Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.


TGA Advises on Using 'Natural' Claims When Advertising to the Public

The TGA has released guidance on the use of 'natural' and related claims when advertising medicines and medical devices to the public. It is recognised that If the advertising does not explain what the term 'natural' (as well as related claims such as 'naturally occurring', 'sourced from nature' and 'naturally derived') means in relation to the particular product being promoted, interpretations by consumers will vary, especially if 'natural' is used as a stand-alone claim. When advertisers use a 'natural' claim, they will either have to provide sufficient information to explain the claim or use it in accordance with the definitions set out in the TGA's guidance. Specific information for consumers on the use of 'natural' claims in relation to medicines and medical devices will be published in coming weeks. Stay tuned!    Source: 'Natural' claim    (Please also read the TGA’s humorous take on this topic, Bee Aware: what’s the buzz on natural claims?)

TGA Provides Summary of Fees and Charges Effective from 1 July 2019

The Therapeutic Goods Administration is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. A fee is charged for a service, such as a product evaluation. A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year. This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation.     Source: TGA fees & charges

Changes to Ingredient Names: End Of Transition Period - Are You Ready?

The transition period for updating medicine ingredient names ends on 30 April 2020. This means that from 1 May 2020 all medicines released for supply in Australia must use the new ingredient names. The four year transition period has provided sufficient time for sponsors to move over to using the new names. With less than 12 months left, consumers and health professionals are expecting to see the new ingredient names on medicine labels and relevant documentation. Questions that listed medicine suppliers need to ask themselves should be: “Do I have a medicine that contains an ingredient on the affected ingredients list?”; “If the ingredient is used as an active ingredient, is the right ingredient name displayed on my medicine labels?”; “If the ingredient is used as an excipient and I include the names of excipients on my labels, is the right ingredient name displayed?”; “If the medicine has an associated product information or consumer medicine information document, is the right ingredient name used in those documents?”; and “If I have advertising materials for my medicine that include ingredient names, is the right ingredient name used in those materials?”.    Source: Ingredient naming deadline

TGA Answers FAQs on Issues Raised by Industry in Relation to Permitted Indications for Listed Medicines

As regular readers of this newsletter are now well aware, the TGA has revised the guidance related to indications for listed complementary medicines in Australia. 'Indications' are statements that describe the specific therapeutic use for a medicine, i.e. a medicine's claimed purpose or health benefit. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance). Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor. Since this new standard has been implemented there have been many questions raised by stakeholders and these are addressed here: Permitted indications FAQs . Also, the TGA has announced the introduction of the ability to use the "TGA Assessed" claimer for complementary medicines that are either ‘registered’ or ‘listed assessed’. Information regarding ‘TGA assessed’ claims for assessed listed and registered complementary medicines can be read here: 'TGA assessed' claims  

TGA Updates the Permissible Ingredients Determination for Listed Medicines

An updated version of Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019 has added 4 new ingredient entries and changed 19 existing ingredient entries to make requirements clearer and less restrictive. Two of the new active ingredients are only available with written authorisation provided by DSM Nutritional Products Pty Ltd (until 30 June 2021). There is also an expansion of the permissible concentration of menthol for dermal application to 25%.    Source: Permissible ingredient update

TGA Seizes Bloodroot Salve (Black Salve) and Bloodroot Capsules on the Gold Coast

The Therapeutic Goods Administration, in conjunction with Queensland Police Services and the Australian Taxation Office, executed a search warrant at a business premises on the Gold Coast, Queensland. During the search, the TGA seized various items. This included 27 jars of suspected Bloodroot Salve (commonly known as Black Salve), 84 bottles of product suspected to be Triple Strength Bloodroot Capsules and 30 bottles of suspected Double Strength Bloodroot Capsules. The operation was part of an investigation into the alleged importation, advertising and unauthorised supply of unapproved therapeutic goods, including scheduled medicines. A number of items and devices were also uncovered and seized, allegedly relating to manufacturing of therapeutic goods. Enquiries are still underway and further action will be dependent upon the outcome of investigations. (Bloodroot Salve, more commonly known as Black Salve, is a topical paste. It is commonly classified as an 'escharotic', as it is corrosive and can destroy skin tissue, causing disfigurement. Application can result in dead skin tissue and a thick dark scar. Bloodroot capsules may contain several of the same ingredients as Black Salve).    Source: Bloodroot salve raid

TGA Seizes SARMs and Nootropics Using Search Warrants

The Therapeutic Goods Administration (TGA) executed four search warrants connected to a business operating in the Sutherland Shire, Sydney. This was undertaken in conjunction with NSW Police, the Australian Federal Police (AFP), the Australian Taxation Office (ATO) and NSW Health. During the search, various items were seized. These items allegedly include raw materials and finished Selective Androgen Receptor Modulators (SARMs), and Nootropic products. The products are not included in the Australian Register of Therapeutic Goods (ARTG) and therefore cannot be supplied in Australia. The operation was part of an investigation into the alleged importation, advertising and supply of unapproved therapeutic goods, including scheduled medicines.   Source: TGA SARM bust    (Please also see related story (copyright) by Cheryl Tay, NutraIngredients-Asia SARMs harm )

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Receives NutraIngredients-USA Editors Award for Industry Initiative of the Year

RFA Regulatory Affairs congratulates the American Botanical Council - American Herbal Pharmacopoeia – and the National Center for Natural Products Research on being awarded the 2019 Industry Initiative of the Year for their Botanical Adulteration Prevention Program. This newsletter has repeatedly run stories on this excellent industry initiative and we are delighted that this group has been recognised within the industry. The BAPP focuses on educating herb and natural product industry members to identify unethical sellers of adulterated and fraudulent raw botanical materials, botanical extracts, and essential oils. This is achieved via the publication of 50 (to date) credible and authoritative peer-reviewed documents; plus interviews with trade media; speeches at industry, scientific and professional conferences; and direct consultation with members of the industry.    Source: BAPP award

Aloe Vera Bulletin Published by Botanical Adulterants Prevention Program

The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) announces the publication of a new Botanical Adulterants Prevention Bulletin (BAPB) on aloe vera (Aloe vera) leaf gel- and juice-derived ingredients. This new publication documents adulteration of aloe vera leaf gel and juice with undeclared maltodextrin and ingredients from other Aloe species.    Source: Aloe vera adulteration


Calls for Health Star Ratings on Packaged Food to be Compulsory

The current use of ‘Health Star Ratings’ on packaged foods is not mandatory and is only being displayed on around 30 per cent of foods. Most of these products have scored at the upper end of the five-star scale and public health experts are concerned some producers are "gaming the system" by exploiting loopholes around sugar, salt and fat content. The federal government has commissioned an independent five year review into the health star ratings, which is due this month. There is concern that the dietary guidelines are skewed towards the interests of food companies. There have been calls for the algorithm to be improved in order to incorporate added sugars, increase penalties on salt content, and remove undue benefits from protein.    Source: Daniel McCulloch, Good Food Health star ratings

Sugary Cereals Targeted Under Health Star Proposal

Sugary breakfast cereals that seem healthy could lose up to 2.5 stars if the ministers reviewing the Health Star Rating system adopt a proposal to differentiate between naturally occurring sugars and added sugar. New modelling from consumer advocacy group Choice shows how the proposed change to the system's algorithm would penalise products such as Kelloggs' Nutri-Grain and Nestle's Milo cereal, while increasing ratings for "healthier" products that contain naturally occurring sugars, such as yoghurt and fruit.    Source: Jenny Noyes, SMH Sugars aint sugars

NSW Food Authority Publishes 50th Edition of Foodwise Publication

From humble beginnings as a printed newsletter in December 2005, The New South Wales’ Foodwise publication has evolved into an interactive digital information resource for the NSW food industry. The aim of Foodwise remains unchanged: communicating regularly and directly with readers to keep the local food industry partners informed about important issues across their sector.    Source: Foodwise

April 2019 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 latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of April. Among the pathogenic organisms detected in these imported foods were, Listeria monocytogenes, coagulase positive Staphylococci E coli, Bacillus cereus, and Salmonella, as well as the toxins chlorpyrifos and aflatoxin and many more.   Source: Latest failed foods

FSANZ Notifications—

Application A1163 - Food Irradiation definition of herbs and spices: The purpose of this Application is to vary Food Standard 1.5.3 Irradiation of Food to remove the reference to Schedule 22 in relation to the definition of Herbs and Spices.    Source: Herb & spice irradiation

Application A1164 – Pullulanase from Bacillus licheniformis as a processing aid (enzyme): ​​The purpose of this Application is to seek approval to permit the use of the enzyme Triacylglycerol lipase from Trichoderma reesei as a processing aid in the manufacturing of cereal-based products.    Source: Bacillus enzyme

Application A1169 - Alpha-glucosidase from Trichoderma reesei as a PA (enzyme): The purpose of this application is to consider whether to permit the use of Alpha-glucosidase enzyme from a recombinant strain of Trichoderma reesei as a processing aid.    Source: Alpha-glucosidase  

Application A1178 – Method AOAC 2017.16 as a new method of analysis for total dietary fibre: The purpose of this Application is the addition of a new total dietary fibre method, AOAC 2017.16, as a permitted method in Schedule 11 of the Australia and New Zealand Food Standards Code.    Source: Measuring dietary fibre

Application A1180 – Natural Glycolipids as a preservative in non-alcoholic beverages: The purpose of this application is to permit the use of long-chain glycolipids from Dacryopinax spathularia (Natural Glycolipids) as a preservative in non-alcoholic beverages.   Source: Natural glycolipid

Application A1181 – Maximum residue limits for Imazapyr in Barley Grain: The purpose of this application is to increase the maximum residue limit for imazapyr in barley grain from 0.05ppm to 0.7ppm.   Source: Imazapyr

Legal: Australian Tariff Classification Update

What do baby wipes, vitamins, weight loss tablets and apple cider have in common? They have all been the subject of Australian legal decisions regarding their tariff classification. The relevance of the decisions goes beyond just the goods that are the subject of the decision, but extends to all importers for goods into Australia. The classification principles set out in the following cases need to be kept in mind no matter what the product. Some important take-home messages drawn from these examples are: if the term in dispute (e.g. ‘Food’) is an everyday item, the decision maker should not apply technical or strained meanings. The decision maker should apply their everyday understanding of the word; and, a product not clearly identifiable as food and consumed for a reason other than nutrition, may not be classified as a food.  This has significant impact for the health food industry.    Source: Hunt & Hunt Lawyers Legal definitions

Odd Spot: DNA Discovery Traces Most of the World's Macadamias Back to One Australian Tree

Queensland researchers are shocked to discover the global macadamia industry may have originated from nuts from a single tree or small number of trees, taken from Queensland to Hawaii in the 19th century. Given the lack of genetic diversity in the $3 billion crop, the race is on to preserve wild macadamia trees to improve traits like disease resistance, size and climate adaptability. Using DNA analysis from commercial macadamia orchards in Hawaii the macadamia ancestry could be traced all the way back to a tiny patch of wild trees which still exist on private property at Mooloo, near Gympie in south east Queensland.    Source: Jennifer Nichols, ABC News Macadamia origins

NZ Food Notice: Food for Export - Exemptions from Domestic Compositional Requirements No. 2 2019

The purpose of this Notice, issued by the New Zealand Department of Primary Industries, is to exempt food for export from certain requirements of the New Zealand standards where the importing country requirements differ. This includes, but is not limited to, exempting product from certain requirements of the Australia New Zealand Food Standards Code. This Food Notice came into force on 5 June 2019. This Notice should be read by operators of businesses that process or package food for export from New Zealand.     Source: NZ food export exemptions


Top Four Dietary Supplement Trends in New Zealand Revealed by National Industry Organisation

Natural Health Products New Zealand has identified four trends driving dietary supplement market growth in the country, ranging from emerging vitamins and minerals, the Ayurveda medicine revival, gut health, and the incorporation of hemp seeds.   Source: (Copyright) Tingmin Koe, Nutra Ingredients-Asia NZ dietary supplement trends

Trends, Packaging and Preparation: Aussie Supermarket Chiefs Reveal Secrets for Food Firms to Get on Shelf

An expert panel from major Australian supermarkets Drakes, Coles and The Natural Grocery Company have revealed that food firms who stay on trend, focus on packaging and come well-prepared will increase their chances of getting their products on store shelves.   Source: (Copyright) Pearly Neo, Food Navigator-Asia Food marketing

How Technology Will Disrupt Direct Selling – Are You Ready?

There is a quote attributed to Henry Ford that goes, “If I had asked people what they wanted, they would have said a faster horse.” This quote highlights the fact that when it comes to innovation, incumbents and established entities are blind to what’s coming until it’s too late. What implications are there for direct selling models when innovation and disruption is on the rise?   Source: Vince Han, World of Direct Selling Direct selling disruption

Quote for the month:

“If you are sad, add more lipstick – then attack!”   Coco Chanel


Your Questions About the New NICNAS Scheme Get Answered

As reported in May 2019 edition of this newsletter, there is now a new Australian industrial chemicals law – the Industrial Chemicals Act 2019. From 1 July 2020, NICNAS will be replaced by the Australian Industrial Chemicals Introduction Scheme (AICIS). This law also gives effect to the ban on the use of new animal test data for ingredients solely used in cosmetics. Please note that the ingredients in cosmetics are still regarded as industrial chemicals under the new scheme.     Source: AICIS Q&A

Delegate-only Decisions on Agricultural and Veterinary Chemicals may Affect Cosmetics

The latest version of the Poisons Standard (1 June 2019) indicates that the following two substances - N,N-dimethyloctanamide (CAS number 1118-92-9); and N,N-dimethyldecanamide (CAS number 14433-76-2), have gone from unscheduled to Schedule 6 Poisons, with no cut-off concentrations or exemptions from scheduling. This was a delegate-only decision that was not subject to a public consultation period. The substances were referred for scheduling by the APVMA, however the final decision applies to all uses of the substances, not just the AgVet use. Uses other than in AgVet products were identified as part of the scheduling consideration, including in coatings, industrial cleaning products, and processing aids. The European Chemicals Agency (ECHA) has also identified uses in polishes and waxes, washing & cleaning products including machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners. As such, manufacturers of cosmetic products may need to review their methods.   Source: Cosmetic ingredient rescheduling

ACCC Recalls Phytoplex Nourishing Skin Cream

The Australian Competition and Consumer Commission has recalled a cosmetic product supplied by Medline Two International Australia. Phytoplex Nourishing Skin Cream has been recalled due to the presence of certain species of mould, Penicillium chrysogenum and Penicillium flavigenum. The affected products are not likely to have any adverse effects in healthy individuals, but may pose a risk to people with weakened immune systems.    Source: Skin cream recall


TGA Fees and Charges Summary from 1 July 2019

The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. A complete list of the new fees and charges that come into effect from 1st July 2019 can be read here: FY 2019/2020 TGA fees

TGA Lists Important Dates for Suppliers of Complementary Medicines

May 2019 - TGA notifies of fees and charges for 2019-20 (becoming effective from 1 July 2019);

1 July to 22 July 2019 – Period for sponsors to submit their declarations of $0 turnover for any relevant ARTG entries;

1 August 2019 – Annual charge invoices for all non-exempt ARTG entries will be issued;

15 September 2019 – Deadline to pay annual charges invoices.   

TGA Safety Advisories—  

Hair Tonic and Hairpro Capsules: Global Therapeutics, following a safety investigation by the TGA, is recalling all batches and all pack sizes of its Fusion Hair Tonic and Oriental Botanicals Hairpro capsules, due to the risk of liver injury. The recalled products all contain the same ingredients, including the herb Fallopia multiflora. The TGA previously published a safety advisory regarding the potential for liver injury in people who consume products containing Fallopia multiflora, as we reported in the April 2019 edition of this newsletter. The TGA has received 15 reports of liver-related adverse events since 2014 associated with Fusion Hair Tonic and Oriental Botanicals Hairpro, including six cases with markers of severe liver injury. The liver injuries led to hospitalisation in three cases. To date, all cases reported in Australia have either improved or resolved after discontinuation of the product. While the risk of drug-induced liver injury is low, it has the potential to be life-threatening.   Source: Hair-Pro hazard

Vitex agnus-castus - potential for interaction with oral contraceptives: Vitex agnus-castus is mostly marketed for menstrual disorders, including symptoms of premenstrual syndrome and/or menopause and acne and is permitted for use in listed medicines in Australia. The TGA has received one report of an unintended pregnancy following concurrent use of Vitex agnus-castus and norethisterone, a progesterone-only oral contraceptive pill. One other similar case has also been reported internationally. Health Canada and the European Medicines Agency (EMA) advise consumers to consult a health practitioner prior to using Vitex agnus-castus-containing products if they are taking hormone-containing medications such as progesterone preparations, oral contraceptives or hormone replacement therapy. Vitex agnus-castus is also known as Chaste Tree, Chasteberry and Monk's Pepper.   Source: Vitex / Pill interaction

University of Sydney Pulls Claims that Elderberries Can Fight Flu

One of Australia’s leading universities has been forced to retract a claim its study showed eating elderberries could help beat the flu after admitting it was overhyping its own science. The University of Sydney also concealed the research was part-funded by company Pharmacare - which sells elderberry-based flu remedies - at the company's request.   Source: Liam Mannix, SMH Elderberry abuse

TGA Continues Action Against Peptide Clinics Australia for Alleged Advertising Breaches

The Federal Court has granted leave to the Secretary of the Department of Health to continue court proceedings against Peptide Clinics Australia (Peptide Clinics Pty Ltd) following the company's liquidation in March this year. The Secretary commenced proceedings in November last year for alleged breaches of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2015. The alleged breaches relate to inappropriate online advertisements for 'peptides' and other prescription-only products. In Australia, advertisements for medicines and other types of therapeutic goods must not be misleading and they must not advertise prescription-only medicines to the public.   Source: Court proceedings

Medical Board of Australia Consultation for Doctors Recommending Complementary Medicines

The Medical Board of Australia has released a public consultation paper to seek feedback on options for clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments. This consultation has been extended until 30 June 2019.   Source: Medical doctor consultation

REMINDER: Very Important Information for All Suppliers of Listed Medicines. Don’t Let Your Product Get Cancelled!

Due to the importance of this information we are repeating the story that we placed in recent editions of this  newsletter. Suppliers of listed complementary medicines will already know that they must now only use indications included in the list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens. The key transition dates to note are: 6th September 2019 when the 'fee-free' period for sponsors to transition existing listed products ends. After that date an application fee will apply to all transitioning products in accordance with the TGA's Schedule of fees and charges (currently $820 per product); and 6th March 2021 when any ARTG entries that have not transitioned to Permitted Indications will be automatically cancelled. So please ensure that your product’s indications are compliant before these dates, otherwise you will face significant costs or possible cancellation of your product from the ARTG.   Source: Permitted indications

RFA Regulatory Affairs provides training on preparing and reviewing permissible indications for your products so you can make these changes. To book a course, enquire about pricing, or if you have any questions on the topics covered or your suitability for training, contact us at +61 2 96608027; or This email address is being protected from spambots. You need JavaScript enabled to view it.

Sigma Healthcare to Face Investor Questions Over Claims it Mishandled Prescription Drugs

Pharmaceutical supplier Sigma Healthcare will face shareholder questions over claims that it failed to properly handle a range of popular over-the-counter and prescription drugs that get processed through its distribution centres. There are concerns that product quality may have been compromised due to improper handling and storage, with current and former Sigma workers saying that prescription medicines used to treat bacterial infections, depression, high blood pressure and diabetes were left out in 30 to 40 degree heat for hours over the summer months.   Source: Handling of medicines

GSK and Novartis Misled Consumers with Voltaren Osteo Gel Claims

The Federal Court has accepted admissions by GlaxoSmithKline Consumer Healthcare Australia Pty Ltd (GSK) and Novartis Consumer Health Australasia Pty Ltd (Novartis) that they breached the Australian Consumer Law by making false or misleading representations in the marketing of Voltaren Osteo Gel and Voltaren Emulgel pain relief products. GSK and Novartis admitted that from January 2012 to March 2017, they marketed Osteo Gel as being specifically formulated and more effective than Emulgel in treating osteoarthritis related pain and inflammation. In fact, Osteo Gel and Emulgel products are essentially the same. An Australian Competition & Consumer Commission investigation found that despite having the same active ingredients, Osteo Gel was often sold at a significantly higher retail price than Emulgel.    Source: Voltaren collusion

Do You Need an Australian Sponsor for Your Complementary Medicine or Medical Device?

The TGA requires therapeutic products to be supplied by an Australian “sponsor”. The sponsor may be an individual resident in Australia, or an entity incorporated in Australia and conducting business in Australia where the representative of the entity also resides in Australia. The label of any medicine supplied in Australia must include the name and contact details of the Australian sponsor or distributor. For overseas companies, appointing an independent distributor as your sponsor may potentially present a serious disadvantage. Independent distributors may act for any number of companies supplying similar therapeutic products, which can become a conflict of interest.  The Australian sponsor/distributor controls the product registrations and can cancel or amend them at any time and has access to confidential product information held by the TGA. RFA Regulatory Affairs can help you set up your own independent Australian sponsor company.

USA Attorneys General Call for Rationalisation of Banking Laws for Emerging Cannabis Industry

33 States and several USA Territories have decriminalised the medical use of marijuana; some now even allow for recreational usage. Trouble is, cannabis is still listed as prohibited under the Federal Controlled Substances Act. The A-Gs of all of these jurisdictions have written to Congress looking for a solution. Until there is some harmonisation of State-Federal legislation in these areas, Federal banking statutes push all financial transactions into a grey area dominated by cash payments and out of reach for taxation and other regulatory compliance purposes. Industry analysts estimate the 2017 revenue spent on cannabis of $8.3 billion will rise to $25 billion per annum by 2015.     Source: Cannabis law reform USA

(Related story: USA Lawmakers Introduce Comprehensive Marijuana Reform Legislation, the Marijuana Freedom and Opportunity Act, to remove marijuana from the Controlled Substances Act (CSA), thus ending the nearly century-long federal policy of criminalization and prohibition.    Source: Marijuana law reform ).

From High to Health — The Evolution of Cannabis Applications in APAC

Supplements containing cannabidiol (CBD) and functional foods with hemp are among the biggest buzz categories in nutrition right now, but can they become mainstream commercial success stories in the Asia-Pacific region?   Source (Copyright): Cheryl Tay, Nutra Ingredients-Asia CBD in APAC 


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