For instance, it is proposing oral tablets with the length or largest dimension longer than 22 mm to show more information, such as the size of the dosage units and instructions on how to consume the product on the labelling.
Oral capsules with length longer than 23.3mm, or width greater than 9 mm are also included in the proposal.
Aside from capsules and tablets, other dosage formats that have exceeded size thresholds, such as lozenge, pastille, chewable, and gum would also be affected by the proposal.
This is except for cases where the directions for use on the label are clear enough such that the product will not be swallowed whole.
For example, a chewable tablet with label directions that ‘tablets may be sucked, chewed or swallowed’ would be affected by TGA’s newly proposed labelling requirements.
The proposal, however, is not applied to products for children, and the TGA is proposing a transition period of two years for companies to update their labels.
The proposal is open for public consultation until July 11.
Currently, there are no legislated limits on the size of solid oral dosage forms for medicines in Australia.
There are also no general labelling requirements for warnings or information about size for large dosage forms.
“We have considered available evidence when establishing these proposed thresholds for labelling requirements.
“However, we need to consider if there is other evidence to support a smaller or larger threshold. As part of this consultation, we are seeking feedback on whether the proposed size thresholds for the new labelling rules should be smaller or larger,” said the TGA.
Choking cases: What and who
The move is in response to choking cases related to the swallowing of health supplements in larger size. Examples include those containing calcium carbonate and cholecalciferol or vitamin D3.
The TGA told NutraIngredients-Asia that it had received 80 choking reports involving listed medicines – which is what health supplements are categorised as in Australia – between January 1, 2021, and June 6, 2024.
Most cases (12 per cent) involved listed medicines containing calcium carbonate and cholecalciferol. Another 10 per cent involved products containing Euphausia superba or krill oil.
The increase in cases was already seen in 2020, where it received 76 such reports.
Majority of the cases (26 per cent) involved omega-3 or fish oil, while another 21 per cent were products containing glucosamine and chondroitin.
Multivitamins and minerals is another category most associated with choking cases in Australia. Choking cases include both choking and the presence of foreign body in the throat.
In cases where age was recorded, it was observed that two out of three involved seniors aged 65 and above.
Some of the cases had led to hospitalisation and there was a death case.
Other points proposed
Warning statements, a true to size image of the product, and directions for use are also put up in TGA’s proposal to alert consumers in taking these products with caution.
For instance, it is proposing to print the statements “warning: large tablets” and “swallow with water” on the product labelling.
“Feedback provided during the 2023 targeted consultation suggested that the word ‘warning’ was not required, and that the statement ‘large [dosage unit name]’ was enough.
“We are concerned that if the word ‘warning’ is not present, consumers might not realise that the intent of the statement is to inform them of a potential choking hazard.
“We are seeking your feedback, especially from consumers and health professionals, on the importance of the word ‘warning’ to draw attention to the potential risks from the large size of the dosage unit,” said the TGA.
An image of the dosage unit that is true to size, alongside the words ‘actual size’, might also be required to be printed on the product label.
This is except for cases where at least one entire dosage unit can be seen through the container and primary pack without opening the packaging.
The information would be required on the container, intermediate packaging and primary pack, but would not be required on the front panel where the name of the medicine is most prominently shown, added the TGA.
CMA: TGA’s proposals are more restrictive
On the other hand, Complementary Medicines Australia (CMA) said that TGA’s proposals – especially regarding the size threshold – were more restrictive than those CMA itself had proposed during the targeted consultation.
This is because the size threshold proposed by the TGA would affect at least half of the existing products.
The industry body said that information from member firms last year suggested that about 45 to 50 per cent of all products are greater than 22mm long.
Also, between 37 per cent and 70 per cent of all listed medicines are greater than 9mm wide.
“Considering the number of products likely to be affected, proposed changes have the potential to have significant impacts, and further information on a regulatory Impact Analysis is currently being sought,” said CMA.
