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Why Aren’t Supplements Regulated Like Medicines?

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So, recently I was interviewed about supplements and how the supplement industry has changed over time. It was a pleasant chat, albeit one I doused with a sprinkle of cynicism. At one point, I was asked a fairly straightforward question. What supplements do people actually need?

My answer was none. When pressed, I summoned all my Irish wit and charm to answer… ‘yeah … none.’

Now before people jump down my throat about B12 deficiencies, folic acid or Vitamin D, never mind creatine, my point was far more boring. Eventually I explained that there is no medical necessity for otherwise healthy people to take supplements.

And look, I am a massive hypocrite. I take creatine every day, fish oils every few days, and every few mornings I’ll lazily throw milk and protein powder together and call it ‘breakfast’. But still, I’ll double down that none of that is necessary.

The supplement industry does not agree with my cynicism. Whenever I visit the US, I’m met with pills and potions promising better sleep, less stress, faster metabolism or ‘5-hour energy’. Add in protein powders, pre-workouts, joint supplements, creatine, etc., and it all becomes a ‘bit much.’

Why can supplements, with miraculous results, be sold so easily? Irish comedian Dara Ó Briain has a wonderful bit about alternative medicine. “Do you know what we call alternative medicine that works? Medicine!”.

So are supplements ‘alternative medicine’ or ‘medicine?’ to use Ó Briain’s distinction. Do they work or are they more of a vibe? Supplement companies cannot make outlandish claims but they are allowed to say their products ‘support’ sleep, muscle growth, fat loss and whatever esle we’re worried about.

The reason this distinction exists is, predictably, an American tale about lobbying power and Congressional oversight, mixed with a steady dose of fitness capitalism.

Supplements as subscription services

In 1901 the world’s first bodybuilding star, Eugen Sandow, began promoting a milk-based protein supplement named Plasmon. It was a short-lived sponsorship but tellingly, it saw Sandow make remarkable claims about Plasmon’s health and strength benefits. At one point Sandow claimed to have drank nothing but Plasmon shakes for several weeks, while maintaining his body weight and even increasing his strength. Given that liquid diets are generally better known for producing rapid weight loss than feats of muscular improvement, some cynicism seems warranted.

The basic premise of Sandow’s sponsorship, which he later brought into his cocoa business, was sound. If people bought his supplement, they would become regular customers. A similar logic re-emerged in the fitness industry in 1946 when Bob Hoffman, owner of York Barbell, met American nutritionist Paul Bragg.

In a series of rather interesting exchanges, Bragg told Hoffman that selling barbells was a fool’s game. A barbell could last a lifetime. The real money, Bragg explained, was in selling nutritional supplements. Then Hoffman would have a customer for life. There was, in Bragg’s mind, ‘tremendous income’ in supplements, although sadly for Bragg, Hoffman initially dismissed the idea.

He came around, though a few years later when he realised the truth in Bragg’s words. The reason for his transformation was simple. Someone else was making money! In the early 1950s, Irvin Johnson (who later renamed himself as Rheo H. Blair) began selling high-protein foods in Hoffman’s Strentgh and Health magazine, as well as Peary Rader’s Ironman.

Seeing the money Johnson’s protein foods were making, Hoffman got in on the act. So too did bodybuilding impresario Joe Weider. By the middle of the 1950s, supplements and claims that young men were increasing their muscle mas and size in ‘28 days’ were common in bodybuilding magazines. Heck, the magazines even had photographs to prove that these transformations were legitimate.

The timing was hard to ignore. After the 1954 World Weightlifting Championships, Bob Hoffman and the American physician John Ziegler became interested in reports that Soviet lifters were using testosterone. Ziegler came home, experimented with testosterone and worked with Ciba Pharmaceuticals to produce a new anabolic steroid, Dianabol, released in 1958.

Some of the first people to trial Dianabol were Hoffman’s weightlifters and their bodybuilding friends. So when Hoffman or Weider ran before-and-after photos crediting their supplements, the bodies in them belonged to enhanced athletes.

This, in a nutshell, is why I’m cynical about supplements. Modern fitness supplements and steroids effectively grew up together.

The body beside the tub

Who remembers the “dat dere Cell-Tech” meme? It was supposedly the response that Mr. Olympia legend Ronnie Coleman gave when a fan asked him whether he was natural. Coleman’s response? All he took was ‘dat dere Cell-Tech’, a creatine supplement that was ‘24 times more powerful’ than your average creatine (a line that has stuck with me for twenty years).

‘Dat dere Cell-Tech’ was funny because it was a wink and a nod to the fact that Coleman was clearly enhanced but rarely, if ever, discussed it.

The most controversial moment of my early gym years was undoubtedly found in Chris Bell’s 2008 documentary Bigger, Stronger, Faster. In it, fitness model Christian Boeving was asked at the filming of a MuscleTech Hydroxycut advertisement whether or not he used steroids. Boeving casually said that he used steroids as well as the supplements he advertised.

He believed that people should be smart enough to know that he was enhanced but that he did not advertise products that he did not personally use. The problem, obviously, was that his sponsors did not use nuance in their advertising.

This cycle, pun intended, still exists in the online age wherein TikTok and Instagram influencers continue to promote ‘miracle’ supplements for their enhanced physiques. So if we know that the industry is based on half-truths why aren’t we regulating them differently?

Regulating Supplements

In 1994, the US Congress passed the Dietary Supplement Health and Education Act of 1994 or DSHEA. The act tried to provide greater clarity and oversight over supplementation.

Although seen as a landmark moment, it was a continuation of previous battles. During the 1970s, the Proxmire Amendments were passed in the USA, which limited the Food and Drug Administration (FDA)’s ability to regulate high-potency vitamin and mineral supplements. At the time, there was an attempt to class high-dosage supplements as medical drugs, which would restrict their usage. Lobbying and political pressure prevented this and, in many people’s minds, the logic was sound.

Vitamin C was not chemotherapy, and nobody really wanted every vitamin tablet spending years moving through a pharmaceutical approval system.

It is at this point that we turn to Mel Gibson.

In the fight against more government regulation, the supplement industry commissioned this admittedly brilliant advertisement. In it, Mel Gibson’s house is raided by federal agents because Gibson had the temerity to take vitamin C. The message was fairly straightforward. Government regulation meant a nanny state where Big Brother was always watching.

Now, the FDA was not going to barge in celebrity actor’s homes, no matter how funny this may be. They were hoping to make the industry more responsive to the need for evidence-based claims and greater safety. Much of this was lost in the weeds as the general public became distressed and angry at the FDA’s perceived overstep.

The reality was that American supplement manufacturers were coming off of a series of bad mistakes. Beginning in 1989, American doctors began recording an outbreak of eosinophilia-myalgia syndrome in people taking L-tryptophan supplements. In August 1990, 27 deaths were even attributed to people using L-tryptophan products.

The evidence eventually pointed at a company called Showa Denko and their manufacturing processes. For the supplement industry, this was an unfortunate once off which stressed the need for improving manufacturing and quality control. For the FDA, it stressed the need for much greater regulation.

In the end, DSHEA sat awkwardly between these two camps. It kept manufacturers responsible for producing safe products but, at the FDA kept its power to come down on adulterated and misbranded supplements. It also mandated that whenever a supplement contained a new ingredient (that is previously unknown substance), the FDA had to be notified.

Weirdly, things did not get better.

DSHEA gave us the language of “structure” and “function”. Companies could say that a product supported normal body functions or general wellbeing without making the kind of explicit disease claim that would move the product into drug law. Viagra causes my erection but a ‘secret Chinese herb’ supports it (to be clear, I don’t use either, which is undoubtedly a defence that makes me more suspicious).

The FDA did not pre-approve those claims. Manufacturers were expected to possess evidence supporting them and notify the agency after marketing began. Bottles had to have some variation of “These statements have not been evaluated by the Food and Drug Administration” in tiny print.

When the safety net is underneath you

Ephedra became the first great test of the post-DSHEA system. Supplements containing ephedrine alkaloids became popular for weight loss, energy and athletic performance during the 1990s. Hell I remember a time when ephedra was sold pretty much anywhere. It was ‘the’ weight loss drug.

FDA eventually declared dietary supplements containing ephedrine alkaloids adulterated in 2004, thereby banning them because they could potentially hurt consumers. This came after years of consumer complaints and scientific research. The FDA saw a danger, built its case and removed the product.

The unsettling thing is that this took a long time and, while it was happening, anyone walking into a supplement store could buy it in bulk.

OxyElite Pro was another, more concerning, case study. During the 2010s USPlabs sold popular bodybuilding and weight-loss supplements including Jack3d and OxyElite Pro. A reformulated version of OxyElite Pro contained aegeline, which FDA considered a new dietary ingredient requiring notification. USPlabs did not submit the required notification and the product went out to the market anyway. In 2013 doctors in Hawaii began seeing patients with severe hepatitis.

An investigation eventually identified 44 cases meeting its definition. Thirty-six had used OxyElite Pro, two required liver transplants and one died. Investigators found no other common supplement exposure among the cases, although they could not identify the exact mechanism responsible for the liver injury.

The FDA began invesitgating AFTER the illness and injuries began. USPlabs was meant to notify the FDA, chose not to, and got to sell the supplement anyway.

The boring examples

The spectacular cases can make the supplement industry look safer than it is. Liver transplants and stimulant scandals are, thankfully, a rare thing. Far more common are companies mislabelling or misrepresenting what’s in their mixtures.

In 2023 researchers tested 25 melatonin gummy products sold in the US. Among those containing melatonin, the measured amount ranged from 74 per cent to 347% of what the label claimed.

If melatonin isn’t your bag, consider this. ConsumerLab recently obtained FDA figures for 800 supplement manufacturing facilities inspected during fiscal year 2025. Nearly half received Form 483 observations connected with current Good Manufacturing Practice requirements, and the figure among US facilities was 47.6%. That does not mean half of every supplement factory in America was failing basic standards. These were the facilities FDA inspected, rather than a random sample.

Still, when inspectors visited 800 plants, they found enough wrong to cite nearly half of them. I would struggle to describe that as reassuring.

A JAMA Network Open study examining FDA warnings from 2007 to 2016 identified 776 adulterated supplements containing unapproved pharmaceutical ingredients. Most were sold for sexual enhancement, weight loss or muscle building. In 757 cases the pharmaceutical ingredient was absent from the label. Great.

So what would I actually change?

We could, as I often joke, just regulate all supplements like medical drugs. But that may be a smidge extreme. In Canada, natural health products have to recieve a product licence before they hit the shelves. Australia has a ‘risk based model’ where lower risk supplements have lighter requirements than stronger ones. In other words your low dose Vitamin C is fine but your ‘extreme-metabolic-fat-blasting’ pre-workout will face greater testing.

Funnily, supplements can still be found in both countries, which suggests that regulation would not ‘kill’ the industry and may ‘shock horror ’ protect consumers. If I had a magic wand, I would probably use something embarrassingly simple like a green, orange and red light system. Ordinary nutrients with long records of safe use get the lightest route. New concentrated ingredients or products making stronger physiological claims face proper scrutiny before sale. Products that cannot clear that bar do not get sold.

In America, Congress struggles with much smaller changes. In January 2026, Senator Dick Durbin introduced the Dietary Supplement Listing Act, followed by a House version from Maxine Dexter in April. Both bills require supplement manufacturers to list products with FDA. This is a tiny proposal, thirty years after DSHEA, and, at the time of writing, little progress has been made in passing it.

The crux of both bills is whether the FDA should reliably know what is in the supplements on American shelves. Earlier this summer, the American College of Physicians cited poor manufacturing and outlandish claims in the supplement industry and called, if not cried out for, better legislation and a modernization of DSHEA.

Personally, I’m with the doctors over the supplement sellers. The problem for me, as someone who worked in the US and now lives in Ireland, is that this is not just an American story. America leads the way in the fitness industry and, despite greater regulations in the European Union, similar issues apply.

When pressed in my interview, I glibly paraphrased Dara Ó Briain. “You know what we call supplements that work? Steroids!”

In healthy people, there is no obvious reason to take supplements. This doesn’t mean you shouldn’t use them. It just means there’s no stone tablet anywhere reading ‘thou shalt take amino acids.’

There is a second problem particular to fitness. Many of the bodies used to advertise supplements were built through some combination of exceptional genetics, years of work and pharmacology, in whatever order you wish to arrange them. Finally, the supplment industry has convinced us all they are responsible enough to regulate themselves when the reality proves anything but.

So what supplements do people actually need? A better question to ask is ‘what is in your supplements?’

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