Those who have been attending or listening to my recent talks and podcasts may have noticed that I have repeatedly stated that my opinion is that SARS-CoV-2 virus was created in the Wuhan Institute of Virology and somehow entered the general population approximately September 2019. Based on their report, this appears to also be the interim minority opinion of the Senate Committee on Health Education, Labor and Pensions Minority Oversight Staff, which has been archived at the Malone Institute under the government corruption tab, and can be found here.
Here is the cautiously worded but still stunning conclusion of this interim report:
As noted by the WHO Scientific Advisory Group for the Origins of Novel Pathogens, the COVID19 Lancet Commission, and the U.S. Office of the Director of National Intelligence 90-Day Assessment on the COVID-19 Origins, more information is needed to arrive at a more precise, if not a definitive, understanding of the origins of SARS-CoV-2 and how the COVID-19 pandemic began (see footnote). Governments, leaders, public health officials, and scientists involved in addressing the COVID-19 pandemic and working to prevent future pandemics, must commit to greater transparency, engagement, and responsibility in their efforts.
Based on the analysis of the publicly available information, it appears reasonable to conclude that the COVID-19 pandemic was, more likely than not, the result of a research-related incident. New information, made publicly available and independently verifiable, could change this assessment. However, the hypothesis of a natural zoonotic origin no longer deserves the benefit of the doubt, or the presumption of accuracy. The following are critical outstanding questions that would need to be addressed to be able to more definitively conclude the origins of SARS-CoV-2:
What is the intermediate host species for SARS-CoV-2? Where did it first infect humans?
Where is SARS-CoV-2’s viral reservoir?
How did SARS-CoV-2 acquire its unique genetic features, such as its furin cleavage site?
Advocates of a zoonotic origin theory must provide clear and convincing evidence that a natural zoonotic spillover is the source of the pandemic, as was demonstrated for the 2002-2004 SARS outbreak. In other words, there needs to be verifiable evidence that a natural zoonotic spillover actually occurred, not simply that such a spillover could have occurred.
A summary of examples concerning how the corporate media have previously covered the “Lab Leak Hypothesis” explanation of the origins of the COVID-19 pandemic can be found below:
By way of relevant historical context, on approximately 04 January, 2020 I received an unexpected phone call from Dr. Michael Callahan (known to me to have been a CIA agent, and separately confirmed to me by NY Times reporter Davey Alba in February 2022 as a “former” CIA agent).
During this call, Dr. Callahan revealed to me that he was calling from China, and that he was in country under cover of his Harvard Professor appointment. Further information regarding Dr. Callahan can be found in this article by Raul Diego, with research support by Whitney Webb, entitled “DARPA’s Man in Wuhan”. It is important to know that Callahan has provided advice in the White House to at least three US Presidents, including Obama and Trump.
On 04 January 2020, Dr. Callahan told me that there was a novel coronavirus circulating in the Wuhan region, it was looking like a significant biothreat, and I should get “my team” engaged in seeking ways to mitigate the risk of this new agent. My sense from this and subsequent discussions with Dr. Callahan over the next few months during 2020 was that he had been in China as part of an exchange program, sent there under his joint appointment at a Chinese sister hospital of the Massachusetts General Hospital/Harvard Medical School, where he has maintained a faculty appointment since 2005.
Dr. Callahan asserted to me that he had been directly involved in managing hundreds of cases of COVID-19 in Wuhan during early 2020, and according to journalist Brendan Borrell, who has acted as a close ally of Dr. Callahan and published many stories (and a recent book) about his various exploits, Dr. Callahan escaped Wuhan surreptitiously by boat immediately prior to the lockdown of the region on 23 January 2020. If you believe Borrell’s story line (and I do not- Callahan is a CIA trained liar, and I have previously seen Borrell publish unverifiable falsehoods), the heroic Dr. Callahan first stepped into a Wuhan hospital the day before the lockdown:
He went to Wuhan anyway and hunkered down in a guest house, waiting to get the word from his friends. “They had to check in to make sure things were safe for me.” On Jan. 22, Callahan slipped on medical scrubs and donned an N95 mask and a pair of goggles to pass through the entrance of the Wuhan Central Hospital, a boot-shaped glass building rising up from the city’s empty streets. There, his colleagues registered him as a “guest clinical educator,” a title that would allow him into the wards as an observer. The next day, the city locked down. Callahan had just made it into the white-hot center of the outbreak.
Note the careful dissembling and cover that Borrell provides Callahan (and the CIA):
If he went to Wuhan, Callahan knew he couldn’t worry his wife by telling her about his plan. He had to be careful about telling anyone. He didn’t have official permission to travel there, after all. “It was not sanctioned, not authorized,” he said.
When Callahan set down his bag in the lobby of the Westin Hotel and was handed the key card to his room, he had to smirk. There’s 400 rooms in this hotel, and I get the same room every time? he thought. It was a fine room. Clean bathroom, firm mattress. It was also a tell. Ever since Chinese hackers stole a database containing information about his high-level security clearance, Callahan knew that someone might be watching his every move. “I’m not that good-looking of a guy, but you’d think I was Brad Pitt when I go down and get a beer,” he said. “Honeypots. But, you know, we get training for that.”
Who is the “we” that get training to avoid honeypots? Yet another tell….
Borrell now asserts that Callahan left Wuhan one week after his arrival:
All told, Callahan spent almost a week on the ground helping his colleagues keep the hospital functioning, learning about the virus’s toll on the human body, and taking note of what drugs doctors were throwing at the virus. Chinese officials were planning to tighten Wuhan’s quarantine measures, banning residents even from stepping out to buy food. Callahan slipped across the river by boat — “the black-market way” — and returned to Nanjing, where he and his colleagues had a video link with the ICU units in two hospitals in Wuhan and could provide advice and track patient outcomes. Callahan knew he needed to report what he was seeing to his friends in the U.S. government.
Which would mean that Callahan, who reported to me that he had helped manage hundreds of cases of COVID-19 while in Wuhan (600 as I recall Michael bragging, but Borrell says 277), did so early in the outbreak within a one week period. In retrospect, this is yet another lie.
Clearly this story told by Borrell is a limited hangout, as was his prior April 26, 2020 story that Callahan had examined a series of 6,000 Chinese cases during that time and discovered the activity of Famotidine as a COVID-19 treatment. I know for a fact that he never used Famotidine to treat COVID-19 while he was in Wuhan or later when he was managing the Diamond Princess outbreak and setting up the portable hospital in New York City, and only began looking into the potential efficacy after I reported to him on the findings of the group that I was leading (and my own personal experience self-treating with Famotidine when I was infected during the Boston Wuhan-1 outbreak at the end of Feb 2020).
To this point, when this false narrative was published in Science magazine, I requested from Borrell, Callahan, and Science Magazine a copy of the database which was purportedly used to make this discovery, and none of these were able to provide it. I once asked Borrell if he was also CIA, or as Callahan often says “a member of the secret handshake club”. Borrell denied any association, but there is no question in my mind that for some inexplicable reason Borrell has been publishing Callahan’s cover stories for many years. Like this one for example: “95,000 stranded at sea: What happens when a cruise ship becomes a hot zone”.
After returning from China to report to his longstanding close associate Dr. Bob Kadlac (then serving as the Assistant Secretary of Preparedness and Response to the Trump administration), back in Washington DC, Callahan was then deployed to help managing both the Diamond Princess outbreak during the first week of February, 2020, as well as the March 08 Grand Princess outbreak. Which would mean that he would have arrived in Nanjing, China under cover of his Harvard appointment, beginning 22 Jan traveled to Wuhan and managed between 200 and 600 COVID-19 patients, emailed Bob Kadlac on Jan 28 alerting him of the emerging threat (weeks after he had called me), escaped Wuhan by boat returning to Nanjing, continued to monitor hospital COVID-19 management practices remotely from Nanjing, returned to Washington DC to report to Kadlac, and then deployed to the Diamond Princess in Japan during the first week of February.
And during this time, was supposedly was involved in a detailed statistical analysis of a 6,000 patient Chinese database (which no one else has ever seen) to discover that Famotidine is active against COVID-19. I know from personal communication with Michael that he then designed and managed deployment of the tent hospital in NY City, and then deployed to manage and set US policy for COVID-19 treatment and infection control in nursing homes. I also know that he presented the data from our research group at White House and WHO meetings as the support for advocating for Famotidine as a COVID-19 repurposed drug treatment, but did not present data from the ephemeral 6000 person Chinese data base analysis.
As for myself, I downloaded the sequence of the “Wuhan Seafood Market Virus” available on the NIH servers on January 10, and got busy with volunteers from the DTRA-funded project group at Alchem Laboratories in Alachua Florida, which contract (focused on use of biorobots and computational modeling to identify inhibitors of organophosphate chemical toxins) I had helped write and win and for which I was then serving as project manager. I directed the group to focus on identifying repurposed drugs which could inhibit the Papain-like protease of the virus (3-ClPro) as opposed to the main serine protease (M-Pro) which has been the primary focus of Pharmaceutical company research into SARS-1 inhibitors.
Computational docking studies lead to a ranked priority list which included Famotidine, and I confirmed the activity of this agent by treating myself after I was infected during the last week of February 2020. Jill got busy beginning January 04 after the Callahan call, and with my help wrote and self-published (Amazon) a book designed for a lay audience to help them prepare and protect themselves from the novel coronavirus. The highly referenced book (written by a PhD and an MD/MS with decades of experience in infectious disease outbreaks) was published during the first week of February, 2020, and was censored/deleted by Amazon in March 2020 due to “violating community standards” which were not otherwise specified at the time. No appeal.
The fact that Jill and I were able to produce and published this book in a month has been cited by some conspiracy theorists as evidence that I was “in on the game” well before January 04, but I can assure you that this is merely a testimony to the commitment and efforts of Dr. Jill-Glasspool Malone to warn and help our friends, community, social media followers, and the general population. To have this product of such hard work and commitment summarily deleted without appeal by Amazon was deeply damaging to her morale, as it would be to yours.
On a side note, early in February 2020, I directly asked Michael for his opinion on the possibility that the “2019 Novel Coronavirus” (not yet named SARS-CoV-2) originated from a laboratory. His response was that “my people have carefully analyzed the sequence, and there is no evidence that this virus was genetically engineered”. We now know that this was another lie, and that there is clear evidence that SARS-CoV-2 was genetically engineered.
Based on this timeline and history, as well as my own direct personal communication with Dr. Callahan, I strongly suspect that both the gross clinical mismanagement of ventilatory support during the first phase of the outbreak (responsible for up to 30,000 deaths) as well as the stunningly poor management practices of Nursing Home and Extended Care facilities throughout the USA can be directly traced to the influence of Dr. Michael Callahan, DARPAs Man in Wuhan and arguably the top US Government/CIA expert in both biowarfare and gain of function research.
Consistent with this being a limited hangout, much later during early 2022 I received a call from Dr. David Hone, Ph.D., a longtime associate (since he was a post-doctoral student at University of Maryland) and former employee of Dr. Robert Gallo’s Institute of Human Virology, in which he told me that Callahan was not present in Wuhan on January of 2020, that “we did not have anyone there at that time”, and that I should stop asserting otherwise. Dr. Hone was serving as a GS-15 rank DTRA CB civilian rank employee of the DoD at the time, essentially as the Chief Scientific Officer of DTRA CB. Clearly, this timeline is a sensitive topic, and deserves further congressional investigation. Sworn testimony from both Drs. Hone and Callahan should be obtained.
Robert W. Malone is a physician and biochemist. His work focuses on mRNA technology, pharmaceuticals, and drug repurposing research. You can find him at Substack and Gettr
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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.
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).
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.
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).
