Brownstone Institute
UK regulators find Pfizer CEO guilty of misleading public
From the Brownstone Institute
This is the inside story of how UsForThem, a UK children’s welfare campaigning group, held Pfizer to account for misleading parents about Covid vaccine safety.
On 2 December 2021, the UK’s national public broadcaster, the BBC, published on its website, its popular news app, and in a flagship news program, a video interview and an accompanying article under the headline ‘Pfizer boss: Annual Covid jabs for years to come.’
The interview by the BBC’s medical editor, Fergus Walsh, conducted as a friendly fireside chat, gave Dr Albert Bourla, the Chairman and CEO of Pfizer, a free pass promotional opportunity that money cannot buy — as the UK’s public service broadcaster, the BBC is usually prohibited from carrying commercial advertising or product placement.
Perhaps unsurprisingly, Pfizer made the most of that astonishing opportunity to promote the uptake of its vaccine product. As the BBC’s strapline suggests, the key message relayed by Dr Bourla, responding to an obediently leading question from Mr Walsh, was that many more vaccine shots would need to be bought and jabbed to maintain high levels of protection in the UK. He was speaking shortly before the UK Government bought another 54 million doses of Pfizer vaccines.
Misleading statements about safety
Among his explicit and implicit encouragements for the UK to order more of his company’s shots, Dr Bourla commented emphatically about the merits of vaccinating children under 12 years of age, saying “[So] there is no doubt in my mind that the benefits, completely are in favour of doing it [vaccinating 5 to 11 year-olds in the UK and Europe]”.
No mention of risks or potential adverse events, nor indeed the weighing of any factors other than apparent benefits: Dr Bourla was straightforwardly convinced that the UK and Europe should be immunising millions of children.
In fact, it later emerged that the BBC’s article had misquoted Dr Bourla, who in the full video interview recording had ventured the benefits to be “completely completely” in favour of vaccinating young children.
Despite the strength of Dr Bourla’s unconditional and superlative pitch for vaccinating under-12s, the UK regulatory authorities would not authorise the vaccine for use with those children until the very end of 2021; and indeed this came just a few months after the JCVI — the expert body which advises the UK Government on whether and when to deploy vaccines — had already declined to advise the Government to roll out a mass vaccination programme for healthy 12 to 15 year-olds on the basis that “the margin of benefit, based primarily on a health perspective, is considered too small to support advice on a universal programme of vaccination of otherwise healthy 12 to 15-year old children…”.
In response, soon after the interview aired, UsForThem submitted a complaint to the UK’s Prescription Medicines Code of Practice Authority (PMCPA) — the regulator responsible for policing promotions of prescription medicines in the UK. The complaint cited the overtly promotional nature of the BBC’s reports and challenged the compliance of Dr Bourla’s comments about children with the apparently strict rules governing the promotion of medicines in the UK.
A year-long, painful process
More than a year later, following a lengthy assessment process and an equally lengthy appeal by Pfizer of the PMCPA’s initial damning findings, the complaint and all of the PMCPA’s findings have been made public in a case report published on the regulator’s website.**
Though some aspects of that complaint ultimately were not upheld on appeal, importantly an industry-appointed appeal board affirmed the PMCPA’s original findings that Dr Bourla’s comments on using the Covid vaccine for 5 to 11 year-olds were promotional, and were both misleading and incapable of substantiation in relation to the safety of vaccinating that age group.
Even after UsForThem involved a number of prominent UK parliamentarians, including Sir Graham Brady MP, to help accelerate the complaint, the process was dragged on — or perhaps ‘out’ — while the rollout of Pfizer’s vaccine to UK under-12s proceeded, and the BBC’s interview and article stayed online. Even now the interview remains available on the BBC’s website, despite the PMCPA in effect having characterised it as ‘misinformation’ as far as vaccinating children is concerned.
When news of the appeal outcome was first revealed in November 2022 by a reporter at The Daily Telegraph newspaper, Pfizer issued a comment to the effect that it takes compliance seriously and was pleased that the “most serious” of the PMCPA’s initial findings — that Pfizer had failed to maintain high standards and had brought discredit upon and lowered confidence in the pharmaceutical industry — had been overturned on appeal.
It must be an insular and self-regarding world that Pfizer inhabits, that discrediting the pharmaceutical industry is considered a more serious matter than making misleading and unsubstantiated claims about the safety of their products for use with children. This surely speaks volumes about the mindset and priorities of the senior executives at companies such as Pfizer.
And if misleading parents about the safety of a vaccine product for use with children does not discredit or reduce confidence in the pharmaceutical industry, it is hard to imagine what standard can have been applied by the appeal board which overturned that initial finding.
Perhaps this reflects the industry’s assessment of its own current reputation: that misinformation promulgated by one of its most senior executives is not discrediting. According to the case report, the appeal board had regard to the “unique circumstances” of the pandemic: so perhaps the view was that Pfizer can’t always be expected to observe the rules when it gets busy.
Multiple breaches. No meaningful penalty
Indeed, a brief look at the PMCPA’s complaints log confirms that Pfizer has been found to have broken the UK medicines advertising rules in relation to its Covid vaccine a further four times since 2020. Astonishingly, though, for their breaches in this most recent case, and in each of the other cases decided against it, neither Pfizer nor Dr Bourla will suffer any meaningful penalty (the PMCPA will have levied a small administrative charge to cover the cost of administering each complaint). So in practice neither has any incentive to regret the breach, or to avoid repeating it if it remains commercially expedient to do so.
And this is perhaps the crux of the issue: the PMCPA, the key UK regulator in this area, operates as a division of the Association of the British Pharmaceutical Industry, the UK industry’s trade body. It is therefore a regulator funded by, and which exists only by the will of, the companies whose behaviour it is charged with overseeing.
Despite Pharma being one of the most lucrative and well-funded sectors of the business world, the largely self-regulatory system on which the industry has now for decades had the privilege to rely has been under-resourced and has become slow, meek and powerless.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA), a governmental agency, in principle has jurisdiction to hold the BBC accountable for what seems likely to have been mirroring breaches of the medicines advertising rules when it broadcast and promoted Dr Bourla’s comments, but no action has yet been taken.
This case, and the apparent impunity that companies such as Pfizer appear to enjoy, serve as evidence that the system of oversight for Pharma in the UK is hopelessly outdated and that the regulatory authorities are risibly ill-equipped to keep powerful, hugely well-resourced corporate groups in check. The regulatory system for Big Pharma is not fit for purpose; so it is time for a rethink.
Children deserve better, and we should all demand it.
** Endnote: an undisclosed briefing document
As part of its defence of UsForThem’s complaint, Pfizer relied on the content of an internal briefing document that had been prepared for the CEO by Pfizer’s UK compliance team before the BBC interview took place. Pfizer initially asked for that document to be withheld from UsForThem on the grounds that it was confidential. When UsForThem later demanded sight of the document (on the basis that it was not possible to respond fully to Pfizer’s appeal without it), UsForThem was offered a partially redacted version, and only then under terms of a perpetual and blanket confidentiality undertaking.
Without knowing the content of that document, or the scope of the redactions, UsForThem was unwilling to give an unconditional perpetual blanket confidentiality undertaking, but reluctantly agreed that it would accept the redacted document and keep it confidential subject to one limited exception: if UsForThem reasonably believed the redacted document revealed evidence of serious negligence or wrongdoing by Pfizer or any other person, including evidence of reckless or wilful damage to the public health of children, UsForThem would be permitted to share the document, on a confidential basis, with members of the UK Parliament.
This limited exception to confidentiality was not accepted. Consequently UsForThem never saw the briefing document, and instead drew the inference that it contained content which Pfizer regarded as compromising and which it therefore did not wish to risk ever becoming public.
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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