Brownstone Institute
Moderna and Pfizer: Cat Fight!
The legend is that patents are a just reward for new inventions. The reality is that they are government grants of monopoly privilege for industrial interests. What began as a royal privilege left over from feudal times mutated into a right of anyone to deploy the power of the state to block competitors and thus exercise monopoly pricing power based on a statutorily determined amount of time.
For centuries, patents have been debated as to their social and economic merit. That they inhibit competition is beyond dispute. Not even those who reverse engineer a product have the right to produce and sell the results. The only question is whether such interventions are truly necessary to incentivize innovation.
In the case of pharmaceuticals, the justification is a bit different. It has surrounded the supposed need to cover the high costs of research and regulatory compliance. Industries need compensation lest their entire industry becomes unprofitable and we all suffer a lack of medical advances.
None of this pertains in the case of the Covid shots. Moderna received fast-track regulatory approval and $10 billion in tax subsidies for its mRNA innovation. Even then, it claimed the right to demand exclusive rights to its formulas. During the pandemic – during which time the company also enlisted governments and private business into forcing consumers to accept its product – it agreed to forego its claims.
Now that the pandemic is over, and the demand for the shots has plummeted worldwide and vaccine mandates scrapped, Moderns is suing Pfizer for stealing its intellectual property. The court fight could last years, at the end of which they will likely settle and redistribute their loot.
On top of that, both are publicly-traded corporations that made enormous profits off the pandemic, while the jury is still out on whether and to what extent their product proved to be a net benefit in terms of reducing disease severity. It certainly did not stop infection or spread.
To top it off, both companies are granted complete legal indemnification from damages from the shot, according to 42 U.S. Code § 300aa–22. “No vaccine manufacturer,” says the law, “shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”
This is another level of privilege they enjoy, justified on grounds that no vaccine manufacturing company could possibly deal with the cost of vast litigation plus bear the expenses of research and development.
It is simply not possible that any industry could be granted more privileges in the law. Most of them are rather new in a legal sense. Boldrin and Levine have demonstrated that the claims to support this kind of privilege are false in theory, false in history, and false in the current moment.
Without the privilege of the patent, and without vast subsidies, and without indemnification against damages claims, there would have been every incentive just from sales of product to bring an effective product to market if such a thing could exist. Government decided with Operation Warp Speed that such a thing as a Covid vaccine absolutely must exist. It was seen as the only exit strategy. This demand ended up creating enormous distortions around price and effectiveness.
Some people predicted this eventual mess from the beginning. At the very least, the formula for the innovation should have been shared widely so that if the vaccine really did function properly it could be manufactured and distributed in a cost-effective and voluntary way. Those who wanted the shot could have it and the rest of us would have moved on with our lives while trusting the immune system that hundreds of years of science has come to understand and fully appreciate.
And now, after such vast chaos in labor markets from vaccine mandates, after a year and a half of false promises, after near silence on the problem of vaccine injury, and after the corruption of Big Tech, after the legal privileging of mRNA over other technologies, the top two industry leaders are fighting like scorpions in a bottle to retain their industrial privileges granted by the patent office. It’s a heck of a way for this story to end.
To top it off, the actual patent holder for mRNA has opposed these vaccines all along. His name is Robert Malone and he just wrote the following:
Based on my experience, all three of these patents can be readily invalidated due to the failure to cite relevant prior art. To repeat, I have no financial interests here. But the work that I did and the relevant patents that I am a co-author on (which Moderna conspicuously fails to cite) are now in the public domain. They belong to everyone, not to Moderna, or to CureVac, or to BioNTech. And this may explain part of why there has been such an effort to write me out of history. Not only because some seek the Nobel Prize, but also because the intellectual property patent positions of some very profitable companies may become at risk if those contributions are acknowledged.
Not only is Big Pharma being exposed. But also the patent regime. And government itself.
There is absolutely no theory of political economy in existence that could possibly justify this combination of 1) private company with vast tax funding, 2) government-enforced monopoly claims of ownership, 3) indemnification against damage claims, 4) publicly-traded stocks, plus and 5) a forced customer base. And to top it all off, it’s not even clear that the product worked; it certainly did not live up to the wild claims from top government officials.
In any system of government and industry, this combination would cry out for dramatic change. If there is no change, it can only be due to the power of the industry itself. Somehow for them, it is never enough.
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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