robert-forbes.com.au - Robert Forbes and Associates - Regulatory and technical advice to suppliers and manufacturers of complementary medicines, dietary supplements, OTC medicines, cosmetics, personal care products and foods.
To enquire about sponsoring an issue of our newsletter click here.
Robert Forbes and Associates wish you a wonderful Christmas, a safe holiday season and a healthy and successful 2012.
This year Robert Forbes and Associates will again be supporting Nordoff-Robbins Music Therapy Australia, which uses music as a therapeutic tool in schools, disability organisations, hospitals, and nursing homes. Please visit their website and support www.nordoff-robbins.com.au. Donations can be made online.
OTC & Complementary Medicines
Revised Guidelines for OTC Medicines (29 November 2011)
The TGA has invited comment on proposed changes to the regulatory guidelines for OTC medicines. Closing date for comments is 11th February 2012, and proposed changes can be viewed on TGA website. (Source: www.tga.gov.au)
Australia to be the First Country to Adopt New Internationally Harmonised Sunscreen Standards (23 November 2011)
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 Complementary Medicine Ingredients (22 November 2011)
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)
TGA Presentations on GMP Posted on Website (22 November 2011)
Pain Killers Containing Dextropropoxyphene to be Cancelled (22 November 2011)
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)
Serial Fraudster Peter Foster Arrested over SensaSlim Controversy (22 November 2011)
Peter Foster was arrested on November 11th 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)
Deer velvet antler now permitted in listed medicines (17 October 2011)
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).
New Zealand Natural Health Products Bill passes first reading (17 October 2011).
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).
New Processing Aids for Foods (5 December 2011)
FSANZ has approved the enzyme Endoprotease (EC 18.104.22.168) 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.
23rd Australian Total Diet Survey Published (5 December 2011)
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.
New Standard for Production and Processing of Seed Sprouts (22 November 2011)
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)
Apricot Kernels Recalled (22 November 2011)
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)
Comments invited on proposal to allow food derived from genetically modified soybeans (26 October 2011).
The deadline for comments on food derived from herbicide-tolerant soybean line MON87708 is November 19th. (Source: www.foodstandards.gov.au)
Food derived from genetically modified corn approved (26 October 2011).
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)
Minimum alcohol content for wine dropped from 8% to 4.5% (26 October 2011).
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)
Christmas Office Hours
Please note: our office will be closed from Friday the 23rd of December and will reopen on Tuesday the 3rd of January 2012.
One-hour training courses via Skype Along with our popular on-site regulatory training courses we are now also offering one-hour training courses conducted via Skype. These are one-on-one training sessions conducted by appointment, so you can remain in your office and undergo training at a time that suits you. The courses are available to buy through our online shopping cart.