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Brownstone Institute

The Djokovic Outrage

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17 minute read

BY MARK DA CUNHA

Tennis champion Novak Djokovic, who played in the 2021 US Open final, will not play in the 2022 U.S. Open, because of a Biden administration rule that bans unvaccinated non-resident foreigners from entering the U.S. Unvaccinated citizens and foreign permanent residents, who are covid-19 positive, are allowed to enter.

CDC now says the unvaccinated should be treated like the vaccinated

The Biden administration’s excuse is that they are just religiously “following the science.” But, that excuse is no longer available as earlier this month the US Center for Disease Control (CDC) altered its covid-19 guidance saying that the unvaccinated should be treated as the vaccinated:

“CDC’s COVID-19 prevention recommendations no longer differentiate based on a person’s vaccination status because breakthrough infections occur, though they are generally mild, and persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection.”

Despite this reversal from the CDC, the Biden administration still bans unvaccinated non-resident foreigners, like Novak Djokovic, who test negative for covid-19. Welcome to the anti-science, anti-freedom world of Novak Djokovic Vax Mandate Land.

Even more hypocritical is the Biden administration’s present immigration policy that makes exemptions for foreigners who enter illegally south of the U.S. border. Where does “the science,” say that someone unvaccinated who enters illegally is not a health threat, and a foreigner who attempts to enter legally is? That the Biden administration allows unvaccinated, possibly covid-19 positive (untested) foreigners to enter the country illegally via the Southern border with Mexico, but bans an unvaccinated foreigner that tests negative for covid-19, from entering the country legally is unjust in principle and makes a mockery of the rule of law.

Why doesn’t Novak just get vaccinated?

Before he implemented his diet and lifestyle changes, Djokovic’s body tended to break down in long matches as I saw in his 2005 US Open match. I first saw Djokovic play in the 2005 US Open in the first round against French tennis superstar Gael Monfils, where his body broke down in the 4th set which he lost 0-6. After a medical timeout, he did come back to win in the 5th. His early history of breaking down led former US Open champ, Andy Roddick, to quip about Djokovic: “back and hip injury, cramps, bird flu, common cold, and SARS as well.” Today, Djokovic is recognized as the “iron man of tennis,” thanks to his meticulous attention to how he treats his body.

For people who are young and healthy, and do not have compromised immune systems, covid-19 presents a relatively lower threat to their health. This point is made in the Great Barrington Declaration in 2020:

“We know that vulnerability to death from COVID-19 is more than a thousand-fold higher in the old and infirm than the young. Indeed, for children, COVID-19 is less dangerous than many other harms, including influenza. As immunity builds in the population, the risk of infection to all – including the vulnerable – falls. We know that all populations will eventually reach herd immunity – i.e. the point at which the rate of new infections is stable – and that this can be assisted by (but is not dependent upon) a vaccine. Our goal should therefore be to minimize mortality and social harm until we reach herd immunity….The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk. We call this Focused Protection.”

Covid-19 vaccinations are not the panacea that those who religiously mandate universal vaccinations make them out to be, and are also not without their dangers. In some groups, particularly young athletes they have been correlated with heart issues. Though it is a rare phenomenon, it is one that must be considered.

Given that Djokovic has already recovered from a previous covid-19 natural infection, he has natural immunity which, according to a pivotal Israeli study in 2021, is as good as and even superior to artificial immunity:

“This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 [Pfizer-BioNTech] two-dose vaccine-induced immunity.”

Hundreds of other studies have confirmed similar results of protection from natural immunity over-vaccination alone. So, neither does Djokovic’s status as unvaccinated pose a threat to himself.

Vaccination, like any medical treatment, is a personal decision, to be made by the individual. Given that Djokovic has natural immunity from a previous infection (which is superior in terms of protection to double vaccination), covid-19 is far less dangerous to a younger, healthy athlete (covid-19 primarily affects the elderly with a “more than a thousand-fold difference in covid-19 mortality between older and younger people”), and some athletes have had health issues after injecting the relatively new vaccine, it makes sense that Djokovic chose not to get vaccinated despite what the chattering classes and armchair doctors opine. (As a sidenote Gael Monfils was temporarily sidelined for most of 2022, in part, after significant health issues that appeared after he received his third booster shot.)

If one gains natural immunity from prior infection and thus is “naturally vaccinated” why does the U.S. government not treat such “natural vaccination” the same as “artificial vaccination?” The answer is revealed by Dr. Paul Offit – a member, along with Dr. Anthony Fauci, of the FDA panel that advises the Biden administration on dealing with covid-19 – when he explains how the FDA panel came about the decision to not recognize natural immunity: it was not a scientific decision, but a bureaucratic one.

American Tennis players speak up for Djokovic, as the US Tennis Association (USTA) remains silent

Many American tennis athletes have spoken up for Djokovic including 7-time grand slam champion John McEnroe who voiced his support:

“US Government and USTA must work together to allow him to play. If unvaccinated American players can play, Djokovic as one of the legends of the game must be allowed to play. MAKE IT HAPPEN, USTA!”

Other American players supporting Djokovic, include American number one Taylor Fritz (“So it does seem like, you know, what’s the harm of letting the best player in the world come play the US Open?”), John Isner (the ban is “complete lunacy”), and unvaccinated American tennis player Tennys Sangren (who will be playing in this year’s US Open, unvaccinated), as have American politicians (all Republican).

The world’s number one tennis player, and the reigning men’s US Open champion, Daniel Medvedev has also spoken out saying that Novak should be allowed to play.

USTA should have asked for a “national interest” exemption for Djokovic

The “US Open” is named after the United States of America, a country founded on the idea of the individual’s inalienable right to life, liberty, and the pursuit of happiness. Inalienable means that such rights do not come from the government, but are inherent in the individual by their status as a human being. One does not gain rights by being a U.S. citizen/permanent resident; one does not lose rights by being a non-resident foreigner. The Biden administration’s treatment of Novak Djokovic is a clear violation of those principles.

Given that Djokovic’s immunization status poses a health threat to no one, his presence on U.S. soil violates the rights of no one. Given that the CDC has said it is safe for Novak to play, he should be allowed to play. There were several ways this could have happened; the easiest way was for the Biden administration to “follow the science” that it claims to follow and repeal the vaccine mandate requirement entirely that targets non-resident foreigners. This did not happen for Djokovic.

The USTA could have asked for a “national interest” exemption for Djokovic given his status as a professional athlete and the given circumstances. Given the CDC has said the unvaccinated should be treated the same as the vaccinated, the USTA should have asked Mr. Biden to give Djokovic an exemption to enter the US legally, as Biden does for diplomats, refugees, and hundreds of thousands of unvaccinated illegal immigrants.

Sadly, the USTA refused to make any effort to speak up for Djokovic, as has its figurehead “woman’s rights advocate” Billie Jean King, for whom the US Open tennis center is named. (Sadly, for Djokovic, he both “identifies” as and is biologically a “man.”) Would Billie Jean King, and her virtue-signaling bureaucrats at the USTA be silent if such treatment was fostered on Serena Williams?

“My body, my choice” doesn’t only apply to women when pregnant (as in the case of abortion), but applies to all individuals, in all matters, regardless of sex, including the choice to be vaccinated or not. It appears that the USTA, being staffed by Democrats, does not wish to offend the unpopular Biden as if their lack of criticism would improve his popularity.

As a lifetime member of the USTA, I find their inaction toward the injustice towards Novak Djokovic a moral disgrace. The USTA should consider removing “US” from their name and moving the tournament from the city symbolized by the Statue of Liberty or renaming their tournament “US Closed” to immigrants and foreigners who do not genuflect to the whims of their leader. So much for the nation of “Your huddled masses yearning to breathe free, The wretched refuse of your teeming shore. Send these, the homeless, tempest-tossed to me, I lift my lamp beside the golden door!”

The United State Tennis Association’s refusal to speak against Biden’s anti-science, anti-freedom ban of Novak Djokovic from playing in the 2022 US Open is a disgrace.

Novak Djokovic is an international symbol for “my body, my choice”

Djokovic’s unjust treatment by the US government is an imitation of the Australian federal government banning him from playing in the first Grand Slam of the year, the Australian Open, which demonstrated the ban against Djokovic and foreigners like him has nothing to do with science but is purely political. Djokovic was allowed to play in the 2022 French Open and 2022 Wimbledon as the French and British governments have repealed their vaccine mandate policies. Do science and the laws of reality change when one travels to a different country? No, only politics does.

Early this year, it was the anti-freedom, anti-science Australian federal government which harassed, imprisoned, and ceremoniously deported Djokovic (who had a legal travel VISA issued by the Australian government) from Australia preventing him from winning the title on his favorite surface on the hard courts of Melbourne; it was the relatively more freedom-loving, more pro-science British government that allowed Djokovic to enter the UK and win his 7th Wimbledon crown. In the Australian Open’s defense, at least Tennis Australia fought the federal government to get Novak to play. No such effort is being made by the United States Tennis Association (USTA), which is hypocritically silent on the case of the 21-time grand slam champion.

Despite CDC change in guidance to treat the unvaccinated as the vaccinated, the Biden administration has chosen to follow “vaccine apartheid” fascism over “my body, my choice” freedom.

Vaccinations, like any medical treatment, have their pros and cons and must be considered in the full context, in line with other treatments available, based not on the utilitarian needs of government bureaucrats and their political interests, but on the self-interest (pursuit of happiness) and political rights of the individual.

As a world-class male athlete, Novak Djokovic’s example shows that an unvaccinated individual can be a model of health and sports excellence, and survive a covid-19 infection thus gaining natural immunity, all without being vaccinated for covid-19. Such an example is something no vaccine mandate/freedom-hating government official can tolerate.

Novak Djokovic symbolizes the countless number of individuals whose rights are violated because of unscientific and anti-freedom vaccine mandates. Novak Djokovic is not the villain in this story, he is the hero.

This article has been updated given Djokovic’s withdrawal from the 2022 US Open.

Reprinted from Capitalism Magazine.

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Brownstone Institute

The Unmasking of Vaccine Science

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From the Brownstone Institute

By Maryanne DemasiMaryanne Demasi  

I recently purchased Aaron Siri’s new book Vaccines, Amen.  As I flipped though the pages, I noticed a section devoted to his now-famous deposition of Dr Stanley Plotkin, the “godfather” of vaccines.

I’d seen viral clips circulating on social media, but I had never taken the time to read the full transcript — until now.

Siri’s interrogation was methodical and unflinching…a masterclass in extracting uncomfortable truths.

In January 2018, Dr Stanley Plotkin, a towering figure in immunology and co-developer of the rubella vaccine, was deposed under oath in Pennsylvania by attorney Aaron Siri.

The case stemmed from a custody dispute in Michigan, where divorced parents disagreed over whether their daughter should be vaccinated. Plotkin had agreed to testify in support of vaccination on behalf of the father.

What followed over the next nine hours, captured in a 400-page transcript, was extraordinary.

Plotkin’s testimony revealed ethical blind spots, scientific hubris, and a troubling indifference to vaccine safety data.

He mocked religious objectors, defended experiments on mentally disabled children, and dismissed glaring weaknesses in vaccine surveillance systems.

A System Built on Conflicts

From the outset, Plotkin admitted to a web of industry entanglements.

He confirmed receiving payments from Merck, Sanofi, GSK, Pfizer, and several biotech firms. These were not occasional consultancies but long-standing financial relationships with the very manufacturers of the vaccines he promoted.

Plotkin appeared taken aback when Siri questioned his financial windfall from royalties on products like RotaTeq, and expressed surprise at the “tone” of the deposition.

Siri pressed on: “You didn’t anticipate that your financial dealings with those companies would be relevant?”

Plotkin replied: “I guess, no, I did not perceive that that was relevant to my opinion as to whether a child should receive vaccines.”

The man entrusted with shaping national vaccine policy had a direct financial stake in its expansion, yet he brushed it aside as irrelevant.

Contempt for Religious Dissent

Siri questioned Plotkin on his past statements, including one in which he described vaccine critics as “religious zealots who believe that the will of God includes death and disease.”

Siri asked whether he stood by that statement. Plotkin replied emphatically, “I absolutely do.”

Plotkin was not interested in ethical pluralism or accommodating divergent moral frameworks. For him, public health was a war, and religious objectors were the enemy.

He also admitted to using human foetal cells in vaccine production — specifically WI-38, a cell line derived from an aborted foetus at three months’ gestation.

Siri asked if Plotkin had authored papers involving dozens of abortions for tissue collection. Plotkin shrugged: “I don’t remember the exact number…but quite a few.”

Plotkin regarded this as a scientific necessity, though for many people — including Catholics and Orthodox Jews — it remains a profound moral concern.

Rather than acknowledging such sensitivities, Plotkin dismissed them outright, rejecting the idea that faith-based values should influence public health policy.

That kind of absolutism, where scientific aims override moral boundaries, has since drawn criticism from ethicists and public health leaders alike.

As NIH director Jay Bhattacharya later observed during his 2025 Senate confirmation hearing, such absolutism erodes trust.

“In public health, we need to make sure the products of science are ethically acceptable to everybody,” he said. “Having alternatives that are not ethically conflicted with foetal cell lines is not just an ethical issue — it’s a public health issue.”

Safety Assumed, Not Proven

When the discussion turned to safety, Siri asked, “Are you aware of any study that compares vaccinated children to completely unvaccinated children?”

Plotkin replied that he was “not aware of well-controlled studies.”

Asked why no placebo-controlled trials had been conducted on routine childhood vaccines such as hepatitis B, Plotkin said such trials would be “ethically difficult.”

That rationale, Siri noted, creates a scientific blind spot. If trials are deemed too unethical to conduct, then gold-standard safety data — the kind required for other pharmaceuticals — simply do not exist for the full childhood vaccine schedule.

Siri pointed to one example: Merck’s hepatitis B vaccine, administered to newborns. The company had only monitored participants for adverse events for five days after injection.

Plotkin didn’t dispute it. “Five days is certainly short for follow-up,” he admitted, but claimed that “most serious events” would occur within that time frame.

Siri challenged the idea that such a narrow window could capture meaningful safety data — especially when autoimmune or neurodevelopmental effects could take weeks or months to emerge.

Siri pushed on. He asked Plotkin if the DTaP and Tdap vaccines — for diphtheria, tetanus and pertussis — could cause autism.

“I feel confident they do not,” Plotkin replied.

But when shown the Institute of Medicine’s 2011 report, which found the evidence “inadequate to accept or reject” a causal link between DTaP and autism, Plotkin countered, “Yes, but the point is that there were no studies showing that it does cause autism.”

In that moment, Plotkin embraced a fallacy: treating the absence of evidence as evidence of absence.

“You’re making assumptions, Dr Plotkin,” Siri challenged. “It would be a bit premature to make the unequivocal, sweeping statement that vaccines do not cause autism, correct?”

Plotkin relented. “As a scientist, I would say that I do not have evidence one way or the other.”

The MMR

The deposition also exposed the fragile foundations of the measles, mumps, and rubella (MMR) vaccine.

When Siri asked for evidence of randomised, placebo-controlled trials conducted before MMR’s licensing, Plotkin pushed back: “To say that it hasn’t been tested is absolute nonsense,” he said, claiming it had been studied “extensively.”

Pressed to cite a specific trial, Plotkin couldn’t name one. Instead, he gestured to his own 1,800-page textbook: “You can find them in this book, if you wish.”

Siri replied that he wanted an actual peer-reviewed study, not a reference to Plotkin’s own book. “So you’re not willing to provide them?” he asked. “You want us to just take your word for it?”

Plotkin became visibly frustrated.

Eventually, he conceded there wasn’t a single randomised, placebo-controlled trial. “I don’t remember there being a control group for the studies, I’m recalling,” he said.

The exchange foreshadowed a broader shift in public discourse, highlighting long-standing concerns that some combination vaccines were effectively grandfathered into the schedule without adequate safety testing.

In September this year, President Trump called for the MMR vaccine to be broken up into three separate injections.

The proposal echoed a view that Andrew Wakefield had voiced decades earlier — namely, that combining all three viruses into a single shot might pose greater risk than spacing them out.

Wakefield was vilified and struck from the medical register. But now, that same question — once branded as dangerous misinformation — is set to be re-examined by the CDC’s new vaccine advisory committee, chaired by Martin Kulldorff.

The Aluminium Adjuvant Blind Spot

Siri next turned to aluminium adjuvants — the immune-activating agents used in many childhood vaccines.

When asked whether studies had compared animals injected with aluminium to those given saline, Plotkin conceded that research on their safety was limited.

Siri pressed further, asking if aluminium injected into the body could travel to the brain. Plotkin replied, “I have not seen such studies, no, or not read such studies.”

When presented with a series of papers showing that aluminium can migrate to the brain, Plotkin admitted he had not studied the issue himself, acknowledging that there were experiments “suggesting that that is possible.”

Asked whether aluminium might disrupt neurological development in children, Plotkin stated, “I’m not aware that there is evidence that aluminum disrupts the developmental processes in susceptible children.”

Taken together, these exchanges revealed a striking gap in the evidence base.

Compounds such as aluminium hydroxide and aluminium phosphate have been injected into babies for decades, yet no rigorous studies have ever evaluated their neurotoxicity against an inert placebo.

This issue returned to the spotlight in September 2025, when President Trump pledged to remove aluminium from vaccines, and world-leading researcher Dr Christopher Exley renewed calls for its complete reassessment.

A Broken Safety Net

Siri then turned to the reliability of the Vaccine Adverse Event Reporting System (VAERS) — the primary mechanism for collecting reports of vaccine-related injuries in the United States.

Did Plotkin believe most adverse events were captured in this database?

“I think…probably most are reported,” he replied.

But Siri showed him a government-commissioned study by Harvard Pilgrim, which found that fewer than 1% of vaccine adverse events are reported to VAERS.

“Yes,” Plotkin said, backtracking. “I don’t really put much faith into the VAERS system…”

Yet this is the same database officials routinely cite to claim that “vaccines are safe.”

Ironically, Plotkin himself recently co-authored a provocative editorial in the New England Journal of Medicineconceding that vaccine safety monitoring remains grossly “inadequate.”

Experimenting on the Vulnerable

Perhaps the most chilling part of the deposition concerned Plotkin’s history of human experimentation.

“Have you ever used orphans to study an experimental vaccine?” Siri asked.

“Yes,” Plotkin replied.

“Have you ever used the mentally handicapped to study an experimental vaccine?” Siri asked.

“I don’t recollect…I wouldn’t deny that I may have done so,” Plotkin replied.

Siri cited a study conducted by Plotkin in which he had administered experimental rubella vaccines to institutionalised children who were “mentally retarded.”

Plotkin stated flippantly, “Okay well, in that case…that’s what I did.”

There was no apology, no sign of ethical reflection — just matter-of-fact acceptance.

Siri wasn’t done.

He asked if Plotkin had argued that it was better to test on those “who are human in form but not in social potential” rather than on healthy children.

Plotkin admitted to writing it.

Siri established that Plotkin had also conducted vaccine research on the babies of imprisoned mothers, and on colonised African populations.

Plotkin appeared to suggest that the scientific value of such studies outweighed the ethical lapses—an attitude that many would interpret as the classic ‘ends justify the means’ rationale.

But that logic fails the most basic test of informed consent. Siri asked whether consent had been obtained in these cases.

“I don’t remember…but I assume it was,” Plotkin said.

Assume?

This was post-Nuremberg research. And the leading vaccine developer in America couldn’t say for sure whether he had properly informed the people he experimented on.

In any other field of medicine, such lapses would be disqualifying.

A Casual Dismissal of Parental Rights

Plotkin’s indifference to experimenting on disabled children didn’t stop there.

Siri asked whether someone who declined a vaccine due to concerns about missing safety data should be labelled “anti-vax.”

Plotkin replied, “If they refused to be vaccinated themselves or refused to have their children vaccinated, I would call them an anti-vaccination person, yes.”

Plotkin was less concerned about adults making that choice for themselves, but he had no tolerance for parents making those choices for their own children.

“The situation for children is quite different,” said Plotkin, “because one is making a decision for somebody else and also making a decision that has important implications for public health.”

In Plotkin’s view, the state held greater authority than parents over a child’s medical decisions — even when the science was uncertain.

The Enabling of Figures Like Plotkin

The Plotkin deposition stands as a case study in how conflicts of interest, ideology, and deference to authority have corroded the scientific foundations of public health.

Plotkin is no fringe figure. He is celebrated, honoured, and revered. Yet he promotes vaccines that have never undergone true placebo-controlled testing, shrugs off the failures of post-market surveillance, and admits to experimenting on vulnerable populations.

This is not conjecture or conspiracy — it is sworn testimony from the man who helped build the modern vaccine program.

Now, as Health Secretary Robert F. Kennedy, Jr. reopens long-dismissed questions about aluminium adjuvants and the absence of long-term safety studies, Plotkin’s once-untouchable legacy is beginning to fray.

Republished from the author’s Substack

Maryanne Demasi

Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

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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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