Going Smoke-Free… Earning Billions
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Everyone knew why Harold Watkins really shot himself in the chest.
It was January 1939 and Watkins – who’d been let go from his job at Massengill Chemists Company about six months earlier – was, according to his wife, “cleaning his gun,” which led to an accidental discharge. The police said it was suicide.
The newspaper obit said Harold was the “Chemist of Death.”
It had, in fact, been Harold’s bright idea to mix sulfa medicine – the nation’s new miracle drug – with a convenient binding agent that turned out to be toxic antifreeze.

With a dollop of red food coloring and raspberry syrup – and without any product testing on humans or animals – 633 lots of Watkins’ Sulfanilamide Elixir were shipped to pharmacies across America in fall 1937. By the time a panicked Massengill Chemists scrambled to recall them with telegrams like “Product may be dangerous to life! Return at our expense,” about 130 people had died.
Make that 131, if you count the disgraced Harold Watkins.
And President Franklin D. Roosevelt was secretly delighted.
FDR’s sweeping vision for a welfare state – which he described as “a matter of social duty” – saw the launch of dozens of bloated government agencies by 1937, including the Securities And Exchange Commission (“SEC”), the Social Security Administration (“SSA”), the Works Progress Administration (“WPA”), and the Federal Housing Administration (“FHA”).
So far, though, there was no FDA (Food And Drug Administration) as we know it today – just a tiny task force within the U.S. Department Of Agriculture, enforcing a bare-bones piece of 1906 legislation called the Pure Food And Drugs Act. Beyond basic standards of truth in labeling, the Pure Food And Drugs Act didn’t dictate much. The American public didn’t want much.
FDR’s goons had been not-so-subtly angling for more government control over food and drugs for several years. Starting in 1933, the administration debuted a traveling “Chamber of Horrors,” spotlighting products like Pabst’s Okay Specific, a gonorrhea remedy that made things, uh, worse. Ruth Lamb, the docent of the exhibit, made sure to hammer home its main point:
All of these tragedies… have happened, not because government officials are incompetent or callous, but because they have no real power to prevent them.
The Chamber of Horrors – entertaining though it was – didn’t really move the needle on public opinion. The sulfanilamide tragedy, however, did.
In the wave of nationwide horror over the deaths, FDR trotted out a new government bureau whose role was to vet all the food and drugs in the land. He explained in one of his comforting fireside chats…
Only the scientific and disinterested activity of government can protect this honor of our producers and provide the possibility of discriminating choice to our consumers.
The FDA billed itself as a “consumer protection agency,” and what it meant by that is that it wanted absolute control over consumers...
In practice, safeguards against quackery are a good thing (that’s why we have independent journals and scientific review bodies). But FDR’s vision was that the government decides unilaterally what counts as “quackery” and what doesn’t. In his paternal view, giving regular people any information about the chemical or nutritional content of their purchases opened the door to unauthorized practice of medicine.
By the 1960s, with the FDA in full swing, it was unlawful to print ingredient lists on most food or medicine, or to mention the word cholesterol on packaging – and, in fact, it was illegal to print drug descriptions that were “likely to be understood by the ordinary individual.” (This last law was not fully repealed until 2007!)
In other words, you were expected to open your mouth for the government’s spoon and take your medicine like a good boy.
The thalidomide tragedy in the early 1960s – a medicine that caused severe birth defects – gave the FDA an excuse to regulate efficacy as well as safety… thus extending drug pipelines and causing lots of costly delays and backups.
Over the next three decades, the FDA mushroomed into a 10,000-person organization with a billion-dollar-a-year budget, and an increasingly giant mandate that encroached on everything Americans consume: food, medicine, cosmetics, pet food. By the 1970s, they’d extended their purview to “medical devices” – anything from defibrillators to dental floss.
By then, the micromanaging had become so absolute that the FDA routinely did things like seize shipments of expired orange juice at gunpoint, and harass local grocery stores until they quit selling apricots, in case someone took it into their head to grind up apricot seeds (a popular alternative cancer treatment in the ’70s).
Conservatives – especially libertarians – did not go quietly into this good night. Nobel-winning economist Milton Friedman, in particular, had no use for the FDA:
The FDA has done enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs, and by delaying the approval of such drugs as survive the tortuous FDA process.
Various Reagan-era reforms attempted to pare the agency’s powers, but Clinton’s ’90s brought it roaring back in fine fettle.
Which brings us to the Tobacco Wars.
Investigating FUMP Cases!
Rockville, Maryland, is a nice little town about an hour from Meadowdale Farm, home of Porter & Co. It’s also the headquarters for the FDA’s little-known armed enforcement branch, the Botox Police.
The government spends some $77 million yearly on this 280-man force, known officially as the Office of Criminal Investigations (“OCI”) and, unofficially, as the bozos who micromanage cosmetic treatments and vitamin pills. Their jurisdiction is separate from the FBI, and their solve rate is laughable, with about 110 convictions out of nearly a thousand cases in the 2010s.
The OCI (complete with sidearms) primarily investigates what’s known as FUMP cases (foreign, unapproved medical products – aka off-label Botox). They also conduct elaborate stings that involve buying thousands of dollars’ worth of supplements from health-food stores and then... well, that’s it. That’s the sting.
The Botox Police are the brainchild of a meddling FDA Commissioner called David Kessler who took the reins of the agency in 1990 and, on looking around, realized there was one substance left on earth that the FDA did not regulate...
On his first day in office, as he tells it, an aide came up to him and remarked:
Mr. Commissioner, I think you should take on tobacco. FDA regulates everything else that comes into contact with the body, everything we eat and all our drugs. Why doesn’t the FDA regulate tobacco?
Why not, indeed? A question to ponder.
Kessler is on Bill and Hillary Clinton’s Christmas party list. At one of the parties, he got a hold of then-president Bill and told him that the best way to go after tobacco was to “focus on kids.” Shortly thereafter, television PSAs began to appear with Clinton lecturing the youth of America on immoral behavior.
To supplement the TV ads, Kessler formed the OCI, who he tasked to go around and conduct armed raids on tobacco fields and facilities that he felt were non-compliant with FDA standards. In a convenient end-run around actual law enforcement, he contracted with state governments to use underage youth in tobacco stings for which he’d then collect civil penalties... some $800,000 in fines by 2000, which, of course, was worth a lot more in 2000.
Kessler’s main argument was that tobacco was an addictive drug and should be regulated as such. His goal was to classify cigarettes as a “drug delivery device,” which would mean they’d be subject to the FDA’s punitive and prohibitive “pre-market-approval” regulatory pipeline.
Naturally, Big Tobacco did not share this view, which touched off a decade of legal battles...
The Tobacco Wars flamed throughout the ’90s – with Marlboro and Camel painted as the villains against Kessler, the upstanding hero.
In March 2000, the FDA lost a Supreme Court case in which it was determined that cigarettes were not “drug devices” – but that proved to be just a battle, not the war. In 2009, President Barack Obama signed legislation that handed definitive regulatory control of tobacco to the FDA. (By then, Kessler was out as FDA commissioner, but he eventually found a fun second career as COVID advisor to the Biden-Harris team.)
But this was a mere smoke break. The fight started afresh over vapes when they hit the American market, and in 2016, Obama signed the Deeming Rule, which allows the FDA to regulate whatever it “deems” to be a tobacco product.
So that’s it. The FDA now has absolute control over every single substance we consume.
Smoking is a filthy habit, but so is government.
Which is why Trump’s slight relaxation of vape regulation is (paradoxically) a breath of fresh air...
In May 2026, Trump’s FDA announced it does not intend to prioritize enforcement against nicotine-pouch and e-vapor products that have a pending premarket tobacco application (“PMTA”) or a supplemental application accepted for more than 180 days. This might not sound like much... but in the context of the FDA’s tightening noose over the past 90 years, it is a nearly unprecedented loophole that opens up a much quicker path to market for many smokeless tobacco devices.
And it is, of course, great news for vape producers, like the one we are adding to this month’s Best Buys...
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