Brownstone Institute
WHO Accords Warrant Sovereignty Concern
From the Brownstone Institute
In agreeing to undertake to implement the WHO advisories, states will be creating a new system of pandemic management under the WHO authority and binding under international law. It will create an open-ended international law obligation to cooperate with the WHO and to fund it.
On 11 March, my article criticizing what appeared to be a slow-motion coup d’état by the World Health Organization (WHO) to seize health powers from states in the name of preparing for, conducting early warning surveillance of, and responding to “public health emergencies of international [and regional] concern” was published in the Australian. The coup was in the form of a new pandemic treaty and an extensive package of more than 300 amendments to the existing International Health Regulations (IHR) that was signed in 2005 and came into force in 2007, together referred to as the WHO pandemic accords.
The two sets of changes to the architecture of global health governance, I argued, will effectively change the WHO from a technical advisory organisation offering recommendations into a supranational public health authority telling governments what to do.
On 3 May, the Australian published a reply by Dr. Ashley Bloomfield, co-chair of the WHO working group on the IHR amendments. Bloomfield was New Zealand’s Director-General of Health from 2018–22 and received a knighthood for his services in the 2024 New Year’s Honours list. His engagement with the public debate is very welcome.
Rejecting the charge that the WHO is engaged in a power grab over states, Bloomfield wrote that as a one-time senior UN official, I “would know that no single member state is going to concede sovereignty, let alone the entire 194 members.”
I bow to the good doctor’s superior medical knowledge in comparison to my non-existent medical qualifications.
Unfortunately, I cannot say the same with respect to reforms across the UN system, or sovereignty, or the relationship between “We the peoples” (the first three words of the UN Charter), on the one hand, and UN entities as agents in the service of the peoples, on the other. On medical and not health policy issues, I would quickly find myself out of my depth. I respectfully submit that on sovereignty concerns, Dr. Ashley may be the one out of his depth.
On the first point, I was seconded to the UN Secretariat as the senior adviser to Kofi Annan on UN reforms and wrote his second reform report that covered the entire UN system: Strengthening the United Nations: An Agenda for Further Change (2002). The topic of UN reforms, both the case for it and the institutional and political obstacles frustrating the achievement of the most critical reforms, forms a core chapter of my book The United Nations, Peace and Security (Cambridge University Press, 2006, with a substantially revised second edition published in 2017).
I was also involved in a small Canada-based group that advocated successfully for the elevation of the G20 finance ministers’ group into a leaders’ level group that could serve as an informal grouping for brokering agreements on global challenges, including pandemics, nuclear threats, terrorism, and financial crises. I co-wrote the book The Group of Twenty (G20) (Routledge, 2012) with Andrew F. Cooper, a colleague in that project.
On the second point, I played a central role in the UN’s reconceptualisation of sovereignty as state responsibility and citizens as rights holders. This was unanimously endorsed by world leaders at the UN summit in 2005.
On the third point, in Utopia Lost: The United Nations and World Order (1995), Rosemary Righter (the former chief leader writer at the Times of London) quoted Alexander Solzhenitsyn’s description of the United Nations as “a place where the peoples of the world were delivered up to the designs of governments” (p. 85).
So yes, I do indeed know something about UN system reforms and the importance of sovereignty concerns in relation to powers given to UN bodies to prescribe what states may and may not do.
In agreeing to undertake to implement the WHO advisories, states will be creating a new system of pandemic management under the WHO authority and binding under international law. It will create an open-ended international law obligation to cooperate with the WHO and to fund it. This is the same WHO that has a track record of incompetence, poor decision-making, and politicised conduct. The insistence that sovereignty is not being surrendered is formulaic and legalistic, not substantive and meaningful in practice.
It relies on a familiar technique of gaslighting that permits plausible deniability on both sides. The WHO will say it only issued advisories. States will say they are only implementing WHO recommendations as otherwise, they will become rogue international outlaws. The resulting structure of decision-making effectively confers powers without responsibility on the WHO while shredding accountability of governments to their electorates. The losers are the peoples of the world.
A “Litany of Lies” and Misconceptions? Not So Fast.
Bloomfield’s engagement with the public debate on the WHO-centric architecture of global health governance is very welcome. I have lauded the WHO’s past impressive achievements in earlier writings, for example in the co-written book Global Governance and the UN: An Unfinished Journey (Indiana University Press, 2010). I also agree wholeheartedly that it continues to do a lot of good work, 24/7. In early 2020 I fought with a US editor to reject a reference to the possible virus escape from the Wuhan lab because of WHO’s emphatic statements to the contrary. I later apologised to him for my naivete.
Once betrayed, twice shy of the message: “Trust us. We are from the WHO, here to keep you safe.”
Sir Ashley was merely echoing the WHO chief. Addressing the World Governments Summit in Dubai on 12 February, Director-General (DG) Tedros Adhanom Ghebreyesus attacked “the litany of lies and conspiracy theories” about the agreement that “are utterly, completely, categorically false. The pandemic agreement will not give WHO any power over any state or any individual.”
DG Tedros and Sir Ashley do protest too much. If Australia chooses as a sovereign nation to sign them, that does not mean there is no loss of effective sovereignty (that is, the power to make its health decisions) from that point on.
This is why all 49 Republican senators have “strongly” urged President Joe Biden to reject the proposed changes. The expansion of “WHO’s authority over member states during” pandemic emergencies, they warn, would “constitute intolerable infringements upon US sovereignty.” In addition, 22 Attorneys-General have informed Biden that the WHO writ under the new accords will not run in their states.
On 8 May, the UK said it would not sign the new treaty unless clauses requiring transfer of pandemic products were deleted. Under Article 12.6.b of the then-draft, the WHO could sign “legally binding” contracts with manufacturers to get pandemic-related “diagnostics, therapeutics or vaccines.” Ten percent of this is to be free of charge and another ten percent at profit-free prices. In the latest, 22 April draft, this last requirement comes in Article 12.3.b.i in slightly softer language.
The UK wants to retain the right to use British-made products first to address domestic requirements as judged by the government, and only then to make them available for global distribution. The draft, the government fears, will undermine British sovereignty.
On 14 May, five senators and nine representatives from the Australian parliament wrote a formal letter to PM Anthony Albanese expressing deep concern over the likely prospect of Australia signing the accords that “will transform the WHO from an advisory organisation to a supranational health authority dictating how governments must respond to emergencies which the WHO itself declares.” If adopted and implemented into Australian law, they wrote, these would give the WHO “an unacceptable level of authority, power and influence over Australia’s affairs under the guise of declaring ‘emergencies’.”
“Legally Binding” vs “Loss of Sovereignty” is a Distinction without a Difference
They can’t all be part of a global conspiracy to peddle a litany of lies. The WHO is offering up a highly specious argument. Sir Ashley didn’t really engage with the substance of my arguments either. He dismissed criticism of the proposed changes as “an attempt by the WHO to gain the power to dictate to countries what they must do in the event of a pandemic” as a “misconception.”
The G20 Leaders’ Bali Declaration (November 2022, paragraph 19) supported the goal of a “legally binding instrument that should contain both legally binding and non-legally binding elements to strengthen pandemic planning, preparedness and response (PPR) and amendments to the IHR.” In September 2023, the G20 Delhi Leaders’ Declaration (28:vi) envisioned “an ambitious, legally binding WHO” accord “as well as amendments to better implement” the IHR.
Lawrence Gostin, actively involved in the negotiations, was co-author of a report last December that said containing transnational outbreaks under WHO leadership “may require all states to forgo some level of sovereignty.” A joint Reuters-World Economic Forum article on 26 May 2023 stated: “For the new more wide-reaching pandemic accord, member states have agreed that it should be legally binding.”
The WHO itself describes the IHR as “an instrument of international law that is legally-binding on 196 countries.” Last year it published a document that includes section 4.6 on “legally binding international instruments” such as a new pandemic accord.
I get the argument that sovereign states are voluntarily agreeing to this. In terms of legal technicality, it might well be more accurate, as Libby Klein suggests in her draft letter to Australian MPs, to use words and phrases like “ceding autonomy,” “yielding “effective control over public health decisions,” “outsourcing public health decision-making to the WHO,” or “offshoring our public health decision-making.” This is the legalistic distinction that Bloomfield is effectively making.
However, simply because states must voluntarily sign the new WHO accords doesn’t mean they will not be ceding sovereignty once the accords are adopted. With all due respect to Dr. Tedros and Sir Ashley, this is a distinction without a difference. Every single “legally binding” requirement will mean a transfer of effective decision-making power on health issues to the WHO. That is a curtailment of state sovereignty and it is disingenuous to deny it.
Since the creation of the United Nations in 1945, states have been required to conduct themselves increasingly in conformity with international standards. And it is the UN system that sets most of the relevant international standards and benchmarks of state behaviour.
For example, for centuries countries had the absolute right to wage wars of aggression and defence as an acknowledged and accepted attribute of sovereignty. By adopting the United Nations Charter in 1945, they gave up the right to wage aggressive wars. I am very glad they did so. Just because the surrender of this aspect of sovereignty was voluntary, it doesn’t mean there was no surrender of sovereignty.
Similarly, by signing the Nuclear Non-proliferation Treaty (NPT), Australia and around 185 states surrendered their sovereign right to make or get the nuclear bomb. Again, I am very glad they did so.
Article 10 of the treaty does permit withdrawal after a three-month notice to other states parties and the UN Security Council:
Each Party shall in exercising its national sovereignty have the right to withdraw from the Treatyif it decides that extraordinary events…have jeopardisedthe supreme interests of its country.
Australia could still act as a sovereign state and pull out of the NPT but, absent exculpatory events, only at the reputational cost of acting illegally under international law.
North Korea first announced withdrawal from the NPT in 1993, suspended the withdrawal, withdrew in 2003, has conducted six nuclear tests since 2006, and acquired up to 50 bombs. Yet, the UN has refused to accept the withdrawal and it is still listed on the UN website as an NPT member, with the explanatory note that: “States parties to the Treaty continue to express divergent views regarding the status of the DPRK under the NPT.”
Like these two important examples, states will lose key parts of the right to exercise their sovereignty over national policy settings and decisions on health if the WHO accords are adopted. It is their sovereign right to reject the treaties now. They should exercise it before it is too late. The complications entangling the post-Brexit referendum in the UK demonstrate only too vividly how challenging it can be for a state to extricate itself from a supranational authority despite the sovereign right to do so.
The best way to allay these fears and concerns would be to return responsibility to where accountability lies: with the national government and parliament. States should learn to cooperate better in global pandemic management, not hand effective decision-making powers and authority to unelected and unaccountable international technocrats.
The Effort Should Be Put on Indefinite Hold
It is an iron law of politics that any power that can be abused, will be abused by someone, somewhere, some time in the future. For current examples of overreach by a technocrat, look no further than Australia’s eSafety Commissioner. The truly frightening thing about her example is the realisation of just how much her efforts have been deliberately embedded in a global campaign to “bureaucratise” and control the internet.
A softer conclusion is that powers once granted over citizens to authorities are far more difficult to claw back than not giving them the powers in the first place. Thus far from retreating, the Censorship-Industrial Complex is simultaneously being broadened to embrace additional sectors of governance and public policy and globalised.
A report from Leeds University documented that pandemics are rare events. They are not becoming more frequent. For poor countries, their global disease burden is much lower than that of the big killer diseases like TB, malaria, and HIV/AIDS. For industrialised countries like Australia, the disease burden has been greatly reduced since the Spanish flu with improved surveillance, response mechanism, and other public health interventions.
There is no emergency justifying the rushed process. An immediate pause and a slow and deliberative process would lead to better policy development and deliver better national and global health policy outcomes.
“Pause for thought, argue for a wider delay, think it through properly. And don’t sign till it’s right.” David Frost, who led the UK Brexit negotiations.
Just so.
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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