Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


When Does Disease Education Stray Into Product Promotion?

This TGA guidance is to assist providers of disease education activities (including sponsors, health professionals, pharmacies, peak organisations and community educators) to ensure that disease education activities do not inadvertently become advertisements for therapeutic goods. While a disease education activity may legally make reference to a range of treatment options, if the information provided is likely to encourage consumers to seek to obtain a particular good, or seek a prescription for a particular medicine, then it will be considered an advertisement.    Source: Education V Promotion

Are You A Business Involved with Medicinal Cannabis Products but Unsure How to Advertise?

This TGA guidance aims to assist providers of medicinal cannabis products and therapies (including sponsors, manufacturers, importers, pharmacists, health professionals and marketers) to comply with the therapeutic goods advertising restrictions. The focus of this guidance is to help providers understand how to promote their business or service without advertising medicinal cannabis products to the public, which is prohibited.   Source: Medicinal cannabis advertising

TGA Provides Consent to Supply Therapeutic Goods that Don’t Comply With New Label Laws

The TGA has established a process for sponsors of non-prescription medicines (which include complementary and OTC medicines) to request consent for non-compliance with the new TGO No. 92 - Standard for labels of non-prescription medicine, relating to the presentation of the name of the medicine on product labels. This is an interim measure to assist industry to transition to the requirements for TGO 92. This new order includes requirements to ensure easy readability and identification of key health information such as active ingredients.   Source: TGO 92 consent for non-compliance

Advertising of Complementary Medicines: Update

The Complementary Healthcare Council of Australia (CHC) is no longer accepting any new applications for advertising pre-approvals of complementary medicines (CMs). Applications received by CHC before 14 November 2019 will continue to be processed and decided, with final decisions for all these applications to be made by 27 January 2020. From 19 November 2019, all new applications for approval of medicines advertising in any specified media (broadcast, print, cinema or public display) should be lodged with Consumer Healthcare Products Australia (CHP Australia), which was previously known as the Australian Self Medication Industry. These new arrangements will apply until the pre-approval process is disbanded on 30 June 2020. Application fees will not change from those already published on the website.   Source: CM advertising update

Summary: Therapeutic Goods Determinations

Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Registration) Determination 2018: (Sets out the kind of information which must accompany an application for the registration of a complementary medicine, and the form in which the application must be submitted).

Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Section 26AE Listing) Determination 2018: (Sets out the kind of information which must accompany an application for the listing of a complementary medicine under section 26AE of the Therapeutic Goods Act 1989 and the form in which the application must be submitted).

Therapeutic Goods (Permissible Indications) Determination (No.2) 2019: (Specifies the indications that are permitted for use in a medicine listed in the Australian Register of Therapeutic Goods under subsection 26BF of the Therapeutic Goods Act 1989 and any requirements associated with their use in such medicines).

Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019: (Determines those ingredients that may be contained in a medicine that is listed in the Australian Register of Therapeutic Goods ("the Register") under section 26A or 26AE of the Therapeutic Goods Act 1989, and requirements in relation to the inclusion of those ingredients in such medicines).  

Update to Listed Medicine Ingredients

Therapeutic Goods (Permissible Ingredients) Determination (No. 3) has recently been registered on the Federal Register of Legislation. A total of 40 changes have been made in the updated Determination. These changes include: Addition of 6 new ingredient entries; and changes to 34 existing ingredient entries to make requirements clearer and less restrictive.    Source: TGA updates LM ingredients

Consultation: Are Sports Supplements Foods or Therapeutic Goods? CMA Responds

In the October 2019 edition of this newsletter we ran a story with the heading ‘Consultation: Are Sports Supplements Foods or Therapeutic Goods?’. Complementary Medicines Australia has released a major Position Statement regarding this proposed change to legislation, highlighting concerns that may force some current ‘foods’ to be reclassified as ‘medicines’. CMA believes that probably 40% of ‘foods’ in the specialty sports supplement sector may be affected, with a possible cascading or “domino” effect of around 60-80% of products due to other factors such as inability to access manufacturing lines that are licensed under the TGA requirements.    Sources: TGA sports food consultation; &   CMA position statement; & Media comment

Communique: Therapeutic Goods Advertising Consultative Committee

The fourth meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC) was held in Canberra on 17 October 2019. TGACC members represent a diverse range of stakeholders with an interest in the advertising of therapeutic goods, including consumer, industry and health professional bodies. Topics covered included: work on improving granularity of complaints data against Key Performance Indicators; guidance documents on advertising requirements (specifically for providers of medicinal cannabis products), human cell and tissue products and disease education activities; testimonials and endorsements (including the role of social media influencers); and the role product samples.    Source: TGACC communique

The Importance of Approved Terminology for Therapeutic Goods

The TGA develops and maintains approved terminology to ensure the accuracy and consistency of information on the Australian Register of Therapeutic Goods (ARTG). This provides a consistent and standardised method for naming of: ingredients; components; routes of administration; dosage forms; container types; units of expression; and proportion.    Source: Approved terminology

TGA Rules on Products Containing Folate

Clarity has been provided that certain goods containing folate, which are represented as being foods for "special medical purposes" or dietary management, are considered to be therapeutic goods. This is due to the high likelihood that these goods may be used for a therapeutic purpose, i.e. to prevent, cure or alleviate folate deficiency or depression, or an inborn error of folate metabolism. This means they must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) and regulated accordingly.   Source: Folate substances

Changes Made to Propolis and Royal Jelly in Listed Medicine Applications

The TGA has changed the listed medicine application system to allow equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the Australian Registry of Therapeutic Goods (ARTG). Sponsors can now enter propolis and royal jelly preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. This guidance does not apply to ‘Export Only’ medicines. Sponsors of existing listed medicines should review this information before 31 March 2020 to check if they are eligible for a free correction to their ARTG entry.    Source: Propolis & royal jelly

Beware the ‘Barbie Drug’: The Dangers of Using Melanotan

The TGA urges consumers to steer clear of products containing 'melanotan'. These products are usually marketed as injectable tanning products. They are not included on the Australian Register of Therapeutic Goods (ARTG) and have not been assessed for quality, safety or efficacy by the TGA. It is illegal to advertise and supply these products, and their use has proven serious side effects that can be very damaging to one's health (darkened skin, increased moles and freckles, nausea, vomiting, loss of appetite, flushing of the face, involuntary stretching and yawning, and spontaneous erections!). Melanotan and melatonin (which is commonly used as a sleep aid) are different substances, and the above warnings do not apply to melatonin.    Sources: TGA melanotan warning & Lauren Golman, A Current Affair: ACA melanotan story

TGA Safety Advisories- Source: TGA current year alerts

Grakcu capsules: The capsules contain the undeclared substances Sildenafil and Tadalafil

Me2Shape capsules: The capsules contain the undeclared substance Fluoxetine

De2Xy capsules: The capsules contain the undeclared pharmaceutical substance Bisacodyl.

Ying Da Wang tablets: The tablets contain the undeclared substance Sildenafil.


Proposal to Prohibit the Retail Sale of Pure and Highly Concentrated Caffeine Products

As previously reported in the July and September 2019 editions of this newsletter, there has been considerable concern over the health dangers of concentrated caffeine products. Food Standards Australia New Zealand (FSANZ) is now calling for public comment on an urgent Proposal to prohibit the retail sale of pure and highly concentrated caffeine food products in Australia and New Zealand.   Sources: Caffeine regulation & Caffeine regulation 2

Allergy Information for Food Manufacturers, Retailers and Importers

Food manufacturers, retailers and importers are responsible for ensuring their imports are properly labelled and for providing clear, up-to-date and accurate information about the allergen status of their product.    Source: Food allergen portal

FSANZ Releases Regulatory Science Strategy 2019–2023

This Food Standards Australia New Zealand report details the global challenges, trends and emergent risks in a dynamic food system. It describes how FSANZ will continue to align their work to Ministerial priority areas, and sets out a plan to grow scientific and risk analysis capabilities, scientific evidence base and risk assessment methodologies to underpin their standards setting activities. Through the new strategy they aim to build stronger links with academia and industry, further leverage resources through strategic partnerships and communicate the science to meet the needs of stakeholders.   Source: FSANZ regulatory strategy report

Food Recall - Core Powerfoods Frozen Meals

The recall is due to potential microbial (Salmonella Weltevreden) contamination.   Source: Core powerfoods recall

September 2019 Failing Food Report

This latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of September. Among the usual pathogenic organisms detected in these imported foods are such organisms as Staphylococci E coli, Listeria, and Salmonella, and assorted toxins such as arsenic, aflatoxin and others.  Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals and also irradiation. There is also a failed ‘formulated supplementary sports food’ that contained an ‘unapproved novel food’ (Acacia rigidula).   Source: September 2019 food fails  

FSANZ Notifications—

Application A1182 – Glucose Oxidase from Trichoderma reesei as a Processing Aid (Enzyme): The purpose of this application is to approve a Glucose Oxidase enzyme preparation from Trichoderma reesei for use as a processing aid in cereal based products (baking) and egg processing.    Source: Glucose enzyme

Application A1191 – Mono- and diglycerides of fatty acids (471) as a surface coating: The purpose of this application is to extend the permission of the food additive mono- and diglycerides of fatty acids (INS 471) as a surface coating on fruit & vegetables to increase postharvest shelf life.    Source: Food coating

Proposal P1054 – Pure and highly concentrated caffeine products: This urgent proposal is to amend the Code to prohibit the retail sale of pure and highly concentrated caffeine food products.    Source: Caffeine fix

Sticky Situation: Australia-New Zealand Tensions Rise Over Million-Dollar China Manuka Honey Battle

Australia and New Zealand have been involved in a battle over the latter’s bid to trademark the term ‘Manuka’ in China for months, with no end in sight and increasingly terse accusations flying back and forth across the Tasman Sea.    Source: (Copyright) Pearly Neo, FoodNavigator-Asia Manuka monopoly

The Lantern Project: Improving Nutrition and Food Choices for Elderly Australians

One way to enhance agency and ensure that residents of aged care facilities have access to adequate choice of nutritious foods would be to implement a mandatory legislative instrument for a nationally consistent approach to the interpretation of food laws that apply to aged care facilities. This legal requirement should have an emphasis on providing stimulating food choices even though the food safety definition of the elderly consumer is as a “vulnerable person”. The Lantern Project is a non-profit organisation with a vision to improve the quality of life of older Australians through good food and nutrition.     Source: Joe Lederman, FoodLegal The Lantern Project

The Countries with the Best and Worst Food Systems

The Netherlands is the best place to eat overall, Chad the worst. The USA has the cheapest food in the world compared to the price of other goods, but falls down for food-related health problems. Cambodia has the healthiest food, but a lot of malnourished people as well. Best Places To Eat: The Netherlands, followed by France, Switzerland (equal score); then, Denmark, Sweden, Austria, Belgium (equal score), and Ireland, Italy, Portugal, Luxembourg, Australia (equal score).     Source: Ben Schiller, Fast Company Food countries


General Interest: Vaccines - Inoculating Against Fear

Along with good nutrition and public sanitation, vaccination is one of the most effective ways to prevent diseases. In Australia, the Therapeutic Goods Administration regulates vaccines, and we have been lucky enough to be the recipients of one of the most robust and well-regulated childhood vaccination programs in the world. Australia has played its part in the scientific advances in vaccine medicine, being world leaders in the research to advance the science of vaccines, with some of the best known medical scientists being Sir Frank McFarlane Burnet, Sir Gustav Nossal, Professor Ian Frazer and most recently, Dr Laura Mackay. So with all the evidence before us, we now face a new question – why are people in Australia and across the developed world demonstrating a growing scepticism in some small pockets of the community, about the value of vaccination? The WHO has named vaccine hesitancy as one of its top 10 threats to global health for 2019. Australia is leading the way on an international level to address the issue of vaccine hesitancy through the International Coalition of Medicines Regulatory Authorities.   Source: Vaccine education

AHPA Webinar: Roadmap to Climate Action & Collaboration in the Herbal & Supplements Industry

The American Herbal Products Association is hosting an important webinar scheduled for 10 AM Wednesday, December 11 10 AM *PT (*Pacific Daylight Time is 18 hours behind Australian Eastern Summer Standard Time, so webinar would commence December 12 at 4am if you were in Sydney). The Climate Collaborative, AHPA, and American Botanical Council Sustainable Herbs Program are partnering to host a special introductory webinar for herbal and supplement companies on how you can join in creating a collaborative industry pathway to reversing climate change, and get access to free resources that can support your own climate action journey. The webinar includes an overview of the Climate Collaborative’s work to date, and brings together a panel conversation on how companies of all sizes in the industry are making their supply chain and sourcing practices integral to their overall approach to climate action.    Source: Webinar for climate action

Training: RFA Provides Comprehensive Training in Regulatory Affairs

Are you looking to expand your knowledge or are you new to Australian regulations related to the supply of foods, cosmetics and/or complementary medicines? Then check out the full list of courses we offer on the Robert Forbes & Associates website . There are 20 courses to choose from and any of these can be undertaken either singly or in groups, from within our Glebe, Sydney office, at your office or remotely via Skype. Contact our training manager Kate Durey This email address is being protected from spambots. You need JavaScript enabled to view it.  to receive the latest information on these training courses at this discount offer. See you in the classroom!

Quote for the month:

“A diamond is a chunk of coal that did well under pressure”    Anonymous

There is no Cosmetics news to report this month, but if you haven’t already seen it, you might like to view: RFA Regulatory Affairs You Tube Video (Cosmetics Regulation)


Country of Origin Labelling for Complementary Medicines Consultation

In February 2017 amendments were made to the Country of Origin Labelling (CoOL) laws that changed the basis for being eligible to make 'Made in Australia' claims, and subsequently access to the Australian Made, Australian Grown (AMAG) logo. The CoOL law amendments focused mainly on the food industry. However, all other products, including complementary medicines (CMs), and goods that wish to make an AMAG claim are also bound by the CoOL laws. All complementary medicine products sold in Australia are regulated by the TGA. While there have been calls to allow all CMs manufactured under TGA authorisation to be allowed use of the AMAG logo, unintended consequences arise when this authorised CM manufacturer is actually off-shore and still able to use the AMAG logo. (Domestic facilities supplying to the domestic market are ‘licensed’ by the TGA but overseas facilities supplying to the domestic market and domestic facilities which supply export markets only, are ‘certified’ by the TGA. The TGA does not require the manufacturing steps to be carried out in Australia). Consultation closes 5pm (AEDT) Wednesday 30 October 2019.     Source: CoOL consultation  

Summary of Deadlines to Comply with TGA Regulatory Changes

With so many recent changes to the regulation of complementary medicines in Australia, all sponsors should be acutely aware of the following important dates:

January 1st 2019 - New Advertising Code became effective;  

March 2019 - enhanced penalties for addressing non-compliant advertising were introduced;

September 2nd 2019 – Immediate new restrictions on caffeine content implemented;

January 1st 2020 - Last date to transition menthol containing medicines for dermal use to new requirements;

April 30th 2020 – Last date for all labels and packages to carry the updated ingredient name;

September 1st 2020 - The four year period to transition labels ends and all labels must comply;

March 2nd 2021 - Changes to content and warning statements, in caffeine containing LMs, transition ends;

March 5th 2021 - End of the phase in period for the permissible indications list, to avoid cancellation.

Important Notice for Advertisers of Complementary Medicines

If you advertise to the public using print media, cinema, billboards or other public displays, then you need to know about changes coming to advertising pre-approvals. In the lead up to the abolition of the therapeutic goods advertising pre-approval requirements in June 2020, the Complementary Healthcare Council of Australia (CHC), also now known as Complementary Medicines Australia (CMA), will cease accepting applications for pre-approval in November 2019. The TGA is working on alternate arrangements to replace CHC/CMA's services with new arrangements commencing by late November or early December 2019 at the latest.   Source: CM advertising changes

2018-19 Annual Report on Therapeutic Goods Advertising Compliance

On 1 July 2018, the TGA became the single body for handling complaints about the advertising of therapeutic goods in Australia. This is the inaugural report on the TGA's complaint handling activity. During the 2018-19 financial year, the TGA received 1468 complaints about the advertising of therapeutic goods. The report uses case studies to illustrate the types of advertising breaches identified and the actions taken by the TGA to remove non-compliant advertising. Of the top 10 most reported-on categories, the ‘Schedule 4 cosmetic category’ (capturing advertising to the public for prescription medicines used for cosmetic procedures such as wrinkle reduction and filling) was by far the largest. Interestingly, there were more complaints concerning the advertising around head-lice than there were regarding weight-loss, detox/diuretics, and cold/flu products combined!     Source: Advertising compliance report

Consultation: Are Sports Supplements Foods or Therapeutic Goods?

In Australia, food and medicines are regulated under separate legislated frameworks. Whether a product for oral consumption is a food or a medicine in law can depend on the specific combination of ingredients, claims and overall presentation. Two products with the same formulation may be characterised differently—one as a food and the other as a medicine—depending on their claims, artwork and other aspects of their packaging. However, a product cannot simultaneously be both food and medicine in law. ‘Sports supplements’ is a broad category of products that straddles the interface between the food and medicine regulatory frameworks. These products often carry explicit or implied claims relating to sport, fitness or recreational performance, and are likely to be marketed and consumed for therapeutic use, yet some of the products may still be considered to be food under law. This TGA consultation is seeking to resolve much of the uncertainty around the regulatory status of sports supplements to ensure those products are regulated appropriately.    Source: Sports supplements consultation

Turmeric Contamination Under the Spotlight

Turmeric is a flowering plant, Curcuma longa of the ginger family, Zingiberaceae, the roots of which are used in cooking. Its most active component, curcumin, has many scientifically-proven health benefits, such as the potential to prevent heart disease, Alzheimer's and cancer. It's a potent anti-inflammatory and antioxidant and may also help improve symptoms of depression and arthritis. A Stanford-led study has now revealed that turmeric produced in Bangladesh, the world’s largest supplier, is often adulterated with a lead-laced chemical compound. Lead chromate is bright orange and has been frequently used as a colour enhancer in the commercial production of Bangladeshi turmeric. Countries importing turmeric for use as either a medicine or a food are at risk. As Complementary Medicines Australia (CMA) points out, the TGA provides strict guidelines and regulations to ensure the integrity and safety of all Australian medicines, including mandatory Good Manufacturing Practices (GMP), batch testing reports and information on the supplier are documented at every stage. Whereas, Australia’s Department of Agriculture targets and monitors food determined to pose a high or medium risk to public health. Foods found to be at risk are then targeted at the rate of 100 per cent until a history of compliance is established. But what about other jurisdictions that don’t require GMP for their complementary medicines, or that don’t have as strict import testing of their imported foods?    Sources: Adulterated turmeric ; Elsevier turmeric study ; CMA turmeric study response 

CMA Publishes Australia’s Complementary Medicines Industry Audit for 2019

As the peak body for the complementary medicines industry, Complementary Medicines Australia (CMA) has been conducting annual reviews of the industry for 10 years. Some of the critical highlights of the 2019 industry audit are: the sector is now a $5.2 billion per annum industry, outpacing Australia’s general economic growth; Australian exports have grown to $1 billion per annum, overtaking the USA to become the largest exporter of Nutrition and Health Food to China; most Australians (7 out of 10) have used at least one form of complementary medicine in the last year and a third of complementary medicines users do so to manage the symptoms of chronic disease.     Source: CMA industry audit

Australian Supplements Regulatory Regime Not World Class…Yet: TGA Chief Warns Industry

The Australian supplements industry may have a much lauded regulatory regime on the global stage, but a leading figure at regulator the Therapeutic Goods Administration (TGA) has argued it is “not yet world class”.    Source: [Copyight] Gary Scattergood, Nutra Ingredients-Asia Oz Regs progress

IADSA International Regulatory Summary

The International Alliance of Dietary / Foods Supplement Associations has summarised the latest regulatory changes now impacting on the food and complementary medicine sectors around the wold. Countries and topics covered include: China (The Chinese State Administration for Market Regulation has issued “Guideline on Warning Statements for Health Food Labeling” which comes into force on 1 January 2020); Japan (Japan’s Consumer Affairs Agency announced the revision of the “Food Labelling Standard”); South Korea (The Korean Ministry of Food and drug safety has revised its Health Functional Food Code); European Union (Empty gelatine capsules could be exempted from border inspections; Italy (Issues curcumin warning); United Kingdom (Helpful links to prepare for No-Deal Brexit); and many more updates affecting Australia, USA, South Africa and others.  Source: IADSA newsflash

Medical Cannabis: Hydrogen Cyanide Could be the Missing Link in Vaping Illnesses

An electronic cigarette or e-cigarette is a handheld battery-powered vaporiser that simulates smoking, but without burning. This form of ingestion has become a popular delivery mode of THC and CBD for recreational and medical users of cannabis, as well as tobacco smokers. Using an e-cigarette is known as "vaping" and the user is referred to as a "vaper." Instead of smoke, the user inhales an aerosol, commonly called vapour, that’s formed after electronically heating the initial liquid. A spike in recent vaping related illnesses and deaths around the world has regulators worried. An early concern has been the effects of inhaling the oils of Vitamin E acetate, used to dilute the primary oils, which can adversely coat the airways. A more recent culprit now appears to be a pesticide residue found in unregulated vaping cartridges. Testing of unregulated or bootlegged vaping devices in one recent USA study showed that all contained myclobutanil, a fungicide that can transform into hydrogen cyanide when burned.    Sources: THC vaping danger ; FDA warning & NYT Vaping deaths   (Please see also: TGA advice on e-cigarettes ;  NICNAS vaping facts ; & Dept. Health warning )


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