Unexpected Consequences of the FDA’s New Vaping Rules

This year, earlier, the U.S. Food and Drug Administration (FDA) finalized its authority to regulate electronic cigarettes and related products as tobacco products. However, these products do not actually contain tobacco.

In doing so, the FDA started the clock on August 8, 2018, ticking away for electronic cigarettes, e-liquids, and other related products that are now considered tobacco products without FDA approval, and the date for keeping them on the market is no longer legally permissible.

If manufacturers conduct a comprehensive study, it is required by the U.S. FDA to consider products for approval to remain on the market only after this "predicate date".

Experts estimate that conducting such research could cost manufacturers at least $30,000 per product they wish to keep on the market. In other words, if an e-liquid manufacturer wants to sell e-liquids in four different flavors, the manufacturer will need to spend around $12 million on research for these four products, with no guarantee that the FDA will approve any of the four liquids.

Some major companies will be able to bear this burden, but it is highly likely that the vast majority of small and independent manufacturers will not, thus leading to business closures.

So, who will use electronic cigarettes if, after August 8, 2018, their preferred products are no longer legally available for purchase? My research team at the Center for Substance Use Research (CSUR) recently asked this question to over 9,000 electronic cigarette users based in the U.S., and the results should alarm the FDA.

First, among former smokers, 8,451 current electronic cigarette users were asked what they might do if, as a consequence of the proposed regulations, the electronic cigarette products they currently use were removed from the market. Among vaping former smokers, about 73% indicated that they would "stock up" on their preferred products before the regulations were implemented.

Nearly 70% indicated that they would start sourcing their electronic cigarettes and e-liquids from unauthorized suppliers, thus fueling a black market for electronic cigarettes. Additionally, 66% of vaping former smokers indicated that they might start importing electronic cigarettes from overseas, and 65% indicated that they would begin making their own e-liquids at home—in other words, they would become not just consumers but also manufacturers of electronic cigarette products.

It is likely that these regulations aimed at addressing the FDA will pose greater risks than the health risks currently posed by electronic cigarette products sold in stores across the U.S. These unexpected consequences—particularly pulling consumers into questionable manufacturing standards and unknown toxic electronic cigarette products in the underground "black market"—could undermine the FDA's ability to assess the public health impacts of its own regulations and compromise the FDA's mission to improve and protect the health of Americans.

Conversely, our respondents indicated that they intend to continue using electronic cigarettes and products, with a very high likelihood of not being able to purchase from licensed suppliers. Only 17.5% of former smokers indicated that they would continue to purchase electronic cigarette products that have been FDA approved, and only 6.2% indicated that they would stop using electronic cigarettes altogether.

Then comes a particularly concerning finding among respondents who have successfully quit smoking—15% indicated that they might start smoking again if they can no longer legally purchase their preferred electronic cigarette products.

The FDA stated that the purpose of the new regulations is to protect Americans from tobacco-related diseases and deaths. However, by rationalizing current users' decisions to turn to black market electronic cigarettes or return to smoking tobacco, the regulations risk causing more harm than the current consumers are facing from the products available in stores.

By starting to purchase electronic cigarettes "off the books" from black market vendors, consumers will effectively become invisible to legitimate suppliers and those public health and regulatory authorities who wish to monitor the population's use of electronic cigarettes. They will be completely visible, however, to black market vendors who will inevitably begin to offer these consumers not just illegal electronic cigarettes.

Even if we accept that a small portion of individuals surveyed will actively seek out black market electronic cigarettes, the FDA's ability to monitor the prevalence, quantity, and frequency of electronic cigarette use after implementing its regulations will be significantly compromised by the health risks associated with using black market products.

Since the announcement, the FDA's "predicate" regulations for electronic cigarettes have been criticized by many health and harm reduction scientists for several reasons, including by Dr. Michael Siegel, a professor of public health at Boston University School of Public Health.

Dr. Siegel, who has 25 years of experience in the field of tobacco control, pointed out that the FDA's predicate regulations actually prohibit manufacturers from making safety improvements to electronic cigarettes if they do not undergo a lengthy, multimillion-dollar approval process, "even if [manufacturers] are aware of serious, potentially life-threatening product defects."

Our research provides another important perspective on this criticism. It is crucial for the FDA and policymakers to recognize the potential harms that could arise if the vast majority of current electronic cigarette users, who may represent millions, express intentions to pursue more risky behaviors after being removed from the legal market.

Clearly, it is necessary for the FDA to monitor the impact of these regulations to determine whether these adverse effects exist, and if so, to consider reconfiguring the regulations. One way to do this is to allow electronic cigarettes and e-liquids currently on the market to continue to be evaluated by regulatory authorities in a lighter form, while imposing stricter regulatory requirements on manufacturers seeking to bring any new products to market.

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

We, along with the vast majority of electronic cigarette manufacturers and consumers, commend regulatory agencies for raising the quality standards of electronic cigarette production, improving the accuracy of product labeling, reducing the presence of toxic substances in electronic cigarettes and e-liquids (which are already significantly lower than levels in cigarette smoke), limiting youth access to electronic cigarettes, and preventing youth from using electronic cigarettes.

We also do not doubt the FDA's sincerity in its efforts to safeguard and improve the health of Americans. However, the evidence from our research is clear: the predicate regulations, if implemented as they are currently written, will significantly increase the risks to the health of electronic cigarette users.

If even a small portion of the individuals surveyed act on their intentions, the health of potentially millions of electronic cigarette users will be threatened and left unprotected by the new regulations.

As the clock ticks toward the August 8, 2018 predicate date, there is much to be done by the FDA and the U.S. Congress to ensure that these unintended consequences do not come to fruition.

Furthermore, there is currently no credible evidence that vaping electronic cigarettes causes harm comparable to that caused by smoking tobacco, but there is evidence that the regulations could drive many electronic cigarette users back to smoking and purchasing electronic cigarettes from manufacturers with little regard for quality and safety, putting consumers' health at risk. There is too much at stake for over 9 million Americans who currently use electronic cigarettes to leave the regulations as they are.

Dr. Christopher Russell is a psychologist and senior researcher at the Center for Substance Use Research in Glasgow, Scotland. Dr. Russell leads the center's research on tobacco harm reduction, focusing particularly on how electronic cigarettes help smokers quit. Dr. Russell leads the research study described in this column.