Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


To Be or Not To Be—‘Natural’. What’s in a Name?

A naturally-occurring chemical is one of the following: Either, an unprocessed chemical occurring in a natural environment — chemicals obtained from plants, microorganisms, the earth, sea or animals without any processing at all, for example blood and milk from animals, minerals, ores, crude oil, coal and natural gas obtained without any processing; OR, a chemical occurring in a natural environment that is extracted using a process that does not cause a chemical change in the substance — this refers to chemicals that occur in nature but which have been extracted using certain processes without changing their chemical composition. If introducers and suppliers extract a chemical by some other means, such as steam distillation or solvent extraction, it will not be a naturally-occurring chemical.    Source: Natural chemicals (See also: Examples of naturally occurring chemicals)


Chinese Millenials Key Demographic for Aussie Supplements

Australian supplement firms should target Chinese millennials if they want to maximise their growth opportunities in the country, the founder and president of the Australia-China SME Association has argued.    Source: Cheryl Tay, Nutraingredients-Asia Marketing in China


Quote for the month:

“The entry point for desktop internet is the search bar. The entry point for the mobile internet is the QR code”   WeChat founder, Allen Zhang



New Product Development

RFA Regulatory Affairs can now guide you from initial concept to successful product launch. We provide technical advice, product development expertise, and regulatory experience to assist you in the launch of your listed complementary medicine or food product. We work closely with your team, ingredient suppliers and contract manufacturer to ensure that your ideas successfully transition from conception to commercial reality.

What we can do for you:

New Concept Identification  

  • Fresh concept ideas
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Product Design  

  • Development of evidence-based formulations by degree qualified nutritionists and herbalists
  • Recommended permitted indications (therapeutic claims) and marketing claims
  • Raw material evaluation
  • Claim substantiation packages
  • Full regulatory evaluation for suitability
  • Assessment of product viability (dosage forms, costs, batch size)

Project Management  

  • Guidance on product development timeline
  • Direct & manage stakeholders
  • Identification of suitable contract manufacturers
  • Management of tender process
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Regulatory Support

  • TGA listing applications
  • Product label preparation or review
  • Coordinate and review QC / GMP documentation
  •  Review advertising

If you’ve got an idea, for either a complementary medicine or food product that you want to explore, then we can help you. Talk to us today:

T: +61 2 9660 8027

E: This email address is being protected from spambots. You need JavaScript enabled to view it.


TGA Launches New Advertising Hub and Online Complaints Form

Consumers can now report dodgy ads for medicines and medical devices through a single online form … anonymously! On 1 July 2018, the Therapeutic Goods Administration launched a web hub bringing together news and information about the regulation of therapeutic goods advertising. This online resource contains tools for both consumers and advertisers, including fact sheets, e-learning modules and forms for reporting unfair or misleading advertising and submitting enquiries. The new complaint form makes it easy for anyone to lodge complaints about advertisements for therapeutic goods. The TGA is now the sole body for handling complaints about medicine and medical device advertisements aimed at the public, with new sanctions and penalties for advertisers who do not comply with regulations. Consumers can use the hub to educate themselves on the rules that protect them against unfair or misleading ads for therapeutic goods. Fact sheets such as "The top 10 things to look out for in medicine advertisements" explain the controls in place to protect the health and safety of consumers. Advertisers can learn how to meet the requirements of a compliant advertisement through e-learning modules on the hub. The first module on the basics of therapeutic goods advertising regulation is now available, with future modules planned for the coming months. Advertisers can also check whether a particular therapeutic good can be advertised to the public by using a simple online decision tool.   Source: TGA advertising hub (You can also choose to attend one of our training courses specific to advertising:

TGA Provides Medicine Labelling Guidance

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders. There are different risks and information requirements associated with medicines prescribed by a medical practitioner (or used in a clinical setting) to those self-selected by consumers. As a result, the labels for these two types of medicines need to reflect the different contexts in which they're used. In recognition of this, medicine label requirements are specified in two separate labelling Orders: Therapeutic Goods Order No. 91 (prescription), and, Therapeutic Goods Order No. 92 (non-prescription). Transition period ends 1 September 2020.   Source: Medicine labelling (RFA also offers training courses on labelling )

TGA Changeover to Therapeutic Goods Advertising Code 2018

The following information is provided for advertisers to explain what will happen in the changeover from the 2015 Code to the 2018 Code. The 2018 Code takes effect from 1 January 2019. On this date, the 2015 Code will be repealed. However, the 2015 Code will still be relevant in some situations. Delaying the date for when the 2018 Code takes effect allows advertisers time to familiarise themselves with it and to bring existing advertising material into compliance. The delay will also allow advertisers to undertake the training and education offered by the TGA.   Source: Advertising code .   Editor’s Note: See the latest updates in two most recent TGA presentations--Code update

TGA Advises on the Future Regulation of Low Risk Products

When the Australian Government required the Therapeutic Goods Administration (TGA) to examine whether the regulatory oversight applying to a range of products that represent a very low safety risk to consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products, over 1,000 submissions were received in response. The proposed options for reform spanned from retaining the status quo to exclusion or exemption from the therapeutic goods regulatory framework. Following analysis of consultation responses, a range of reform activities have been endorsed by Government. It has been decided that there will be no changes concerning the regulation of water soluble vitamins / minerals, nor sunscreens. However there are changes affecting tampons and menstrual caps, nappy rash creams, and hard-surface disinfectants. Anti-perspirants and ear-candles will become exempt from regulation under this code.   Source: Low-risk future

Australia Leads the Way in Regulatory Standards for Complementary Medicines

Mr Carl Gibson, CEO of Complementary Medicines Australia (CMA) syas that Australia leads the way in regulatory standards for complementary medicines. “Whilst criticism can be healthy, increasingly our industry has become the target of irresponsible and ill-informed commentary that appears to stem from a misunderstanding of the existing stringent regulatory standards that apply to complementary medicines in Australia and the recent regulatory changes that have strengthened regulatory controls even further.” “The fact remains that Australian complementary medicines industry operates within one of the most tightly regulated systems in the world, where products are manufactured to a pharmaceutical standard under Good Manufacturing Practice (GMP), and strict safety and quality regulations are enforced by the Department of Health’s Therapeutic Goods Administration (TGA).” “This regulatory approach demands that manufacturers are licensed and inspected and follow the highest standard of GMP, not only for products for the Australian market but also for those exported overseas.”  Source: CMA media release Vitamins in Australia

TGA's Compliance Review Of Sunscreens

Consumer information - In May 2017, the Therapeutic Goods Administration published the laboratory testing results of 31 commonly used sunscreens. These included lotions, creams and aerosol sprays sourced from Australian pharmacies and supermarkets. All of the products tested contained the levels of active ingredients specified on their labels. Since May, the TGA has completed a desktop review of 94 listed sunscreen products, examining the quality, safety and efficacy of sunscreens on the Australian market. TGA found no compliance deficiencies in relation to quality, safety and efficacy in every-day use of these products. (Background: Last Summer there were many media reports of consumers suffering significant sunburn even after using authorised sunscreens in Australia. Consumers are reminded that suncreens will under-perfrom unless the following advice is followed: Apply sunscreen liberally (at least 1 teaspoon/5 ml) to each area (arm, leg, back, etc.) for full coverage and effectiveness; Re-apply sunscreen regularly (every two hours), especially after swimming or towelling (water activities or activities that may cause perspiration require more frequent application); Sunscreen products do not block 100% of UV radiation. You will become sunburnt if your skin is exposed to the sun for extended periods).    Source: Sunscreen effectiveness

Submissions Received: ‘Options For The Implementation Of A Claimer For Efficacy Assessed Non-Prescription Medicines’

Between 10 May and 21 June 2018, the TGA sought comments from interested parties on the review of Consultation: Options for the implementation of a claimer for efficacy assessed non-prescription medicines. All submissions that gave permission to be published on the TGA website are available online in PDF format. The outcomes of this consultation will be published on the TGA website in due course.   Source: TGA submissions

New Zealand Supplement Rules: New Members' Bill Proposes Raft of New Regulations to Replace 1980s Laws

The long-running saga of proposed new regulations for New Zealand's supplement industry has taken another turn, with a new Members' Bill being laid out in parliament detailing a whole new set of proposals.   Source: Gary Scattergood, Nutra Ingredients-Asia NZ rules

TGA Safety Advisories—   Source:

Need for Seal tablets: the tablets contain the undeclared substance sildenafil.

Gold Maka tablets: the tablets contain the undeclared substance sildenafil

One Night Lover tablets: the tablets contain the undeclared substance sildenafil

Details at the bottom of this newsletter.


Australia and New Zealand Ministerial Forum on Food Regulation Communiqué 29 June 2018

The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) met to consider a range of food regulation matters. The Forum comprises all Australian and New Zealand Ministers responsible for food regulation, and the Australian Local Government Association. The Forum oversees the collaborative joint Australia and New Zealand Food Regulation System. Topics covered included: Reduce foodborne illness, particularly related to Campylobacter & Salmonella; Support public health objectives to reduce chronic disease related to overweight and obesity; &, Maintaining a strong, robust and agile Food Regulation System.    Source: ANZ foods

Australia's Country of Origin Labelling Rules Come Into Force with Spot Checks for 10,000 Items

Australia’s new Country of Origin Labelling (CoOL) rules are now fully in force, with regulators set to embark on 10,000 spot checks to ensure adherence.    Source: Lester Wan, Food Navigator-Asia CoOL checks

FSANZ Calls for Comment on Draft Cost Recovery Arrangements

Foods Standards Australia & New Zealand called for comment on a revised approach to cost recovery arrangements. Less than two per cent of FSANZ’s total revenue is generated through cost recovery and only a small number of applications to amend the Code incur costs. The deadline for submissions is 6pm (Canberra time) 2 August 2018.    Source: Call for comment

Consultation on Labelling of Sugars on Packaged Foods and Drinks

The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) is investigating labelling approaches for providing information on sugars to consumers. The Food Regulation Standing Committee (FRSC) is responsible for coordinating policy advice to the Forum and will facilitate stakeholder consultation on the labelling of sugars on packaged foods and drinks. FRSC is inviting stakeholders including industry, public health and consumer organisations and other interested parties to make submissions on the Consultation Paper. The Consultation Paper has been prepared to seek information on the labelling of sugars on packaged foods and drinks.   Source: Sugar consultation

New Food Warning Labels for Protein Shakes After Australian Mum’s Death

Bodybuilding and sports food supplements packaging could carry enhanced warning labels under a proposal being investigated by the Federal Health Minister, Greg Hunt. The safety measure is being considered after it was revealed supplements, including protein shakes, contributed to the death of 25-year-old Meegan Hefford. Unknown to the mother-of-two, she had a rare genetic disorder that stopped her body from properly breaking down protein. Following global coverage of the tragedy, Mr Hunt last year ordered the national food and medicine watchdogs to investigate the regulation of sports food supplements. He said yesterday Food Standards Australia New Zealand and Therapeutic Goods Administration had advised him “no regulatory” gaps existed. However, still concerned at the risk to consumers, Mr Hunt on Friday instructed the Food Regulation Standing Committee (FRSC) to investigate “enhancing the safety of consumers”. He said concerns had been raised about whether products such as the one involved in Ms Hefford’s death were subject to appropriate regulation, including labelling.    Source: Regina Titelius, Protein shake-up

FSANZ Notifications—

Application A1165 – Lysophospholipase from Trichoderma reesei as a Processing Aid (Enzyme): ​The purpose of the Application is to permit the use of lysophospholipase enzyme from Trichoderma reesei as a processing aid for use in starch processing.   Source: Trichoderma enzyme

Application A1166 – Reduction in minimum alcohol for tequila: ​The purpose of this Application is to lower the minimum alcohol percentage by volume from 37% to 35%.   Source:  Tequila!

Application A1167 – Lactase from Bacillus subtilis as a Processing Aid (Enzyme): The purpose of this Application is to permit the use of  lactase enzyme from Bacillus subtilis as a processing aid for use in dairy processing.   Source: Dairy enzyme

Australian (NSW) Food Authority RecallsSource: Current recalls

Loving Earth Coconut Chocolate Butter: Due to the presence of higher than expected levels of tree nuts. The product is labelled ‘MAY CONTAIN TRACES OF NUTS”.

Jimmy Brings Wine: Presence of undeclared allergens (sulphites, milk and eggs).

Mushroom Exchange Sliced White and Brown Mushrooms (various): Potential presence of foreign matter (hard plastic).

Serendipity Vanilla Bean Ice cream: Undeclared allergens (milk and egg).

Frozen Vegetables (various): Possible microbial (Listeria monocytogenes) contamination. (Further reading: Listeria information )

Fresh Fodder Peppered Taramosalata: Presence of undeclared allergens (seafood and soy).

Black & Gold Crumbed Fish Portions: foreign object contamination – (metal).

June 2018 Failing Food Report

The Department of Agriculture and Water Resources targets and monitors food determined to pose a high or medium risk to public health. Risk food is targeted at the rate of 100 per cent until a history of food safety compliance is established. When an emerging human health and safety hazard is identified in food, the department may temporarily increase monitoring and testing. This report details food that was found to fail under the Imported Food Inspection Scheme during the month of June. Among the pathogenic organisms detected in these imported foods were, Salmonella and Vibrio cholera, as well as the toxins Aflatoxin, Histamine and Lead, and more.   Source: June food fails


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