Brownstone Institute
Tremendous Progress in Missouri v. Biden
From the Brownstone Institute
BY 
As I explained previously, the government appealed the district court’s preliminary injunction in Missouri v. Biden, which would prohibit the government from pressuring social media companies to censor Americans online. Two days ago, a three-judge panel in the 5th Circuit court of appeals heard oral arguments from both sides.
Alex Gutentag over at Public yesterday provided a great summary of the judge’s responses during the hearing:
Yesterday the Fifth Circuit court heard oral arguments in the Missouri v. Biden case, and the judges did not hold back. One judge suggested the government “strongarms” social media companies and that their meetings had included “veiled and not-so-veiled threats.”
Another judge described the exchange between the Biden administration and tech companies as the government saying, “Jump!” and the companies responding, “How high?”
“That’s a really nice social media company you got there. It’d be a shame if something happened to it,” the judge said, describing the government’s coercive tactics.
Attorney John Sauer, representing Louisiana, masterfully argued that the government had repeatedly violated the First Amendment. He pointed to specific evidence of coercion in the Facebook Files.
“You have a really interesting snapshot into what Facebook C-suite is saying,” Sauer explained. “They’re emailing Mark Zuckerberg and Sheryl Sandberg and saying things like… ‘Why were we taking out speech about the origins of covid and the lab leak theory?’” The response, Sauer said, was, “Well, we shouldn’t have done it, but we’re under pressure from the administration.”
He also cited an email from Nick Clegg, Facebook President of Global Affairs, that pointed to “bigger fish to fry with the Administration — data flows, etc.”
On Monday, Public reported that these “data flows” referred to leverage the Biden administration had over the company; Facebook needed the White House to negotiate a deal with the European Union. Only through this deal could Facebook maintain access to user data that is crucial for its $1.2 billion annual European business.
But Sauer also made it clear that coercion was not the only basis on which the court could rule against the Biden administration. Joint activity between the White House and social media platforms would also be unconstitutional.
Sauer compared what the government had done to book burning. “Imagine a scenario where senior White House staffers contact book publishers… and tell them, ‘We want to have a book burning program, and we want to help you implement this program… We want to identify for you the books that we want burned, and by the way, the books that we want burned are the books that criticize the administration and its policies.”
Daniel Tenny, the attorney for the Department of Justice, was left nitpicking and misrepresenting the record. In one instance, he denied that Anthony Fauci and Francis Collins had hatched a plan to orchestrate a “takedown” of the Great Barrington Declaration. Why? Because, Tenny said, according to their emails, they actually planned a takedown of “the premises of the Great Barrington Declaration.”
Tenny also stated that social media companies had not removed any true content. From the case’s discovery as well as the Facebook Files we know that is far from true. Facebook, against internal research and advice, did remove “often-true content” that might discourage people from getting vaccinated. Facebook’s own emails clearly suggest that the company only did this due to pressure from figures within the Biden Administration.
Tenny also claimed that when Rob Flaherty, the White House director of Digital Strategy, dropped the F-bomb in an exchange with Facebook it was not about content moderation. In fact, it was precisely about content moderation and occurred during a conversation about how Instagram was throttling Biden’s account. Ironically, the account couldn’t gain followers because Meta’s algorithm had determined that it was spreading vaccine misinformation.
Later, Sauer demolished an earthquake hypothetical that Tenny had introduced to justify state-sponsored censorship. “You can say this earthquake-related speech that’s disinformation is false, it’s wrong,” Sauer said. “The government can say it’s bad, but the government can’t say, ‘Social media platforms, you need to take it down.’ Just like a government can’t stand at the podium and say, ‘Barnes and Noble, you need to burn the bad books, burn the Communist books, whatever it is.’ They can’t say take down speech on the basis of content.”
Based on this hearing, the plaintiffs in Missouri v. Biden may have a strong chance of winning. Biden’s DOJ simply had no valid arguments to present. The evidence is clear: the administration brazenly engaged in an unlawful censorship campaign and instrumentalized private companies to do its bidding. This total disregard for fundamental civil liberties will be a stain on the Democratic Party for years to come.
Matt Taibbi’s reporting on this at Racket News yesterday was likewise excellent. I especially appreciated his colorful account of our brilliant lawyer, John Sauer. A few excerpts:
Early in the afternoon, a three-judge panel met to decide whether or not to revoke a stay of Judge Terry Doughty’s sweeping July 4th order barring a battery of government agencies from contacting social media companies about content moderation. Biden administration counsel Daniel Bentele Hahs Tenny was under fire from the jump.
It was hard not to feel for Tenny. Sitting across from him was a packed table of anxious plaintiffs’ attorneys, including Missouri’s garrulous, tornado-like former Solicitor General John Sauer — the driving force behind the Missouri v. Biden legislation — as well as the current officeholder, a lean, plain-spoken lawyer with Jimmy Stewart vibes named Josh Devine. Tenny, an ashen, slouching figure, was alone. In a case of major historical import, likely headed to the Supreme Court, the federal government hadn’t even sent another lawyer to keep him company. Staring down at his table, he looked like Napoleon Dynamite at lunch.
Called first, Tenny read a speech. He made it through the first thirty seconds well enough, arguing that Doughty’s July 4th order would leave the government “powerless” to discourage social media companies from disseminating “untrue” statements in the event of a natural disaster. Then, almost right away, he stepped in it.
“To take another example,” Tenny went on. “If… a government official were to conclude that it was likely, although not certain, that posts on social media were part of a criminal conspiracy, for example regarding human trafficking… the government official would be powerless to bring those posts to the social media company’s attention.”
Judges Edith Brown Clement, Jennifer Walker Elrod, and Don Willett listened sleepily at first, but all three snapped awake at the words “criminal conspiracy.” Doughty’s July 4th order specifically exempted communications about “criminal activity or criminal conspiracies,” posts that “threaten the public safety,” and communications about things that are “not protected free speech.” Tenny’s remarks more or less immediately drove into this wall of exceptions.
“So you do not believe that either of those are covered by the exception or exclusion specifically contained in the injunction?” asked Elrod.
Things then went bad to worse for the government:
Before long judges were rattling off greatest hits of both the Missouri v. Biden evidence and Facebook Files material, the worst possible scenario. Elrod within minutes was referencing posts by officials like the White House’s Rob Flaherty expressing frustration that content like Tucker Carlson videos or Alex Berenson articles hadn’t been removed.
“What appears to be in the record are these irate messages from time to time from high ranking government officials that say, you didn’t do this yet,” she said. “It’s like ‘Jump!’ and ‘How High?’”
Tenny tried to reorient Elrod to the question of whether or not this constituted overt coercion. If you were coercing, he said, “You wouldn’t say, ‘I’m really mad.’ You would just say, ‘Do this or else,’ and the or else would be clear.”
Elrod, not buying it, launched into an extraordinary counter-argument, comparing the federal government to the mob:
If you’ll excuse me, it’s like if somebody is in these movies that we see with the mob or something. They don’t say and spell out things, but they have these ongoing relationships, and they never actually say, “Go do this or else you are going to have this consequence.” But everybody just knows…
I’m certainly not equating the federal government with anybody in illegal organized crime. But… there are certain relationships where people know things without always saying the “or else.”
Willett put the mob analogy in even plainer language, saying the government’s behavior was a “fairly unsubtle kind of strong-arming,” as in, “That’s a really nice social media platform you got there. It’d be a shame if something happened to it.”
Then our lawyer John Sauer’s took his turn delivering a barrage of evidence and pointed arguments like a caped crusader making short work of helpless thugs:
In the court gallery a few clerks winced at one another at certain points of Tenny’s address, the way people do at boxing matches when someone walks into a face shot. The effect got worse when Tenny walked off and a furious Sauer addressed the judges. While Tenny rambled and spoke in generalities, the loquacious, bespectacled Sauer — who appears descended from some ancient God of rage — tore into the government’s arguments with ferocity and specificity. Judges tried at various points to challenge him, but he kept hurling cites back so fast the queries got lost.
“I would direct the court’s attention to pages 70 to 75 and 80 to 86 of the District court’s opinion,” he’d say, “where he makes specific findings resulting in the conclusion that CISA and the Election Integrity Partnership were, quote, ‘completely intertwined…’”
Taibbi then placed the significance of this case into context, explaining why the case will almost certainly end up at the Supreme Court:
Missouri v. Biden is fast becoming the vehicle through which a diverse series of recent disclosures about government censorship, including the Twitter Files reports, is likely to be litigated at a national level. What was pooh-poohed as conspiracy theory even a year ago is now a cat-hair away from being addressed and potentially proscribed by the country’s highest court. For the issue to get there at all would in itself represent an incredible journey, but signs continue to accumulate that a rare major judicial reprimand of the intelligence and enforcement communities could actually happen, and soon, too.
It would be a mistake to read too much into hearings like yesterday’s. One never knows how judges will rule, even when they appear to show emotion and inclination in court. Sometimes, they’re playing Devil’s advocate. The appellate panel, charged with deciding whether or not to reinstate Doughty’s sweeping order, could easily surprise those who attended and rule against the plaintiffs. Either way, an answer is expected soon. Attorneys present gave estimates ranging from a few weeks to two months for the panel to rule on yesterday’s issue.
A crucial fact of this case, however, is that Doughty’s July 4th order has created a motivation for both sides to push forward to the Supreme Court as soon as possible. Doughty’s ruling, which described the current Internet censorship regime as “arguably… the most massive attack against free speech in United States history,” essentially said that the damage from current government-influenced content moderation schemes may be so extreme that they must be completely enjoined until courts can determine how bad they are. That ruling was a major victory for the plaintiffs, and if the July 14th stay by the Fifth Circuit Court of Appeals remains in place, the plaintiffs will almost certainly appeal right away to a higher court in hopes of restoring their big win.
If the plaintiffs prevail, on the other hand, Doughty’s order will go back in force and the government will essentially be barred from meddling in the speech landscape. The administration has already argued on paper that this can’t be tolerated for any length of time, as any inability to pursue these “initiatives to prevent grave harm to the American people and our democratic processes,” causes the state “irreparable harm.” A more cynical interpretation might be that the “irreparable harm” is the prospect of the administration going without nuclear opinion-managing tools heading into an election year. Either way, a loss on the stay question will similarly motivate the administration to push for immediate Supreme Court consideration.
That’s all for now, folks. I will update you as soon as we get a ruling from the 5th Circuit. I remain optimistic that an eventual win at the Supreme Court will be the first major step toward completely dismantling the government’s censorship leviathan and restoring First Amendment free speech rights for all Americans.
Thank you for your continued support.
Reprinted from the author’s Substack
Author
From the Brownstone Institute
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.
A Legal Showdown
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 Medicine, conceding 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
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
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