Brownstone Institute
The Declaration That Wasn’t Supposed to Happen
From the Brownstone Institute
It’s been a continuing mystery for three years, at least to me but many others too. In October 2020, in the midst of a genuine crisis, three scientists made a very short statement of highly public health wisdom, a summary of what everyone in the profession, apart from a few oddballs, believed only a year earlier. The astonishing frenzy of denunciation following that document’s release was on a level I’ve never seen before, reaching to the highest levels of government and flowing through the whole of media and tech. It was mind-boggling.
For proof that nothing in the document was particularly radical, look no further than the March 2, 2020, letter from Yale University signed by 800 top professionals. It warned against quarantines, lockdowns, closures, and travel restrictions. It said such extreme measures “can undermine public trust, have large societal costs and, importantly, disproportionately affect the most vulnerable segments in our communities.” That document appeared only two weeks before the lockdowns announced by the Trump administration.
That was the period of the grant amnesia. The conventional wisdom turned on a dime toward full backing of regime priorities, a shift more extreme and mind boggling that anything in dystopian fiction.
Seven months later, the Great Barrington Declaration said something very similar to the Yale document. It was a summary statement concerning what governments and society should and should not do during pandemics. They should seek to allow everyone to live as normally as possible in order to avoid guaranteed damage from coerced disruptions. And the vulnerable population – those who would experience medically significant impacts from exposure – should be protected from exposure insofar as doing so is consistent with human rights and choice.
It was nothing particularly novel, much less radical. Indeed, it was accepted wisdom the year before and for the previous century. The difference this time, however, is that the statement was released during the wildest and most destructive science experiment in modern times. The existing policy of lockdowns was utter wreckage: of businesses, schools, churches, civic life, and freedom itself. Masks were being forced on the whole population, including children. Governments were attempting a regime of test, track, trace, and isolate, as if there were ever any hope of containing a respiratory pathogen with a zoonotic reservoir.
The carnage was everywhere already and obvious from a look at every downtown of every city in the US. Stores were boarded up. The streets were mostly empty. The professional class was hunkered down, binging on streaming and gaming services, while the working class was hustling everywhere to deliver groceries to doorsteps. In short, insanity had broken out.
Several groups of doctors had already made strong statements against the goings on, including the frontline doctors group on Capitol Hill and the brilliant Bakersfield doctors, among many individuals. However, they were quickly shot down by major media and blasted for failing to support the great undertaking. Even that was astonishing to watch unfold. It didn’t matter how exalted the reputations of the doctors or scientists were. They were all shot down, more or less instantly, as crazies and cranks.
It was like living in a horror house of mirrors where nothing appears as it is supposed to. At the time, I chalked it all up to mass confusion, cultural amnesia, bad education, government overreach, media ignorance, or just some general tendency of humanity to go mad that I had not previously seen in my lifetime but had only known from history books.
Several top epidemiologists felt the same way. They were Martin Kulldorff from Harvard, Jay Bhattacharya from Stanford, and Sunetra Gupta from Oxford. Together they wrote a very short statement in hopes of bringing public officials and common people back to good sense and rationality. We had the idea of putting it online and inviting others to sign. We were racing against time because there were several interviews coming up. Lucio Saverio-Eastman, now with Brownstone, skipped a nights’ sleep to create the website. He tells the story here.
The blowback began within hours. It was really something to behold. Twitter accounts came out of nowhere to smear the document and its producers and the institution that hosted the event where the scientists explained their thinking. The calumnies and attacks were coming in so quickly that it was impossible to respond. The website itself was subject to open and admitted sabotage, with fake names. That required some fast patches and new levels of security.
It was a storm of frenzy the likes of which I had never seen. It’s one thing to object to a point of view but this was next-level. The hit pieces were pouring out of huge venues, almost as if they had been ordered from the top. Much later we found out that they had in fact been ordered: Francis Collins, the head of National Institutes of Health, called for a “quick and devastating takedown” of the document.
When that revelation came out, it didn’t make much sense to me. I get that this view had become what seemed to be a minority view but how do you “take down” the public health wisdom of one hundred years? The GBD was not the outlying position; the lockdowns were the radical move that never had a scientific justification. They were just imposed as if they were normal even though everyone knew they were not.
Lately we’ve been flooded with more information that starts to make sense of this puzzle. As Rajeev Venkayya had told me the previous April, the whole point of the lockdowns was to wait for the vaccine. Frankly, I didn’t believe him at the time. I should have. After all, it was he who had invented the idea of lockdowns, worked for the Gates Foundation as head of its vaccine advisory, and then moved to a vaccine company thereafter. If anyone knew the real plan, it was he.
In the meantime, we now know there was then being built a vast censorship machinery involving the federal government, outposts as universities such as Stanford and Johns Hopkins, tech companies, and media embeds in all important outlets. It was not only being built but being deployed in order to craft the public mind in ways that would maintain the spirit of fear and the reality of lockdowns until the magic inoculation arrived. The whole plot sounds straight out of a bad Hollywood movie, but it was a plot being enacted in real life.
Think here of the timing of the Great Barrington Declaration. It came out barely a month before the election, after which the plan from the top was to release the vaccine, presumably after the sitting president was defeated. That way the new president could get the credit for the distribution stage and thus would the pandemic end.
The underlying dynamic of the timing of the release of the GBD – we had no clue at all that this was going on – worked utterly to subvert the entire censorship regime. The perception too was that this document would undermine vaccine acceptance. At that point in the great plan, all focus was on molding the public mind toward mass jabbing. That meant cultivating among the population the appearance of expert unity.
“Keeping these measures in place until a vaccine is available will cause irreparable damage, with the underprivileged disproportionately harmed,” said the document. “As immunity builds in the population, the risk of infection to all – including the vulnerable – falls. We know that all populations will eventually reach herd immunity – i.e. the point at which the rate of new infections is stable – and that this can be assisted by (but is not dependent upon) a vaccine. Our goal should therefore be to minimize mortality and social harm until we reach herd immunity.”
Further, “the most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk.”
Reading those words today, in light of what we now know, we can start to make sense of the sheer panic at the top. Natural infection and immunity? Can’t talk about that. The end of the pandemic is not “dependent upon” the vaccine? Can’t say that either. Go back to normal for all populations without significant medical risk? Unsayable.
You need only reflect on the astounding barrage of vaccine propaganda that began immediately upon release, the attempt to mandate it on the whole population and now the addition of the Covid jab to the childhood schedule even though children are of near zero risk. This is all about product sales, as you can easily discern from the unrelenting ad videos made by the new head of the CDC.
As for the product effectiveness itself, there seems to be no end to the ensuing problems. It was not a sterilizing inoculation, and it appears that the manufacturers always knew that. It could not stop infection or transmission. The hazards associated with it were also known early on. Every day, the news gets more grim: in the latest revelation, the CDC seems to have kept two separate books on vaccine injury, one public (showing harms without precedent but which has been deprecated by officials) and one yet to be released.
Even now, therefore, there is every effort being made to keep a lid on what surely ranks as the greatest failure/scandal in the modern history of public health. Some brave experts called it out before the whole calamity unfolded even further.
The problem with the Great Barrington Declaration was not that it was not true. It’s that – unbeknownst to its authors – it flew in the face of one of the most funded and elaborate industrial plots in the history of governance. Just a few sentences sneaking through the wall of censorship they were carefully constructing was enough to threaten and eventually dismantle the best laid plans.
Sometimes just telling the plain truth in well-timed ways is all it takes.
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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