Important information for readers of this newsletter from the editor, Robert Forbes.
As of 30th June 2022, I will no longer be providing regulatory affairs advice. However, I will still be writing this newsletter, which will be published by Regulatory Affairs Training Direct, and all subscribers will continue to receive the newsletter. I will also be conducting the training courses created by RFA along with colleagues in the industry. For training enquiries, I will let you know the email address in the next newsletter. My phone number is +61 410 596 080. For regulatory affairs advice please email David Dwyer.
After being in this wonderful complementary medicine industry since 1980 it is time for me to wind down. Now this month’s news:
Complementary Medicines and Medical Devices:
TGA Website Redevelopment. The TGA is “modernising” its website. Some links will change, and some old pages removed. The TGA is presenting a webinar on 7th and 12th July. To register for the webinar follow this link.
New poisons standard published 1st June. Source: TGA.
TGA fees and charges – increase on the 1st of July each year. Summarised here.
Post-market review of antigen and rapid antigen tests. A summary of the results of testing on 97 products. Source: TGA
Revised evidence guidelines for listed medicines. How to demonstrate the efficacy of listed complementary medicines is acceptable. Source: TGA
Links to 15 presentations given by the TGA at the 2022 ARCS Annual Conference. Source: TGA
Supply of unapproved therapeutic goods: a guide to completing the reporting form. Source: TGA
Therapeutic Goods Advertising Code: the 6 month transition period from the 2018 code to the 2021 code ends 30th June. Source: TGA. Also refer to Complying with advertising requirements and Testimonials and endorsements in advertising
Multiple Sunscreens Recalled - Low levels of benzene detected. The investigation has finished and no other brands have been affected. Source: TGA
Eight infringement notices totalling $106,560 have been issued to Hough Pharma for allegedly failing to provide information to the TGA to demonstrate the safety and performance of three COVID-19 RATs and failing to provide appropriate customer support. Source: TGA
HERO Instant Energy for Male products were tested and found to contain undeclared Tadalafil. The Australian Border Force will seize and destroy future shipments as it is intercepted at the Australian border. Source: TGA
The TGA has commenced court proceedings in the Federal Court of Australia against Prefixx and its sole director, Mr Brad Anthonisz, for alleged unlawful advertising of nicotine vaping products. Several warnings were issued but the advertising and selling of the products continued for some months. Source: TGA
TGA has issued one infringement notice totalling $2,664 to a Queensland based individual for alleged unlawful advertising of therapeutic goods in relation to COVID-19. Source: TGA
The TGA has issued one infringement notice of $2,664 to a NSW based individual for the alleged unlawful advertising of a medicine that was not included in the Australian Register of Therapeutic Goods and was not exempt from being on the ARTG. Source: TGA
The TGA has issued four infringement notices totalling $10,664 to an individual for alleged unlawful importation of 13,500 COVID-19 rapid antigen tests. Source: TGA
Philips Electronics Australia issued with ten infringement notices totalling $133,200 for failing to provide information on Philips CPAP and bi-level PAP (Continuous or bi-level Positive Airway Pressure) machines used for individuals with sleep apnoea, and mechanical ventilators. Source: TGA
Implementation of the Review of Medicines and Medical Devices Regulation. 9 reviews and reforms listed here.
Street sales, online dealers and convenience stores: Inside the thriving black market for nicotine vapes. An interesting article in the press. Source: Sydney Morning Herald.
And: Vape websites send buyers to ‘easy’ online prescriptions, bypassing local GPs. Source: Sydney Morning Herald.
As the Coalition (the former federal government) feuded over vaping, 'personal' donations were made by the pro-vape lobby. A national vaping lobby group donated a total of $44,000 to the Liberal Party but the money was declared as personal gifts from its director on electoral returns. Source: ABC news.
Review of import policy for mushrooms an trifles. The review will consider permitted and prohibited species, country of origin differences, target and hitchhiker pests, substrates approved for use, sterilisation requirements; and on-arrival management. Source: Department of Agriculture, Water and the Environment
Imported food requirements. Information for food importers and brokers acting on behalf of food importers. Source: Department of Agriculture, Water and the Environment
Australia’s Food Safety Report Card. Release for the UN World Food Safety Day. Items noted included ✔︎Less diagnosed salmonella. ✔︎We are washing raw chicken less. ✖︎Handwashing decreases ✖︎Need to close the gender gap. (Women sanitised more often than men) ✖︎Stop picking or eating those wild mushrooms. ✖︎Finally, a big fail for some of the social media giants such as Facebook and WeChat who continue to advertise unregulated food for sale. Source: Food Safety Information Council.
Public consultations that are still open
Food derived from EPA and DHA producing and herbicide-tolerant canola line LBFLFK. Source: FSANZ
Glucoamylase from GM Aspergillus niger (gene donor: Gloeophyllum trabeum) as a processing aid. Source: FSANZ
Alpha-amylase from GM Bacillus licheniformis as a processing aid. Source: FSANZ
Approvals – variations arising from applications and proposals
Maximum Residue Limits (2021). Source: FSANZ
Cetylpyridinium chloride (CPC) as a processing aid. Source: FSANZ
Changes to Health Star Rating system. The Health Star Rating is a front-of-pack labelling system that rates the overall nutrition profile of packaged foods with a rating from ½ a star to 5 stars. Changes are due to come into effect by 14 November 2022. Source: NSW Food Authority newsletter.
Bovine lactoferrin in infant formula products. Source: FSANZ
Very Low Energy Diets (VLED). This application seeks to amend the Food Standards Code to include foods suited for Very Low Energy Diets in foods for special medical purposes. Source: FSANZ
Dineamic Creamy Pesto Pumpkin Gnocchi With Broccoli – presence of a foreign matter – plastic. Source: FSANZ
Cosmetics, Personal Care and TGA Listed Sunscreens:
Melbourne e-commerce business fined $13k for unauthorised imports. Investigators from AICIS have fined a Melbourne e-commerce order fulfilment business more than $13,000 for allegedly importing industrial chemicals without the required registration. Source: AICIS