Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


New Database Portal for Complementary Medicine

The Karl und Veronica Carstens Foundation is launching a free database portal for complementary medicine, naturopathy and homeopathy. In total, 96,000 items of scientific literature, among them more than 30,000 clinical research papers and more than 9,000 basic research publications, can now be searched for free – a service unique in form and scale for scientists, practitioners, therapists and students.    Source: Data portal

TGA Releases Latest Version of Australian Regulatory Guidelines for Complementary Medicines (ARGCM)

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. This most recent Version 7.0 was released in October 2017 and has been re-structured to increase accessibility for intended users.    Source: Reg. guidelines 

TGA Presents Revised Draft List of Permitted Indications

The first draft list of permitted indications was published on 5 July 2017. A revised draft list has now been published to provide stakeholders with the opportunity to review and comment prior to the permitted indications reform coming into effect. Additional supporting materials have also been provided to assist stakeholders in understanding how the list will work and how the regulatory requirements for listed medicines will change. Sponsors should not make regulatory decisions based on this preliminary information, as changes may occur before finalisation and implementation of the supporting legislation. The revised draft list of permitted indications will be available on TGA website until 31 October 2017.    Source: Permitted indications draft

TGA Publishes Outcomes of Advertising Complaints

The Therapeutic Goods Administration lists outcomes where the advertiser has taken specific action to address identified breaches of therapeutic goods advertising legislative requirements and is compliant at the date for which the complaint investigation was finalised. The advertiser's actions have been taken following TGA investigations into these complaints. All of these complaints were the subject of a complaint to the Complaints Resolution Panel. They were referred to the TGA for follow-up action because the advertiser did not fully comply with the Panel's request to address breaches of the therapeutic goods advertising legislation.    Source: Advert outcomes

TGA Publishes Guidelines for Medicinal Marijuana

This guidance is for consumers, health professionals, sponsors and manufacturers who are involved in providing appropriate patients with access to medicinal cannabis products as an unapproved drug through the Special Access Scheme (SAS) or Authorised Prescriber Scheme. The term 'medicinal cannabis products' covers a range of cannabis preparations intended for therapeutic use, including pharmaceutical cannabis preparations, such as oils, tinctures and other extracts.    Source: Medicinal pot

Editor’s note: For those interested in looking at TGA academic studies and research references on marijuana’s impact on pain relief and other medical conditions: Marijuana research

TGA Updates SUSMP ‘Poisons Standard’

The Poisons Standard has been presented with a view to promoting uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia. The Poisons Standard is the legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). This latest update has particular relevance for those involved in the supply of cosmetics associated with the ingredients methylisothiazolinone, methylchloroisothiazolinone, and geraniol.    Sources: SUSMP update ; & Legislation

TGA Announces Labelling Changes: Information for Sponsors

The TGA has made several amendments to the new labelling Orders TGO 91 & TGO 92. Many of the recent amendments were made as a direct result of feedback from industry stakeholders. The TGA has also introduced labelling requirements for medicines supplied in Australia. These changes were introduced on 31 August 2016 which started the four year transition period.    Source: Label changes

TGA Publishes Presentations Given at Recent TGA Pharmacovigilance Inspection Program Information Sessions

Presentations cover the pharmacovigilance inspection guidelines, preparing for inspections, inspection process, and close out of inspections.    Source: Pharmacovigilance

TGA Safety AdvisoriesSource: 2017 alerts    

Jimpness Beauty Fat Loss capsules: the capsules contain the undeclared substance phenolphthalein.



What You Need to Know About Australia’s Health Star Rating on Foods

The Federal Government's Health Star Rating claims to "take some of the guess work out of shopping" and help consumers "make smarter choices" when it comes to buying food. But when Milo, a chocolate powder that's almost 50 per cent sugar, clinches 4.5 (out of 5) stars, how much can we trust the system? Alexandra Jones from the George Institute for Global Health in Sydney told AM radio that the food industry is intentionally prolonging a review of the scheme's rules. "It's a well-known tactic of the food industry to ask for more evidence and consultation as a way of delaying meaningful public health policy," Ms Jones said.    Source: Food stars ;

Related story: Try this quick quiz Health Star Ratings: Can you guess which of these foods have more stars? Source: Food star quiz

Australia Food Safety Week

This year's theme is 'Is it done yet? Use a thermometer for great food, cooked safely every time'. Information and activities can be found here: Food safety week ; See also Raw and Risky Foods Quiz

 NSW Food Authority Recalls—

Ming Lee Trading Pty Ltd Dried Black Dates: Ming Lee Trading Pty Ltd has recalled Dried Black due to the presence of a chemical contaminant.    Source: Bad dates ; See also: Food recall FAQs

FSANZ Publishes Annual Report 2016-2017

Food Standards Australia New Zealand (FSANZ) supports and encourages the dissemination and exchange of information. FSANZ’s purpose is to contribute to the cooperative food regulatory system by developing evidence-based standards, providing evidence-based advice, coordinating regulatory responses and providing information about food standards.    Source: Annual report

FSANZ Notifications—

Application A1142 – Addition of Prescribed Method of Analysis for Resistant Starch: The purpose of the Application is to add a method of analysis for dietary fibre and other fibre content for specifically named fibre content of food (resistant starch).    Source: Starch Application A1151–Beta-Galactosidase from Papiliotrema terrestris as a Processing Aid (Enzyme): The purpose of the Application is to amend Schedule 18 of the Australia New Zealand Food Standards Code to include ß-Galactosidase from Papiliotrema terrestris as a Processing Aid.    Source: B-galactosidase

Application A1150 – Glucosylated Steviol Glycosides: The purpose of the Application is to permit the use of glucosylated steviol glycosides as an intense sweetener in various foods.    Source: Steviols

Proposal P1034 – Chemical Migration from Packaging into Food: The purpose of this Proposal is to assess the public health and safety risk of chemicals which may migrate from packaging materials into food, and to identify and manage any risks.    Source: Plastics risk ; Editor’s note: due to “FSANZ’s risk assessment (concluding) that the human health risk posed by CMPF in Australia and New Zealand is low” it has therefore abandoned further study of this issue Summary & conclusion



Marketing Claims Under Scrutiny at Upcoming Colmar Brunton Event

Market research agency Colmar Brunton has announced a Melbourne seminar on how to make substantive marketing claims. To be held on the morning of Wednesday 15 November 2017, the ‘How to make claims stick’ seminar will include presentations by FoodLegal Principal, Charles Fisher and National FMCG Director, Dr Denise Hamblin. Charles will discussing how to substantiate marketing claims in Australia from a legal perspective. He will be sharing with us the risks and how to avoid consumer misinterpretation as well as insights into making sure the market wants what we’re claiming before we embark on NPD.    Source: Australian Food News Marketing seminar


Quote for the month:

“At first they will ask why you are doing it. Then they will ask how you did it”    Anon



RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available

Are you new to the Australian market? Are you unsure about how to comply with recent changes to TGA regulations such as the new TGA Order 92? Do you have a new member of your regulatory or marketing team and would like them to be trained on food classifications and labelling in Australia? Do you want to supply cosmetics but aren’t quite sure what the label is required to look like? RFA Regulatory Affairs offers Skype training so that you can train at home or from your office at a time that suits, or you and your team can come to our office in Glebe for a group-training session. Our courses cover complementary medicines, cosmetics and food products and a range of topics from labelling to GMP requirements.

All courses are presented in a modular format of either two or three hour’s duration.

Training resources are provided and certificates are presented to each participant at the successful conclusion of each module.

You can find more information at RFA Training Courses or email us This email address is being protected from spambots. You need JavaScript enabled to view it.  to discuss your requirements.



This Month’s Newsletter Sponsor:


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ACCC Concludes Investigation Into ALDI 'Flushable' Wipes

The Australian Competition & Consumer Commission has completed its investigation into ALDI’s ‘flushable’ wipes and will take no further action after ALDI stopped selling its personal hygiene wipes and removed potentially misleading claims from its bathroom cleaning wipes packaging. In July this year, the ACCC raised concerns with ALDI regarding its promotion of certain ‘flushable’ wipes products. At the time, ALDI was promoting the Green Action Flushable Bathroom Cleaning Wipes (100pk) in its Special Buys catalogue. The product included claims that the wipes were ‘flushable’ and able to ‘disintegrate in the sewage system’. ALDI responded to the ACCC’s concerns by removing the product from sale. “The ACCC raised concerns with ALDI about the use of the term ‘flushable’ on its wipes packaging, as this claim may mislead consumers if it cannot be substantiated. Australian water authorities face significant problems when non-suitable products are flushed down the toilet as they contribute to blockages in household and municipal sewerage systems,” ACCC Chairman Rod Sims said.    Source: Flushable wipes

Researchers Claim to Find Link Between Hair Dye and Breast Cancer (again!)

Professor Kefah Mokbel, a breast cancer surgeon at the Princess Grace Hospital in central London, has recently been reported to have reviewed studies of whether women who dyed their hair had a greater risk of breast cancer. He found a 14 per cent rise. However, the study upon which these conclusions are based is not identified. Nevertheless, this story was published in both The Australian newspaper and UK Metro at about the same time this month. Please note that the supposed link between hair dyes and cancer is not new and has been debunked at both the Australian based  and the UK CTPA has posted the statement “Hair Dyes Are Safe To Use” on their  website. 

Robert Forbes and all of our associates are aware of the great tragedy that has recently unfolded in USA. As regular visitors to Supply Side West at the Mandalay Bay, Las Vegas  we have been personally saddened at this great loss. We send all of our readers our love and best wishes as we all try to come to terms with this senseless suffering and immense pain. Let the healing begin.


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