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.
Outbreaks of Campylobacter food poisoning reported
FSANZ has advised that there have been outbreaks of Campylobacter food poisoning linked to dishes such as pâté, where poultry liver has been undercooked. Like other poultry meat, livers need to be cooked all the way through to kill bacteria that may be present. Lightly frying the surface is not enough. FSANZ states that cooked whole livers may still be slightly pink in the centre, but they should never be bloody or look raw.
Cancellations from the ARTG following compliance review
Five listed medicines have been removed from the ARTG following a compliance review.
Permitted (coded) indications for listed medicines
The TGA is seeking comments from interested parties on proposed reforms relating to 'Permitted (coded) indications' for listed medicines. Currently, when listing a medicine on the ARTG via the Electronic Lodgement Facility (ELF), sponsors may either select indications from a coded list or use a free text field to describe indications in their own words. Unlimited use of the free text field has resulted in a large number of inappropriate indications and other statements being entered on the ARTG. The TGA proposes to remove the free-text option and require sponsors to select indications from a list of permitted indications only.
Complementary medicines reforms
The Therapeutic Goods Administration (TGA) has started work on a series of reforms to complementary medicines that seeks to improve community confidence in the safety and quality of these medicines. The reforms are part of the TGA reforms: A blueprint for TGA's future ("the Blueprint"), including a number of recommendations from the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines.
Three imported “herbal” products found to contain undisclosed prescription medicine
The TGA is working with Australian Customs and Border Protection Services (Customs) to help stop future shipments of Libigirl capsules, Best Slim capsules and Meizi Evolution Botanical Slimming soft gel capsules from entering Australia. These products are presented as being “100% natural” or “herbal”. However, Libigirl capsules contain the undeclared prescription substances sildenafil and tadalafil, Best Slim capsules contain the undeclared prescription substance sibutramine, a prescription-only medicine - the active ingredient in Reductil – which was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. Meizi Evolution Botanical Slimming soft gel capsules also contain the undeclared prescription substance sibutramine.
TGA appoints new advisory council
The TGA has appointed a group of health care professionals to monitor its performance and communications.
BSE food safety risk assessment reports for the Netherlands, Croatia and Vanuatu
FSANZ has determined that the risk assessments for these countries show that effective controls for BSE are in place. FSANZ has concluded that the risk posed to consumers from the export of beef products from these countries is negligible.
Infant formula requirements - proposed changes
Food Standards Australia New Zealand invites submissions on proposed changes – closing date is 20th December 2012. FSANZ is considering an application to reduce the minimum required level of L-histidine from 12 mg/100 kJ to 10 mg/100 kJ. FSANZ states that this level is comparable to the average L?histidine content of breast milk and is considered adequate to support the growth of formula-fed infants, and the proposed change would provide consistency with international and overseas food standards, and reduce trade barriers. No public health and safety issues have been identified with the proposed change.
