Lindsey StroudAnother 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.
Lindsey Stroud is creator and manager of Tobacco Harm Reduction 101.
Nope. No. No way. We do not need more nanny government under the phony guise of “safety” telling us what to do. There is nothing in the Constitution that gives the government the right to micromanage our lives. The government should stop trying to regulate vice and leave people alone. The entire smoking government/NGO complex is one big grift.
This is just my opinion: I’m a conservative/libertarian and believe the Federal government is doing too much. The more responsibility you give it, the more bureaucrats are going to be hired and the more money from taxpayers is going to be squeezed from those taxpayers.
If a person (even a child) wants to kill him/herself by smoking or vaping to keep from smoking then that is the responsibility of him/her (or the parents). Why should it be someone else’s?
Even in the 1930s cigarettes were called coffin nails. And they are. But the coffin-if the Government discovers any more voluntary acts to legislate on-is likely to be not only for the smoker but also for the suffocating debt that our government is adding to.
I understand the argument that Government pays for down the line doctor/hospital care should it be needed when they get older but that is a different argument. This argument veers to whether taxpayers should pay for and use a government medical system whose coverage is constantly increasing as technology and innovations increase.
The more tasks you give an organization like FDA or promulgate in legislation (like Medicare/Medicaid) the more funds are going to be needed to accomplish the task-especially when we get liberal judges to interpret what that legislation means.
As I mentioned, this is one of the big reasons why our deficits and debt is getting so high. Pretty soon everyone will be going to a hospital with neck injuries-as we stretch our necks to see how high the Debt has become.
I am nearly 80 years old. I know that the Federal Government-with its programs-will take care of me should I get sick-but why is this its responsibility?
We have a nearly $37 Trillion debt and right now the interest we are paying is nearly as much (if not more) than the money we spend on defense.
Isn’t the first responsibility of the Government to defend us-and isn’t that more important than the this smoking/vaping crisis. I’m not saying the crisis is unimportant. My point is that demand is infinite, especially if someone else is paying for the increase of that demand.
I understand that we do need an FDA to make sure we aren’t poisoned. But it is interesting to note that our country was fine before the FDA came into existence. Apparently, the manufacturers realized if anyone was poisoned by its product, it might affect future sales. Even the mentally deficient purveyers of the product realized this.
I’d also like to note: The FDA-who is suppose to regulate our food supply- is the same FDA that has allowed oil products like red dyes and seed oils to be added to our foods. Both have been found to be existentially dangerous to our longevity Apparently, our food supply has been regulated alright-but not by the Government’s legislators but by the Food Industry.
This is not monopoly money we are spending; it is yours and mine!
What bothers me are all of the commonly promoted lies about vaping. This issue will never be properly handled until people deal in truth, and stop believing the false narrative that smoking and vaping are the same, or that they are health danger equivalents. They are not. There is no tobacco or smoke in vape. Vape is just heated (not burned) liquid with nicotine. Anyone could make e-cigarette vape liquid at home (vegetable glycerin, liquid nicotine, natural flavorings). I’m no doctor, but from what I’ve read, nicotine, while addictive (like caffeine and social media) is not the harmful part of smoking. The tar and chemicals in cigarette smoke from tobacco are what causes the major harms to health Every time I read an article, they conclusively and generically mention the “health dangers” of vaping (always carefully lumped together as smoking/vaping), but they curiously never actually say what the purported “health concerns” of vaping are, or what causes them. (The well-publicized deaths from purported “vaping” a few years ago were reportedly from the addition of vitamin E to some fraudulent cannabis vapes). The Big Tobacco lobby is behind the confusion around vaping, and the biggest proponent of the heavy regulation of vaping (and they don’t care about anyone’s health). Anyone could cheaply make and sell vape. Big Tobacco can’t let that open competition to tobacco stand. So, they confuse and scare people about vaping, make vape heavily regulated, and now you need tens of millions of dollars, plus research and skilled lawyers just to get through the complex regulatory process and approvals (which mostly never come, unless you have an “in” with the regulators). Who has those type of resources, experience, and relationships? Big Tobacco! Moat created, competition eliminated. Make smokers believe there is no benefit to switching, and, if any competition to tobacco does eventually topple it, it can only come from them, and will only benefit them. Who holds those limited number of vape approvals from the FDA, and why is the government spending so much effort stomping out “unauthorized vape” and not so much on approving more? The heavy regulation of vape protects profits, not health. People should stop buying the lies and emotional hysteria about vaping, and stop erroneously conflating it with smoking. It should be promoted as a safer alternative to smoking. This is in the entire nation’s interest, as even if there ultimately are some health concerns with vaping, they will be a tiny fraction when compared to smoking. If every cigarette smoker switched to vape, the smoking health scourge in this country would fade into a memory.
With a $37 trillion deficit, wars looming in Europe, and an American bureaucracy that cannot be tamed, Congress is fussing over vaping? How stupid are we, anyway?