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Brownstone Institute

Sweden Did Exceptionally Well During the COVID-19 Pandemic

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From the Brownstone Institute

BY Peter C. GøtzschePETER C. GØTZSCHE

No wonder the news media are totally silent about the data that show that Sweden’s open society policy was what the rest of the world should have done, too. Numerous studies have shown Sweden’s excess death rate to be among the lowest in Europe during the pandemic and in several analyses, Sweden was at the bottom.

This is remarkable considering that Sweden has admitted that it did too little to protect people living in nursing homes.

Unlike the rest of the world, Sweden largely avoided implementing mandatory lockdowns, instead relying on voluntary curbs on social gatherings, and keeping most schools, restaurants, bars and businesses open. Face masks were not mandated and it was very rare to see any Swede dressed as a bank robber.

The Swedish Public Health Agency “gave more advice than threatened punishment” while the rest of the world installed fear in people. “We forbade families to visit their grandmother in the nursing home, we denied men attendance at their children’s births, we limited the number who were allowed to attend church at funerals. Maybe people are willing to accept very strong restrictions if the fear is great enough.”

If we turn to other issues than mortality, it is clear that the harms done by the draconian lockdowns in the rest of the world have been immense in all sorts of ways.

For any intervention in healthcare, we require proof that the benefits exceed the harms. This principle was one of the first and most important victims of the pandemic. Politicians all over the world panicked and lost their heads, and the randomised trials we so badly needed to guide us were never carried out.

We should abbreviate the great pandemic to the great panic.

In my book, “The Chinese virus: Killed millions and scientific freedom,” from March 2022, I have a section about lockdowns.

Lockdown, a questionable intervention

The reborn intolerance toward alternative ideas has been particularly acrimonious in the debate about lockdowns.

There are two main ways to respond to viral pandemics, described in two publications that both came out in October 2020.

The Great Barrington Declaration is only 514 words, with no references. It emphasizes the devastating effects of lockdowns on short- and long-term public health, with the underprivileged disproportionately harmed. Arguing that for children, COVID-19 is less dangerous than influenza, it suggests that those at minimal risk of death should live their lives normally to build up immunity to the virus through natural infection and to establish herd immunity in the society.

It recommends focused protection of the vulnerable. Nursing homes should use staff with acquired immunity and perform frequent PCR testing for COVID-19 of other staff and all visitors. Retired people living at home should have groceries and other essentials delivered to their home and should meet family members outside when possible.

Staying home when sick should be practiced by everyone. Schools, universities, sports facilities, restaurants, cultural activities, and other businesses should be open. Young low-risk adults should work normally, rather than from home.

I have not found anything in the Declaration to be factually wrong.

The other publication is the John Snow Memorandum, which came out two weeks later.  Its 945 words are seriously manipulative. There are factual inaccuracies, and several of its 8 references are to highly unreliable science. The authors claim that SARS-CoV-2 has high infectivity, and that the infection fatality rate of COVID-19 is several times higher than that of seasonal influenza.

This is not correct (see Chapter 5), and the two references the authors use are to studies using modelling, which are highly bias-prone.

They also claim that transmission of the virus can be mitigated through the use of face masks, with no reference, even though this was, and still is, a highly doubtful claim.

“The proportion of vulnerable people constitute as much as 30% of the population in some regions.” This was cherry-picking from yet another modelling study whose authors defined increased risk of severe disease as one of the conditions listed in some guidelines. With such a broad definition, it is easy to scare people. However, they did not tell their readers that the modelling study also estimated that only 4% of the global population would require hospital admission if infected,36 which is similar to influenza.

The two declarations did not elicit enlightened debates, but strongly emotional exchanges of views on social media devoid of facts. The vitriolic attacks were almost exclusively directed against those supporting the Great Barrington Declaration, and many people, including its authors, experienced censorship from Facebook, YouTube and Twitter.

The Great Barrington Declaration has three authors; the John Snow Memorandum has 31. The former was published on a website, which is kept alive, the latter in Lancet, which gives its many authors prestige.

In 2021, over 900,000 people had signed the Great Barrington Declaration, including me, as I have always found that the drastic lockdowns we have had, with all its devastating consequences for our societies, were neither scientifically nor ethically justified. I did Google searches to get an idea how much attention the two declarations have had. For the Great Barrington Declaration, there were 147,000 results; for the John Snow Memorandum only 5,500.

The Great Barrington Declaration has not had much political impact. It is much easier for politicians to be restrictive than keeping the societies open. Once a country has taken drastic measures, such as lockdowns and border closings, other countries are accused of being irresponsible if they don’t do the same – even though their effect is unproven. Politicians will not get in trouble for measures that are too draconian, only if it can be argued that they did too little.

In March 2021, Martin Kulldorff and Jay Bhattacharya, two of the three authors of the Great Barrington Declaration, drew attention to some of the consequences of the current climate of intolerance.  In many cases, eminent scientific voices have been effectively silenced, often with gutter tactics. People who oppose lockdowns have been accused of having blood on their hands and their university positions threatened.

Many have chosen to stay quiet rather than face the mob, for example Jonas Ludvigsson, after he had published a ground-breaking Swedish study making it clear that it is safe to keep schools open during the pandemic, for children and teachers alike. This was taboo.

Kulldorff and Bhattacharya argued that with so many COVID-19 deaths,  most of which have been in old people, it should be obvious that lockdown strategies have failed to protect the old.

The attacks on the Great Barrington Declaration appear to have been orchestrated from the top. On 8 October 2020, Francis Collins, the director of the US National Institutes of Health (NIH), sent a denigrating email to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and advisor for several US Presidents, where he wrote:

“This proposal from the three fringe epidemiologists who met with the Secretary seems to be getting a lot of attention – and even a co-signature from Nobel Prize winner Mike Leavitt at Stanford. There needs to be a quick and devastating published take down of its premises. I don’t see anything like that online yet – is it underway?”

Stefan Baral, an epidemiologist from Johns Hopkins, reported that a letter he wrote about the potential harms of population-wide lockdowns in April 2020 was rejected by more than 10 scientific journals and 6 newspapers, sometimes with the pretence that there was nothing useful in it.  It was the first time in his career that he could not get a piece placed anywhere.

In September 2021, BMJ allowed Gavin Yamey and David Gorski to publish an attack on the Great Barrington Declaration called, Covid-19 and the new merchants of doubt.  A commentator hit the nail when he wrote:

“This is a shoddy smear that is not for publication. The authors have not shown where their targets are scientifically incorrect, they just attack them for receiving funding from sources they dislike or having their videos and comments removed by social media corporations as if that was some indication of guilt.”

Kulldorff has explained what is wrong with the article. They claimed the Declaration provides support to the anti-vaccine movement and that its authors are peddling a “well-funded sophisticated science denialist campaign based on ideological and corporate interests.” But nobody paid the authors any money for their work or for advocating focused protection, and they would not have undertaken it for a professional gain, as it is far easier to stay silent than put your head above the parapet.

Gorski is behaving like a terrorist on social media, and he is perhaps a troll. Without having any idea what I had decided to talk about, or what my motives and background were, he tweeted about me in 2019 that I had “gone full on antivax.”  My talk was about why I am against mandatory vaccination for an organisation called Physicians for Informed Consent. Who could be against informed consent? But when I found out who the other speakers were, I cancelled my talk.

In January 2022, Cochrane published a so-called rapid review of the safety of reopening schools or keeping them open. The 38 included studies comprised 33 modelling studies, three observational studies, one quasi‐experimental and one experimental study with modelling components. Clearly, nothing reliable can come out of this, which the authors admitted: “There were very little data on the actual implementation of interventions.”

Using modelling, you can get any result you want, depending on the assumptions you put into the model. But the authors’ conclusion was plain nonsense: “Our review suggests that a broad range of measures implemented in the school setting can have positive impacts on the transmission of SARS‐CoV‐2, and on healthcare utilisation outcomes related to COVID‐19.”

They should have said that since there were no randomised trials, we don’t know if school closures do more good than harm. What they did is what Tom Jefferson has called “garbage in and garbage out … with a nice little Cochrane logo on it.”

About the failing scientific integrity of Cochrane reviews, the funder of the UK Cochrane groups noted in April 2021 that, “This is a point raised by people in the Collaboration to ensure that garbage does not go into the reviews; otherwise, your reviews will be garbage.”

Even though there was nothing to conclude from it, the authors filled 174 pages – about the length of the book you are currently reading – about the garbage they included in their review, which was funded by the Ministry of Education and Research in Germany.

A 2020 rapid systematic review in a medical journal found that school closures did not contribute to the control of the SARS epidemic in China, Hong Kong, and Singapore.

Lockdowns could even make matters worse. If children are sent home to be looked after by their grandparents because their parents are at work, it could bode disaster for the grandparents. Before the COVID-19 vaccines became available, the median age of those who died was 83.

The whole world missed a fantastic opportunity to find out what the truth was by randomising some schools to be closed while keeping others open, but such trials were never done. Atle Fretheim, research director at the Norwegian Institute of Public Health, tried to do a trial but failed. In March 2020, Norwegian government officials were unwilling to keep schools open. Two months later, as the virus waned, they refused to keep schools closed. Norwegian TV shot the messenger: “Crazy researcher wants to experiment with children.” What was crazy was not to do the study. Craziness was also the norm in USA. In many large American cities, bars were open while schools were closed.

When people argue for or against lockdowns and how long they should last and for whom, they are on uncertain ground. Sweden tried to go on with life as usual, without major lockdowns. Furthermore, Sweden has not mandated the use of face masks and very few people have used them.

Author

  • Peter C. Gøtzsche

    Dr. Peter Gøtzsche co-founded the Cochrane Collaboration, once considered the world’s preeminent independent medical research organization. In 2010 Gøtzsche was named Professor of Clinical Research Design and Analysis at the University of Copenhagen. Gøtzsche has published more than 97 papers in the “big five” medical journals (JAMA, Lancet, New England Journal of Medicine, British Medical Journal, and Annals of Internal Medicine). Gøtzsche has also authored books on medical issues including Deadly Medicines and Organized Crime. Following many years of being an outspoken critic of the corruption of science by pharmaceutical companies, Gøtzsche’s membership on the governing board of Cochrane was terminated by its Board of Trustees in September, 2018. Four board resigned in protest.

Brownstone Institute

The Unmasking of Vaccine Science

Published on

From the Brownstone Institute

By Maryanne DemasiMaryanne Demasi  

I recently purchased Aaron Siri’s new book Vaccines, Amen.  As I flipped though the pages, I noticed a section devoted to his now-famous deposition of Dr Stanley Plotkin, the “godfather” of vaccines.

I’d seen viral clips circulating on social media, but I had never taken the time to read the full transcript — until now.

Siri’s interrogation was methodical and unflinching…a masterclass in extracting uncomfortable truths.

In January 2018, Dr Stanley Plotkin, a towering figure in immunology and co-developer of the rubella vaccine, was deposed under oath in Pennsylvania by attorney Aaron Siri.

The case stemmed from a custody dispute in Michigan, where divorced parents disagreed over whether their daughter should be vaccinated. Plotkin had agreed to testify in support of vaccination on behalf of the father.

What followed over the next nine hours, captured in a 400-page transcript, was extraordinary.

Plotkin’s testimony revealed ethical blind spots, scientific hubris, and a troubling indifference to vaccine safety data.

He mocked religious objectors, defended experiments on mentally disabled children, and dismissed glaring weaknesses in vaccine surveillance systems.

A System Built on Conflicts

From the outset, Plotkin admitted to a web of industry entanglements.

He confirmed receiving payments from Merck, Sanofi, GSK, Pfizer, and several biotech firms. These were not occasional consultancies but long-standing financial relationships with the very manufacturers of the vaccines he promoted.

Plotkin appeared taken aback when Siri questioned his financial windfall from royalties on products like RotaTeq, and expressed surprise at the “tone” of the deposition.

Siri pressed on: “You didn’t anticipate that your financial dealings with those companies would be relevant?”

Plotkin replied: “I guess, no, I did not perceive that that was relevant to my opinion as to whether a child should receive vaccines.”

The man entrusted with shaping national vaccine policy had a direct financial stake in its expansion, yet he brushed it aside as irrelevant.

Contempt for Religious Dissent

Siri questioned Plotkin on his past statements, including one in which he described vaccine critics as “religious zealots who believe that the will of God includes death and disease.”

Siri asked whether he stood by that statement. Plotkin replied emphatically, “I absolutely do.”

Plotkin was not interested in ethical pluralism or accommodating divergent moral frameworks. For him, public health was a war, and religious objectors were the enemy.

He also admitted to using human foetal cells in vaccine production — specifically WI-38, a cell line derived from an aborted foetus at three months’ gestation.

Siri asked if Plotkin had authored papers involving dozens of abortions for tissue collection. Plotkin shrugged: “I don’t remember the exact number…but quite a few.”

Plotkin regarded this as a scientific necessity, though for many people — including Catholics and Orthodox Jews — it remains a profound moral concern.

Rather than acknowledging such sensitivities, Plotkin dismissed them outright, rejecting the idea that faith-based values should influence public health policy.

That kind of absolutism, where scientific aims override moral boundaries, has since drawn criticism from ethicists and public health leaders alike.

As NIH director Jay Bhattacharya later observed during his 2025 Senate confirmation hearing, such absolutism erodes trust.

“In public health, we need to make sure the products of science are ethically acceptable to everybody,” he said. “Having alternatives that are not ethically conflicted with foetal cell lines is not just an ethical issue — it’s a public health issue.”

Safety Assumed, Not Proven

When the discussion turned to safety, Siri asked, “Are you aware of any study that compares vaccinated children to completely unvaccinated children?”

Plotkin replied that he was “not aware of well-controlled studies.”

Asked why no placebo-controlled trials had been conducted on routine childhood vaccines such as hepatitis B, Plotkin said such trials would be “ethically difficult.”

That rationale, Siri noted, creates a scientific blind spot. If trials are deemed too unethical to conduct, then gold-standard safety data — the kind required for other pharmaceuticals — simply do not exist for the full childhood vaccine schedule.

Siri pointed to one example: Merck’s hepatitis B vaccine, administered to newborns. The company had only monitored participants for adverse events for five days after injection.

Plotkin didn’t dispute it. “Five days is certainly short for follow-up,” he admitted, but claimed that “most serious events” would occur within that time frame.

Siri challenged the idea that such a narrow window could capture meaningful safety data — especially when autoimmune or neurodevelopmental effects could take weeks or months to emerge.

Siri pushed on. He asked Plotkin if the DTaP and Tdap vaccines — for diphtheria, tetanus and pertussis — could cause autism.

“I feel confident they do not,” Plotkin replied.

But when shown the Institute of Medicine’s 2011 report, which found the evidence “inadequate to accept or reject” a causal link between DTaP and autism, Plotkin countered, “Yes, but the point is that there were no studies showing that it does cause autism.”

In that moment, Plotkin embraced a fallacy: treating the absence of evidence as evidence of absence.

“You’re making assumptions, Dr Plotkin,” Siri challenged. “It would be a bit premature to make the unequivocal, sweeping statement that vaccines do not cause autism, correct?”

Plotkin relented. “As a scientist, I would say that I do not have evidence one way or the other.”

The MMR

The deposition also exposed the fragile foundations of the measles, mumps, and rubella (MMR) vaccine.

When Siri asked for evidence of randomised, placebo-controlled trials conducted before MMR’s licensing, Plotkin pushed back: “To say that it hasn’t been tested is absolute nonsense,” he said, claiming it had been studied “extensively.”

Pressed to cite a specific trial, Plotkin couldn’t name one. Instead, he gestured to his own 1,800-page textbook: “You can find them in this book, if you wish.”

Siri replied that he wanted an actual peer-reviewed study, not a reference to Plotkin’s own book. “So you’re not willing to provide them?” he asked. “You want us to just take your word for it?”

Plotkin became visibly frustrated.

Eventually, he conceded there wasn’t a single randomised, placebo-controlled trial. “I don’t remember there being a control group for the studies, I’m recalling,” he said.

The exchange foreshadowed a broader shift in public discourse, highlighting long-standing concerns that some combination vaccines were effectively grandfathered into the schedule without adequate safety testing.

In September this year, President Trump called for the MMR vaccine to be broken up into three separate injections.

The proposal echoed a view that Andrew Wakefield had voiced decades earlier — namely, that combining all three viruses into a single shot might pose greater risk than spacing them out.

Wakefield was vilified and struck from the medical register. But now, that same question — once branded as dangerous misinformation — is set to be re-examined by the CDC’s new vaccine advisory committee, chaired by Martin Kulldorff.

The Aluminium Adjuvant Blind Spot

Siri next turned to aluminium adjuvants — the immune-activating agents used in many childhood vaccines.

When asked whether studies had compared animals injected with aluminium to those given saline, Plotkin conceded that research on their safety was limited.

Siri pressed further, asking if aluminium injected into the body could travel to the brain. Plotkin replied, “I have not seen such studies, no, or not read such studies.”

When presented with a series of papers showing that aluminium can migrate to the brain, Plotkin admitted he had not studied the issue himself, acknowledging that there were experiments “suggesting that that is possible.”

Asked whether aluminium might disrupt neurological development in children, Plotkin stated, “I’m not aware that there is evidence that aluminum disrupts the developmental processes in susceptible children.”

Taken together, these exchanges revealed a striking gap in the evidence base.

Compounds such as aluminium hydroxide and aluminium phosphate have been injected into babies for decades, yet no rigorous studies have ever evaluated their neurotoxicity against an inert placebo.

This issue returned to the spotlight in September 2025, when President Trump pledged to remove aluminium from vaccines, and world-leading researcher Dr Christopher Exley renewed calls for its complete reassessment.

A Broken Safety Net

Siri then turned to the reliability of the Vaccine Adverse Event Reporting System (VAERS) — the primary mechanism for collecting reports of vaccine-related injuries in the United States.

Did Plotkin believe most adverse events were captured in this database?

“I think…probably most are reported,” he replied.

But Siri showed him a government-commissioned study by Harvard Pilgrim, which found that fewer than 1% of vaccine adverse events are reported to VAERS.

“Yes,” Plotkin said, backtracking. “I don’t really put much faith into the VAERS system…”

Yet this is the same database officials routinely cite to claim that “vaccines are safe.”

Ironically, Plotkin himself recently co-authored a provocative editorial in the New England Journal of Medicineconceding that vaccine safety monitoring remains grossly “inadequate.”

Experimenting on the Vulnerable

Perhaps the most chilling part of the deposition concerned Plotkin’s history of human experimentation.

“Have you ever used orphans to study an experimental vaccine?” Siri asked.

“Yes,” Plotkin replied.

“Have you ever used the mentally handicapped to study an experimental vaccine?” Siri asked.

“I don’t recollect…I wouldn’t deny that I may have done so,” Plotkin replied.

Siri cited a study conducted by Plotkin in which he had administered experimental rubella vaccines to institutionalised children who were “mentally retarded.”

Plotkin stated flippantly, “Okay well, in that case…that’s what I did.”

There was no apology, no sign of ethical reflection — just matter-of-fact acceptance.

Siri wasn’t done.

He asked if Plotkin had argued that it was better to test on those “who are human in form but not in social potential” rather than on healthy children.

Plotkin admitted to writing it.

Siri established that Plotkin had also conducted vaccine research on the babies of imprisoned mothers, and on colonised African populations.

Plotkin appeared to suggest that the scientific value of such studies outweighed the ethical lapses—an attitude that many would interpret as the classic ‘ends justify the means’ rationale.

But that logic fails the most basic test of informed consent. Siri asked whether consent had been obtained in these cases.

“I don’t remember…but I assume it was,” Plotkin said.

Assume?

This was post-Nuremberg research. And the leading vaccine developer in America couldn’t say for sure whether he had properly informed the people he experimented on.

In any other field of medicine, such lapses would be disqualifying.

A Casual Dismissal of Parental Rights

Plotkin’s indifference to experimenting on disabled children didn’t stop there.

Siri asked whether someone who declined a vaccine due to concerns about missing safety data should be labelled “anti-vax.”

Plotkin replied, “If they refused to be vaccinated themselves or refused to have their children vaccinated, I would call them an anti-vaccination person, yes.”

Plotkin was less concerned about adults making that choice for themselves, but he had no tolerance for parents making those choices for their own children.

“The situation for children is quite different,” said Plotkin, “because one is making a decision for somebody else and also making a decision that has important implications for public health.”

In Plotkin’s view, the state held greater authority than parents over a child’s medical decisions — even when the science was uncertain.

The Enabling of Figures Like Plotkin

The Plotkin deposition stands as a case study in how conflicts of interest, ideology, and deference to authority have corroded the scientific foundations of public health.

Plotkin is no fringe figure. He is celebrated, honoured, and revered. Yet he promotes vaccines that have never undergone true placebo-controlled testing, shrugs off the failures of post-market surveillance, and admits to experimenting on vulnerable populations.

This is not conjecture or conspiracy — it is sworn testimony from the man who helped build the modern vaccine program.

Now, as Health Secretary Robert F. Kennedy, Jr. reopens long-dismissed questions about aluminium adjuvants and the absence of long-term safety studies, Plotkin’s once-untouchable legacy is beginning to fray.

Republished from the author’s Substack

Maryanne Demasi

Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

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Brownstone Institute

Bizarre Decisions about Nicotine Pouches Lead to the Wrong Products on Shelves

Published on

From the Brownstone Institute

  Roger Bate  

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.

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

Roger Bate

Roger Bate is a Brownstone Fellow, Senior Fellow at the International Center for Law and Economics (Jan 2023-present), Board member of Africa Fighting Malaria (September 2000-present), and Fellow at the Institute of Economic Affairs (January 2000-present).

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