The Pathway to Solving the Combustion Problem Is Clear
The U.S. Senate Judiciary Committee recently held a hearing on strengthening enforcement efforts against illegal e-cigarettes to better combat the youth vaping epidemic. The hearing was a rare example of bipartisan agreement in understanding both the scope of the problem and the need to act quickly and efficiently to stave off the negative outcomes of a poorly regulated tobacco and nicotine marketplace. The panel of senators raised several concerns related to the abundance of illegal electronic nicotine delivery systems (ENDS) in the marketplace—many of which are manufactured in China. They also expressed major concern that these products often find their way into the hands of youth. These concerns are valid, and the regulatory agency responsible for evaluating these products should be held accountable for the current situation within both the legal and illegal ENDS marketplace.
Illicit Market Concerns and the Center for Tobacco Products
Although several individuals provided testimony, two stood out because of the information they provided. The first was Brian King, PhD, MPH, the current director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). His testimony provided the senators with a description of steps the CTP has taken to attempt to regulate the industry as a whole and disrupt the massive growth of the unregulated marketplace. His testimony revealed that the organization’s attempts have been lacking (amounting to a handful of warning letters, fines, and product seizures), and the illicit marketplace has continued to grow and thrive. King emphasized that the unforeseen growth of the ENDS marketplace and the high volume of premarket tobacco product applications (PMTAs) has created a significant burden for the CTP that has prevented them from reviewing PMTAs in a timely manner. He reiterated this point multiple times, noting that without additional resources (through allowing for the collection of user fees), the process was unlikely to improve.
The harsh reality is that the PMTA review process is fundamentally flawed, and pouring more funds into it is unlikely to yield a solution that caters to consumers’ needs or effectively addresses the issues of the illicit marketplace and illegal youth access. Specifically, the CTP has implemented a regulatory process without clearly defining those requirements to manufacturers. The Tobacco Control Act states that any new product introduced into the marketplace must be appropriate for the protection of public health (APPH). This phrase is often used by the CTP, and the burden of meeting this standard is placed on the manufacturers. The reality, however, is that APPH has never been operationally defined—which is a key requirement for any scientific investigation—and no standards, required product characteristics, or required testing have been put forth for manufacturers to follow. Without a clear definition of the standard for APPH, how it is evaluated, and a process to follow, manufacturers are left to play a guessing game as they complete the application materials that the CTP requires. Moreover, until the PMTA application requirements are codified into law, the CTP has the ability to modify its interpretation of APPH to bend to individual bias and political pressure, neither of which has a place in protecting public health. Thus, current problems with the PMTA application process underscore the need for a more efficient and effective solution to the ENDS regulation problem.
The second testimony of particular interest was that of Tony Abboud, the executive director of the Vapor Technology Association (VTA). His statements reflected many of the same frustrations that the Judiciary Committee expressed, with the addition of clear strategies that could help solve the identified problems. The VTA is highly concerned about the presence of an illicit marketplace, stating that the manufacturers of ENDS products strive to be in compliance with the law but that the delays and inaction of the CTP have led to a de facto ban on ENDS products. He explained that the lack of products available to market legally is forcing retailers to attempt to meet consumer needs by usurping unclear rules and regulations. Abboud shared that most retailers want to be in compliance with the law but also feel a responsibility to provide adults with viable alternatives to combustible cigarettes that have been shown through multiple scientific investigations to carry fewer potential health risks.
Youth Uptake Concerns, Including Flavor
All members of the committee and all of those providing testimony agreed that youth use of ENDS products was a problem that needed to be addressed. By design, marketing techniques are tailored to grab the attention of current and potential consumers, regardless of age, which means that some ENDS marketing is likely influencing youth uptake. Thus, clear marketing guidelines should be established and implemented that allow consumers to garner clear information about products, but that also eliminate imagery and descriptors directed toward youth. Importantly, flavors of any particular type should not be disallowed from marketing material; instead, manufacturers should be held to guidelines about the manner in which the flavor characteristics are communicated to the consumer. Flavor is a powerful tool in helping adult consumers transition to a combustion-free lifestyle, and those tools should be marketed and implemented in a fair and responsible manner.
Along the same lines, sweeping flavor bans are not the solution to the youth use problem. They are, however, key in helping to improve the health of smokers worldwide. Unfortunately, the youth use problem has become a red herring, often sucking the oxygen out of conversations related to the harm-reduction benefits of ENDS. Yet youth ENDS use mirrors the same trajectory of other age-gated products like alcohol: Numbers are decreasing, but underage individuals are still able to obtain via older friends or family members or irreputable retailers not abiding by the law. With the implementation of Tobacco 21, however, if the CTP were to focus on regulation within the legal marketplace, it would help solve illicit trade issues directly and underage access indirectly.
Next Steps
The outcome of this hearing is, as always, to be determined. The testimonies that were given put a clear spotlight on the CTP, which has been admonished for its ineffectiveness in addressing the current problems of the ENDS marketplace. To take steps toward a functioning marketplace, clear regulatory guidelines must be established immediately—something that the CTP has the purview and experience to do. To date, 23 products (which include several different formats of ENDS products with differing nicotine concentrations, delivery mechanisms, etc.) have met the internal requirements of APPH. The CTP should share which tests generated sufficient data for securing APPH status, what acceptable constituents are allowed, and what levels of nicotine are acceptable. With clear guidance from the CTP, the manufacturers would understand what is necessary and sufficient for a product to meet the published standard and would be able to submit applications that are appropriate for review. This would also allow the CTP to be able to evaluate applications more efficiently. The net outcome would be both enhanced regulatory evaluation and swift resolution of any questions associated with whether a product has obtained the required marketing order from the CTP. Continuing to ignore the systemic flaws of the PMTA process without adjusting it, regardless of whether additional resources are secured, will only continue to prolong the growth of the illicit marketplace and delay the potential health savings that would be available to adults who want to stop smoking but continue to use nicotine products.