Brownstone Institute
Stop Vaccinating Children: It’s Neither Medically Justified Nor Ethical
As time passes, Covid policy is proving to be a bigger threat than Covid disease. Promoted as an initial protection measure to buy much-needed time against a once-in-a-century pandemic, it became a way of life to which health bureaucrats and autocratically-inclined leaders became addicted and are having trouble letting go.
Yet in the UK: “The effects of lockdown may now be killing more people than are dying of Covid.” An editorial in the Telegraph emphasized the importance of establishing why a meaningful cost-benefit analysis of Covid policy was not carried out. Former UK Supreme Court Justice Lord Sumption describes lockdown as “an experiment in authoritarian government unmatched in our history even in wartime.” Australia’s vaunted success in controlling the pandemic in 2020–21, meanwhile, looks increasingly hollow in 2022 (Figure 1).
The instinct to protect offspring is one of the most powerful in nature across all species, with examples only too common of parents, especially mothers, sacrificing themselves in a desperate effort to save their young. On September 4, on the edge of the Bandhavgarh Tiger Reserve in central India, Archana Choudhary was working in the fields with her 15-month toddler when a tiger appeared and sunk its teeth into the baby’s head. Choudhary grappled the tiger with her bare handstrying to free the baby from its jaws until, hearing her screams, villagers came to her assistance with sticks and stones and the tiger fled. Both Mum and Bub were taken to hospital, with the mother’s wounds being the more serious. A real-life Tiger Mom!
The hardwired instinct to protect children might explain why in jurisdictions where vaccines have been approved for children, the takeup, especially for young children, has lagged well behind the adult vaccination rates. The effort to psychologically nudge and politically coerce children’s vaccination is abhorrent, distressing and puzzling in equal measures.
Children Are at Very Low Risk
Abhorrent, because it’s an acute manifestation of the evil that has taken hold following the fear induced in peoples by deliberate psychological campaigns of terror propaganda, aided and abetted by mainstream and social media. Large numbers of people in Western societies have actively colluded with governments in imposing harms on children. Debbie Lerman wrote an excellent account on this site of how instilling and sustaining mass fear was the one unifying theme that explains all the otherwise crazy edicts and policy interventions by the US government.
In almost all Western countries, the average age of Covid deaths has been higher than the average life expectancy and the mortality risk to children is lower by a thousandfold. This is the first occasion in history where children have been made to bear the heaviest costs, with futures mortgaged to massive debts, educational opportunities drastically curtailed and exposure to potentially harmful and even lethal medical interventions, just so the old can cling on to life for a few more months and years. Take two telling examples.
In January UNICEF reported on the devastating setbacks to children’s education. Robert Jenkins, UNICEF Chief of Education, said “we are looking at a nearly insurmountable scale of loss to children’s schooling.” Large-scale independent studies published in early September documented a two-decade reversal in children’s educational progress in the US. Japan experienced a jump in suicides by more than 8,000 between March 2020 and June 2022 compared to pre-pandemic numbers, mostly among women in their teens and 20s.
Unlike the flu, which tends not to discriminate between different age cohorts, coronavirus is very age-specific. The exceptional and extreme age-segregation of Covid deaths was known very early in the pandemic. On April 30, 2020, the Daily Mail reported that children under 10 are not transmitters of the disease. Despite more than 26,000 Covid-related deaths in the UK, experts who reviewed the data failed to find a single case of an infected under-10 who had passed on the disease to an adult.
The BBC reported on May 7, 2020 that in England and Wales, there were only around 300 deaths in under-45s compared to around 24,000 in over-65s. Older people with pre-existing health conditions were the most at risk, as shown in a visually striking age-adjusted graph from the BBC (Figure 2). For those under 20, the risk is negligible. In October 2020, the Great Barrington Declaration – with 932,500 signatories currently, including 63,100 doctors and medical and public health scientists – noted that the mortality risk of Covid in the young was a thousand-fold less than in the old and infirm.
On June 30, 2021, Prof. Robert Dingwall, a member of the Joint Committee on Vaccination and Immunisation that advises the UK government, said letting children catch Covid would be better than vaccinating them. Their intrinsically low risk from Covid means they may be “better protected by natural immunity generated through infection than by asking them to take the ‘possible’ risk of a vaccine.”
In July, Stanford University’s Cathrine Axfors and John Ioannidis published their estimate that survivability of infected under-20s is 99.999%, falling to 99.958% for the under-50s..
The persistence of the drive to vaccinate children is puzzling because the lockdown and vaccine narratives are falling apart. One driver of this is the growing realization that excess death counts from all-cause mortality have risen in many countries, including Australia, Netherlands and the UK.
Death is the one statistic that cannot be fudged or subjected to definitional spin. In their analysis of the 50 US states, John Johnson and Denis Raincourt show that if anything, lockdown states have higher all-cause mortality rates than contiguous non-lockdown states. In many cases deaths also seem to track vaccination campaigns in successive doses.
In part the situation reflects the monomaniacal obsession with Covid to the exclusion of other leading killer diseases. The Telegraph pointed out that the UK National Health Service is once again on the verge of collapse, this time from “a tsunami of non-Covid patients who were denied treatment during the pandemic.”
Lockdown Back Pedalling
As noted by Carl Heneghan and Tom Jefferson of Oxford University, prominent practitioners of evidence-based medicine rather than modelling-based projections, the “lockdown back-pedalling race” has begun. In late August, former UK Chancellor Rishi Sunak said it had been a mistake to empower the government’s scientific advisory committee SAGE, whose analyses and forecasts were dominated by gloom and doom unless stringent restrictions were put in place yesterday.
He added that insufficient attention had been paid to the knock-on effects of lockdowns on health, education and the economy. The fear messaging had also been wrong and harmful in destroying trust in public institutions. Critics attributed his Damascene conversion to a desperate effort to revive his faltering campaign for leadership of the Conservative Party and hence becoming prime minister of the UK.
I believe this is wrong. By then the writing was clearly on the wall and Sunak, by all accounts a fundamentally decent man, wanted to go on the public record, inwardly accepting that he had already lost, in order to put obstacles in the path of future lockdowns. In that sense Sunak’s Spectator interview is more accurately read as the start of the unravelling of the great Covid narrative. Sure enough, he was soon followed by former cabinet colleagues and parliamentarians.
Former Transport Secretary Grant Shapps revealed he brought along his own spreadsheets on international data to cabinet discussions to counter SAGE analysis and advice. Even Sunak’s leadership rival, and now PM, Liz Truss claims she too was opposed to lockdowns. Unfortunately, this is contradicted by her public record but no matter, she has boxed herself in as regards returning to lockdown in the future.
Meanwhile, Denmark has banned vaccines for under-18s and under-50s can get a booster only with a doctor’s prescription. The CDC’s new guidance acknowledges the “transient” protection from vaccination against infection and transmission and the reality of naturally-acquired immunity through infection.
It therefore recommended against any further discrimination by vaccination status for most settings. Yet, again demonstrating bureaucrats’ infinite capacity for idiocy, the ban on unvaccinated visitors to the US was maintained and stopped Novak Djokovic from competing in athe US Open that was denuded of serious star power in the men’s semis and finals.
Vaccines for Australian Children
In Israel, as succinctly summarized by Will Jones, public health authorities and the government deliberately covered up serious vaccine side-effects. In September we learnt that several Australian health officials were on a government- sponsored visit as guests of Israel’s Ministry of Health.
On July 19, Australia’s Therapeutic Goods Administration (TGA) granted provisional approval to Moderna for administering Spikevax vaccines to children aged 0.5–5 years. Provisional because they are still undergoing clinical trials to assess full safety. The decision is especially strange in light of concerning reports of deaths, adverse events and long-term side-effects accompanying vaccines. The Therapeutic Goods Regulation (1990) restricts provisional approvals to medicines for “the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition.”
This would appear to rule out provisional vaccine approval for children below five, as shown in the empirical data from New South Wales (NSW). The resilience of the under-50s can be seen in Figure 3. In the 14-week period May 22–August 27, they made up 27.3% of Covid-related hospitalization and 19.7% of ICU admissions, but only 1.4% of deaths. In the same period, just 0.11% of all Covid-related deaths in NSW were children and young people up to the age of 19 (Figure 4).
On this basis, a group of lawyers is aiming to file a crowd-funded case in the High Court (Australia’s equivalent of the US Supreme Court) against the decision. But so far Australian courts have been disappointingly supine toward health edicts.
The TGA’s website states that its “regulatory costs are mostly recovered through annual fees and charges levied on the sponsors and manufacturers of therapeutic goods.” An article in the British Medical Journal by Maryannne Demasi, published on June 29, documented that a compromising 96% of the TGA’s A $170mn 2020–21 budget came from industry sources, higher than the rates (in descending order) for the European, UK, Japanese, US and Canadian counterparts.
This is beyond regulatory capture and closer to the regulator being in the pocket of the regulated. Should we be surprised that the TGA approved nine of every ten applications from drug companies that year? The TGA “firmly denies that its almost exclusive reliance on pharmaceutical industry funding is a conflict of interest,” and the TGA is an honourable regulator. Yet the sad reality is the global drug industry has a particularly scandal-ridden record in influencing regulatory decisions via funding with regard, for example, to opioids, Alzheimer’s drugs, influenza antivirals, pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents, etc.
In the Declaration for the Protection of Children and Young People from the Covid-19 Response in May 2021, the Pandemics Data and Analytics (PANDA) group said that Covid-19 is “a disease for which they [the young] carry essentially no risk.” Therefore vaccinating children is “all risk, no benefit.” Are we really going to engage in child sacrifice on the altar of Big Pharma?
Directing attention and resources without age-stratified discrimination – because “everyone is equally at risk” – made no medical or policy sense, unless, as Lerman postulates, the primary goal was to inculcate a self-sustaining state of mass panic. So even the children had to be routinely tested, isolated, deschooled, masked and vaccinated as part of what Swedish Dr. Sebastian Rushworth called the “Covid mania” and “collective state of hysteria.”. Universal vaccines is like the drunk looking for car keys near the light from the street lamp instead of where he lost them.
Against the extremely low serious risk from Covid with a survival rate of 99.99% for 0-19 year olds, the likely greater risk from vaccines, and the completely unknown long-term effects of the new-technology vaccines, if I had young children, I’d resist attempts to jab them, to the death if necessary.
Ordinarily, it would be best to put the whole Covid nightmare behind us and move on. This might be one of the rare exceptions, for accountability for the pain and harms inflicted on individuals and society is the best, and likely the only effective insurance against a repeat.
On July 23 the World Health Organization declared monkeypox, which so far has affected few people in a handful of countries, a public health emergency of international concern.
David Bell and Emma McArthur warn that the global pandemic industry has no plans for a return to normal. This is why the chief architects of population-wide lockdown and vaccine policies must be identified, put in the dock and made to answer and pay for their misdeeds.
Lest we forget.
Author
From the Brownstone Institute
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
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
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