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Brownstone Institute

The Latest “Bird Flu” Psyop

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18 minute read

From Brownstone Institute

By Robert W. Malone Robert Malone

I am expert in influenza, and have consulted with the WHO over the past two decades on the topic of flu vaccines. This is one subject matter I am extremely knowledgeable about. This goes back to my medical school days, when I worked with Robert Lamb, one of the top influenza virus specialists in the world. It extended through much of my career, including my serving as Director of Clinical Influenza Vaccine Research for Solvay Biologicals, in which I oversaw over $200 million in federal (BARDA) alternative (cell-based) influenza vaccine research funding.

What is happening now with “Bird flu” is another psyops campaign being conducted by the administrative/deep state, apparently in partnership with Pharma, against the American people. They know and we know that the “vaccines” being produced will be somewhat ineffective, as all flu “vaccines” are. The government is chasing a rapidly evolving RNA virus with a syringe, just like they did with HIV and Covid-19.

Generally, the currently circulating avian influenza strain in the US does not include any cases of human-to-human transmission. And the current mortality, with over 60 cases identified, is 0%. NOT 50%.

All the while they are getting prepared to roll out masks, lockdowns, quarantines, etc.

All the while getting ready to roll out mRNA vaccines for poultry and livestock, as well as for all of us.

The more they test, the more “Bird flu” (H5N1) they will find. This “pandemic” is nothing more than an artifact of their newly developed protocols to test cattle, poultry, pets, people, and wildlife on a massive scale for avian influenza. In years past, this was not even considered. In the past, the USG did fund a massive testing and surveillance program called “Biowatch.” That program was a colossal failure and a massive waste of money. Billions of dollars.

Of course, these facilities producing the tests have been repurposed from the Covid-19 testing facilities.

Key questions include:

Will we all comply?

Will we be forced to comply?

Will President Trump go along with the PsyWar/psyops campaign again?

We will know soon enough.


As the United States is testing everyone who has even the mildest symptoms for the H5N1 (avian) influenza, guess what – they are finding it! This is what we call in the lab, a “sampling bias.”

Globally, from 1997 until the present, there have been 907 reported cases of H5N1. And in fact, this particular outbreak was not the worst – and it is the only one where a massive testing campaign has occurred. It appears that this is partly due to the new diagnostic capabilities developed and deployed during Covid-19. The more you test, the more you find. But is it clinically significant?

The Case Study of Tetanus: Supply Chain Issues.

The CDC recommends a booster for the tetanus vaccine every 10 years for adults.

However, research published almost a decade ago suggests that the protection from tetanus and diphtheria vaccination lasts at least 30 years after completing the standard childhood vaccination series.


“We have always been told to get a tetanus shot every 10 years, but actually, there is very little data to prove or disprove that timeline. When we looked at the levels of immunity among 546 adults, we realized that antibody titers against tetanus and diphtheria lasted much longer then previously believed.”

-Mark K. Slifka, Ph.D, study author


This research, published in a highly reputable journal, suggests that a revised vaccination schedule with boosters occurring at ages 30 and 60 would be sufficient. As this was published in early 2016, the US government, at the very least, could have commissioned easily designed prospective and retrospective studies to confirm these results. And those results would have been published by now, with the tetanus adult schedule revised to reflect what is now known about the durable immunity of tetanus and diphtheria vaccines. Reducing the boosters to just two shots would save the government vast sums of money.

Not only that, but both the tetanus and diphtheria vaccines carry risks for adults. It is estimated that 50%–85% of patients experience injection site pain or tenderness, 25%–30% experience edema and erythema. Higher preexisting anti-tetanus antibody levels are also associated with a higher reactogenicity rate and greater severity (reference).

Anaphylaxis after tetanus vaccination represents a rare but potentially serious adverse event, with an incidence of 1.6 cases per million doses. That means if 100 million adults receive the booster every ten years, 320 cases of anaphylaxis will be avoided over the 30-year period – from those two boosters being eliminated. Tetanus has always been a “rare” disease, spread through a skin wound contaminated by Clostridium tetani bacteria, commonly found in soil, dust, and manure. Before vaccines were available, there were about 500 cases a year, with most resulting in death. Concerns about vaccine-associated adverse events when immunizations were performed at short intervals led to a revision of the tetanus/diphtheria vaccination schedule in 1966 to once every 10 years for patients >6 years of age.

It has recently come to my attention that the traditional stand-alone tetanus vaccine (TT) that one used to receive as an adult has been discontinued due to WHO recommendations. Their reasoning being:


Use of TTCV combinations with diphtheria toxoid are strongly encouraged and single-antigen vaccines should be discontinued whenever feasible to help maintain both high diphtheria and high tetanus immunity throughout the life course.

WHO Position Paper


The CDC blames the shuttering of the only plant producing TT for the current lack of a stand-alone TT vaccine.

Now, in order to get a booster tetanus shot, an adult must take the following.

  • TdSanofi’s Tenivac protects against tetanus and diphtheria. Given to people 7 years and older as a booster every 10 years. *A version also includes pertussis (eg DPT), but due to the risk of encephalitis, it is not recommended as a booster.

Why is the DPT combination vaccine discouraged in adults due to encephalitis risk, but is it recommended for children? Another one of those inconvenient issues that plague the CDC-recommended childhood vaccine schedule.

From the CDC website

While supplies of diphtheria, tetanus, and pertussis (Tdap) vaccines (Sanofi’s Adacel and GSK’s Boostrix) aren’t limited, they are more expensive, and a very small fraction of patients can develop encephalopathy (brain damage) from the pertussis component.

In the United States, diphtheria is virtually non-existent, with only 14 cases reported between 1996 and 2018. Of those cases reported, most were from international travelers or immigrants.

The market for a stand-alone TT vaccine vanished worldwide due to WHO recommendations to stop the sales of the TT vaccine. Which was due to the relatively few, economically stressed countries where diphtheria is still an issue. So, therefore, the only facility manufacturing the TT vaccine was shut down within the last year.

The blowback from the WHO recommendations is that now there is a shortage of tetanus and diphtheria (Td) vaccine in the United States, according to the Centers for Disease Control and Prevention  (CDC) website.

This all comes down to poor planning. And illustrates why supply chain issues and infectious disease countermeasure stockpiles are essential considerations for governments.

The good news is that unless one is immunosuppressed, most of us have almost lifelong immunity against tetanus and diphtheria.

My recommendation is that unless one gets a very deep and dirty puncture wound and has not had a tetanus shot in over ten years or longer, avoid that booster.


Here is the ugly secret about influenza vaccines. They are given to protect one group of vulnerable people. Those who are immunosuppressed, and that cohort includes the very elderly.

If those influenza vaccine manufacturing plants only make enough vaccines for those susceptible to a severe case of the flu, there would not be enough of a market to sustain their production costs. Furthermore, if there were a pandemic of some sort of highly pathogenic influenza, there would not be sufficient capacity to make enough vaccines to meet demand.

Egg-based influenza vaccine production requires super “clean” eggs; about 100 million “clean” fertilized eggs are needed annually for vaccine production in the US alone. Candidate vaccine viruses are injected into the eggs. If the process is shuttered, the whole production comes to a screeching halt. Many vaccines can be stored for long periods. Even as long as a decade. This stockpiling system works well for DNA viruses with a low mutation rate. Stockpiling is rarely a solution for vaccines developed for RNA viruses that mutate rapidly.

Therefore, the influenza vaccine is pushed on the American people year after year. As a way to maintain “warm base manufacturing” and ensure sufficient market size to support industrial operations.

I have spoken on this subject at the WHO and US government agencies, as well as many, many conferences. Unfortunately, because the mRNA and RNA vaccine platforms require a lot of freezer space (commonly -20°C) to stockpile for even short periods, this limits the ability to stockpile. Furthermore, the frozen storage requirements are only for up to 6 months. That means stockpiling for more extended storage is not currently done, and it is back to square one on the supply chain issue.

The issue with freezer space and mRNA vaccines is one that most likely won’t be solved. This benefits the manufacturers of this vaccine technology – the US government has an endless need for new vaccines as the old ones expire.

My small hope is that the mRNA platform will be too costly to justify its continued use, as appeals concerning safety (or lack of) seem to fall on deaf FDA ears.


In the meantime, don’t believe the hype generated by ex-officials from the Biden and Trump administrations.

Both Dr. Lena Wen, CNN correspondent, and Dr. Redfield, ex-director of the CDC, have gone on to mainstream media shows and promoted the narrative that the case fatality rate for avian influenza is over 50 percent. This, frankly, is a lie that the WHO is promoting. Bird flu generally is not tested for when someone has flu symptoms. When an outbreak of avian flu occurs on a poultry farm, testing of farm workers who are seriously ill will commence. This has led to the generation of the 890 case reports since 2003. Of those seriously ill patients reported to the WHO, over 50 percent died.

This is not an actual case fatality rate of avian flu around the world. It is, again, a sampling error due to a tiny data set derived from those who are at greatest risk due to general health. And just like the WHO reported on an exaggerated case fatality rate for mPOX, which was also based on a sampling error, or for Covid-19, again a sampling error, it is now used to justify psychological bioterrorism on the world population. Please don’t fall for it.

El Gato Malo on X succinctly points out that Dr. Leana Wen and her public health ilk are advancing:

1. Do more of the same lousy testing used in Covid-19 to overstate a disease and cause panic.

2. Develop another non-sterilizing non-vaccine that does not work to be pushed on “the vulnerable.”

3. Doing it “right now” under EUA, so whoever makes these tests and jabs can cash in and be shielded from liability.

4. Claiming that proxies like “triggers antibody production” demonstrate clinical clinical efficacy.

It’s just one last smash-and-grab for cash before the Brandon (Biden) administration ends. Anyone who falls for this one will truly fall for anything.

Question: what are Leana’s conflicts of interest? Who is paying her or giving her grants?


For those that haven’t viewed Dr. Redfield speaking of the avian flu case fatality rate, have a watch below. It is genuinely shocking. This fear-mongering comes from an ex-director of the CDC. Shame on him.

Frankly, it reminds me of the 51 intelligence officials claiming that Hunter Biden’s laptop was fake.

One has to wonder what conflict of interest motivated him to say this on national TV?

Remember in the US, there have been 62 cases of avian influenza discovered, and all but one case were very mild.


This deep dive into the supply chain issues is meant to show that public health has put itself into a groupthink situation that it can’t escape.

Many solutions to this quandary do not involve an evermore expanding schedule of vaccinations, stockpiled for some future use. I have some general thoughts before I sign off.

  • The use of early treatments via safe, proven drugs is a good solution.
  • We now have many antibiotics to treat bacterial infections. Vaccines do not always need to be our first defense.
  • Our medical system is very good at treating infectious diseases. The risks from such diseases are much less than it once was. People do not have to live in fear of infectious disease. I like to ask people, how many people do you know have died of flu? If you know of any (I don’t), how old were they?
  • The need to scare people into more and more vaccines is a dangerous trend.
  • And yes, the more vaccinations one receives, the more likely an adverse event.
  • Vaccinating pregnant women and babies should always be a last resort.
  • It is time for Congress to rethink the vaccine liability laws.

Republished from the author’s Substack

Author

Robert W. Malone

Robert W. Malone is a physician and biochemist. His work focuses on mRNA technology, pharmaceuticals, and drug repurposing research.

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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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