Brownstone Institute
The WHO and Phony International Law
From the Brownstone Institute
A new pandemic treaty is in the works. Countries are negotiating its terms, along with amendments to international health regulations. If ready in time, the World Health Assembly will approve them in May. The deal may give the WHO power to declare global health emergencies. Countries will promise to follow WHO directives. Lockdowns, vaccine mandates, travel restrictions, and more will be in the works. Critics say that the agreements will override national sovereignty because their provisions will be binding. But international law is the art of the Big Pretend.
You drive down Main Street. Cars are parked everywhere. The signs say “No Parking” but they also say, “The City does not enforce parking restrictions.” In effect there’s no rule against parking. Laws are commands imposed with the force of the state. Rules without sanctions are mere suggestions. Some people may honor the request, but others won’t. Those who disagree with the rule can safely ignore it. In domestic law, “enforceable” and “binding” are synonyms.
But not in international law, where promises are called “binding” even if they are unenforceable. In the international sphere, countries are the highest authority. Nothing stands above them with the power to enforce their promises. No such courts exist. The International Court of Justice depends on the consent of the countries involved. No international police enforce its orders. The UN is a sprawling bureaucracy, but in the end, it is merely a place for countries to gather. The WHO is a branch of the UN whose mandate countries negotiate amongst themselves.
In the proposed pandemic treaty, parties are to settle disputes through negotiation. They may agree to be subject to the International Court of Justice or to arbitration. But they cannot be required to.
Yet international law jurists insist that unenforceable treaty promises can be binding. “The binding character of a norm does not depend on whether there is any court or tribunal with jurisdiction to apply it,” Daniel Bodansky, a professor of international law at Arizona State University, wrote in a 2016 analysis of the Paris climate agreement. “Enforcement is not a necessary condition for an instrument or norm to be legally binding.” Without this Big Pretend, international law would collapse like a house of cards on a windy beach.
All countries are sovereign. They are free to retaliate against each other for perceived wrongs, including breaches of treaty promises. They can seek to have other countries censured or expelled from the international regime. They can impose trade sanctions. They can expel ambassadors. But retaliation is not “enforcement.” Moreover, international relations are a delicate business. Aggrieved countries are more likely to express their disappointment in carefully crafted diplomatic language than to burn bridges.
The threat from WHO proposals come not from outside but from within. We live in a managerial age, run by a technocratic elite. Over time, they have acquired for themselves the discretion to direct society for the common good, as they declare it to be.
As journalist David Samuels puts it, “Americans now find themselves living in an oligarchy administered day-to-day by institutional bureaucracies that move in lock-step with each other, enforcing a set of ideologically-driven top-down imperatives that seemingly change from week-to-week and cover nearly every subject under the sun.” These bureaucracies regulate, license, expropriate, subsidize, track, censor, prescribe, plan, incentivize, and inspect. Pandemics and public health are the most recent justifications for yet more control.
Domestic governments, not international bodies, will impose WHO recommendations on their citizens. They will pass laws and policies that incorporate those directives. Even an exasperated WHO Director-General Tedros Adhanom Ghebreyesus said so in a briefing this week. “There are those who claim that the pandemic agreement and [amended regulations] will cede sovereignty…and give the WHO Secretariat the power to impose lockdowns or vaccine mandates on countries…These claims are completely false…the agreement is negotiated by countries for countries and will be implemented in countries in accordance with your own national laws.”
Ghebreyesus is correct. Local and national authorities will not give up their powers. To what extent international commitments will be “binding” on a country depends not on international law but on that country’s own domestic laws and courts. Article VI of the US Constitution, for example, provides that the Constitution, federal laws, and treaties together “shall be the supreme Law of the Land.” That does not mean that treaties supersede the Constitution or federal laws. Domestic legislation and policy will be required for the proposed pandemic treaty and WHO directives to be enforced on American soil. Such legislation is an exercise of sovereignty, not a repudiation of it.
The proposals are not benign. Domestic authorities seek cover for their own autocratic measures. Their promises will be called “binding” even though they are not. Local officials will justify restrictions by citing international obligations. Binding WHO recommendations leave them no choice, they will say. The WHO will coordinate their imperatives as the face of global public health.
The WHO is not taking over. Instead, it will be the handmaiden for a coordinated global biomedical state. Managers hate straight lines. Diffuse, discretionary powers avoid accountability and the rule of law. The global health regime will be a tangled web. It is meant to be.
Author
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
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.
Author
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