Brownstone Institute
Enough With These Dangerous Calculations
From the Brownstone Institute
Now that there is more open talk about vaccine injury, we are continually assured that overall these vaccines were worth it even so. The thought always occurs: it has not been worth it for the injured. Nor is their injury lessened by the knowledge that others were helped, if they were.
What precise metric are we going to use to determine costs and benefits population-wide? Many millions were forced to take experimental injections that they did not want nor need. Many were injured and with no chance of compensation. This is gravely unjust. You don’t need to take recourse to fancy philosophical conjectures (The Trolley Problem, The Lifeboat Dilemma, The Fat Man on the Bridge, etc.) to do the utilitarian calculation.
And yet, such calculations are precisely what the defenders of society-wide pandemic interventions are citing as evidence that we can and should do it again. The costs are high, they now admit, but worth the benefit.
Well, maybe not. It’s hard to say but they will keep working on it. They will decide in due course.
This is the argument of Professor John M. Barry. His book on the 1918 flu pandemic kicked off the entire pandemic-planning industry once George W. Bush read the book flap in 2005. Barry’s new article in the New York Times raises alarms about the Avian Bird Flu, the same as the whole pandemic industry is doing right now, and makes the argument that the interventions last time were just great overall.
“Australia, Germany and Switzerland are among the countries that demonstrated those interventions can succeed,” he claims even though all three countries have been torn apart by the pandemic response that is still rocking politics and showing itself in economic decline “Even the experience of the United States provides overwhelming, if indirect, evidence of the success of those public health measures.”
What is that indirect evidence? This you won’t believe: that flu deaths dramatically fell. “The public health steps taken to slow Covid contributed significantly to this decline, and those same measures no doubt affected Covid as well.”
That’s a heck of a thing. If you burn down the house to kill the rats and fail, but happen to kill the pets, surely you have some bragging rights there.
There is indeed a big debate on why seasonal flu seems to have nearly disappeared during the pandemic. One theory is simple misclassification, that flu was just as present as always but labeled Covid because PCR tests pick up even slight elements of the pathogen and financial incentives drove one to displace the other. There is surely an element of this.
Another theory relates to crowding out: the more serious virus pushes aside the less serious one, which is an empirically testable hypothesis.
A third explanation might in fact be related to interventions. With vast numbers staying home and the banning of gatherings, there was indeed less opportunity for pathogenic spread. Even if granting that is true, the effect is far from perfect, as we know from the failure of every attempt to achieve zero Covid. Antarctica is a good example of that.
That said, and even postulating this might be correct, there is nothing to prevent the spread among the population after opening except with even worse results because immune systems are degraded for lack of exposure.
Barry concedes the point but says “such interventions can achieve two important goals.” The first is “preventing hospitals from being overrun. Achieving this outcome could require a cycle of imposing, lifting and reimposing public health measures to slow the spread of the virus. But the public should accept that because the goal is understandable, narrow and well defined.”
Fine, but there is a major glaring error. Most hospitals in the US were not overrun. There is even a genuine question about whether and to what extent New York City hospitals were overrun but, even if they were, this had nothing to do with hospitals in most of the country. And yet the grand central plan closed them all for diagnostics and elective surgeries. In major parts of the country, parking lots were completely empty and nurses were furloughed in more than 300 hospitals.
Overall, that scheme (and who imposed this?) didn’t work too well.
The second supposed benefit you can predict: shutting down buys time “for identifying, manufacturing and distributing therapeutics and vaccines and for clinicians to learn how to manage care with the resources at hand.” This is another strange statement because authorities actually removed therapeutics from the shelves all over the country even though physicians were prescribing them.
As for the supposed vaccine, it did not stop infection or transmission.
So that scheme didn’t work either. There is also something truly cruel about using compulsory methods to preserve the population’s immunological naïveté in anticipation of a vaccine that may or may not work and may or may not cause more harm than good. And yet that is precisely the plan.
The most alarming part of Barry’s article, even aside from his incorrect claim that masks work, is this statement: “So the question isn’t whether those measures work. They do. It’s whether their benefits outweigh their social and economic costs. This will be a continuing calculation.”
Again we are back to benefit vs costs. It’s one thing for a person confronting a true moral or personal difficulty to make that calculation and live with the consequences. Every philosophical problem listed above – Trolly Cars and Lifeboats – involves personal choices and single decision-makers. In the case of pandemic planning and response, we are talking about groups of intellectuals and bureaucrats making decisions for the whole of society. In the last go-round, they made these decisions for the entire world with catastrophic results.
Many hundreds of years ago and following, the Western mind decided that giving such power to elites was not a good idea. The “continuing calculation” about what costs and benefits are experienced by billions of people from compulsory impositions is not something we should risk, not even with AI (which Barry says will solve the problems next time). Instead, we generally decided that a presumption of freedom is a better idea than empowering a small elite of scientists with the power to make “continuing calculations” for our supposed benefit.
Among many problems with the scientistic scheme for elite rule in the realm of infectious disease is that the population as a whole has no way to evaluate schemes and claims made to them by the government itself. They told us terrible population-wide death would come from Covid but it turned out to be exactly what others said back in February 2020; a disease impactful mainly on the aged and infirm.
Similarly, with the bird flu, we’ve been through a quarter century of claims that half of humanity could die from it. So far, every jump from animals to humans has resulted in reparable maladies like conjunctivitis.
But let’s say the bird flu really does get bad. Should the scientists who ruled us last time be trusted to do it again? That’s Barry’s plea: he demands “trust in government.” At the same time, he wants government to have the power to censor dissent. He falsely claims that last time, “there was no organized effort to counter social media disinformation” despite vast evidence of exactly this.
More information is actually what we need, especially from dissidents. For example, Barry celebrates that dexamethasone worked against Covid. But he fails to point out that the “experts” said in February 2020 that dexamethasone should not be used. Indeed, if you followed the Lancet, you would not have used them at all. In other words, Barry’s article refutes itself simply by showing the experts were desperately wrong in this case.
And, honestly, he knows this. Every bit of it. I have no doubt that if we met for cocktails, he would agree with most of this article. But he would also quickly point out that, after all, the New York Times commissioned the article so he can only say so much. He is merely being strategic, don’t you know?
This is the problem we face today with nearly all ruling-class intellectuals. We don’t actually disagree that much on the facts. We disagree on how much of the facts we are in a position to admit. And this puts Brownstone in a very awkward position of being a venue to say publicly what most people in the know say only privately. We do it because we believe in doing so.
All of which underscores the more general point: government and its connected scientists simply cannot be trusted with this kind of power. The last experience illustrates why. We forged our societies to have laws and guaranteed liberties that can never be taken away, not even during a pandemic. It is never worth using the power of the state to ruin lives to fulfill anyone’s abstract vision of what constitutes the greater good.
Author
From the Brownstone Institute
A walk through a dozen convenience stores in Montgomery County, Pennsylvania, says a lot about how US nicotine policy actually works. Only about one in eight nicotine-pouch products for sale is legal. The rest are unauthorized—but they’re not all the same. Some are brightly branded, with uncertain ingredients, not approved by any Western regulator, and clearly aimed at impulse buyers. Others—like Sweden’s NOAT—are the opposite: muted, well-made, adult-oriented, and already approved for sale in Europe.
Yet in the United States, NOAT has been told to stop selling. In September 2025, the Food and Drug Administration (FDA) issued the company a warning letter for offering nicotine pouches without marketing authorization. That might make sense if the products were dangerous, but they appear to be among the safest on the market: mild flavors, low nicotine levels, and recyclable paper packaging. In Europe, regulators consider them acceptable. In America, they’re banned. The decision looks, at best, strange—and possibly arbitrary.
What the Market Shows
My October 2025 audit was straightforward. I visited twelve stores and recorded every distinct pouch product visible for sale at the counter. If the item matched one of the twenty ZYN products that the FDA authorized in January, it was counted as legal. Everything else was counted as illegal.
Two of the stores told me they had recently received FDA letters and had already removed most illegal stock. The other ten stores were still dominated by unauthorized products—more than 93 percent of what was on display. Across all twelve locations, about 12 percent of products were legal ZYN, and about 88 percent were not.
The illegal share wasn’t uniform. Many of the unauthorized products were clearly high-nicotine imports with flashy names like Loop, Velo, and Zimo. These products may be fine, but some are probably high in contaminants, and a few often with very high nicotine levels. Others were subdued, plainly meant for adult users. NOAT was a good example of that second group: simple packaging, oat-based filler, restrained flavoring, and branding that makes no effort to look “cool.” It’s the kind of product any regulator serious about harm reduction would welcome.
Enforcement Works
To the FDA’s credit, enforcement does make a difference. The two stores that received official letters quickly pulled their illegal stock. That mirrors the agency’s broader efforts this year: new import alerts to detain unauthorized tobacco products at the border (see also Import Alert 98-06), and hundreds of warning letters to retailers, importers, and distributors.
But effective enforcement can’t solve a supply problem. The list of legal nicotine-pouch products is still extremely short—only a narrow range of ZYN items. Adults who want more variety, or stores that want to meet that demand, inevitably turn to gray-market suppliers. The more limited the legal catalog, the more the illegal market thrives.
Why the NOAT Decision Appears Bizarre
The FDA’s own actions make the situation hard to explain. In January 2025, it authorized twenty ZYN products after finding that they contained far fewer harmful chemicals than cigarettes and could help adult smokers switch. That was progress. But nine months later, the FDA has approved nothing else—while sending a warning letter to NOAT, arguably the least youth-oriented pouch line in the world.
The outcome is bad for legal sellers and public health. ZYN is legal; a handful of clearly risky, high-nicotine imports continue to circulate; and a mild, adult-market brand that meets European safety and labeling rules is banned. Officially, NOAT’s problem is procedural—it lacks a marketing order. But in practical terms, the FDA is punishing the very design choices it claims to value: simplicity, low appeal to minors, and clean ingredients.
This approach also ignores the differences in actual risk. Studies consistently show that nicotine pouches have far fewer toxins than cigarettes and far less variability than many vapes. The biggest pouch concerns are uneven nicotine levels and occasional traces of tobacco-specific nitrosamines, depending on manufacturing quality. The serious contamination issues—heavy metals and inconsistent dosage—belong mostly to disposable vapes, particularly the flood of unregulated imports from China. Treating all “unauthorized” products as equally bad blurs those distinctions and undermines proportional enforcement.
A Better Balance: Enforce Upstream, Widen the Legal Path
My small Montgomery County survey suggests a simple formula for improvement.
First, keep enforcement targeted and focused on suppliers, not just clerks. Warning letters clearly change behavior at the store level, but the biggest impact will come from auditing distributors and importers, and stopping bad shipments before they reach retail shelves.
Second, make compliance easy. A single-page list of authorized nicotine-pouch products—currently the twenty approved ZYN items—should be posted in every store and attached to distributor invoices. Point-of-sale systems can block barcodes for anything not on the list, and retailers could affirm, once a year, that they stock only approved items.
Third, widen the legal lane. The FDA launched a pilot program in September 2025 to speed review of new pouch applications. That program should spell out exactly what evidence is needed—chemical data, toxicology, nicotine release rates, and behavioral studies—and make timely decisions. If products like NOAT meet those standards, they should be authorized quickly. Legal competition among adult-oriented brands will crowd out the sketchy imports far faster than enforcement alone.
The Bottom Line
Enforcement matters, and the data show it works—where it happens. But the legal market is too narrow to protect consumers or encourage innovation. The current regime leaves a few ZYN products as lonely legal islands in a sea of gray-market pouches that range from sensible to reckless.
The FDA’s treatment of NOAT stands out as a case study in inconsistency: a quiet, adult-focused brand approved in Europe yet effectively banned in the US, while flashier and riskier options continue to slip through. That’s not a public-health victory; it’s a missed opportunity.
If the goal is to help adult smokers move to lower-risk products while keeping youth use low, the path forward is clear: enforce smartly, make compliance easy, and give good products a fair shot. Right now, we’re doing the first part well—but failing at the second and third. It’s time to fix that.
Author
From the Brownstone Institute
Cigarettes kill nearly half a million Americans each year. Everyone knows it, including the Food and Drug Administration. Yet while the most lethal nicotine product remains on sale in every gas station, the FDA continues to block or delay far safer alternatives.
Nicotine pouches—small, smokeless packets tucked under the lip—deliver nicotine without burning tobacco. They eliminate the tar, carbon monoxide, and carcinogens that make cigarettes so deadly. The logic of harm reduction couldn’t be clearer: if smokers can get nicotine without smoke, millions of lives could be saved.
Sweden has already proven the point. Through widespread use of snus and nicotine pouches, the country has cut daily smoking to about 5 percent, the lowest rate in Europe. Lung-cancer deaths are less than half the continental average. This “Swedish Experience” shows that when adults are given safer options, they switch voluntarily—no prohibition required.
In the United States, however, the FDA’s tobacco division has turned this logic on its head. Since Congress gave it sweeping authority in 2009, the agency has demanded that every new product undergo a Premarket Tobacco Product Application, or PMTA, proving it is “appropriate for the protection of public health.” That sounds reasonable until you see how the process works.
Manufacturers must spend millions on speculative modeling about how their products might affect every segment of society—smokers, nonsmokers, youth, and future generations—before they can even reach the market. Unsurprisingly, almost all PMTAs have been denied or shelved. Reduced-risk products sit in limbo while Marlboros and Newports remain untouched.
Only this January did the agency relent slightly, authorizing 20 ZYN nicotine-pouch products made by Swedish Match, now owned by Philip Morris. The FDA admitted the obvious: “The data show that these specific products are appropriate for the protection of public health.” The toxic-chemical levels were far lower than in cigarettes, and adult smokers were more likely to switch than teens were to start.
The decision should have been a turning point. Instead, it exposed the double standard. Other pouch makers—especially smaller firms from Sweden and the US, such as NOAT—remain locked out of the legal market even when their products meet the same technical standards.
The FDA’s inaction has created a black market dominated by unregulated imports, many from China. According to my own research, roughly 85 percent of pouches now sold in convenience stores are technically illegal.
The agency claims that this heavy-handed approach protects kids. But youth pouch use in the US remains very low—about 1.5 percent of high-school students according to the latest National Youth Tobacco Survey—while nearly 30 million American adults still smoke. Denying safer products to millions of addicted adults because a tiny fraction of teens might experiment is the opposite of public-health logic.
There’s a better path. The FDA should base its decisions on science, not fear. If a product dramatically reduces exposure to harmful chemicals, meets strict packaging and marketing standards, and enforces Tobacco 21 age verification, it should be allowed on the market. Population-level effects can be monitored afterward through real-world data on switching and youth use. That’s how drug and vaccine regulation already works.
Sweden’s evidence shows the results of a pragmatic approach: a near-smoke-free society achieved through consumer choice, not coercion. The FDA’s own approval of ZYN proves that such products can meet its legal standard for protecting public health. The next step is consistency—apply the same rules to everyone.
Combustion, not nicotine, is the killer. Until the FDA acts on that simple truth, it will keep protecting the cigarette industry it was supposed to regulate.
Author
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