Brownstone Institute
WHO IHR Modifications Were Illegally Approved
From the Brownstone Institute
By
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 discussion. They 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.
Brownstone Institute
Bizarre Decisions about Nicotine Pouches Lead to the Wrong Products on Shelves
From the Brownstone Institute
A walk through a dozen convenience stores in Montgomery County, Pennsylvania, says a lot about how US nicotine policy actually works. Only about one in eight nicotine-pouch products for sale is legal. The rest are unauthorized—but they’re not all the same. Some are brightly branded, with uncertain ingredients, not approved by any Western regulator, and clearly aimed at impulse buyers. Others—like Sweden’s NOAT—are the opposite: muted, well-made, adult-oriented, and already approved for sale in Europe.
Yet in the United States, NOAT has been told to stop selling. In September 2025, the Food and Drug Administration (FDA) issued the company a warning letter for offering nicotine pouches without marketing authorization. That might make sense if the products were dangerous, but they appear to be among the safest on the market: mild flavors, low nicotine levels, and recyclable paper packaging. In Europe, regulators consider them acceptable. In America, they’re banned. The decision looks, at best, strange—and possibly arbitrary.
What the Market Shows
My October 2025 audit was straightforward. I visited twelve stores and recorded every distinct pouch product visible for sale at the counter. If the item matched one of the twenty ZYN products that the FDA authorized in January, it was counted as legal. Everything else was counted as illegal.
Two of the stores told me they had recently received FDA letters and had already removed most illegal stock. The other ten stores were still dominated by unauthorized products—more than 93 percent of what was on display. Across all twelve locations, about 12 percent of products were legal ZYN, and about 88 percent were not.
The illegal share wasn’t uniform. Many of the unauthorized products were clearly high-nicotine imports with flashy names like Loop, Velo, and Zimo. These products may be fine, but some are probably high in contaminants, and a few often with very high nicotine levels. Others were subdued, plainly meant for adult users. NOAT was a good example of that second group: simple packaging, oat-based filler, restrained flavoring, and branding that makes no effort to look “cool.” It’s the kind of product any regulator serious about harm reduction would welcome.
Enforcement Works
To the FDA’s credit, enforcement does make a difference. The two stores that received official letters quickly pulled their illegal stock. That mirrors the agency’s broader efforts this year: new import alerts to detain unauthorized tobacco products at the border (see also Import Alert 98-06), and hundreds of warning letters to retailers, importers, and distributors.
But effective enforcement can’t solve a supply problem. The list of legal nicotine-pouch products is still extremely short—only a narrow range of ZYN items. Adults who want more variety, or stores that want to meet that demand, inevitably turn to gray-market suppliers. The more limited the legal catalog, the more the illegal market thrives.
Why the NOAT Decision Appears Bizarre
The FDA’s own actions make the situation hard to explain. In January 2025, it authorized twenty ZYN products after finding that they contained far fewer harmful chemicals than cigarettes and could help adult smokers switch. That was progress. But nine months later, the FDA has approved nothing else—while sending a warning letter to NOAT, arguably the least youth-oriented pouch line in the world.
The outcome is bad for legal sellers and public health. ZYN is legal; a handful of clearly risky, high-nicotine imports continue to circulate; and a mild, adult-market brand that meets European safety and labeling rules is banned. Officially, NOAT’s problem is procedural—it lacks a marketing order. But in practical terms, the FDA is punishing the very design choices it claims to value: simplicity, low appeal to minors, and clean ingredients.
This approach also ignores the differences in actual risk. Studies consistently show that nicotine pouches have far fewer toxins than cigarettes and far less variability than many vapes. The biggest pouch concerns are uneven nicotine levels and occasional traces of tobacco-specific nitrosamines, depending on manufacturing quality. The serious contamination issues—heavy metals and inconsistent dosage—belong mostly to disposable vapes, particularly the flood of unregulated imports from China. Treating all “unauthorized” products as equally bad blurs those distinctions and undermines proportional enforcement.
A Better Balance: Enforce Upstream, Widen the Legal Path
My small Montgomery County survey suggests a simple formula for improvement.
First, keep enforcement targeted and focused on suppliers, not just clerks. Warning letters clearly change behavior at the store level, but the biggest impact will come from auditing distributors and importers, and stopping bad shipments before they reach retail shelves.
Second, make compliance easy. A single-page list of authorized nicotine-pouch products—currently the twenty approved ZYN items—should be posted in every store and attached to distributor invoices. Point-of-sale systems can block barcodes for anything not on the list, and retailers could affirm, once a year, that they stock only approved items.
Third, widen the legal lane. The FDA launched a pilot program in September 2025 to speed review of new pouch applications. That program should spell out exactly what evidence is needed—chemical data, toxicology, nicotine release rates, and behavioral studies—and make timely decisions. If products like NOAT meet those standards, they should be authorized quickly. Legal competition among adult-oriented brands will crowd out the sketchy imports far faster than enforcement alone.
The Bottom Line
Enforcement matters, and the data show it works—where it happens. But the legal market is too narrow to protect consumers or encourage innovation. The current regime leaves a few ZYN products as lonely legal islands in a sea of gray-market pouches that range from sensible to reckless.
The FDA’s treatment of NOAT stands out as a case study in inconsistency: a quiet, adult-focused brand approved in Europe yet effectively banned in the US, while flashier and riskier options continue to slip through. That’s not a public-health victory; it’s a missed opportunity.
If the goal is to help adult smokers move to lower-risk products while keeping youth use low, the path forward is clear: enforce smartly, make compliance easy, and give good products a fair shot. Right now, we’re doing the first part well—but failing at the second and third. It’s time to fix that.
Addictions
The War on Commonsense Nicotine Regulation
From the Brownstone Institute
Cigarettes kill nearly half a million Americans each year. Everyone knows it, including the Food and Drug Administration. Yet while the most lethal nicotine product remains on sale in every gas station, the FDA continues to block or delay far safer alternatives.
Nicotine pouches—small, smokeless packets tucked under the lip—deliver nicotine without burning tobacco. They eliminate the tar, carbon monoxide, and carcinogens that make cigarettes so deadly. The logic of harm reduction couldn’t be clearer: if smokers can get nicotine without smoke, millions of lives could be saved.
Sweden has already proven the point. Through widespread use of snus and nicotine pouches, the country has cut daily smoking to about 5 percent, the lowest rate in Europe. Lung-cancer deaths are less than half the continental average. This “Swedish Experience” shows that when adults are given safer options, they switch voluntarily—no prohibition required.
In the United States, however, the FDA’s tobacco division has turned this logic on its head. Since Congress gave it sweeping authority in 2009, the agency has demanded that every new product undergo a Premarket Tobacco Product Application, or PMTA, proving it is “appropriate for the protection of public health.” That sounds reasonable until you see how the process works.
Manufacturers must spend millions on speculative modeling about how their products might affect every segment of society—smokers, nonsmokers, youth, and future generations—before they can even reach the market. Unsurprisingly, almost all PMTAs have been denied or shelved. Reduced-risk products sit in limbo while Marlboros and Newports remain untouched.
Only this January did the agency relent slightly, authorizing 20 ZYN nicotine-pouch products made by Swedish Match, now owned by Philip Morris. The FDA admitted the obvious: “The data show that these specific products are appropriate for the protection of public health.” The toxic-chemical levels were far lower than in cigarettes, and adult smokers were more likely to switch than teens were to start.
The decision should have been a turning point. Instead, it exposed the double standard. Other pouch makers—especially smaller firms from Sweden and the US, such as NOAT—remain locked out of the legal market even when their products meet the same technical standards.
The FDA’s inaction has created a black market dominated by unregulated imports, many from China. According to my own research, roughly 85 percent of pouches now sold in convenience stores are technically illegal.
The agency claims that this heavy-handed approach protects kids. But youth pouch use in the US remains very low—about 1.5 percent of high-school students according to the latest National Youth Tobacco Survey—while nearly 30 million American adults still smoke. Denying safer products to millions of addicted adults because a tiny fraction of teens might experiment is the opposite of public-health logic.
There’s a better path. The FDA should base its decisions on science, not fear. If a product dramatically reduces exposure to harmful chemicals, meets strict packaging and marketing standards, and enforces Tobacco 21 age verification, it should be allowed on the market. Population-level effects can be monitored afterward through real-world data on switching and youth use. That’s how drug and vaccine regulation already works.
Sweden’s evidence shows the results of a pragmatic approach: a near-smoke-free society achieved through consumer choice, not coercion. The FDA’s own approval of ZYN proves that such products can meet its legal standard for protecting public health. The next step is consistency—apply the same rules to everyone.
Combustion, not nicotine, is the killer. Until the FDA acts on that simple truth, it will keep protecting the cigarette industry it was supposed to regulate.
-
espionage1 day agoChinese-Owned Trailer Park Beside U.S. Stealth Bomber Base Linked to Alleged Vancouver Repression Case
-
Digital ID2 days agoCanada moves forward with digital identification for federal benefits seekers
-
Alberta2 days agoSchool defunding petition in Alberta is a warning to parents
-
Business2 days agoLiberals refuse to disclose the amount of taxpayer dollars headed to LGBT projects in foreign countries
-
Daily Caller1 day agoLaura Ingraham Presses Trump On Allowing Flood Of Chinese Students Into US
-
Crime23 hours agoCBSA Bust Uncovers Mexican Cartel Network in Montreal High-Rise, Moving Hundreds Across Canada-U.S. Border
-
Daily Caller1 day agoUS Nuclear Bomber Fleet Shares Fence With Trailer Park Linked To Chinese Intel-Tied Fraudster
-
Environment23 hours agoThe Myths We’re Told About Climate Change | Michael Shellenberger




