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How is the regulation on Health Food in Australia different from other countries?

How is the regulation on Health Food in Australia different from other countries?

In Australia, vitamin, mineral, herbal and other health supplements are referred to as Complementary Medicines by the Australian government. These products are regulated as therapeutic goods under the control of the Therapeutic Goods Administration (TGA) within the Commonwealth Department of Health and Ageing.

All medicines in Australia, both complementary and conventional, must be manufactured under pharmaceutical standards of good manufacturing practice (GMP). All medicines must be on the Australian Register of Therapeutic Goods (ARTG) as either listed or registered.

All prescription medicines and the majority of over-the-counter (OTC) pharmaceutical medicines are registered and labelled ‘AUST R’, while the majority of Complementary Medicines are listed and are labeled ‘AUST L’. Registered medicines have been evaluated by the TGA for quality, safety and efficacy. Listed medicines have been similarly assessed – only not for efficacy. Companies making claims for efficacy however, must hold evidence that supports these claims. Any high-level claim of efficacy for a serious disease requires registration and TGA assessment.

In contrast, vitamin, mineral, herbal and other health supplements in the United States are regulated as dietary supplements. The U.S. Food and Drug Administration (FDA) are not involved in the assessment or certification of these types of products to ensure the quality, safety and efficacy.

Under the Australian Government TGA requirements, all health food supplements listed under the Australian Register of Therapeutic Goods (ARTG) with a Aust L number have to undergo a range of manufacturing testing such as microbiological tests for total viability count, mould & yeast, E. Coli, salmonellas, enterobacteria, etc; and chemicals tests for the presence of harmful heavy metals such as mercury, etc; according to the safety requirement for relevant finished products and the associated raw materials before manufacturing. All the testing records for each batch of finished products are fully documented and samples of finished products have to be kept by the manufacturer and the product owner for at least two years for retrospective checking and verification.

This places Australia at the forefront of complementary medicine regulation and ensures that Australian consumers have medicines produced at a high level of quality control.

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