The FDA-CTP must repair their regulatory process to solve the illicit ENDS problem

In the past week, Food and Drug Administration (FDA) Commissioner Robert Califf has been questioned twice by the U.S. House of Representatives: first during a House Oversight Committee hearing and then during a House Appropriations Committee hearing. Though both covered a wide range of FDA-centered activities, many questions were asked regarding the activities of the Center for Tobacco Products (CTP).

One bipartisan critique of the FDA is its inability to resolve the proliferation of illegal electronic nicotine delivery systems (ENDS) in the marketplace. The reality is that ENDS products (often referred to as vapes or e-cigarettes) have helped many consumers switch from combustible cigarettes to products that are significantly less risky. Consumers want the product, and retailers are finding ways to get these unauthorized products into their hands.

This serious scrutiny of the FDA’s inability to manage the tobacco and nicotine product market in the United States is a result of the CTP’s actions over 14 years of regulatory mismanagement. Most—if not all—manufacturers and retailers want to comply, but if the pathway to compliance is uncertain and overly burdensome in terms of cost and time, actors in the marketplace will find a way to provide consumers with the products they desire. In our country, this has led to the infusion of hundreds (if not thousands) of nicotine products that do not have marketing granted orders (MGO) from the FDA. The policing and removal of these products will be a herculean task; however, the presence of these products is a symptom of the CTP’s ineptitude rather than the criminal activity of retailers. A fair and effective functioning regulatory process is the only real solution to undermine this illicit marketplace.

Commissioner Califf stated that from his perspective, the agency’s first line of defense was a regulated industry itself, functioning in a manner that produces compliant products. However, the alternative nicotine delivery product industry (manufacturers and retailers) has received little to no support from regulatory agencies as to how to effectively comply in a manner that supports consumer needs.

The primary concern is the product review process itself. The CTP has often stated that the burden of reviewing millions of applications is overwhelming for the center. Nevertheless, the CTP has yet to provide clear direction as to what information is required to build a successful premarket tobacco product application. Instead, its unclear guidance document has led to millions of denied applications and only a handful of MGOs. If the requirements for a successful product application are so opaque that the overwhelming majority of applications fail, how can manufacturers perform their role as responsible partners in regulating a safe consumer marketplace? The untold millions spent on applications that might meet an undisclosed (and potentially unknown) standard to effectively produce a product that could meet the unpublished criteria is a burden that has eliminated potential manufacturers (mainly small or medium-sized companies). Instead, it has generated a marketplace where only the largest and wealthiest tobacco companies can survive—and one where illicit products proliferate.

The absence of clear standards and practices has led to the influx of illicit vaping products. If the CTP focused on scientific standards instead of political and bureaucratic pressures, manufacturers and retailers could participate as compliant partners in protecting public health. Nearly half a million Americans die each year due to long-term use of combustible tobacco products. Until that number is reduced dramatically, the CTP’s actions should be questioned and the FDA’s leadership held accountable regarding how they have sought to directly reduce smoking-related deaths in our country. Greatly reducing the death and disease associated with smoking tobacco should be the only metric by which the CTP assesses its performance. Nothing else reaches this level of urgency.