Australians, despite being fatties, love taking dietary supplements. Think your vitamins, minerals and fish oils. In Australia, 1 in 3 men and 1 in 2 women take some form of dietary supplement daily. Despite this, however, otherwise healthy adults don’t actually need to. Unless you’re a pregnant woman or strict vegetarian (who are advised to take folic acid + iodine, and vitamin b12, respectively), you’re probably getting a perfectly adequate amount from your diet alone. At least, the majority of adults do. This is why the Australian Dietary Guidelines only recommend taking supplements if you are eliminating a food group from your diet. So then why do almost half of us take them?
Well, the answer is simple enough. We want to be healthy. Decades of advertising, Old Wives’ Tales, and shoddy science have told us that dietary supplements can, and will, make us just that. Despite the overwhelming evidence that a lot of dietary supplements offer little or no benefits, and don’t actually do the thing they claim to on the bottle. But that’s the thing – it’s on the bottle. You can’t expect everyday consumers to have a quick peep at the latest peer-reviewed meta-analysis of randomised double-blind placebo-controlled trials. Surely there must be a Government agency with enough regulatory zeal out there protecting them.
Well, the thing is, there isn’t. Not really. And as for why not? Well, that’s kind of a depressing story.
But first, some background. In America, the Food and Drug Administration, or FDA, is “responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices…”. They are technically, but not effectively responsible for supervising dietary supplements. And it’s not because they don’t fit into that definition – they do. But in order to explain The FDA’s comically small control over dietary supplements, we must first start as all good stories do:
Part 1: Death
It began in America in the late 1980s. A debilitating, incurable, and potentially fatal neurological disease was affecting the public, starting with three people in New Mexico. Relatively quickly, the culprit was revealed to be a contaminated batch of the supplement Tryptophan, an amino acid. What had happened was a new bacteria strain infected the production of the supplement at the Japanese manufacturing site, it got sent to market, and people started to become sick. But because the FDA did not have the authority to recall products, they had to request that firms recall the supplement, and urge consumers to stop taking it. Over a six-month period, more than 1500 Americans suffered from the disease, and 36 people died.
After this outbreak, the FDA attempted to increase regulations on dietary supplements. They proposed a bill that created a new standard – significant scientific agreement – which required a product be proved both safe and effective before reaching the public. This is more or less the same standard that drugs go through before approval – and it’s an arduous process that takes thousands of hours and millions of dollars.
Part 2: Lobbying
At the risk of losing, literally, billions of dollars, the dietary supplement industry launched a doubled-sided lobbying campaign that was as dramatic as it was effective. For the public, they framed the proposed bill as an inherent attack on Americans’ freedom, and enlisted celebrities like Mel Gibson to star in their adverts.
Never one to risk ‘muh freedoms’, Americans rallied in the millions to write to Congress. It was the second largest letter-writing campaign in all of U.S. history, only beaten by the Vietnam War.
At the same time, targeting Congress, the Nutritional & Dietary Supplements industry made a generous ‘donation’ to Senator Orrin G Hatch in the sum of $95,750 USD. Shortly after, the senator criticised the FDA, saying they were a “tiny agency possessed by a regulatory zeal equalling none”. In a definitely shocking and complete twist of fate, Hatch went on to sponsor the bill that would later become DSHEA, or the Dietary Supplement Health and Education Act of 1994.
This was the bill, or more accurately, is now the act, that requires the FDA to prove that a firm’s product is unsafe before they are allowed to remove it from the marketplace. As opposed to having the firm prove their product is safe and effective before being allowed to sell it to the public. Effectively, people have to get sick before the FDA has any ability to take action.
Now I know what you’re thinking: it’s good fun to laugh at Americans and their wack-a-doo ways, knowing that us responsible countries are nothing like them. Then you learn Canada had a similar battle a few years after the U.S. And that concerns you, because like any sane person, you’re a big fan of Cold Australia and their handsome Prime Minister, so you dig a little deeper.
An Australian Context
You learn that in Australia, supplements are considered “Complementary Medicines” and that they’re regulated by the Therapeutic Goods Administration, the TGA. The TGA categorise their complementary medicines into two broad classes: AustR and AustL.
AustR products are considered higher risk, and therefore must be ‘R’egistered with the TGA. AustL products are considered lower risk, and only need to be ‘L’isted there. All well and good. But besides that, what are the actual differences between them?
Well, the TGA claims that they fully and comprehensively evaluate products for quality, safety and efficacy before they will register them. Unfortunately, the same is not true when it comes to listings. “Under the current system, you can get your product stamped with an official-looking number by simply applying online … the TGA does not check any AustL products to see if they work or even if they are safe”, Rachel Dunlop, post-doctoral fellow reported for The Conversation.
Okay, maybe a little worrying. But if Johnny Depp’s dogs taught us anything, it’s that Australia has strict laws when it comes to health. Surely a good majority of the products would be registered, right? Well, luckily, the TGA has made this data available to the public. The amount of complementary medicines registered by the TGA? 42. The amount of complementary medicines listed by the TGA? 86,896.
But this of course has nothing to do with the fact that the Australian complementary medicine industry is worth around 4 billion dollars. Nothing at all.
Drugs – they have side effects, who knew?
The scary thing is, vitamin and mineral supplements are still drugs, definitionally, even if they aren’t regulated as such. They have a physiological effect when ingested and over-consumption can be dangerous. They can even affect other drugs you’re taking. Fat-soluble vitamins can be especially hazardous. Unlike their water-soluble counterparts, where in most (but not all) cases the excess will simply be urinated away, vitamins A, D, E and K will be stored in your liver and soft tissues and can cause conditions like hypervitaminosis.
Iron can also be particularly dangerous because it is one of the few minerals humans cannot expel from their bodies, excluding via blood loss, so it can quickly accumulate. This can lead to iron poisoning in the short term and iron overload in the long term. Subsequently leading to an increase in risk of getting a whole host of diseases, like heart disease, liver failure, scarring of the stomach, and even death. And this is why only people who have been diagnosed with iron deficiency anaemia should be taking iron supplements.
We all want to be healthy, that’s why we’re okay with shilling out a few extra dollars every month for the assurance dietary supplements provide. Maybe some of us have even heard that most people don’t actually need them, but ‘you never know’. What if we’re in the minority who actually do? After all, what’s the worst that could happen? Lose a couple of dollars?
Nobody talks about dietary supplements like they can pose a potential threat. They’re never thought of as bad. At worst? Ineffective. At best? They’re a magic-pill that’s making you stronger, and healthier, and prettier. They prevent diseases, hell maybe they even cure them. Dietary supplements are not ‘worth the risk’ because to many, there is no risk to take.
But it is not that simple. Dietary supplements have side effects. They can alter how medications are absorbed. They can be overdosed on. They are a drug.
If you’re concerned that you’re not getting the right amount of vitamins and nutrients from your diet, talk to your doctor about it. Get your blood checked. Don’t prescribe yourself the minimally-regulated result of a decades-old lobbying campaign. And stop wasting your money on expensive urine. Or you know, slow but inevitable liver failure.