Complementary Medicines and Medical Devices:
Therapeutic goods advertising compliance: 2020-21 Annual Report
Summarises compliance outcomes including examples, infringements and court actions. 55% of complaints originated from consumers, 18% from other companies. We recommend all suppliers of complementary medicines read this report. Source: TGA
HealthHub247 Pty Ltd and its director have been convicted of the unlawful manufacture, counterfeit, advertising and supply of sports supplements that contain prohibited substances, including substances banned by the World Anti-Doping Agency such as DMAA and DMBA, which are of danger to health. The company and its director Mr Croucher pleaded guilty to all charges. The director was sentenced to 12 months imprisonment and released on a two-year good behaviour bond. The Court noted that if not for Mr Croucher's serious ill-health, he would have served time in custody. Source: TGA
Unlawful importation of face masks – court action initiated in the Federal Court against Enviro Tech Holdings Pty Ltd (Enviro Tech), and its executive officers (Connie and Jerry Triantos). In December 2020, Enviro Tech was issued with a $13,320 infringement notice for the alleged breach. However, as Enviro Tech did not pay the infringement notice, further legal action is now being taken. Source: TGA, Notices of Filing and Hearing here and here.
Melbourne-based individual fined $18,648 for alleged unlawful advertising of nicotine vaping products. Source: TGA
Former export manager of pharmaceutical ingredient company pleads guilty to criminal cartel charges
On the 26th October Christopher Kenneth Joyce, formerly of Alkaloids of Australia Pty Ltd, pleaded guilty to three criminal cartel charges and admitted his guilt in respect of seven further offences, relating to his conduct involving price fixing, bid rigging and market allocation cartel arrangements between Alkaloids of Australia and overseas suppliers of scopolamine N-butylbromide, manufactured from the Duboisia plant, which is native to Australia. Source: ACCC
Listed medicines compliance reviews
Applications for listed medicines are not reviewed by the TGA at the time of submission. However a listed medicine can be selected for a compliance review after it has been placed onto the parket. Review can be targeted or random. Information about the reviews is contained in this TGA webpage. You can view the results of the compliance reviews here.
Revised list of ingredients permitted in listed medicines
Has just been published, includes changed ingredients and fice new ingredients including hydrolysed chicken cartilage extract. Source: Federal Register of Legislation.
Guidance on the regulation of software-based medical devices.
Guidance document published to assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices. Source: TGA
Responses to consultation on proposed amendments to the Poisons Standard
The TGA has published 402 responses received from various individuals, professional and industry associations to proposed amendments for 12 substances. Source: TGA
Revised poisons standard published
Electronic version is now available for SUSMP No. 34 (Poisons Standard October 2021). Source: Federal Register of Legislation.
Interim decisions on proposed amendments to the Poisons Standard
Including ethanol and isopropanol in hand sanitisers, methanol in hand sanitisers, and eugenol. Source: TGA
Publication of expert panel report on psilocybin and MDMA
This is a systematic literature review of the roles of MDMA and psilocybin for the treatment of mental health conditions. The full panel report is available. Source: TGA
Are your Finished Product Specifications (FPS) up to date?
All FPS should be reviewed withing a reasonable time frame such as 3 years, and should take into account changes to various limits and mandatory tests – such as heavy metals - that have occurred since the FP was last written or revised. Contact RFA for assistance.
Selling products in China?
In April this year, the General Administration of Customs of China issued new regulations for the “Registration and Administration of Overseas Producers of Imported Food” and “Administrative Measures on Import and Export Food Safety”, which will come into force from 1 January 2022. For information, contact your industry association.
Sports foods containing DMAA
It is already illegal for sports food brands containing DMAA to be sold. It has been included in Appendix C of the Poisons Standard which means the sale, supply and use of DMAA will be prohibited. Source: NSW Food Authority
South Island White Mist Sauvignon Blanc has been recalled due to the presence of an undeclared allergen – sulphites.
Barossa Fine Foods ham products – “No Added Nitrite Ham 100g” due to possible (listeria monocytogenes) microbial contamination, and “Double Smoked Ham 100g” due to due to (listeria monocytogenes) microbial contamination.
Weis Dairy Free Dark Chocolate & Coconut Multipack due to the presence of an undeclared allergen (soy).
Banks and Burbidge Alcohol Free Gin – potential for microbial contamination
Devondale 100% Sparkling Apple Juice due to a packaging fault resulting in the potential for glass breakage.
Nature's Delight Xmas Liquorice Mix 500G - the product contains gluten but the label has a ‘Gluten Free’ claim.
Fruit X Berries Blueberry Chocs - presence of an undeclared allergen (tree nuts [macadamia]).
HLY Brown Sugar Cake - presence of an undeclared allergen (soy)
Essential Ingredient Corn Tortillas - presence of an undeclared allergen (wheat).
FSANZ calls for comment on changing definitions for genetically modified foods
Current definitions of ‘food produced using gene technology’ and ‘gene technology’ lack clarity and need to be updated. In the first of two rounds of public consultation, FSANZ invites interested parties to comment on its proposed approach to (a) revise and expand the process-based definition for ‘gene technology’ to capture all methods for genetic modification other than conventional breeding; and (b) revise the definition for ‘food produced using gene technology’ to include specific product-based criteria for excluding certain foods from pre-market safety assessment and approval as GM food. Foods that do not meet all relevant exclusion criteria would still require an application to FSANZ. Source: FSANZ
Amendments and applications to amend the Food Standards Code
Including nicotinamide riboside chloride as Vitamin B3 in foods for special medical purposes, β Galactosidase from Bacillus subtilis (Enzyme) as a processing aid in dairy food applications, Source: FSANZ. Also Low-THC hemp leaf, seed sprout and root as food and food ingredients - FSANZ
Cosmetics, Personal Care and TGA Listed Sunscreens:
AICIS publishes guidelines on “natural” and “organic”
Is my ingredient natural? This is often a difficult question to answer. This guideline explains the AICIS position on “natural” including what extraction processes cause a chemical change. If all the ingredients in your product meet AICIS’ legal definition of a naturally occurring chemical (and you don’t introduce any other industrial chemicals), then you do not need to register with AICIS. Source: Australian Industrial Chemicals Introduction Scheme (AICIS)
Chemicals with no known commercial use in Australia
AICIS has identified chemicals on the Australian Inventory that it believes are not being manufactured, imported or used in Australia for commercial purposes. If you are using one of the chemicals you can contact AICIS before 17th December. Source: AICIS general information, and list of chemicals