Feature

Hidden dangers lurk in many sports supplements


Doug Hendrie


22/07/2020 1:51:14 PM

Experts have warned of undeclared poisons in supplements, especially grey market products from overseas. Is tighter regulation the solution?

Supplements
What is in the supplements? Experts say there can be real danger.

The use of sports supplement is hugely popular among athletes and fitness fiends, but many unknowingly risk consuming poisonous substances that can cause injury or death.
 
Australia’s chief anti-doping scientist wants GPs to know there are health risks associated with supplements that apply to athletes and recreational users alike.
 
Dr Naomi Speers, Chief Science Officer at the Australian Sports Anti-Doping Authority (ASADA), told newsGP studies have found a ‘notable proportion’ of supplements are contaminated with potentially poisonous substances that are often undeclared on the label.
 
While overseas-imported supplements pose the greatest risk, there have also been many cases of Australian supplements containing substances that are dangerous to and banned in sport.
 
Anabolic steroids and dangerous stimulants such as methylhexanamine and related compounds are common adulterants, while many products list higenamine (a beta-2 agonist) as an ingredient, despite being prohibited by the World Anti-Doping Authority (WADA).
 
Methylhexanamine is listed as a Schedule 10 poison due to the risk to cardiac health, and has been linked to at least five deaths internationally.
 
‘This has a strong stimulant effect and it is found in pre-workout preparations; that’s why people use it. But I don’t think the benefits outweigh the risks to heart and other organ health,’ Dr Speers said.
 
‘We encourage athletes to first consider their needs with their doctor and whether those needs can be met without supplements. If the athlete decides to proceed and accepts the associated risk, then use a batch-tested supplement. They are the highest quality and lowest anti-doping risk.
 
‘That applies to all consumers, in fact – it means significantly less risk from undeclared poisons.’
 
Batch-tested supplements are scrutinised for WADA-banned substances in an independent quality assurance laboratory. But even tested supplements cannot be 100% guaranteed to be free of dangerous or banned substances.
 
‘The range of substances used in supplements is constantly changing, so labs might not be testing for every possible prohibited product,’ Dr Speers said.
 
‘Supplements might contain traces of stimulants or be subject to failures to remove carryover from other products in the manufacturing line.
 
‘There are other products where it has been purposefully added and not declared on the label. Sometimes, complicated chemical names are used, so it’s difficult for users to identify what actual ingredients are contained in the supplement.
 
‘If there’s no effectiveness and you’re taking a risk, why bother? If there is a potential effectiveness and a small risk, you can make an informed choice about whether the benefit outweighs the risk. Batch-tested supplements are an important way to decrease the risk.’
 
A 2016 survey of 67 sports supplements readily available in Australia found 20% had one or more ingredients banned by WADA. None of the products with banned substances had them listed as ingredients, while two products posed ‘a very real risk to health’, according to independent quality assurance laboratory LGC, which ran the survey.
 
While the need to avoid career-damaging anti-doping sanctions may keep professional athletes from using more dangerous products, amateur bodybuilders and sportspeople also need to be aware of the health and anti-doping risks.
 
‘Unfortunately, what we’re seeing in results from athletes is that some are using supplements with undeclared ingredients. We’re concerned for their health as well as from an anti-doping position,’ Dr Speers said.  
 
Under WADA’s Strict Liability principle, the onus for compliance is on the athlete – meaning they can still be penalised if they use supplements with unlisted banned substances.
 
‘The stakes for athletes are really high. That’s why we do not recommend the use of any supplements,’ Dr Speers said.  
 
Around one third of ASADA’s potential doping violations are linked to supplement use.
 
James Cook University Associate Professor Shane Brun told newsGP that many sportspeople take supplements without being aware of the risks.
 
In a recent AJGP article, Associate Professor Brun notes that doctors treating athletes should be aware it is likely their patient is taking supplements, given studies have found the prevalence of supplement use among athletes to range between 62% and 88%.
 
‘A lot of gym junkies think they’re safe because they read the label,’ Associate Professor Brun said. ‘The reality is, due to the lack of regulations, many are tainted with steroids or amphetamines – because they give results.
 
‘The user gains muscle bulk and keeps using it. 
 
‘There’s regulation in place, but only for those purchased within Australia. A lot of users purchase supplements from overseas.
 
‘People don’t realise how dangerous it is.’

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Many athletes and sportspeople take supplements without being aware of the risks.

Regulatory change likely
A key issue is the way supplements are regulated.
 
In Australia, food and medicines are regulated separately in recognition that the categories have different uses and risks.
 
In April, Australian supplement manufacturer ATP Science received fines in excess of $302,000  from the Therapeutic Goods Administration (TGA) for, amongst other things, allegedly making prohibited representations regarding cancer and treatment of mental health conditions.
 
But the line blurs with sports supplements, which can be regulated either as food or a medicine depending on the specific combination of ingredients, claims and overall presentation.
 
The TGA is attempting to more clearly delineate the grey area between sports supplements marketed as foods and those that should be regulated as medicines.
 
Even supplements with well-known ingredients like green tea and caffeine can pose major threats at high doses, with a recent death caused by a teaspoon of caffeine powder and a liver failure to a green tea extract shake.
 
Deaths and serious harm caused by sports supplements both in Australia and overseas led Federal Health Minister Greg Hunt to push for ways to improve safety of sports supplements use, a TGA spokesperson told newsGP.
 
Under a current TGA proposal, certain sports supplements currently marketed as food would instead be regulated as medicines, such as those containing high-risk ingredients like prescription medicine ingredients, as well as those presented in a medicinal dosage form such as tablets or capsules.
 
In a February presentation to industry stakeholders, TGA chief Adjunct Professor John Skerritt stated that under the proposed changes, the affected supplements would be those that claim to ‘improve or maintain physical or mental performance in sport, exercise or other recreational activity’ while also containing ingredients not suitable for food, such as scheduled poisons or WADA-banned substances, or being presented in a tablet, capsule or pill.
 
In 2018–19, almost half (48%) of all closed advertising complaints to the TGA were for products not included in the list of approved medicines ­– the Australian Register of Therapeutic Goods (ARTG).
 
Many of these complaints are understood to be about sports supplements.
 
‘If the Government decides to declare that certain sports supplements are to be regulated as medicines, there will be sufficient time provided for many of the affected products to transition to any new framework,’ the TGA spokesperson said.
 
Sports supplements containing only food ingredients and presented in traditional food forms would continue to be regulated as foods.
 
A decision on the proposal was expected in May, but has been delayed due to the large number of stakeholder submissions, with a decision now expected in July.
 
If the proposal goes ahead, regulating supplements of concern as medicines would allow more regulatory control over the ingredients used, as well as the therapeutic actions that could be claimed, with the additional restrictions on advertising medicines also coming to bear.
 
Supplements declared to be therapeutic goods (medicines) would have to be included in the ARTG, or the formulation changed to be regulated as food in order to be legally supplied.
 
If this goes ahead, sports supplements regulated as medicines that breach the applicable regulatory requirements could be cancelled from the ARTG, advertisements pulled, fines issued and court action undertaken.
 
But even if the changes do go through, grey market imports where buyers purchase dangerous supplements from overseas are likely to be harder to stop.
 
‘The TGA will conduct an investigation in instances where it becomes aware of allegations that therapeutic goods are being supplied outside of the regulatory requirements,’ the spokesperson said.
 
‘The TGA works closely with the Australian Border Force, and relevant state and territory authorities, to detect potentially harmful products being imported into Australia and detain them as appropriate.
 
‘The TGA continually advises consumers to exercise extreme caution when purchasing medicines from overseas internet sites, particularly if the supplier does not require a prescription which would be a requirement in Australia for that product.
 
‘Products purchased over the internet may be counterfeit and contain undisclosed ingredients or potentially harmful ingredients or contaminants, and may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.’
 
Ben Crowley, the owner of Australian supplement manufacturer Bulk Nutrients, told newsGP he feels matters will not improve broadly unless border control is tightened to prevent importation of potentially dangerous supplements.
 
‘Virtually every product with banned substances has come from overseas. If we are legitimately concerned with safety, where are these banned goods coming from? Let’s police that first and foremost,’ Mr Crowley said.
 
‘I have real concerns over whether they can effectively hit their [safety] goals unless we ramp up border controls. The more we restrict supplements here, the more that people will buy from overseas. We need more scrutiny both here and overseas.
 
‘But we welcome more consistent and clearly understood legislation applied across the board. That will be a good thing.’

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Dr Naomi Speers, Chief Science Officer at the Australian Sports Anti-Doping Authority, told newsGP studies have found a ‘notable proportion’ of supplements are contaminated with potentially poisonous substances that are often undeclared on the label.

Stronger regulations long overdue
Monash University public health expert Associate Professor Ken Harvey told newsGP that moves to strengthen regulation of the supplement sector are long overdue.
 
Associate Professor Harvey has registered complaints about a number of illegal sports supplements in his role as President of Friends of Science in Medicine.
 
‘Sports supplements are where the most egregious breaches occur. Some really do have dangerous products in them – some have caused liver failure,’ he said. 
 
Associate Professor Harvey said independent testing in labs is useful but no guarantee of safety.
 
‘Additives vary from batch to batch, so a particular batch can be free [of additives] this month, but there’s something in it next month,’ he said.
 
But many complaints have not been resolved, Associate Professor Harvey said, and those that do go to court often lead to the company declaring bankruptcy and then restarting under a different name – the practice known as ‘phoenixing’.
 
‘There has to be a better way of doing things. Companies can drag it out for years while still promoting their products and making money,’ he said.
 
‘Penalties are just the cost of doing business.’
 
Associate Professor Harvey attended a stakeholder meeting in February, where many in the Australian sports supplement industry were supportive of TGA efforts to get illegal and dangerous drugs out of supplements.
 
But, he said, some in the audience expressed concern that if they reformulated their products, they would lose market share to ‘cowboys’ who would not follow suit.
 
‘Cowboy companies can continue to promote illegal products for years after complaints have been first raised, laughing all the way to the bank,’ Associate Professor Harvey said.
 
These concerns led to the Save Aussie Supplements campaign, launched by Australian supplement manufacturers.
 
‘Australians wanting to improve their health and performance, could be forced to search elsewhere if they can’t buy their supplements locally – turning them instead to unregulated websites overseas,’ the campaign website states.
 
A hidden arms race
Human and Supplement Testing Australia (HASTA) is one of the two laboratories that tests sports supplements in Australia. Its business development manager Jane Smithers told newsGP that responsible sports supplement manufacturers are very different to the unregulated products online.
 
‘Manufacturers who send their products to us are generally legit manufacturers with careful use of raw materials, so the positive rates in those products are really low,’ she said.
 
‘Our rates [of adulteration] are probably less than 1%. But when we went out and bought supplements off the shelf and from online stores, we got a 10–15% adulteration rate.
 
‘We screen for more than 200 banned drugs – stimulants, diuretics and so on – so you can say that this product is safer because it has been tested.’
 
A 2015 Dutch study of supplements bought online found that almost two-fifths contained adulteration or dangerous substances.
 
Ms Smithers said that issues could arise from accidental contamination, as well as deliberate adulteration.
 
‘With legitimate manufacturers, you’re more likely to have true contamination from botanical ingredients or from contract manufacturing facilities with cross-contamination,’ she said.
 
‘When you buy it off the shelf for “bulking” and “shredding” in the gym market, they tend to have adulteration. You can find websites telling you which supplement gives you best muscle bulking. These can use ingredients not listed on the labels.
 
‘The WADA-banned ingredient list only applies to tested athletes.’
 
Grey market supplement manufacturers will often engage in an arms race with testing authorities, by finding analogous substances.
 
In 2012, the TGA banned the use of DMAA (1,3-dimethylamylamine) after a fatality linked to the substance.
 
But Ms Smithers said some manufacturers soon found an analogue substance – 1,3-dimethylbutylamine, known as DMBA – to get around the regulations.
 
‘It’s difficult to stay ahead of the chemical analogues. You hope you’re not far behind the new thing,’ she said.
 
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