Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

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)

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)

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)

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)

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