Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines (“Dietary supplements”):
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: http://www.rfaregulatoryaffairs.com/training-courses)
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 http://www.rfaregulatoryaffairs.com/training-courses )
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: https://www.tga.gov.au/current-year-alerts
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
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, news.com.au Protein shake-up
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 Recalls – Source: 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
When are ‘Naturals’ not Natural? When you’re in Aldi
Products marketed by supermarket giant Aldi using the term "naturals" don’t need to be made of mostly natural ingredients if the word is less prominent on the packaging and sold in a discount bin, the Federal Court has ruled. Aldi’s popular Protane Moroccan Argan Oil hair treatments promise a "naturals" formula on the bottle, referring to the ingredient "argan oil" found in the product, even though many of the ingredients are not natural. But because the writing is small, below the name of the product, and because it’s often found in a discount bin in a discount supermarket, the court found that ordinary consumers would understand the "Naturals" label refers only to the presence of the ingredient "argan oil" and not whether the product is composed of mostly natural elements. Source: David Estcourt, SMH Aldi naturally
Sigma Hit by Competitor’s Blow
In a body blow to the pharmaceutical wholesaler, Sigma is set to lose its biggest retail customers in June next year. Sigma has been unable to reach agreement on a new supply contract for the 400 stores in the Chemist Warehouse retail chains, which command around a 23 percent share of the total retail pharmacy market. The Chemist Warehouse Group, which includes My Chemist Group, My Beauty Sport and ePharmacy, an online pharmacy, has opted instead for a five-year supply contract with Ebos Group. Ebos, which is listed on both the Australian and New Zealand stock exchanges and is currently the supplier for the Terry White Chemmart pharmacy chain, estimates the new contract will generate around $1 billion in wholesale sales in its first year. Source: Inside FMCG Sigma dumped
Quote for the month:
“Competition is the keen cutting edge of business. Always shaving away at costs” Henry Ford
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
- Identify ingredients and suppliers
- Sense-check your concepts
- Assistance in defining your concept for efficient product development
- 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)
- Guidance on product development timeline
- Direct & manage stakeholders
- Identification of suitable contract manufacturers
- Management of tender process
- Manage pilot trials
- 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
Art & Music Can Build Healthy Communities
Fundraising event, ART OF MUSIC, is held every two years. A group of Australia's top musicians and visual artists come together to create an original exhibition where each artist chooses an iconic Australian/NZ song to inspire a piece of artwork. The artwork is then auctioned during a gala dinner in the spectacular Grand Court of the Art Gallery of NSW. All proceeds go to Nordoff-Robbins Music Therapy, an inspirational charity that uses the power of music to transform lives. Music is used in live and interactive sessions to help people cope with the struggle of living with a wide range of needs. These include children and adults with physical and intellectual disability, autism, trauma, illness, dementia, behaviour disorders and learning difficulties. For more information visit noro.org.au.
RFA Regulatory Affairs is proud to be a Gold sponsor of Nordoff Robbins Music Therapy
Cosmetics (& Household cleaning products):
Accord Australasia Sets Up ‘WashWise’ – All You Ever Wanted to Know About Washing
Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic and specialty products, their raw materials suppliers and service providers. Accord’s latest initiative, The WashWise website, provides a wealth of information on sustainable laundry practices – whilst also assisting consumers to use laundry products correctly. WashWise provides tips and information about doing the laundry for Australians who value a great clean, the environment, and saving money. Source: WashWise
NSW Government Warning After Children's Lead Poisoning Linked to Eyeliner
The New South Wales state Government has issued a public health warning over an imported eyeliner that contains dangerously high levels of lead and other hazardous metals. Health authorities in western Sydney were alerted to the product, manufactured in Pakistan and sold in some Indian and Pakistani stores in Sydney, after three children from the same family became sick. doctors tested the children and found elevated levels of lead in their blood. An investigation indicated the health concerns were likely to have been caused by one of the Hashmi brand eyeliners. Testing of the Hashmi Surmi Special and Hashmi Khol Aswad eyeliners revealed an 84 per cent lead content. The tests also found the two eyeliners contained high levels of dangerous metals including arsenic, cadmium, chromium and mercury. Source: Nour Haydar, ABC News Toxic eyeliner
Complementary Medicines (“Dietary supplements”):
Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 – Update
The Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018 was registered on the Federal Register of Legislation (FRL) on 15 June 2018. Changes include - Addition of 9 new excipient ingredients with associated requirements relating to their use; Changes to 75 existing ingredient entries; and, Removal of 4 ingredients. The TGA has included an 18-month transition period for most changes to the Permissible Ingredients Determination. Consequently, the new Determination includes transitional arrangements for existing medicines that are currently listed in the Register to comply with some new requirements for ingredients. The transitional provisions do not apply to new products that are entered into the Register. The transition period ends on 1 January 2020. Source: Permissible ingredients 2018
Australian Government Specifies Cannabis Import / Export Controls
The Office of Drug Control (Dept. of Health) has detailed the conditions that some cannabis products may be imported and exported from and to Australia. Export is permissible for ‘medicinal cannabis products manufactured in Australia under a GMP licence’; for ‘medicinal cannabis products listed as export-only, or registered, on the Australian Register of Therapeutic Goods (ARTG)’; & for ‘extracts of cannabis (or extracts of cannabis resin) manufactured under a Narcotic Drugs Act 1967 licence and permit that are not in the final dosage form’. For Imports, ‘approval must be granted by the national governments of both the importing and exporting countries before shipment can occur. Food grade/nutritional products derived from hemp may not meet Australian manufacturing requirements’. Source: Medicinal cannabis
Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015. The guidance for the proposed Therapeutic Goods Advertising Code 2018 is still under development and will be consulted on from mid-June 2018. Source: Advertising medicines
TGA Fees and Charges From 1 July 2018 Summary
For a complete summary of the latest fees and charges for non-prescription medicines, listed medicines (including for export only), registered complementary medicines and the newly established ‘assessed listed complementary medicines’, please visit this site. Source: Non-prescription medicines Manufacturing inspections and GMP clearance fees can be read here: Manufacturing fees
TGA Safety Advisories— Source: https://www.tga.gov.au/current-year-alerts
Solve Botanical Slimming capsules: contains furosemide (frusemide), phenolphthalein and paracetamol.
Meltz – Instant Energy For Males tablets: contains the undeclared substance vardenafil.
Bulbao Male Enhancer tablets: contains the undeclared substances sildenafil, tadalafil and yohimbine.
Platinum - Male Enhancer capsules: contains the undeclared substances sildenafil, sulfosildenafil and sulfoaildenafil.
Camellia sinensis (green tea) extract (potential risk of harm to the liver!)
Consumers and health professionals are advised that rare cases of harm to the liver have been associated with products that contain Camellia sinensis (green tea) extracts. Medicines containing C. sinensis extracts have been associated with a number of cases of liver toxicity world-wide, although the incidence appears to be rare and unpredictable. The majority of C. sinensis use (including green tea in beverage form) is unlikely to cause harm, therefore the TGA considers that a recall of C. sinensis products is not warranted. The underlying reasons why liver injury has occurred are not well understood at this stage. Twenty adverse events have been reported to the TGA associated with both C. sinensis-containing products and liver injury. All but one of these events involved products containing concentrated extracts of the ingredient. Most cases (17) involved multiple suspected products and/or multi-ingredient products. In three cases, the sole suspected product contained C. sinensis as the only active ingredient. Source: Green tea risk
TGA Outlines the Future Regulation of Low Risk Products
The Government required the Therapeutic Goods Administration (TGA) to examine whether the regulatory oversight applied 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. The status quo will prevail for ‘Water soluble vitamins and minerals, as well as for sunscreens’. Products which are changing include: Tampons and menstrual cups (exempt goods); Nappy rash creams / treatments (exempt goods) (only if they are currently listed or Class 1 devices, but not if they are currently registered); Hard surface disinfectants - exempt goods (if currently listed as hospital grade without specific claims), but registered hard surface disinfectants with specific claims will be moved from the registered to listed other therapeutics goods (OTG); Antiperspirants (excluded); and, Ear candles (excluded). Source: Low risk products
TGA Updates the Listed Medicines Application & Submission User Guide
Do you want to prepare an application to list a medicine? Then this latest guide is just for you. Most listed medicines are complementary medicines, such as: vitamin and mineral formulations, herbal preparations, homeopathic preparations, and essential oils. The TGA Business services (TBS) portal provides an electronic facility for the listing of medicines on the Australian Register of Therapeutic Goods (ARTG). All necessary tools required to lodge, change and maintain an application for a listed medicine are accessible via TBS. This guide is intended to be used as a step‐by‐step description of each process of the application and submission process. Each section will outline the functionality and describe how each section should be completed. Source: DIY listed medicines
Editor’s note: Please remember that if you get stuck, you can always try one of our own in-house training courses via http://www.rfaregulatoryaffairs.com/training-courses or failing that, engage with us directly and we can do all of the work for you. www.rfareg.com
Turmeric Adulteration Bulletin
Jointly published by the American Botanical Council (ABC), American Herbal Pharmacopoeia (AHP), and the National Center for Natural Products Research (NCNPR), the Botanical Adulterants Prevention Program has recently highlighted the widespread practice of adulteration of global turmeric (Curcuma longa rhizome) supplies. Few herbal dietary supplement ingredients have seen such a steep sales increase over the past five years as turmeric. Turmeric has been the top-selling dietary supplement in US natural food stores since 2013, and it ranked fifth in sales in mainstream retail outlets in 2017. The new bulletin, written by Ezra Bejar, PhD, an expert in botanical research in San Diego, California, lists the known adulterants, details analytical approaches to detect adulterants, and provides information on the nomenclature, cultivation, harvest, and market importance of turmeric. Source: Turmeric bulletin