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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.
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