Permitted indications rules: Around 10% of Australian supplement products not transitioned to new list

15-Mar-2021 - Last updated on 15-Mar-2021 at 02:02 GMT

Listed complementary medicines are supposed to make health claims based on a list permitted by the TGA from March 6 this year. ©Getty Images

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About 10 per cent of complementary medicines in Australia did not manage to transit to the new list of health indications permitted by the Therapeutic Goods Administration (TGA) and have been cancelled.

This is according to data shared by the Complementary Medicines Australia (CMA).

The deadline for transiting into permitted indications, also known as the TGO 92 framework, ended on March 6.

The framework requires supplement manufacturers to make health indications only based on what is permitted by the TGA, instead of the previous “free-text” indications.

The list of permitted indications can be found on the TGA website. Some examples of the permitted indications, for example, include “enhance/promote healthy digestion”, “maintain/support healthy digestion”, and “maintain/support digestion/assimilation of nutrients” when it comes to a product with digestive functions.

Complementary medicines which failed to transit from “free-text” indications to permitted indications will be cancelled from the Australian Register of Therapeutic Goods (ARTG) after the deadline has passed.

Citing figures obtained from TGA three weeks before the deadline, CMA said out of a total of 12,500 complementary medicines, about 10 per cent of the products had not changed into permitted indications.

The industry body added that it was unaware of sponsors that only managed to make the cut at the last minute. This is mainly because they have been given a three-year transition period.

Most of the products cancelled are legacy products that pre-date TGA set-up, Carl Gibson, CEO of CMA told NutraIngredients-Asia.

Legacy products refer to those which are no longer sold in the market, but manufacturers/brand owners continued to auto-renew the product license to keep them on the ARTG, so that they could re-launch the products if they want to.

“Sponsors have stopped renewing the product because they have decided that they are not going to release it into the market anymore.”

On the other hand, some sponsors had re-categorised and reduced the number of products they have decided to renew.

“Some people have taken the opportunity to re-arrange or consolidate their products.

“I know one sponsor who has 100 products and utilised the opportunity to streamline the products by doing away with 10 of his products.”

Gibson said the purpose was to cut down on the amount of administrative work required to transit all products to the new framework.

He added that sponsors with products that would be struck off from the ARTG would receive a reminder from the TGA. As such, there have been no known cases of unexpected cancellation.

“We did not receive calls [on unexpected cancellations] from the member companies at all, so we knew that there have been touchpoints or reminders that their products will be cancelled, and they could make the decision to either reformulate, take them off the market, or to have a new product.”