‘Time is running out’: Four-pronged approach for firms to meet Australian TGA’s new health claim rules

From March 6 next year, companies which register its products with the Australian Register of Therapeutic Goods (ARTG) should ensure that health claims made by the products are selected from a list of permitted indications​.

Companies are no longer allowed to make ‘free-text’ claims based on the scientific evidence that they have gathered about their products.

Products which failed to follow the new rules will be cancelled from the ARTG listing and no longer legal for sale.

According to the TGA, as of end August, 76% out of all the 10,373 listed medicines currently listed in the ARTG have transitioned to permitted indications.

Speaking to NutraIngredient-Asia, ​product development and regulatory consultancy firm Take Friday Off said that firms could follow a four-step approach when making the changes.

This will require sponsors/brand owners to have a high-level overview of all the standards, founding partner Dane Renshaw said.

To start off, he said that sponsors should update the evidence that they hold for their products so that it is compliant with current evidence. 

Doing so prevents the product from running into issues during TGA's post-market review. It also reduces the chances of the competitor's regulatory team in spotting potential problems with the product. 

Second, based on evidence available, sponsors can update the product’s health claims on the ARTG by making a selection from the list of permitted indications.

Third, sponsors can then update the product label with the new health claims, while ensuring that this is done in accordance with the new labelling order.

The new product labelling rule ‘Therapeutic Goods Order No. 92 (TGO 92)’​ has come in force from September 1. It states the permitted label presentation and information to be included on the label. For instance, the product needs to state if it contains allergens.

Renshaw said the problem was that some companies had updated the labelling but not the health claims. This means that they have to change their product label again to include the new health claims.

Lastly, sponsors should ensure that claims made on the product label correspond with information registered on the ARTG.

The consulting firm believes that the above method can prevent double handling or back tracking of past efforts.  ​

“It becomes a seamless exercise when you can look at all the different pieces of the puzzle and how they fit together,”​ Renshaw said.

Founding partner Gabriel Perera also recommended sponsors to prioritise the above steps for its top 10 best-sellers while working on the others at the same time. 

Challenges​

One of the challenges that firms might face is the time constraint in completing the process due to delays in making the preparation.

“A lot of people think they have got heaps of time. The reality is, you don't update your labels very regularly,” ​said Perera, who counts Blackmores and TCI among his previous employers.  

“It is only when you do a new production batch, which might not happen for four months that you do this exercise and by that time, potentially, it is already 2021 and you are in trouble.”​

He said he had seen cases where some brands only have half of their range that was kept up to date.

The duo also stressed that firms cannot simply replace their old health claims with the closest possible from the list of permitted indications as they need to take into account new scientific evidence.

In certain cases, firms might have to reformulate their products, instead of simply updating the health claims and this would require more time and effort.

Reformulation opportunity​

From his experience working with the sponsors, Perera said about 30% have considered the reformulation of their products, beyond updating of health claims.  

“This (updating to permitted indications) is actually a good opportunity for brands to take a look at their formulas, to see if the ingredients are outdated or if the evidence is not quite where it could be,”​he said.

Most of the permitted indications, he said, were in fact “very good”​ and could allow sponsors to make attractive claims for their products.

He added that some of the popular functions that firms were considering when making new products included gut and immune health, gut and mental health, sleep improvement, stress reduction, and energy.