If Congress Wants Real Solutions To So-Called Illicit Vapes, Real Reform – Not Lip Service – Is Required

Lindsey Stroud

Another day, another congressional hearing where well-meaning but misinformed federal lawmakers grilled witnesses over the Biden administration’s handling of consumer protection issues. 

On April 9, the House Committee on Oversight and Government Reform held a hearing titled Restoring Trust in FDA: Rooting Out Illicit Products. Lawmakers sharply criticized the U.S. Food and Drug Administration’s (FDA) performance under the Biden administration, citing regulatory failures, food safety lapses, the mishandling of the infant formula crisis, and lack of clarity around hemp regulations. Of particular focus was the FDA’s inability to prevent the flood of illicit and counterfeit nicotine products into the U.S. market and its sluggish review of safer nicotine alternatives. 

While lawmakers are correct that the FDA needs serious reform to address the ongoing tobacco epidemic, more hearings aren’t the solution. Instead of wasting time and taxpayer dollars on performative oversight, Congress should fix the very laws that have hampered innovation and limited adult access to less harmful alternatives to cigarettes. 

As Guy Bentley of the Reason Foundation noted during the hearing, it is currently easier for manufacturers to bring to market combustible cigarettes, cigars, or pipe tobacco than safer alternatives like e-cigarettes, heated tobacco products, or nicotine pouches. 

This disparity stems from Congress’ 2009 Family Smoking Prevention and Tobacco Control Act (TCA), which mandates that all new tobacco products undergo the premarket tobacco product application (PMTA) process – a lengthy, costly, and opaque system that has become a public health failure. In more than a decade, the FDA has authorized just 76 products through this pathway, while thousands of more harmful combustibles continue to be sold under the far less rigorous substantial equivalence process. 

Worse still, only 34 e-cigarette products – all in tobacco or menthol flavors – have received FDA authorization. This is grossly inadequate for the more than 20 million American adults who vaped in 2023. Meanwhile, the FDA has issued warning letters, fines, and injunctions, targeting both large and small manufacturers for selling so-called unauthorized products – many of which are helping adults quit smoking. 

Congress created this regulatory bottleneck. Yet instead of legislating solutions, lawmakers express outrage at the very consequences of the system they established. 

This is not the first time Congress has held hearings on vaping. In July 2019, the Subcommittee on Economic and Consumer Policy spent two days interrogating JUUL’s role in the so-called youth vaping epidemic. Just months later, the subcommittee convened again to discuss e-cigarettes broadly. In 2024, former FDA Commissioner Robert Califf appeared before the full committee to discuss the agency’s broader performance. 

Despite repeated oversight, the FDA has only intensified its efforts to eliminate safer nicotine products from the market, rather than speeding up approvals or targeting illicit manufacturers. Enforcement actions have ramped up, yet the fundamental regulatory problem remains unaddressed. 

Compounding the problem is FDA’s broken funding structure. The Center for Tobacco Products (CTP) receives no federal appropriations and is entirely funded by user fees – primarily from combustible cigarette sales, which account for more than 80% of its budget. Each year, the agency requests expanded authority to apply user fees to newer products, but Congress has failed to act. 

This catch-22 leaves the FDA financially dependent on the very products it should be working to replace. It’s no wonder that only a handful of reduced-risk products have been authorized while hundreds of new cigarettes continue to enter the market. 

There is still a path forward. Before youth vaping became a media firestorm, several members of Congress introduced bills to revise the arbitrary predicate date and reduce the burden of the PMTA process. Lawmakers can also pressure the agency to exercise enforcement discretion and prioritize bad actors – not American small businesses navigating an unworkable system. 

Sitting in hearing rooms won’t solve the real issue. More than 20 million adults are vaping today, and many younger adults are functionally smoke-free by WHO standards. Yet they’re increasingly driven to unregulated products because of a regulatory structure that Congress refuses to fix. 

If lawmakers are serious about protecting public health and restoring trust in the FDA, they must pass legislation that empowers the agency, fosters innovation, and accelerates the shift away from combustible cigarettes – not just stage another hearing. 

Originally published in Issues & Insights.