Latest Regulatory News
TGA 21 day timeline for cancelling products prior to annual charges
The TGA advises that they will now take 21 working days to cancel the listing or registration of a product from the Australian Register of Therapeutic Goods (ARTG) after receipt of the sponsor’s request to have their product cancelled. If a sponsor does not want to be liable for an annual charge they should submit their required for cancellation by close of business 1st June 2012.
TGA publishes list of registered complementary medicines
Complementary medicines can be “registered” as opposed to “listed” on the ARTG. Registered medicines are fully assessed for quality safety and efficacy, whereas listed medicines are assessed for quality and safety, although the sponsor must hold evidence to support the product claims, and this evidence can be requested by the TGA. Only 25 complementary medicines are registered and these can be viewed on the TGA website – news page.
Warning notice regarding promotion of black and red salves as a treatment for cancer
Black and red salves (also known as Cansema, or Bloodroot Sanguinaria canadensis with the active caustic ingredient sanguinarine), are being promoted as alternative treatments for cancer. These products can lead to burning and destruction of normal tissue and result in severe scarring.
Revised guidelines for evidence to support product claims for complementary medicines
Listed complementary medicines may make “general” and “medium” level claims. Registered complementary medicines may make “high” level claims. The guidelines as to what constitutes appropriate evidence are being revised. To receive the revised guidelines, subscribe to the TGA email update service – go to TGA website then /newsroom/subscribe.htm.
Companies fined for false claims
Club Trading and Distribution was fined by the ACCC for falsely claiming that Double D eucalyptus oil was made in Australia, when it was an imported product. Rosie’s Free Range Eggs was fined for falsely claiming its eggs were free range, when most of the eggs were from caged hens.
Action on retail price maintenance
Another wholesale supplier, Edwards Essences, has accepted court-enforceable undertakings in relation to its action in pressuring its retail customers to not sell its ingredients for home brewing below a minimum price.
Food Standards Australia New Zealand proposes a different approach to regulation of nutritive substances in foods and novel foods
FSANZ has released a consultation paper (available on their website) which proposes to replace the current definitions for novel foods and nutritive substances with new criteria for eligibility. Non-eligible foods would need to be assessed. Closing date for submissions is 21st May 2012.
Symposium on regulation of nanoparticles
Nanotechnology is a sometimes controversial topic. At this forum hosted jointly by NICNAS and APVMA stakeholders with opposing views were brought together to discuss the issues. Interviews with participants can be viewed on the APVMA’s website.
Importing cosmetics into Australia – NICNAS summarises regulatory requirements
Published in their latest newsletter, this article serves to remind importers of cosmetics of their obligations, namely the registration of the importer, the need for ingredients to be included on the Australian Inventory of Chemical Substances, correct labelling, and awareness of any restrictions noted in the poisons schedule (SUSMP). RFA regularly advises companies selling cosmetics on compliance with these and other requirements such as product claims. Contact RFA if you need assistance.