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Brownstone Institute

WHO IHR Modifications Were Illegally Approved

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18 minute read

From the Brownstone Institute

By ROBERT MALONE   

The 77th meeting of the World Health Assembly concluded Saturday, June 01, 2024. This particular Assembly meeting, the first following the Covid crisis, failed to achieve agreement on the wording or passage of a proposed World Health Organization (WHO) pandemic “treaty,” also referred to as an “agreement.” In parallel to the treaty, the World Health Assembly (in close cooperation with the US HHS/Biden administration) has been working on “updating” the existing (2005) International Health Regulations (IHR) agreement, which historically functioned as a voluntary accord establishing international norms for reporting, managing, and cooperating in matters relating to infectious diseases and infectious disease outbreaks (including “pandemics”).

In blatant disregard for established protocol and procedures, sweeping IHR amendments were prepared behind closed doors, and then both were submitted for consideration and accepted by the World Health Assembly quite literally in the last moments of a meeting that stretched late into Saturday night, the last day of the meeting schedule.

Although the “Article 55” rules and regulations for amending the IHR explicitly require that “the text of any proposed amendment shall be communicated to all States Parties by the Director-General at least four months before the Health Assembly at which it is proposed for consideration,” the requirement of four months for review was disregarded in a rush to produce some tangible deliverable from the Assembly. This hasty and illegal action was taken in direct violation of its own charter, once again demonstrating an arbitrary and capricious disregard of established rules and precedent by the WHO under the leadership of the Director-General.

There was no actual vote to confirm and approve these amendments. According to the WHO, this was achieved by “consensus” among this unelected insider conclave rather than a vote; “Countries agreed by consensus to amend the International Health Regulations, which were last changed in 2005, such as by defining the term “pandemic emergency” and helping developing countries to gain better access to financing and medical products,” a WHO statement reported, continuing that “countries” agreed to complete negotiations on the pandemic accord with the year, “at the latest.”

Representatives from many WHO member nation-states were not in the room, and the ones that were there were encouraged to keep quiet. After the non-vote, there was giddy celebration of this achievement, clearly demonstrating the lack of somber maturity, commitment to both rules and careful diplomatic consensus, and absence of serious intent and purpose warranted by the topic.

This was clearly an insider clique acting unilaterally to circumvent normal process and mirrors a similar process used to confirm the re-appointment of Tedros Ghebreyesus to the Director-General position. This unelected WHO clique of “true believers” clearly signals that it believes itself above any requirements to comply with established international norms and standards, including its own. By their actions you will know them; the giddy arrogance of these actions predicts that WHO decision-making will continue to be arbitrary, capricious, and politicized, and will continue to reflect the will of various insider interest groups (and nation-states) rather than anything even approximating a broad-based international consensus.

Here in the United States, these unilateral actions, backed by an executive branch and bureaucracy that repeatedly demonstrates a deep disdain for the rule of law and the US Constitution, may require that individual States pass legislation to reject the WHO Amendments to IHR based on the illegality of the process and violation of Article 55. Similar discussions are occurring in the UK and across many WHO member states, adding momentum to the emerging WHO-exit movement.

For those not familiar, the current WHO Director-General Tedros Adhanom Ghebreyesus is neither a physician nor a trained public health or epidemiology specialist, but rather is an Ethiopian microbiologist, malaria researcher, and politician.

The hastily approved IHR consolidates virtually unchecked authority and power of the Director-General to declare public health emergencies and pandemics as he/she may choose to define them, and thereby to trigger and guide the allocation of global resources as well as a wide range of public health actions and guidances. These activities include recommendations relating to “persons, baggage, cargo, containers, conveyances, goods and postal parcels,” but based on earlier draft language of proposed IHR amendments and the WHO pandemic “accord” are likely to extend to both invasive national surveillance and mandated public health “interventions” such as vaccines and non-pharmaceutical interventions such as social distancing and lockdowns. Not to mention the continuing weaponization of public health messaging via censorship of dissenting voices and liberal use of the fear-based tactics known as information or psychological bioterrorism to mobilize public opinion in favor of WHO objectives.

The IHR amendments retain troubling language regarding censorship. These provisions have been buried in Annex 1,A.2.c., which requires State Parties to “develop, strengthen and maintain core capacities…in relation to…surveillance…and risk communication, including addressing misinformation and disinformation.”

The requirement that nations “address” “misinformation and disinformation” is fraught with opportunities for abuse. None of these terms is defined in the document. Does “addressing” it mean censoring it, and possibly punishing those who have offered divergent opinions? We have already seen how doctors and scientists who disagreed with the WHO narrative under Covid-19 were censored for their views – views that turned out to be true. Some who offered protocols not recommended by the WHO even had their licenses to practice medicine threatened or suspended. How much worse will this censorship be if it is baked in as a requirement of the International Health Regulations?

The “surveillance” requirement does not specify what is to be surveilled. The IHR amendments, however, should be read together with the proposed Pandemic Treaty, which the WHO is continuing to negotiate. Article 5 of the most recent draft of the Treaty sets forth the “One Health Approach,” which connects and balances human, animal, plant, and environmental health, giving a pretext for surveillance on all these fronts.

Meanwhile, Article 4: Pandemic Prevention and Public Health Surveillance, states:

The Parties recognize that environmental, climatic, social, anthropogenic [climate change caused by people], and economic factors increase the risk of pandemics and endeavor to identify these factors and take them into consideration in the development and implementation of relevant policies…” Through the “One Health” approach, the WHO is asserting its authority over all aspects of life on earth, all of which are apparently to be surveilled.

Regarding the IHR, Article 35 details the requirements of “Health Documents,” including those in digital format. The system of digital health documents is consistent with, and in my opinion a precursor to, the Digital IDs described by the World Economic Forum. According to the attached WEF Chart, people will need a Digital ID to:

  • Access healthcare insurance and treatment
  • Open bank accounts and carry out online transactions
  • Travel
  • Access Humanitarian Services
  • Shop and conduct business transactions
  • Participate in social media
  • Pay taxes, vote, collect government benefits
  • Own a communication device [such as a cell phone or a computer]

In other words, individuals will need Digital IDs to access almost every aspect of civilized society. All of our actions, taken with the use of Digital IDs, will be tracked and traced. If we step out of line, we can be punished by, for example, being severed from our bank accounts and credit cards – similar to what happened to the Canadian Truckers. Digital IDs are a form of mass surveillance and totalitarian control.

These Digital IDs are currently being rolled out by the World Health Organization in collaboration with the European Union. Most of us will agree that this is not the way forward to make the world safer but rather is a path leading towards a techno-totalitarian hellscape.

To support decision-making, the IHR authorizes the Director-General to appoint an “IHR Expert Roster,” an “Expert Committee” selected from the “IHR Expert Roster,” as well as a “Review Committee.” However, although the committees may make recommendations, the Director-General will have final decision authority in all relevant matters.

To further illustrate the point, the revised IHR directs that “The Director-General shall invite Member States, the United Nations and its specialized agencies and other relevant intergovernmental organizations or nongovernmental organizations in official relations with WHO to designate representatives to attend the Committee sessions. Such representatives may submit memoranda and, with the consent of the Chairperson, make statements on the subjects under discussionThey shall not have the right to vote.”

The approved amendments redefine the definition of a “Pandemic Emergency;” include a newly added emphasis on “equity and solidarity;” direct that independent Nations (“States Parties”) shall assist each other to support local production capacity for research, development, and manufacturing of health products; that equitable access to relevant health products for public health emergencies including pandemics shall be facilitated; and that developed nations shall make available “relevant terms of their research and development agreements for relevant health products related to promoting equitable access to such products during a public health emergency of international concern, including a pandemic emergency.”

The amended IHR also directs that each nation (“States Parties”) shall “develop, strengthen and maintain core capacities” for “preventing, preparing for and responding to public health risks and events,” including in relation to:

  • Surveillance
  • On-site Investigations
  • Laboratory diagnostics, including referral of samples
  • Implementation of control measures
  • Access to health services and health products needed for the response
  • Risk communication, including addressing misinformation and disinformation
  • Logistical assistance

The amended IHR also includes copious new language, terms, and conditions relating to the responsibilities of “States Parties” to perform surveillance and transparent timely reporting of information relating to infectious disease outbreaks. This includes multiple references to information gathering, sharing, and distribution, including the need to counter the distribution of “misinformation and disinformation”.

There is the appearance that some of this new text may be informed by the recent failure of China (PRC/CCP) to provide timely and complete reporting of events and information relating to the initial SARS-CoV-2 outbreak. Unfortunately, this failure to inform in a timely manner was not unique. There is a long history of repeated, chronic problems with transparent national reporting of infectious disease outbreaks. A variety of adverse economic and political impacts are associated with infectious disease outbreaks, and this creates a strong incentive for both local politicians and public health officials to minimize initial reporting of unusual infectious disease signals or findings.

The amended IHR frequently refers to “scientific principles as well as the available scientific evidence and other relevant information” as a key factor in guiding decision-making. However, the IHR does not acknowledge the diversity of opinion surrounding what are considered sound and valid “scientific principles” or “scientific evidence,” and there is no indication that the World Health Assembly or the WHO recognizes how readily “scientific principles” and “scientific evidence” were manipulated or otherwise biased during prior public health crises, and the likelihood that this will continue to happen on a regular basis unless reforms designed to respect diversity of opinion and interpretation are implemented. There seems to be a complete lack of self-awareness of the rampant groupthink that chronically characterizes WHO decision-making during both the Covid crisis as well as prior public health events of concern.

Although many of these revisions are generally reasonable and aligned with good and practical international public health norms and actions, and in some cases are greatly improved relative to prior draft language, the recent history of WHO mismanagement and actual WHO spreading and amplification of mis- and disinformation regarding SARS-CoV-2 virology, immunology, and pathophysiology, pharmaceutical and non-pharmaceutical interventions for SARS-CoV-2 raise legitimate concerns about how these words will be interpreted and implemented.

Furthermore, the pattern of repeated arbitrary, capricious, and scientifically unjustifiable decisions regarding Covid and monkeypox suggests that expanding the authority of either the Director-General or the WHO is unwise at this time. Rather, more mature, thoughtful, and prudent evaluation of that recent experience argues for reduced rather than expanded authority, and for a more decentralized, multilateral model for the management of global and regional public health risks and events. The world does not need more condescending authoritarianism from those entrusted to facilitate international cooperation in public health.

Just speaking in terms of best practices, it is clearly inappropriate to rely on administrators with such a vested personal interest in the outcome to be so intimately involved in crafting sweeping international policy changes. This revision process should have been managed by an independent commission of seasoned, objective experts who were carefully vetted to minimize potential conflict of interest.

The hasty willingness to bypass its own charter by unilaterally and arbitrarily jamming these changes through on extremely short notice raises further concerns regarding the reliability, maturity, and competency of the WHO, the World Health Assembly, and the Director-General to provide the calm, steady hand so sorely needed after the mismanaged major public health catastrophe and global trauma which all have experienced over the last four years.

The world, its inhabitants, those who work to provide medical care, and the overall world health enterprise deserve better.

Author

Robert W. Malone is a physician and biochemist. His work focuses on mRNA technology, pharmaceuticals, and drug repurposing research. You can find him at Substack and Gettr

Brownstone Institute

The Unmasking of Vaccine Science

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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

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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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