Strengthening Efforts Against Illicit Electronic Cigarettes: A Bipartisan Consensus
Recently, the United States Senate Judiciary Committee held a hearing focused on strengthening efforts to combat illegal e-cigarettes, in an effort to better combat the youth vaping epidemic. This event was marked by a rare bipartisan consensus recognizing the scale of the problem and the need to act quickly to avoid the negative consequences of a poorly regulated tobacco and nicotine market. The senators expressed their concerns about the proliferation of electronic nicotine delivery systems (ENDS) illegal products, often made in China, which frequently fall into the hands of young people. Responsibility for the current situation, both in the legal and illegal ENDS market, lies with the regulatory agency responsible for evaluating these products.
Illicit Market Concerns and the Center for Tobacco Products
During the hearing, two testimonies particularly attracted attention. Brian King, PhD, MPH, current director of the FDA's Center for Tobacco Products (CTP), described the steps the CTP is taking to regulate the industry and curb the growth of the unregulated market. Despite these efforts, the organization has only managed to issue a few warning letters, fines and product seizures, allowing the illicit market to flourish. King noted that the influx of applications for tobacco products (PMTA) has overwhelmed the CTP, preventing it from processing these applications in a timely manner. He stressed the need for additional resources, including through the collection of user fees, to improve the process.
The PMTA review process is fundamentally flawed and investing more will not be enough to meet consumer needs or address illicit market and youth access issues. The CTP has implemented a regulatory process without clearly defining the requirements for manufacturers. The Public Health Protection Standard (APPH) has never been operationally defined, leaving manufacturers guessing about CTP expectations. Until PMTA requirements are codified into law, the PTC can change its interpretation of the APPH according to political pressure, which has no place in protecting public health.
Testimonial from the Vapor Technology Association
Tony Abboud, executive director of the Vapor Technology Association (VTA), expressed the same frustrations as the Judiciary Committee, while offering clear strategies to address the issues identified. The VTA is concerned about the presence of an illicit market and says ENDS product manufacturers are seeking to comply with the law, but CTP's delays and inaction are creating a de facto ban on ENDS products. Abboud explained that the lack of legal products forces retailers to bend unclear rules to meet consumer needs. The majority of retailers want to comply with the law while offering adults alternatives to combustible cigarettes, which are known to pose fewer health risks.
Youth and Aroma Adoption Issues
All hearing participants agreed that youth use of ENDS products was an issue that needed to be addressed. Marketing techniques must be clear and not aimed at young people. Flavorings, important in helping adults quit smoking, should not be banned, but rather regulated to avoid attracting young people. Blanket flavor bans are not the solution and risk distracting from the harm reduction benefits of ENDS. With the implementation of Tobacco 21, the CTP should focus on regulating the legal market to address issues of illicit trade and underage access.
Next steps
The testimonies highlighted the shortcomings of the CTP in the regulation of ENDS. For a functional market, clear guidelines must be established immediately. The CTP must share the tests necessary to obtain APPH status, acceptable constituents and nicotine levels. This would allow manufacturers to submit appropriate applications, thereby facilitating assessment by the CTP. Ignoring systemic flaws in the PMTA process will prolong the growth of the illicit market and delay potential health benefits for adults wishing to quit smoking while continuing to use nicotine products.
