From the Brownstone Institute

 Roger Bate 

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

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).

From the Brownstone Institute

Clayton J. Baker, MD 

Way back in the B.C. era (Before Covid), I taught Medical Humanities and Bioethics at an American medical school. One of my older colleagues – I’ll call him Dr. Quinlan – was a prominent member of the faculty and a nationally recognized proponent of physician-assisted suicide.

Dr. Quinlan was a very nice man. He was soft-spoken, friendly, and intelligent. He had originally become involved in the subject of physician-assisted suicide by accident, while trying to help a patient near the end of her life who was suffering terribly.

That particular clinical case, which Dr. Quinlan wrote up and published in a major medical journal, launched a second career of sorts for him, as he became a leading figure in the physician-assisted suicide movement. In fact, he was lead plaintiff in a challenge of New York’s then-prohibition against physician-assisted suicide.

The case eventually went all the way to the US Supreme Court, which added to his fame. As it happened, SCOTUS ruled 9-0 against him, definitively establishing that there is no “right to die” enshrined in the Constitution, and affirming that the state has a compelling interest to protect the vulnerable.

SCOTUS’s unanimous decision against Dr. Quinlan meant that his side had somehow pulled off the impressive feat of uniting Antonin Scalia, Ruth Bader Ginsberg, and all points in between against their cause. (I never quite saw how that added to his luster, but such is the Academy.)

At any rate, I once had a conversation with Dr. Quinlan about physician-assisted suicide. I told him that I opposed it ever becoming legal. I recall he calmly, pleasantly asked me why I felt that way.

First, I acknowledged that his formative case must have been very tough, and allowed that maybe, just maybe, he had done right in that exceptionally difficult situation. But as the legal saying goes, hard cases make bad law.

Second, as a clinical physician, I felt strongly that no patient should ever see their doctor and have to wonder if he was coming to help keep them alive or to kill them.

Finally, perhaps most importantly, there’s this thing called the slippery slope.

As I recall, he replied that he couldn’t imagine the slippery slope becoming a problem in a matter so profound as causing a patient’s death.

Well, maybe not with you personally, Dr. Quinlan, I thought. I said no more.

But having done my residency at a major liver transplant center in Boston, I had had more than enough experience with the rather slapdash ethics of the organ transplantation world. The opaque shuffling of patients up and down the transplant list, the endless and rather macabre scrounging for donors, and the nebulous, vaguely sinister concept of brain death had all unsettled me.

Prior to residency, I had attended medical school in Canada. In those days, the McGill University Faculty of Medicine was still almost Victorian in its ways: an old-school, stiff-upper-lip, Workaholics-Anonymous-chapter-house sort of place. The ethic was hard work, personal accountability for mistakes, and above all primum non nocere – first, do no harm.

Fast forward to today’s soft-core totalitarian state of Canada, the land of debanking and convicting peaceful protesters, persecuting honest physicians for speaking obvious truth, fining people $25,000 for hiking on their own property, and spitefully seeking to slaughter harmless animals precisely because they may hold unique medical and scientific value.

To all those offenses against liberty, morality, and basic decency, we must add Canada’s aggressive policy of legalizing, and, in fact, encouraging industrial-scale physician-assisted suicide. Under Canada’s Medical Assistance In Dying (MAiD) program, which has been in place only since 2016, physician-assisted suicide now accounts for a terrifying 4.7 percent of all deaths in Canada.

MAiD will be permitted for patients suffering from mental illness in Canada in 2027, putting it on par with the Netherlands, Belgium, and Switzerland.

To its credit, and unlike the Netherlands and Belgium, Canada does not allow minors to access MAiD. Not yet.

However, patients scheduled to be terminated via MAiD in Canada are actively recruited to have their organs harvested. In fact, MAiD accounts for 6 percent of all deceased organ donors in Canada.

In summary, in Canada, in less than 10 years, physician-assisted suicide has gone from illegal to both an epidemic cause of death and a highly successful organ-harvesting source for the organ transplantation industry.

Physician-assisted suicide has not slid down the slippery slope in Canada. It has thrown itself off the face of El Capitan.

And now, at long last, physician-assisted suicide may be coming to New York. It has passed the House and Senate, and just awaits the Governor’s signature. It seems that the 9-0 Supreme Court shellacking back in the day was just a bump in the road. The long march through the institutions, indeed.

For a brief period in Western history, roughly from the introduction of antibiotics until Covid, hospitals ceased to be a place one entered fully expecting to die. It appears that era is coming to an end.

Covid demonstrated that Western allopathic medicine has a dark, sadistic, anti-human side – fueled by 20th-century scientism and 21st-century technocratic globalism – to which it is increasingly turning. Physician-assisted suicide is a growing part of this death cult transformation. It should be fought at every step.

I have not seen Dr. Quinlan in years. I do not know how he might feel about my slippery slope argument today.

I still believe I was correct.