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High-risk sports supplements to be regulated as medicines
The TGA will regulate supplements formulated to look like medicines with therapeutic claims from 30 November.
Sports supplements shaped like medicines will be more strictly regulated – or have to change form under new rules.
The move will bring greater regulatory scrutiny to the $2 billion sector, with undeclared dangerous substances such as stimulants, steroids and poisons sometimes present in the supplements, as Australia’s top anti-doping scientist has previously warned.
For example, four people have died in Australia from ‘fat shredder’ supplements in the last five years due to a chemical that can effectively cook internal organs.
The Therapeutic Goods Administration (TGA) declaration affects sports supplements with specific higher-risk ingredients, such as intentionally added substances banned by the World Anti-Doping Agency, as well as other intentionally added substances, and substances scheduled in the Australian Poisons Standard, which may include prescription medicine ingredients.
The move is aimed at reducing the risks from potentially dangerous ingredients after a spate of supplements-linked deaths internationally and in Australia. At least six liver and kidney transplants have been required due to sports supplement consumption, according to the TGA.
In its explanatory material, the TGA states some companies ‘may have exploited uncertainty, potential confusion and “grey areas” by marketing these products as foods and therefore potentially avoiding appropriate regulatory oversight’.’
The new regulation is aimed at separating out higher-risk and lower-risk supplements, and applying more oversight to those deemed higher risk.
Medicines must be manufactured in accordance with good manufacturing practice to ensure the quality of the product, with extra labelling, advertising and evidence requirements.
Many GPs regularly treat supplement users, given estimates for supplement use range as high as 88% of athletes, but may not be aware their patient is regularly ingesting them.
Public health advocate Associate Professor Ken Harvey told newsGP the move is broadly a positive one.
‘It’s good insofar as the TGA has removed the anomaly that sports supplements purporting to be “foods” [have previously] escaped TGA regulation and, as from 30 November 2020, products with high-risk ingredients on the Poisons Standard or Prohibited List will be subject to TGA compliance action,’ he said.
‘If the TGA acts, this should remove many products I’ve complained about.’
The TGA also states the changes will ‘allow prompt regulatory action for such products including those supplied via the internet and imported into Australia’. That is aimed at concerns among Australian manufacturers that grey market imports from manufacturers in less-regulated nations could simply bypass more stringent local rules.
Vitamins and minerals and products such as meal replacement shakes that do not make therapeutic claims will not be affected.
‘[Some supplements] contain ingredients that have stimulant or other drug-like effects, such as changes to hormone levels, or are in a medicinal dosage form (eg tablets, pills and capsules). These products can present a higher risk to the consumer and it is therefore inappropriate to have them available for purchase as foods,’ the TGA website states.
The declaration will also require sports supplements presented in medicine-like form such as pills – but which lack the riskier ingredients – will have three years to either change their dosage form and remain regulated as food, or apply to become a medicine.
‘One study suggests that up to 19% of sports supplements in Australia contain substances that are banned in sport,’ the TGA website states. ‘Moreover, a number of serious adverse events, including events that have led to death, involving the use of certain sports supplements have occurred in Australia and internationally.
‘Case studies report instances of renal failure and exercise-related rhabdomyolysis (damage and subsequent breakdown of skeletal muscle); liver damage and failure; lupus-like syndrome (an auto-immune syndrome with joint and muscle pain, fatigue and inflammation to the lining of the heart and lungs); interstitial nephritis (hindering the ability of the kidneys to work properly); cardiac toxicities; compartment syndrome (muscle pressure build up resulting in severe pain and weakness); and haemorrhagic stroke among other sequelae.’
These serious medical issues have largely affected younger healthy people.
Associate Professor Harvey, for his part, believes three years represents a ‘very generous transition’ for the lower-risk sports supplements presented as tablets and pills.
The TGA declaration also includes two substances considered to have a high enough risk profile to require regulation as a therapeutic good, but which are not currently listed on the Poisons Standard or prohibited:
- Dendrobium (dendrobium nobile) – often listed as a stimulant for sports performance. The TGA states the inclusion of dendrobium ‘provides legal clarity that sports supplements containing this ingredient are indeed therapeutic goods’
- Methylliberine – a psychoactive stimulant. The TGA cites Advisory Committee for Novel Foods (ACNF) concerns that the substance ‘has no nutritional value, does not appear to fit under a food standard and has no tradition of use as a food in the form in which it is presented … in addition, there is currently a lack of robust safety assessment data on methylliberine, its effects on the human body and its synergistic effect on the action of other stimulants, such as caffeine’
The TGA declaration comes after 18 months of consultation and preparation, which attracted 43 written submissions as well as 14,000 signatories to the ‘Save Aussie Supplements’ campaign.
The TGA dismissed this campaign as ‘largely based on a misperception’ around the scope of supplements to be affected.
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