TGA Australia fines Akula Foods for unregistered Ayurvedic alternative medicine imports

28 Feb 2024 --- The Therapeutic Goods Administration (TGA), a division of the Australian government’s Department of Health and Aged Care issued two infringement notices worth AUD$37,560 (US$24,400) to Akula Foods for the alleged unlawful import of unregistered Ayurvedic complementary medicines.

The company was implicated in attempting to import Himalaya-branded Ayurvedic medicines for wholesale supply to retailers. One of the products, Himalaya branded Neem tablets, contained the ingredient Azadirachta indica, commonly known as neem.

“Unregistered products have not been evaluated by the TGA for their safety, quality and efficacy as those approved by us for supply in Australia and may be unsafe. They could also contain undisclosed harmful ingredients that could cause a serious adverse reaction,” a TGA spokesperson, tells Nutrition Insight.

“The TGA has issued several safety alerts to remind consumers of the potential health risks of using unapproved therapeutic goods.”

Neem — with the exception of debitterized neem seed oil — is categorized as a Schedule 10 substance in the Poisons Standard and is considered dangerous to human health. The substance is prohibited from supply and use in Australia.

“Infringement notices are an opportunity for entities to pay an amount as an alternative to having court proceedings brought against them. We cannot compel the recipient of an infringement notice to pay it. Payment of infringement notices is not an admission of liability. However, if entities decide not to pay infringement notices, civil or criminal court proceedings may be brought against them,” the spokesperson says.

Not entered in the register
The second unregistered product should have been included on the Australian Register of Therapeutic Goods. Therapeutic goods, including traditional and alternative medicines, must be entered into the register before they can be lawfully imported unless an exemption applies. The safeguard has been put in place to ensure product safety, quality and performance.

Since 31 March 2023, the TGA has issued 67 infringement notices totalling AUD$731,940 (US$476,190) in relation to unlawful importations of unapproved therapeutic goods.

“The TGA works closely with the Australian Border Force to detect alleged unlawful importations of medicines, including unlawful ayurvedic medicines, and takes appropriate compliance action. Anyone can report counterfeit products, suspicious or illegal activity or make a report about non-compliant advertising to the TGA,” the spokesperson says.

The TGA warned that those considering importing unregistered therapeutic goods into Australia, including complementary, over-the-counter and traditional medicines, should comply with the regulatory scheme. Suppliers who do not follow the requirements risk financial penalties, including seizure of the products, fines and other legal action as appropriate.Neem is categorized as a Schedule 10 substance in the Poisons Standard.

“The TGA takes non-compliance with the Act seriously. Consistent with our regulatory compliance framework, we employ various compliance and enforcement tools. These range from guidance to warning letters, infringement notices and civil or criminal court proceedings to address alleged breaches of the Act, including alleged unlawful import of unregistered products,” the spokesperson says.

Current consumer purchasing behavior shows that the digital mindset of convenience heavily influences the bone health segment and has merged with extracts revered in traditional holistic medicinal practices, botanicals, fruit extracts with antioxidant properties, phytonutrients and micronutrients.

Recent court outcomes
Any business that wants to supply health treatments or services using therapeutic goods must educate itself about the obligations under the Therapeutic Goods Act and its regulatory framework, as recent court outcomes support.

When deciding on a course of action to take in a particular case, TGA takes the seriousness of the alleged non-compliance and failure to follow the regulatory requirements into consideration; the compliance history and behavior of the responsible person or business and the level of compliance of the particular industry sector.

The TGA states that “ignorance is not accepted as a defense for unlawfully importing and supplying products,” and significant fines or penalties will result from regulatory action. They urge members of the public who suspect non-compliance to report illegal or questionable practices online.

Meanwhile, a research team in China has developed a method to pinpoint active ingredients from traditional Chinese medicine (TCM) formulations. TCM formulas require multiple herbs for their formulations, which act synergistically. The technique was used on Xiaoer-Feire-Kechuan , a specific TCM with an 11-ingredient formula used to treat cough and lung inflammation in children.

By Inga de Jong