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The Therapeutic Goods Administration (TGA) has issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines.
It is alleged the company attempted 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. Neem (except debitterised neem seed oil) is categorised as a Schedule 10 substance in the Poisons Standard. This means it is considered dangerous to human health and is prohibited from supply and use in Australia.
The other product is not included on the Australian Register of Therapeutic Goods (ARTG). Therapeutic goods, including traditional and complementary medicines must be entered in the ARTG before they can be lawfully imported unless an exemption applies. This is an important safeguard to help ensure the safety, quality and performance of products.
The TGA warns those considering importing unregistered therapeutic goods into Australia, including complementary, over the counter and traditional medicines, that they should be aware of, and comply with, the applicable regulatory scheme. Importers who don’t follow the requirements risk financial penalties including seizure of the products, fines and other legal action as appropriate.
As supported by recent court outcomes, any business seeking to supply health treatments or services using therapeutic goods must be aware of their obligations under the Therapeutic Goods Act and its regulatory framework. Ignorance is not accepted as a defence for unlawfully importing and supplying products - significant fines or penalties can result from regulatory action.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400