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Brownstone Institute

What’s Really Happening with Mpox

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12 minute read

From the Brownstone Institute

By David BellDavid Bell

The Mpox Emergency

The World Health Organization (WHO) acted as expected this week and declared Mpox a Public Health Emergency of International Concern (PHEIC). So, a problem in a small number of African countries that has killed about the same number of people this year as die every four hours from tuberculosis has come to dominate international headlines. This is raising a lot of angst from some circles against the WHO.

While angst is warranted, it is mostly misdirected. The WHO and the IHR emergency committee they convened had little real power – they are simply following a script written by their sponsors. The African CDC, which declared an emergency a day earlier, is in a similar position. Mpox is a real disease and needs local and proportionate solutions. But the problem it is highlighting is much bigger than Mpox or the WHO, and understanding this is essential if we are to fix it.

Mpox, previously called Monkeypox, is caused by a virus thought to normally infect African rodents such as rats and squirrels. It fairly frequently passes to, and between, humans. In humans, its effects range from very mild illness to fever and muscle pains to severe illness with its characteristic skin rash, and sometimes death. Different variants, called ‘clades,’ produce slightly different symptoms. It is passed by close body contact including sexual activity, and the WHO declared a PHEIC two years ago for a clade that was mostly passed by men having sex with men.

The current outbreaks involve sexual transmission but also other close contact such as within households, expanding its potential for harm. Children are affected and suffer the most severe outcomes, perhaps due to issues of lower prior immunity and the effects of malnutrition and other illnesses.

Reality in DRC

The current PHEIC was mainly precipitated by the ongoing outbreak in the Democratic Republic of Congo (DRC), though there are known outbreaks in nearby countries covering a number of clades. About 500 people have died from Mpox in DRC this year, over 80% of them under 15 years of age. In that same period, about 40,000 people in DRC, mostly children under 5 years, died from malaria. The malaria deaths were mainly due to lack of access to very basic commodities like diagnostic tests, antimalarial drugs, and insecticidal bed nets, as malaria control is chronically underfunded globally. Malaria is nearly always preventable or treatable if sufficiently resourced.

During this same period in which 500 people died from Mpox in DRC, hundreds of thousands also died in DRC and surrounding African countries from tuberculosis, HIV/AIDS, and the impacts of malnutrition and unsafe water. Tuberculosis alone kills about 1.3 million people globally each year, which is a rate about 1,500 times higher than Mpox in 2024.

The population of DRC is also facing increasing instability characterized by mass rape and massacres, in part due to a scramble by warlords to service the appetite of richer countries for the components of batteries. These in turn are needed to support the Green Agenda of Europe and North America. This is the context in which the people of DRC and nearby populations, which obviously should be the primary decision-makers regarding the Mpox outbreak, currently live.

An Industry Produces What It Is Paid for

For the WHO and the international public health industry, Mpox presents a very different picture. They now work for a pandemic industrial complex, built by private and political interests on the ashes of international public health. Forty years ago, Mpox would have been viewed in context, proportional to the diseases that are shortening overall life expectancy and the poverty and civil disorder that allows them to continue. The media would barely have mentioned the disease, as they were basing much of their coverage on impact and attempting to offer independent analysis.

Now the public health industry is dependent on emergencies. They have spent the past 20 years building agencies such as CEPI, inaugurated at the 2017 World Economic Forum meeting and solely focused on developing vaccines for pandemic, and on expanding capacity to detect and distinguish ever more viruses and variants. This is supported by the recently passed amendments to the International Health Regulations (IHR).

While improving nutrition, sanitation, and living conditions provided the path to longer lifespans in Western countries, such measures sit poorly with a colonial approach to world affairs in which the wealth and dominance of some countries are seen as being dependent on the continued poverty of others. This requires a paradigm in which decision-making is in the hands of distant bureaucratic and corporate masters. Public health has an unfortunate history of supporting this, with restriction of local decision-making and the pushing of commodities as key interventions.

Thus, we now have thousands of public health functionaries, from the WHO to research institutes to non-government organizations, commercial companies, and private foundations, primarily dedicated to finding targets for Pharma, purloining public funding, and then developing and selling the cure. The entire newly minted pandemic agenda, demonstrated successfully through the Covid-19 response, is based on this approach. Justification for the salaries involved requires detection of outbreaks, an exaggeration of their likely impact, and the institution of a commodity-heavy and usually vaccine-based response.

The sponsors of this entire process – countries with large Pharma industries, Pharma investors, and Pharma companies themselves – have established power through media and political sponsorship to ensure the approach works. Evidence of the intent of the model and the harms it is wreaking can be effectively hidden from public view by a subservient media and publishing industry. But in DRC, people who have long suffered the exploitation of war and the mineral extractors, who replaced a particularly brutal colonial regime, must now also deal with the wealth extractors of Pharma.

Dealing with the Cause

While Mpox is concentrated in Africa, the effects of corrupted public health are global. Bird flu will likely follow the same course as Mpox in the near future. The army of researchers paid to find more outbreaks will do so. While the risk from pandemics is not significantly different than decades ago, there is an industry dependent on making you think otherwise.

As the Covid-19 playbook showed, this is about money and power on a scale only matched by similar fascist regimes of the past. Current efforts across Western countries to denigrate the concept of free speech, to criminalize dissent, and to institute health passports to control movement are not new and are in no way disconnected from the inevitability of the WHO declaring the Mpox PHEIC. We are not in the world we knew twenty years ago.

Poverty and the external forces that benefit from war, and the diseases these enable, will continue to hammer the people of DRC. If a mass vaccination campaign is instituted, which is highly likely, financial and human resources will be diverted from far greater threats. This is why decision-making must now be centralized far from the communities affected. Local priorities will never match those that expansion of the pandemic industry depends on.

In the West, we must move on from blaming the WHO and address the reality unfolding around us. Censorship is being promoted by journalists, courts are serving political agendas, and the very concept of nationhood, on which democracy depends, is being demonized. A fascist agenda is openly promoted by corporate clubs such as the World Economic Forum and echoed by the international institutions set up after the Second World War specifically to oppose it. If we cannot see this and if we do not refuse to participate, then we will have only ourselves to blame. We are voting for these governments and accepting obvious fraud, and we can choose not to do so.

For the people of DRC, children will continue to tragically die from Mpox, from malaria, and from all the diseases that ensure return on investment for distant companies making pharmaceuticals and batteries. They can ignore the pleading of the servants of the White Men of Davos who will wish to inject them, but they cannot ignore their poverty or the disinterest in their opinions. As with Covid-19, they will now become poorer because Google, the Guardian, and the WHO were bought a long time back, and now serve others.

The one real hope is that we ignore lies and empty pronouncements, refusing to bow to unfounded fear. In public health and in society, censorship protects falsehoods and dictates reflect greed for power. Once we refuse to accept either, we can begin to address the problems at the WHO and the inequity it is promoting. Until that time, we will live in this increasingly vicious circus.

Author

  • David Bell

    David Bell, Senior Scholar at Brownstone Institute, is a public health physician and biotech consultant in global health. He is a former medical officer and scientist at the World Health Organization (WHO), Programme Head for malaria and febrile diseases at the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland, and Director of Global Health Technologies at Intellectual Ventures Global Good Fund in Bellevue, WA, USA.

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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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Addictions

The War on Commonsense Nicotine Regulation

Published on

From the Brownstone Institute

Roger Bate  Roger Bate 

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

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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