, laud regulators’ efforts to improve the quality standards in e-cigarette manufacturing, improve the accuracy of product labeling, reduce the levels of toxicants present in e-cigarettes and e-liquid (which are already many orders of magnitude lower than the levels found in cigarette smoke), restrict young people’s access to e-cigarettes, and deter young people from using e-cigarettes.

We also do not question that FDA is sincere in its efforts to protect and improve and protect the health of Americans. But the evidence from our study is clear: the deeming regulations, if implemented as they are currently written, rationalize several behaviors that would significantly increase e-cigarette users risk for ill health.

If even a small proportion of the individuals we surveyed were to act upon their intentions, the health of potentially millions of e-cigarette users would be threatened, not protected, by the new regulations.

With the clock ticking toward the August 8, 2018 predicate date, there is much that can be done, both by FDA and by the U.S. Congress, to ensure these unintended consequences never come to fruition.

There is no credible evidence to date that vaping e-cigarettes causes anywhere close to the harm that is caused by smoking tobacco, but there is evidence that the regulations will likely drive many e-cigarette users back to smoking, and to buy e-cigarette products of unknowable quality and safety from vendors with little care for the consumer’s health. There is far too much at stake for the over 9 million Americans who currently use e-cigarettes to leave the regulations as they are.

Dr. Christopher Russell Ph.D. is a psychologist and senior research fellow at the Centre for Substance Use Research in Glasgow, Scotland. Dr. Russell leads the Centre’s tobacco harm reduction research studies, with a particular focus on how vapers and e-cigarettes are helping smokers to quit. Dr. Russell led the research study described in this column.