Brownstone Institute
The Vaccine Was “95% Effective” How?
From the Brownstone Institute
BY
The 1840 Treaty of Waitangi between the British Crown and Maori chiefs was a landmark event in the history of New Zealand. Drafted in English, a Maori translation was prepared, ostensibly to ensure that Maori could have an accurate understanding of the terms. In retrospect, it is less clear that a meeting of the minds was intended:
The English and Māori texts differ. As some words in the English treaty did not translate directly into the written Māori language of the time, the Māori text is not a literal translation of the English text. It has been claimed that Henry Williams, the missionary entrusted with translating the treaty from English, was fluent in Māori and that far from being a poor translator he had in fact carefully crafted both versions to make each palatable to both parties without either noticing inherent contradictions.
“The covid vaccine is 95% effective” is a contemporary Treaty of Waitangi. The original is in the language of clinical trials. It was never translated. The public interpreted this phrase in their native language, normal English. What Pfizer said and what the public heard were quite different. The public would have been far more skeptical of these products had the clinical trial results been translated into normal English.
What we need is a proper translation and an explanation of how miscommunication happened.
The Injections Did Not Stop Infection
By now, everyone knows that the Pfizer and Moderna products did not stop people from getting Covid. Covid disease has mowed a wide strip through the double and triple-masked talking heads who told everyone that the shots would make them immune.
What is less well known is that:
- The products were never expected to stop infection or transmission.
- The clinical trials did not test for their ability to do so.
A clinical trial is designed to test a drug for effectiveness, which is strictly defined by one or more endpoints. An endpoint is a measurable outcome that can be assessed for each participant. With that in mind, prevention of infection was not an endpoint of the BioNTech/Pfizer injection clinical trials. And, this was known in 2020 before the products were approved for emergency use and distributed to the public starting in 2021.
In this New England Journal of Medicine research summary, Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine, under Limitations and Remaining Questions, we find that “whether the vaccine protects against asymptomatic infection and transmission to unvaccinated persons” remains unanswered by the clinical trial.
What did the clinical trial test for, if not the ability of the mRNA vaccine to stop transmission and/or infection? The trial was designed to test the ability of the injections to prevent “symptomatic Covid 19 cases” defined as one or more of a number symptoms and a positive test (see page 7 of the supplementary appendix for details).
@pfizer tweeted in Jan 2021 that stopping transmission was their “highest priority”. Their product does not do that, nor did the tweet make a claim that it did so. But it was their highest priority nonetheless. That, and getting as many people injected as possible.

Failure to Prevent Infection Was Known Before the Rollout
In October 2022, a Pfizer executive testified to an EU body that Pfizer had not tested the ability of the vaccine to stop transmission. This story was shocking to some and generated accusations that Pfizer had lied about the capabilities of the shots. But this information had been available since the trial results were released early in 2021. Pfizer had already been criticized for this.
Dr William A Haseltine PhD, wrote in Forbes in September 2020:
What would a normal vaccine trial look like?
One of the more immediate questions a trial needs to answer is whether a vaccine prevents infection. If someone takes this vaccine, are they far less likely to become infected with the virus? These trials all clearly focus on eliminating symptoms of Covid-19, and not infections themselves. Asymptomatic infection is listed as a secondary objective in these trials when they should be of critical importance.
On October 21, 2020 the editor of the BMJ (British Medical Journal) Peter Doshi asked:
Will covid-19 vaccines save lives? Current trials aren’t designed to tell us
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”
Yet the current phase III trials are not actually set up to prove either. None of the trials currently underway are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus….
Is It Even a Vaccine?
A vaccine that prevents infection is known as “neutralizing” or “sterilizing”. I am a software engineer with no training in medicine, pharmacology or clinical trials. I consider myself a good barometer of what the average untrained person would think about such things. Prior to 2021 I had thought that immunity was a necessary condition for a drug to earn the title of “vaccine”. If anyone had asked me, I would have told them that the Covid injections were a treatment, not a vaccine.
The Wikipedia article about vaccines (Mar 5 2023) aligns with my untrained understanding:
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. … A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body’s immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future.
Cornell Law provides the following legal definition of vaccine, sourcing 26 USC § 4132(a)(2), which is consistent with the above:
The term “vaccine” means any substance designed to be administered to a human being for the prevention of 1 or more diseases.
The definition published by the CDC prior to 2021 said much the same. But the CDC website changed the definition on or after August 2021. The older version found on the internet archive is here (emphasis added):
Immunity: Protection from an infectious disease. If you are immune to a disease, you can be exposed to it without becoming infected.
Vaccine: A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.
Here is the new version (emphasis added):
Vaccine: A preparation that is used to stimulate the body’s immune response against diseases.
The earlier pair of definitions is quite easy to understand. The latter, much more difficult. What exactly is a “preparation”? Does a vaccine stimulate the body or only prepare the body? What is or is not a vaccine according to the new definition?
While the CDC may think that they can change the meanings of words whenever they like, public memory retains the original meaning. The assumption of immunity permeates almost all non-expert level discussion of vaccines. A web search for “why are vaccines good” shows results that assume or imply immunity.
Even the CDC did not finish the job of memory-holing the old language. On the very same CDC website, under 5 Reasons It Is Important for Adults to Get Vaccinated, we read “By getting vaccinated, you can protect yourself and also avoid spreading preventable diseases to other people in your community.” And then, “Vaccines Can Prevent Serious Illness”.
The timing of the CDC’s edit suggests to me that prior to 2021, the CDC had the same understanding of vaccines as I do. I believe that they wanted a new definition because they knew that the products being developed at warp speed were not vaccines in the original sense of the word. And it was important that those products be called “vaccines” for reasons that I will explain later. This incident brings to mind a meme that I no longer have a link to. captioned: “We changed what ‘definition’ means so you can’t say that we redefined anything.”
What Does “95% Effective” Mean?
The “95% effective” message was repeated in nearly all reporting on the clinical trials. But the question, “effective at doing what?” was rarely asked. To answer this requires walking down the links of a chain of terminology from the world of clinical trials.
The first link in the chain is “risk”. Risk is the probability of a bad outcome. These are assumed to happen randomly within a group. A clinical trial must define in advance the bad outcomes that the drug intends to avoid. The next link is “endpoint”. Each distinct bad outcome is an “endpoint”. The trial compares the endpoints between a control group who did not take the drug and a test group, who did.
The purpose of a clinical trial is to determine the ability of a drug to reduce risk. A drug that reduces risk is “effective”. There are two ways of quantifying risk reduction. From the NIH glossary:
Absolute risk reduction (ARR) or risk difference
the difference in the incidence of poor outcomes between the intervention group of a study and the control group. For example, if 20 per cent of people die in the intervention group and 30 per cent in the control group, the ARR is 10 per cent (30–20 per cent).
Relative risk (RR)
the rate (risk) of poor outcomes in the intervention group divided by the rate of poor outcomes in the control group. For example, if the rate of poor outcomes is 20 per cent in the intervention group and 30 per cent in the control group, the relative risk is 0.67 (20 per cent divided by 30 per cent).
The difference between the ARR and RR (also known as “RRR”, to align with ARR) is in the denominator. The ARR divides by the number of participants in one of the groups. The RRR divides by the number of people with bad outcomes in the control group – a necessarily much smaller number.
The ARR is the number most relevant for a drug – such as the Pfizer injections – that was to be given to everyone. But the RRR is the preferred method of presentation for pharma when they want to exaggerate the effectiveness of a drug because it will always be a much larger number. Would you take a drug that could reduce the incidence of a rare disease by 50%? From 10 per 1 million to 5 per 1 million is an 50% RRR and an 0.0005% ARR.
The 95% figure cited for the covid injections is the relative risk. The absolute risk reduction was 0.84%. In a slide deck from the Canadian Covid Care Alliance(CCCA), slide 11 shows how the 91% was achieved (it is 91%, not 95%, because the it refers to an earlier version of the study):

The research paper COVID-19 vaccine efficacy and effectiveness—the elephant (not) in the room puts the ARR in the 1% range. The CCCA slide deck gives an ARR of 0.84%, though it is not clear how they reached this number, based on the other numbers in their slides.
A clinical trial finding of a 1% ARR means that 99% of the people who take the drug either did not experience the condition that the drug treats, or they did experience it, but were not helped by the drug. The 1% both had the condition and were helped by the drug. Another way of saying this is the Number Needed to Treat (NNT). NNT is the reciprocal of the ARR and is the number of people who must take the drug to help one person reach the endpoint. An ARR of 1% corresponds to an NNT of 100 people.
We can now answer the question of the meaning of vaccine effectiveness. The endpoint of the trial was a severe confirmed case of covid at least 7 days after the second dose. This endpoint requires the participant in the trial to have covid symptoms and a positive covid test. “95% effective” means that 95% of the patients who had Covid symptoms and a positive test were in the control group. Five percent were in the test group.
Here’s what “95% effective” did not mean: if you take the shots, then you will have a 95% lower chance of getting covid. But that is how most people understood it because that is what the words mean in normal English.
Then the Lying Started
Once the public had their hopes raised by the false translation of the “95% effective” message, the pandemic-industrial-complex went into high gear to amplify it. They stated the incorrect message loudly, frequently, and as if it were fact. The injections would – with 100% certainty (perhaps 200%) – protect you from infection. Many of the people who said this were doctors or scientific researchers who must have understood how to interpret clinical trials.
Here are some choice quotes that did not age well:
- “You’re not going to get Covid if you have these vaccinations.” Joe Biden, CNN Town Hall July 2021
- “Now we know that the vaccines work well enough that the virus stops with every vaccinated person. A vaccinated person gets exposed to the virus, the virus does not infect them, the virus cannot then use that person to go anywhere else,” she added with a shrug. “It cannot use a vaccinated person as a host to go get more people. [Vaccines] will get us to the end of this.” – Rachel Maddow, March 2021
- “When people are vaccinated they can feel safe that they won’t get infected, whether they’re outdoors or indoors.” – Dr. Anthony Fauci, May 2021(outdoors: seriously?)
- “Vaccination against COVID-19 prevents breakthrough infections, Stanford researchers find.” – Stanford Medicine, July 2021
- Vaccinated people become “dead ends” for the virus – Anthony Fauci, May 2021
Demonizing the Unvaxxed
The public has consistently over-estimated the infection fatality rate of Covid. Some even believed the fatality rate to be above 10%. They believed that we were in great danger. They also believed that the “95% effective” vaccine would bring the pandemic to a quick end, once everyone had taken it. Anyone who refused to do so was therefore risking not only their own life, but everybody else’s as well.
Dr Anthony Fauci estimated herd immunity would emerge when around 60% of the population had taken the vaccine … or perhaps 70, 80, no wait … 85%. Or maybe 100% (which would include large numbers who already had natural immunity). Bill Gates extended that to everyone on earth.
The narrative then turned to demonization of those who refused to submit to vaccine coercion. The selfish anti-social behavior of the anti-vaxxers with their stubborn attachment to “free dumb” that was keeping everyone locked indoors and forcing us all to wear diapers on our faces. Yale University behavioral researchers tested messaging strategies to determine whether shame, embarrassment or fear was most effective.
President Biden said that we the nation was experiencing a “pandemic of the unvaccinated”. Later, Biden ominoulsy warned the unvaccinated that he had been waiting a long time for them to get injected, but “our patience is wearing thin”. In December of 2021 the White House issued a cheery year end greeting to the vaccinated. The unvaccinated, on the other hand, were “looking at a winter of severe illness and death.” Merry Christmas.
Even South Park, which I consider a reliable source of contrarian political opinion, ran a storyline set in the year 2050 in which every single character had to be vaccinated for the 30-year pandemic to end. This episode featured one lone holdout who would not get vaccinated due to a crustacean allergy i.e. for “shellfish reasons”. This gag took aim at people who considered the vaccine to be a violation of body autonomy, and those who objected to components used in its development for religious reasons, thereby scoring a “two for one”.
Volumes can, and will, be written about the intense onslaught of propaganda aimed at getting two needles in every deltoid. I will provide one more example that represents no more than the median level of insanity; plenty of people called for the same or worse. @ClayTravis, in February 2023, tweeted the results of a Rasmussen poll from 2022:
Last January 60% of Democrats wanted to lock everyone who didn’t get the covid shot in their houses. Over 40% of Democrats wanted those who rejected the covid shot sent to quarantine camps. Over 40% also wanted anyone who criticized the covid shot fined & imprisoned. Over a quarter wanted those who didn’t get the covid shot to have their kids seized.
While there were many agendas driving the madness, the Treaty of Waitangi effect was a critical part in carrying it out. If the message had been that “everyone is going to get exposed to covid – injected or not”, then it could not have happened. The misunderstanding convinced the public that mass vaccination would stop the pandemic; and that the holdouts were prolonging it. Without this belief, none of the coercion made any sense: employment mandates, school mandates, quarantine camps, or vaccine passports. As the hysteria fades, the last remaining mandates are being dropped as the reality sinks in that the shots do not stop the spread.
Welcome to Waitangi World. I hope that you have a pleasant stay.
Brownstone Institute
The Unmasking of Vaccine Science
From the Brownstone Institute
By
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.
A Legal Showdown
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 Medicine, conceding 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
Brownstone Institute
Bizarre Decisions about Nicotine Pouches Lead to the Wrong Products on Shelves
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.
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Bruce Dowbiggin7 hours agoWayne Gretzky’s Terrible, Awful Week.. And Soccer/ Football.
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espionage10 hours agoWestern Campuses Help Build China’s Digital Dragnet With U.S. Tax Funds, Study Warns
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Agriculture6 hours agoCanada’s air quality among the best in the world
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Business8 hours agoCanada invests $34 million in Chinese drones now considered to be ‘high security risks’
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Economy9 hours agoAffordable housing out of reach everywhere in Canada
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Fraser Institute2 days agoClaims about ‘unmarked graves’ don’t withstand scrutiny
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Energy2 days agoMeet REEF — the massive new export engine Canadians have never heard of
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National2 days agoCanada’s free speech record is cracking under pressure






