Alternative medicine products found to breach regulations

Herbal medicines, supplements, vitamins on the shop shelf.

Hot issue … 90 per cent of tested alternative medicines found to be non-compliant.

Nine out of 10 alternative medicine products checked by the therapeutics watchdog have been found to breach regulations, fuelling calls for tougher controls of the $4 billion-a-year industry.

The breaches, largely relating to false claims of curative powers on labels, have triggered the removal from shelves of about a dozen products found during a random review to have failed compliance tests. But the federal Therapeutic Goods Administration found that alternative medicine companies can exploit a regulatory loophole by relisting banned products – sometimes within 24 hours – by using a different brand name.

The disclosure of a 90 per cent non-compliance rate was made in a ”hot issue” briefing document to the government, made public by the federal Department of Health and Ageing. 

As a result a ”significant number” of products were removed from the Register of Therapeutic Goods, the document said, adding that ”this information is not publicly available”.

Products removed from the register cannot be legally sold. There are 10,250 complementary medicines, including vitamins, minerals and herbal preparations, listed on the therapeutic goods register.

The document said a review of about 400 – or 26 per cent – of newly listed medicines last financial year found 90 per cent did not comply with regulations.

”The high level of … compliance irregularities presents a major risk to confidence in the Australian government’s regulatory framework for complementary medicines and the complementary industry itself,” the document said.

”The majority … take appropriate corrective actions when compliance issues are brought to their attention. However, a small percentage of the industry is consistently non-compliant.”

A spokeswoman for the TGA said yesterday 150 requirements and many non-compliance issues were the result of relatively minor matters, including wrong-sized fonts on labels. Most matters of non-compliance could be rectified but 3 per cent of randomly reviewed products were removed from the market by the TGA.

The agency is working with the industry to improve compliance and make the public aware the TGA does not evaluate alternative medicines for efficacy before they go on sale.

The Consumer Health Forum, which is pressing the government to strengthen the regulation of complementary medicines, has called for more clarity in the marketing of the products.

The forum’s chief executive, Carol Bennett, said there needed to be more honesty in marketing ”so consumers who buy these products know [the products have] not gone through a test”.

Ms Bennett said that often, even after complementary medicines were found to have misleading labels, companies were able to circumvent regulations or were subject to weak penalties under civil law.


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