Last night I emailed the public affairs unit of the Department of Health and Ageing about the recent Croakey articles on the Therapeutic Goods Administration.
Below is my request, and the response.
Dear public affairs
Croakey has recently run several articles related to the TGA generally, and comp medicine regulation, and TGA media management. This is the most recent post and it links back to the previous articles.
I am very keen to publish a response or responses from the TGA to the matters raised.
• If there are any factual errors in any of the posts, please point these out
• if the TGA would like to respond to any of the specific concerns/questions raised or more broadly, this would be welcome
• if Kay McNiece or McNiece Communications would like to respond to the post on media relations issues, this would also be very welcome.
If anyone from the TGA would like to discuss this request, I’d be very happy to chat.
The TGA responds
Kay McNiece, Media Adviser, TGA, writes:
Thank you for the opportunity to respond to your articles on the regulation of complementary medicines in Australia. The TGA welcomes public scrutiny and debate.
There are 10,000 complementary medicines listed with the TGA on the Australian Register of Therapeutic Goods.
In general these products are considered to be low risk due to the nature of the ingredients they contain.
Listed medicines may only contain pre-approved low-risk ingredients and must not make claims nor impute that they provide benefit for the treatment or prevention of serious illness.
To ensure the safety of preparations used in complementary medicines, certain restrictions are applied including dosages and labeling. For example, herbal ingredients containing caffeine require label warnings.
Unlike many other countries in the world Australia ensures that complementary medicines are manufactured safely and only contain approved, low-risk ingredients.
This is not the case in the US, Europe or New Zealand where the controls on manufacturing quality, ingredients and claims that operate in Australia do not apply.
There are strict advertising rules about making health claims and sanctions, including removal from the Register or criminal charges, can be laid by the TGA.
Unlike higher risk registered medicines, listed medicines are not evaluated for efficacy before entry on the ARTG and consumers should be aware that the TGA regulates these products for safety but cannot guarantee if they work.
Consumers should also be reminded that while the effectiveness of complementary medicines is not evaluated by the TGA, the manufacturing quality and the ingredients are. Consumers should therefore avoid purchasing complementary medicines over the Internet, or from other sources if they do not have an Aust-L number showing that they have been listed in the ARTG.
Because of the low risk of listed complementary medicines, the TGA considers it appropriate for sponsors to apply to be on the Register on-line but sponsors of Listed medicines are required to hold evidence in support of claims made for their products and to produce this to the TGA for review upon request. If this is found to be inadequate, the TGA can take appropriate regulatory action.
In response to community concerns about the listing of complementary medicine, the TGA recently convened a working party of consumers and industry representatives to ensure that all parties are clear about their regulatory obligations and to explore ways of strengthening compliance.
Further information can be found here: How complementary medicines are regulated in Australia