Brownstone Institute
The Trouble with Testing
From the Brownstone Institute
Deborah Birx is at it again, urging mass testing for the detection of bird flu. She wants cows and dairy workers examined to ferret out asymptomatic infections and exposures in animals and people. We have the technology so why not use it, she demands to know. We are making the same mistake we made with Covid early on, she argues.
The role of testing is relatively uncontroversial but it probably should be. Early on in the Covid crisis, though completely against the lockdowns, I was an enthusiast for testing simply because I thought doing so would overcome the epistemic void that was driving public panic.
If you are scared of a disease and have no means to discover whether or not you have it, what is your choice but to hop around in a frenzy and comply with every edict? That was my thinking in any case. We live and learn.
What’s left out of the testing issue is the great question of why. Is it track, trace, and isolate? That has been proven impossible – and long known to be impossible – in the case of a fast-spreading and fast-mutating respiratory virus with a zoonotic reservoir. They tried it anyway with many states quickly hiring tens of thousands of contact tracers.
The iTunes and Google app stores had contact tracing programs you could download. That way if you came close to someone who had tested positive, you would be alerted. It worked like a digital leper’s bell. In fact, even now, the airlines are still doing Covid contact tracing for flying in and out of the country.
Another possible rationale is likely the one in the mind of Birx. She was formed in the AIDS era where the goal was zero infections. Early on, she was a proponent of zero Covid and made that very clear. She is a virus exterminationist: every policy is structured to drive infections, cases, and even exposure to zero, despite the utter impossibility of this goal.
Another possible rationale would be to discern early intervention therapies for people who need them. But realizing that goal is contingent on two other conditions: having therapeutics available and knowing with some sense of confidence that an asymptomatic infection is certainly going to get worse.
Think of the movie Contagion (2011) in this way. It was a killer virus that you get and get worse and then die, all rather quickly. In the movie, the job of the health authorities was always to find the infected and notify everyone with whom they had contact. By the way, this didn’t even work in the film but we are presented with some impressive disease forensics that ended up isolating patient zero.
Again, the question beckons: why are we doing all this? The goals of stopping the spread, driving exposure to zero, and actually treating the sick (if they are sick versus just exposed) are certainly in tension with each other. If you are going to embark on an elaborate and invasive scheme to find and isolate every instance of the pathogen, it’s a good idea to know what precisely you are trying to achieve with the effort. No interviewer has been smart enough to ask this fundamental question of Birx.
And keep in mind that Birx does not want to limit testing to people. She wants cows and chickens tested too, and there’s no particular reason to limit it to that. It could include every member of the animal kingdom, every four-legged creature, and every fish and foul. The expense would be enormous and truly unthinkable, driving the cost of meat production sky-high, especially given the inevitable slaughters that would be mandated.
This is made worse, as we learned last time, by PCR tests that can be set at any cycle rate to discover the mere presence of a virus in just about anything. The last time, this led to unwarranted assumptions of contagiousness, up to 90 percent in 2020, as reported by the New York Times. Because there was and is so much confusion about this piece, let’s quote it directly.
The PCR test amplifies genetic matter from the virus in cycles; the fewer cycles required, the greater the amount of virus, or viral load, in the sample. The greater the viral load, the more likely the patient is to be contagious.
This number of amplification cycles needed to find the virus, called the cycle threshold, is never included in the results sent to doctors and coronavirus patients, although it could tell them how infectious the patients are.
In three sets of testing data that include cycle thresholds, compiled by officials in Massachusetts, New York and Nevada, up to 90 percent of people testing positive carried barely any virus, a review by The Times found.
On Thursday, the United States recorded 45,604 new coronavirus cases, according to a database maintained by The Times. If the rates of contagiousness in Massachusetts and New York were to apply nationwide, then perhaps only 4,500 of those people may actually need to isolate and submit to contact tracing.
While it’s not quite precise to say that the PCR tests generate 90% false positives, it is correct to say that in those tests looked at by the NYT at the height of the pandemic, 90 percent of positive results did not warrant concern at all. They should have been thrown out entirely.
That’s a serious problem for the test, track, trace, and isolate regime that Birx is proposing. Is it any wonder that people today are highly suspicious of this entire idea? Rightly so. Nothing is to be gained by throwing the whole of society into a mysophobic panic when the tests themselves are so poor at discerning the difference between a mild exposure and a medically significant case.
For more on this, see my interview with Jay Bhattacharya, who was onto this problem very early on.
Indeed it was precisely the PCR tests that created this wild confusion between an exposure, an infection, and an actual case. The word case in the past had been reserved for someone actually sick and needing some medical intervention. For reasons never explained, that entire language was blown up, such that OurWorldinData suddenly started listing every documented PCR exposure as a case, creating the feeling of disaster when actually life was functioning entirely normally. The better the authorities got at testing, and the more universal the testing mandates, the sicker the population seemed to be getting.
This all depends on the conflation of exposure, infection, and cases.
Once the disease panic is created, what’s left to do about it remains entirely within the realm of public health authorities. Already last week, the authorities ordered 4 million chickens to be slaughtered. Already more than 90 million birds have been killed since 2022.
As Joe Salatin points out: “The policy of mass extermination without regard to immunity, without even researching why some birds flourish while all around are dying, is insane. The most fundamental principles of animal husbandry and breeding demand that farmers select for healthy immune systems. We farmers have been doing that for millennia. We pick the most robust specimens as genetic material to propagate, whether it’s plants, animals, or microbes.”
This is precisely where this obsession with testing gets us. Whether it is animals or humans, the power of government to compel disease tests and act on the results has led to destructive policies in every instance. You might think we would have learned. Instead, reporters just let Birx ramble on without asking fundamental questions about severity, purpose, viability, or consequences.
There has probably in the history of government never been a more presumptuous aspiration than for bureaucrats to seek to manage the whole of the microbial kingdom. But that is where we are. There’s never been a better time for every citizen of a would-be free nation to proclaim: my biology is none of the government’s business.
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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