The TGA announced that sports supplements will be regulated as therapeutic goods so long as they make therapeutic claims and/or contain higher-risk ingredients and/or come in tablets, capsules, pills form.
Examples of therapeutic claims include gaining muscle, increasing mental focus, increasing metabolism, increasing testosterone levels, preparing for workout, and recovering from workout.
Companies will have about two months to prepare themselves to TGA’s standards if their products contain substances scheduled in the 1) Poisons Standard or 2) the World Anti-Doping Code International Standard Prohibited List or a substance relevant to dendrobium or methylliberine.
From Novembrr 30 this year, such products will need to be entered in the Australian Register of Therapeutic Goods (ARTG) and regulated as therapeutic goods before they could be advertised and sold in the market.
Others which do not contain the higher risk ingredients but come in tablets, capsules, or pills and make therapeutic claims are given three years to comply with the requirements (until 30 Nov 2023).
The decision was made following 18 months of consultation with the industry stakeholders.
“We believe the TGA is basically taking a sledgehammer to crack a nut. TheTGA is exercising its muscle and providing a very high level of regulations going forward to supplements,” said Complementary Medicines Australia (CMA) CEO Carl Gibson.
“I will prefer to see the TGA focus on the illegal imports of the sports supplements ingredients, rather than try to over-regulate a very compliant sports supplement sector,” he said.
He added that the CMA would conduct discussions with the TGA to ensure that the transition happens smoothly and also to appeal to the health minister to focus on address illegal importation.
Prior to the decision, sports supplements are regulated as foods via the Formulated Supplementary Sports Foods framework and can make therapeutic claims, as well as being made in formats that are associated with medicines rather than foods.
Under the new ruling from TGA, products which do not fall into any of the above categories will continue to be regulated as foods. Examples include meal replacement shakes, muesli bars, and protein powders.
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Producing the sports supplements to TGA standards means that consumers will need to bear a higher cost, said Gibson.
For instance, companies will need to pay about AUD$1k (USD$702) to list a product in the ARTG.
In addition, companies will need to prepare evidence pack to back up each of the therapeutic claims on their products, and the evidence pack will cost about another AUD$45k (US$31k) to AUD$50k (US$35k).
Affected companies which have decided to comply with TGA standards will also need to ensure that the products are made in TGA-audited and GMP-certified facilities, which will add onto the cost.
This also means that Australia-made products will become less price competitive in the export market, said Gibson.
He added that there was also the concern of whether the industry has the capability to produce the number of sports supplements present in the market in the future.
“We also flagged the issue on the capability of the amount of TGA listed facility that can produce the quantities of sports supplements today.
“We are trying to assess if there is the capability and the facilities available to produce that level of sports supplements moving forward.”
Another option for the affected companies is to modify their product so that it can be regulated as foods, however, it might not be in their interest to do so.
For instance, they could modify their product by changing the product claims to not refer to performance in sport, exercise or other recreational activity.
“That will damage them when it comes to promotion and marketing of their product in the stores, because they wouldn’t be able to make claims on those products going forward,” said Gibson.
They can also change the product formulation to remove ingredients in scope, or change the product dosage form from tablet, capsules, or pills to more traditional food presentations.