The product of regulatory sloth 

With over 30 million Americans still using combustible tobacco, millions of Americans remain in harm’s way. That’s because millions of illegal Chinese e-cigarette imports are flooding the U.S., often with enticing flavors, addicting a new generation of children to tobacco products while simultaneously avoiding FDA product regulation. Bureaucratic failure has, yet again, driven us to where we are today. 

Created as part of the Family Prevention and Tobacco Control Act, the FDA Center for Tobacco Products is charged with regulating the tobacco product marketplace under the “appropriate for protection of public health” standard. Under this standard, the FDA is supposed to consider marketing authorization for new products by weighing the likelihood of a product decreasing the number of tobacco users or pushing current users to less harmful products, inducing new tobacco users, and the effects on the population as a whole. Simply put: cessation, harm reduction and prevention.  

But the FDA has focused on prevention while forgetting the other two pillars of public health: cessation and harm reduction. As a public health physician, I recognize the importance of meeting people where they are. 

The FDA is responsible for the timely review of product applications, issuance of guidance and, arguably most important, enforcement and removal of illegally marketed products. As the nation’s product regulator for over one-fifth of consumer spending across a variety of areas, the agency takes this responsibility seriously in all other product areas. Yet, in the only marketplace glutted with unauthorized products coming from our greatest geopolitical adversary, the agency has put millions of Americans are risk and failed to meet the standard that Congress set for the agency.  

In 2022, Congress amended the Tobacco Control Act to ensure an appropriate framework existed to conduct enforcement on synthetic nicotine products, many of which pose significant harm to consumers. Nearly 18 months later, the agency has yet to finish its full review of over 9,500 accepted applications for products using synthetic nicotine, with many of these products currently illicitly marketed and available to the general public. Now President Biden is doubling down, requesting $100 million more in additional funding. 

Harry Truman said it best “The buck stops here.”  

Bureaucratic sloth has continued in the face of both illegal Chinese products flooding the marketplace addicting children and changing public health evidence, with a recent study in the New England Journal of Medicine study demonstrating the effectiveness of e-cigarettes in supporting smokers from abstaining from combustible tobacco. Those seeking to quit smoking combustible cigarettes need a variety of offramps to choose from and deserve better from the chief regulatory agency tasked with improving the public health. 

With widespread questions as to the agency’s effectiveness from – ironically – both the public health community and industry, with the American Public Health Association Executive Director Georges Benjamin noting that “all of our regulatory agencies need to deal with the urgency of an urgent problem,” the agency commissioned an external review of its tobacco product regulatory program. Completed and published in December 2022, the Reagan-Udall Foundation report recommended a number of key actions. 

First and foremost, that the FDA should issue an updated strategic plan — the first in over five years — and define its regulatory and scientific priorities with associated metrics to assess its performance. A business with over 1,000 employees and products consumed by millions of Americans lacking a strategic plan would be unheard of. Yet, for the regulator of the only product marketplace known to cause harm and even result in death, this is the accepted norm. 

Secondly, with the agency having collected $17 million in monetary penalties at the time of the report’s issuance in a decade of operations and millions of illegal products shipped in daily from China, organizations know that they can make millions or billions while the FDA turns a blind eye. American parents must not be abandoned by one of the nation’s most powerful medical products regulator. While recent FDA action removed $18 million in illegal products from the marketplace, regular and meaningful enforcement is a must to ensure that a new generation of children does not become addicted and adults do not consume illegal or potentially adulterated products. 

Finally, with the FDA having received millions of applications over the past few years, establishing a routine product review process, procedures and transparency within its existing statutory authorities is key. The public health community and physicians can help their patients and the broader public make the most informed and personalized decisions on the products that will ultimately help them achieve their goal of quitting smoking. 

We have seen the cost of bureaucratic inaction, as physicians, public health experts, taxpayers and parents. With the FDA announcing a plan action, now is the time to enforce the laws on the books and execute on the objectives Congress gave to them. 

Brian J. Miller is a nonresident fellow at the American Enterprise Institute and an assistant professor of medicine at Johns Hopkins University.