The TGA has invited comment on proposed changes to the regulatory guidelines for OTC medicines. Closing date for comments is 11^th February 2012, and proposed changes can be viewed on TGA website. (Source: www.tga.gov.au)

Changes include the new definition of “Broad Spectrum” UVA, based on a test which is more stringent than current; and for SPF, a modified test method. Read about these changes in Dermatest’s newsletter. (Source: Dermatest)

Compositional guidelines for “added alpha-casozepine enriched hydrolysed milk protein”, “DHA-rich oil derived from microalgae Schizochytrium sp.”, “Steviol glycosides” and “Zeaxanthin” have been added to the TGA website. (Source: TGA)

Topics include GMP audits, clinical trials, release of therapeutic goods for supply in Australia, and quality risk management. (Source: http://www.tga.gov.au/newsroom/events-presentations-manuf.htm)

The product names are Capadex, Di-Gesic, Doloxene and Paradex. These products will be cancelled from the Australian Register of Therapeutic Goods on 1st March 2012. The TGA believes that the risks (serious adverse cardiovascular events) outweigh the benefits. (Source: TGA)

Peter Foster was arrested on November 11^th and placed into custody over the SensaSlim nasal spray, which was marketed with false claims. Foster has been convicted previously over Bai Lin slimming tea, the Chaste Corporation, financial crimes in the Pacific island countries, and was controversially an adviser to Cherie Blair, the wife of then British PM Tony Blair. (Source: ACCC)

The TGA has announced that deer velvet antler and slice, from two species of deer farmed in New Zealand, is now permitted as an active ingredient in listed medicines. Deer velvet has a long history of use as an ingredient in traditional Chinese medicines (Source: http://www.comlaw.gov.au/Details/F2011L02069).

The NZ Natural Health Products Bill is intended to regulate “therapeutic type dietary supplements” (as opposed to food-type, which are now covered by a Food Standard). The bill will also provide a list of prohibited ingredients and a list of ingredients that can be used in natural health products. A simple process for adding new ingredients to the list of those that can be used is also proposed. There will be a three-year transitional period to assist the industry comply with the new regulation (Source: NZ Government ministerial press release).

FSANZ has approved the enzyme Endoprotease (EC 3.4.21.26) as a processing aid and comment is sought on proposals to allow the enzyme amylomaltase (from genetically modified microorganisms) as a processing aid and dibromo-dimethylhydantoin as a processing aid for poultry and meat.

More than 1500 samples of 92 foods commonly used in Australia were analysed for the presence of agricultural and veterinary contaminants, some mycotoxins and nutrients. Conclusion is that the safety of Australian food supply has been confirmed. Report is published in full on FSANZ website.

FSNAZ has drafted a new standard for primary production and processing of seed sprouts. This is to address the problem of food-borne illnesses from ingestion of contaminated sprouts, which cost Australia approximately $2.1 million in 2005 - 2006. (Source: FSANZ)

FSANZ has ordered a recall of 1 kg bags of apricot kernels supplied by ChiTree. These kernels contain a high level of hydrocyanic acid which is potentially toxic when consumed in large doses. The product will be re-labelled and will include warnings on the use of the product. (Source: FSANZ)

FSANZ is updating a series of fact sheets which can be viewed here: http://www.foodstandards.gov.au/scienceandeducation/factsheets/

The deadline for comments on food derived from herbicide-tolerant soybean line MON87708 is November 19th. (Source: www.foodstandards.gov.au)

FSANZ has approved foods derived from herbicide-tolerant corn line DAS-40278-9. The food labelling will need to include the GM statement. (Source: www.foodstandards.gov.au)

Food Standards Australia New Zealand has amended the Australia only Standard 4.5.1 (wine production requirements) so that the minimum alcohol content for wine and sparkling wine produced in Australia has been lowered from 8% to 4.5%.
The amendment is relevant to wine produced in Australia only and does not apply to wine made in New Zealand or to wine imported into Australia and New Zealand, and brings Australia into harmony with the European Union export requirements, thus facilitating trade with the EU. (Source: www.foodstandards.gov.au)