Swisse secured the “assessed listed” status for the product Swisse Ultiboost High Strength Krill Oil on August 10, which it will be selling as an “assessed listed” product next year.
It is currently selling the same formulation, sold under the product named Swisse Ultiboost High Strength Deep Sea Krill Oil, under the “listed” medicine status.
With the “assessed listed’ status, the product will be able to make two specific health claims, according to Brad Sanderson, Translational Science & Human Studies at H&H Group – parent company of Swisse.
They are “relieves knee pain in individuals with mild to moderate osteoarthritis” and “increases knee physical function in mild to moderate osteoarthritis”.
The active ingredient in the product is the krill (euphausia superba) oil marketed as Superba BOOST by Aker BioMarine.
Swisse will enjoy exclusivity to the scientific data and health claims related to its upcoming launch for the next five years.
The “assessed listed” status is part of Australia’s Therapeutic Goods Administration’s (TGA) regulatory framework for complementary medicines.
In Australia, complementary medicines refer to non-prescription medicines available from health food shops, supermarkets, and pharmacies. Examples include nutritional supplements, vitamins and minerals, traditional herbal medicines, and ayurvedic medicines.
Ever since it was introduced in 2018, only three products that have secured the “assessed listed” status.
The other two products are Caruso’s Prostate Eze Max and Hydralyte Orange Flavoured Effervescent Electrolyte Tablets.
Such products could contain low risk ingredients but are able to make higher level indications or health claims, unlike the usual ‘listed’ medicines.
For example, Swisse Ultiboost High Strength Deep Sea Krill Oil, which is currently sold under the ‘listed’ medicines status, can only make general claims such as “supports heart, brain and eye health” and “easily absorbed”.
“Assessed listed” products are also identified by the “TGA assessed” symbol on its packaging and promotional materials.
As there are only two “assessed listed” products available in the market currently, there is a need for consumer education in this space.
“Through education on listed (AUSTL) and assessed (AUST L(A)) products, consumers will be equipped with the knowledge to easily identify products in the market that are based on quality science,” said Sanderson.
To be qualified for the ‘assessed listed’ status, products need to be assessed by the TGA for its scientific evidence and the health claims that they are making.
Swisse, alongside Aker BioMarine and Australia’s national science agency Commonwealth Scientific and Industrial Research Organisation (CSIRO), had cooperated on a six-month double-blind, randomised, and placebo-controlled human clinical trial to test the effects of the product.
Findings of the study were published in The American Journal of Clinical Nutrition last year, which showed that supplementation of the krill oil product has relieved knee pain and stiffness, as well as increasing knee physical function in adults suffering from mild to moderate osteoarthritis.
“It is encouraging that companies like Swisse have secured access to this regulatory pathway. It recognises their ongoing commitment to research, enabling new innovative products, with more specific evidence-based information, which explains complementary medicines in more detail,” said Complementary Medicines Australia CEO, John O’Doherty.
TGA receives six “assessed listed” applications
The TGA says it has received six new “assessed listed” medicines applications as of August this year.
Assessment is made based on the totality of evidence provided by the applicants, said a TGA spokesman.
“The evidence package provided with each application is evaluated on its own merit and can vary widely with each application.
“The recommendation is made based on the totality of evidence considered in the evaluation, which serves to establish the balance of benefits and risks of the medicine in relation to its intended use.”
The regulator added that it has received several requests for information about the framework and has been providing information to future applicants through pre-submission meetings and email enquiries.
The process would involve an application fee of A$2,040 (US$1,300) and an evaluation fee of A$15,651 (US$9,977).
The application is required to be evaluated within 150 working days after the application has been accepted for evaluation, the regulator added.
