Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

The Australian regulatory guidelines for complementary medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia. If you want to supply a complementary medicine in Australia, you may choose to employ a regulatory affairs consultant.   Source: CM guidelines

Bee Sexy Slimming capsules - The Therapeutic Goods Administration has tested a product labelled Bee Sexy Slimming capsules and found that the capsules contain the undeclared substance sibutramine. Consumers are advised that sibutramine is a prescription-only substance in Australia. Sibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke.   Source: Bee sexy

Vigour 300 tablets - The TGA has tested a product labelled Vigour 300 tablets and found that the tablets contain the undeclared substance sildenafil (active ingredient in Viagra).   Source: Vigour 300

Quality Bakers Australia Various Bread Rolls - has recalled multiple bread roll products due to the potential presence of foreign matter (metal pieces).   Source: Bread roll metal

Woolworths Singleton Australian Mince (various) - Woolworths Limited has recalled Australian pork, beef and lamb mince sold from its Woolworths Singleton store in NSW due to a packaging fault resulting in the presence of metal fragments.   SourceMince metal

Pandaroo Sushi Ginger - G & L YUEN Pty Ltd trading as YUEN’S MARKET TRADING CO. has recalled Pandaroo Sushi Ginger due to the presence of foreign matter (glass).   Source: Sushi ginger

Consumers and health professionals are advised that the TGA is aware of overseas safety concerns relating to homeopathic teething products, which are potentially harmful for infants and children,and is investigating the issue. The USA Food and Drug Administration published a safety alert and media release stating that homeopathic teething tablets and gels may pose a risk to infants and children. The TGA is conducting urgent laboratory testing of homeopathic teething products currently marketed in Australia to ascertain whether any action is required here.   Source: teething troubles   

Application A1135 – Beta-galactosidase from Bacillus licheniformis as a Processing Aid (Enzyme)

The purpose of the Application is to permit the use of a new source of beta-galactosidase from Bacillus licheniformis to be used as a processing aid during the production of reduced lactose or lactose free milk and dairy products.   Source:Bacillus enzyme

Application A1113 – Extension of Use of Propionates in Processed Meat

The purpose of the Application is to request the extension of use of propionates as anti-microbial preservatives in processed meat products.   Source:Meat propionates

Application A1115 – Irradiation of Blueberries & Raspberries

The purpose of the Application is to seek permission to irradiate blueberries and raspberries for phytosanitary purposes against fruit flies and other critical plant pests, at levels between 150 Gray (Gy) and 1 kGy.   Source: Berry irradiation

Proposal P1027 – Managing Low-level Ag & Vet Chemicals without Maximum Residue Limits

The purpose of this Proposal is to manage low-level agricultural and veterinary chemicals without MRLs (i.e. the food is not listed in Schedule 20, but the chemical is).    Source: Residual levels

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