TGA Extends Fee-Free Window for Current Listed Medicines to Update their Permitted Indications

The fee-free period for sponsors to transition existing listed medicines to permitted indications has been extended until 6 March 2021 (previously scheduled to end 6 September 2019). The Permissible Indications Determination came into effect on 6 March 2018 with a three-year transition period for sponsors of existing listed medicines to re-list their products using permitted indications. Listed medicines that have not transitioned to permitted indications will be automatically cancelled from the register on 7 March 2021.    Source: LM fee-free period

TGA Makes Changes to High-Moderate Risk Permissible Ingredients – Caffeine

Responding to an inadvertent fatal caffeine overdose, as reported in the July 2019 edition of this newsletter, the Therapeutic Goods Administration has made immediate changes to the Therapeutic Goods (Permissible Ingredients) Determination. Highly concentrated caffeine in any dosage form will become ineligible for listing and therefore illegal to supply. Caffeine as an individual ingredient is permitted for oral use at a maximum daily dose of 100mg. However, caffeine when present as a component of other herbal ingredients will now have dosage restrictions so that the medicine does not provide more than 400mg total caffeine per day. For comparison, one teaspoon of instant coffee contains about 80mg caffeine. A maximum dose of 100mg per 3 hours will also be required. These limits consider consumption from other sources such as food, and the adverse effects which are seen when caffeine intake exceeds 400mg/day or more frequent dosing. The following requirements have immediate effect: undivided preparations (e.g. bulk powders) must not contain a concentration of total caffeine greater than 4%; and divided preparations (e.g. tablets) must not contain a concentration of total caffeine greater than 33%. Further changes to both dosage requirements and label advisories for all caffeine containing products are available at Source: Caffeine restrictions    (Please see also: Permissible ingredients determination update and SUSMP amendment consultation.  Also - FSANZ Caffeine Report  & SMH Caffeine fatality ).

TGA Makes Interim Decision in Relation to Sanguinaria Canadensis (bloodroot)

Due to safety issues concerning the use of 'black salve', a delegate of the TGA previously made an application to the Advisory Committee of Medicine Scheduling to make Sanguinaria canadensis, or blood root, a Schedule 10 substance when containing 0.01% or more of sanguinarine. S10 are substances of such danger to health as to warrant prohibition of sale, supply and use. This decision is not expected to affect medicines currently listed on the ARTG, including other herbs with sanguinarine as a component such as Greater Celandine (Chelidonium majus), or homoeopathic listings of S. canadensis, but will make ineligible any and all supply, in Australia, of black salve or similar topical preparations or any preparations of blood root with more than 0.01% sanguinarine.   Source: Interim decision-sanguinarine

TGA Makes Interim Decision in Relation to Cosmetic Ingredient, Arbutin

A private applicant proposed including arbutin as a specific entry in the Poisons Standard, and to allow its use in oral herbal preparations containing 500mg or less of arbutin per recommended daily dose. Arbutin is currently scheduled as a derivative of hydroquinone. The interim decision is to create a new Schedule 4 entry for arbutin with an exemption for oral herbal preparations containing 500mg or less of arbutin per recommended daily dose. There is no change proposed for cosmetic use (i.e. remains as Schedule 2 or 4). The delegate noted: “As the nature of the current scheduling application and associated toxicological data was in reference to the traditional use of arbutin in herbal preparations, I find that on balance, the topical use of arbutin should be considered in a separate consultation. This would allow for specific consideration of toxicity data on the dermal effects of arbutin”. Comments are due back to the TGA by 10 October 2019.    Source: Interim decision - Arbutin

TGA Proposes Changes for Low-Negligible Risk Permissible Ingredients

The Therapeutic Goods (Permissible Ingredients) Determination specifies all of the ingredients that are available for use in listed and assessed listed medicines and their associated requirements. Currently, the affected ingredients include boron, Withania somnifora, Vitex agnus-castus, Plantago spp, and psyllium husk. The proposed ingredient changes in this consultation have been reviewed and categorised as being of low-negligible risk. The purpose of this consultation is to provide an opportunity to comment on these proposed changes which are due to commence on 2 March 2020     Source: Low risk ingredients     (Please also see: Changes to permissible ingredients determination )

TGA Consultation: Increased Online Access to Ingredient Information

The TGA is seeking feedback on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG). They are responding to consumers wishing to more easily have access to this information. By making this information available in the public ARTG view, which is available on the TGA website, the TGA hopes to help consumers make more informed and safer choices about their medicines.    Source: Ingredient access

TGA Provides ‘Decision Tree’ for Mandatory Information Required When Advertising Therapeutic Goods

This decision tree has been designed to help suppliers identify what information must be included when advertising therapeutic goods to the public in order for the advertising to comply with the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The decision tree provides sponsors with the minimum set of information required in advertisements under the Code, based on the type of therapeutic good and the type of advertisement. Additional information in the advertisement may also be added, provided these minimum requirements are met. Important Notes: Representations that refer to serious forms of a disease, condition, ailment or defect are ‘restricted representations’ and prior approval from the TGA is required before advertising these goods; Advertisements for medicines intended to appear in 'specified media' (e.g. free-to-air television, radio, newspapers, magazines, billboards) require pre-approval.     Source: Therapeutic goods advertising   (See also: Application form for approval of an advertisement )

PharmaCare Fined For Alleged Advertising of Cancelled Therapeutic Good

Australian company PharmaCare has paid penalties of $12,600 after the Therapeutic Goods Administration issued an infringement notice for the alleged advertising of a therapeutic good after it had been cancelled from the Australian Register of Therapeutic Goods (ARTG). The product, Sambucol Cold & Flu Kids Liquid, was audited during a routine compliance review. The TGA found that the application to include the medicine on the ARTG was false or misleading, as the scientific evidence PharmaCare held to support some of the indications for the medicine was inadequate. As a result, the TGA cancelled the product from the ARTG in June 2019, however the product was still being advertised on PharmaCare’s website after the cancellation.    Source: Pharmacare fined

TGA Summarises Latest Changes to Medicine Labelling Requirements

The TGA has recently introduced improvements to help bring Australian medicine labels up to date and align them with international best practice. A series of posters are being developed for both professionals and consumers, alerting them to the new labelling system. These posters are a quick reference guide highlighting some of the key medicine labelling changes. You can download these posters to print and display for those wanting to know more about the current labelling designs and their purpose.     Source: Medicine labelling posters    (Please also see: Labelling changes for sponsors )

TGA Report on the Review into the 2016 Medicinal Cannabis Amendments to the Narcotic Drugs Act 1967

The Final Report, tabled in Parliament on 5 September 2019 by Professor John McMillan AO, contains 26 recommendations to improve the regulatory framework for the cultivation, production and manufacture of medicinal cannabis in Australia. Minister Hunt has accepted all 26 recommendations put forward by Professor McMillan, which broadly aim to reduce the regulatory burden on industry, promote and allow greater flexibility in the administration of the legislation to support industry innovation and development.    Source: Medicinal cannabis report

Natural Health Products New Zealand Successfully Challenges Study on Fish Oil Labels

A study, recently published in the New Zealand Medical Journal, that suggested consumers were getting short-changed over fish oil supplements, has been retracted. The study sampled 10 of the most popular fish oil products available in New Zealand and indicated that fewer than half were found to have the same amount of omega-3 fatty acid content (EPA and DHA) indicated on the label, while the rest contained only between 48 and 89 per cent of claimed fish oil. Natural Health Products New Zealand (NHPNZ) contested the study and pointed out three obvious errors in the study: 1 – that there were fundamental calculation errors that significantly skewed the results; 2 – questions over the origin of the input data; and, 3 – methodology errors concerning sample size and product definitions. While the journal claims that it will be publishing a retraction in its next edition, NHPNZ has called for the NZMJ to also issue a media-statement to the general public that this study has been retracted not only from the journal itself but from all other published locations as well. NHPNZ has also asked for a public apology from the journal, to all those parties adversely affected by this faulty journal article.    Source: Jamie Morton, NZ Herald Fish oil study flawed     (Please see also: NHPNZ letter of objection ; and (subscription) NZMJ notice of retraction)

Introducing OneCAM - The Unified Voice of Australia’s Complementary Health Industry

OneCAM is a collaboration between Complementary Medicines Australia (CMAustralia), the Australian Traditional-Medicine Society (ATMS), the Naturopaths & Herbalists Association of Australia (NHAA) and the Complementary Medicine Association (CMAssociation). OneCAM will represent the majority of Australian complementary medicine practitioners and industry, and be the one representative voice when it comes to government policy, the media and the general public.   Source: OneCAM commences

TGA Safety Advisories- Source: TGA current year alerts

Ballerina Anti-Obesity capsules: The capsules contain the undeclared substances phenolphthalein and sibutramine.

Slimina Weight Loss capsules: the capsules contain the undeclared substance phenolphthalein and paracetamol.

TGA Safety Advisory Update: Arthrem capsules

The sponsor of this product has cancelled Arthrem capsules from the Australian Register of Therapeutic Goods, meaning that it can no longer be legally supplied in Australia. In addition, a retail level recall was undertaken in relation to this product on 5 September 2019. (In March 2018, Consumers and health professionals were advised that the TGA was monitoring the safety of Arthrem capsules, which contained the herbal ingredient Artemisia annua extract as the only active ingredient. The TGA is monitoring Arthrem capsules due to identification of a safety concern regarding this product and the potential risk of harm to the liver. The New Zealand therapeutic goods regulator, MedSafe, has published an alert regarding this product after receiving 14 reports of liver toxicity associated with the use of Arthrem).    Source: Arthrem capsules deleted

TGA Recall - Jin Gui Shen Qi Wan Pills

Consumers and health professionals are advised that Shen Neng Herbal Medicines Group, in consultation with the TGA, is recalling all batches of Jin Gui Shen Qi Wan - 金 匮 肾 气 丸 - (AUST L 217716) due to potential toxicity. Samples tested by the TGA have been found to contain levels of aconitum alkaloids that are higher than the limit permitted for a listed medicine. Aconitum alkaloids are toxic to humans and an accidental overdose could be fatal in a small child.     Source: Aconite pill recall

Australian Company, Redback SARMs, Pays Fine for Advertising Prescription-Only Substances

Australian business, Redback SARMs, has paid penalties of $15,210 after the Therapeutic Goods Administration issued six infringement notices for the alleged advertising of Schedule 4 (prescription-only) substances, including Selective Androgen Receptor Modulators (SARMs), and Melanotan II. The TGA is reminding businesses that prescription-only medicines cannot be advertised to the public. Online interfaces that allow consumers to review and self-select their desired prescription-only medicines for subsequent prescribing and supply will generally be considered advertising for those medicines. Businesses should also be aware that promoting general classes of prescription-only medicines (like SARMs) is also likely to be considered advertising.    Source: Prescription meds advertising

NZ Deer Velvet Company Sold 11 Million Capsules Containing Filler Instead of Active Ingredient

A New Zealand deer velvet company knowingly sold 11 million deer velvet capsules filled with carob instead of the stated amount of deer velvet, a court has heard. Silberhorn and its sole director, Ian Carline of Invercargill, was originally hit with 101 charges that were laid under the Fair Trading Act in the long-running Commerce Commission investigation, which started in August 2014. The court heard that some 11 million capsules were given a carob filler instead of the stated amount of deer velvet, saving about 500 kilograms of deer velvet with the potential gain for the company being estimated at $1.2 million. Ian Carline previously told the court he would use himself "as a guinea pig" saying that he gauged the potency of his products by conducting tests on himself, including whether he got nose bleeds.    Source: Hamish McNeilly, Stuff Deer-velvet fail

Accord Enters Into Innovation Partnership with Monash University

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. Monash University is one of Australia's leading universities and ranks among the world's top 100. Together they have developed an Innovation Partnership Agreement which aims to not only improve the rigour of Accord’s advocacy but will also enhance students’ and researchers’ links to industry.   Source: Accord - Monash partnership

View: RFA Regulatory Affairs You Tube Video (Cosmetics Regulation)

Amendments to Imported Food Regulations

Changes to the Imported Food Control Regulations 2019 take effect on 1 October 2019. There are three changes that will potentially impact importers and their brokers: 1. Commercial imports taken to be for private consumption reduced from 10 kilograms/litres to 1 kilogram/litre; 2. All commercial imports of prohibited plants and fungi will be subject to the Imported Food Inspection Scheme (IFIS); 3. Clarification of powers of authorised officers.     Source: Food control

Department of Agriculture Toughens Stance on Importer Transgressions

The Biosecurity Act has been in operation for 3 years and the Department of Agriculture is adopting a less tolerant attitude towards non-compliance. The department will issue infringement notices and take other enforcement action in appropriate circumstances.   Source: Biosecurity crackdown

Australia and New Zealand Ministerial Forum on Food Regulation Communiqué

The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) met on 16 August 2019 to consider a range of food regulation matters. The Forum comprises all Australian and New Zealand Ministers responsible for food, and the Australian Local Government Association. Key topics and outcomes from the meeting include: Health star rating five-year review; supporting the public health objectives to reduce chronic disease related to overweight and obesity; labelling of sugars on packaged foods and drinks; fast food menu board labelling; fermented beverages; and, salmonella enteriditis. In addition to items discussed at the meeting, the Forum also ratified a number of recent decisions from out-of-session processes, including modernisation of the food regulation system, and, energy labelling of alcoholic beverages.   Source: Food forum communiqué

Agriculture Department Updates Formulated Supplementary Sports Food Regulations

The Advisory Committee on Novel Foods (ACNF) has determined that Acacia rigidula is to be a novel food. As such, the safety of this food has not been established, and there is no tradition of use as food in Australia and New Zealand; and there may be potential for adverse effects if consumed. [Supplementary sports foods are foods specifically formulated to assist sports people in achieving specific nutritional or performance goals. Some ‘sports supplements’, particularly those in tablet or capsule form, may be considered to be therapeutic goods, rather than formulated supplementary sports foods. Determining whether a product is a food or a therapeutic good can be difficult at times because it depends on many factors, such as ingredients, dosage form and in particular the way in which the product is presented for supply, including advertising and labelling].   Source: Supplementary sports food

July 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 June. 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 hydrocyanic acid, arsenic, aflatoxin and many more. Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals and also irradiation.   Source: Latest failed foods (Please see also FSANZ Food recall list )

FSANZ Notifications—

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

Application A1174 – Xylanase from Trichoderma reesei as a PA (Enzyme): The purpose of this Application is to permit the use of Xylanase from Trichoderma reesei as a Processing Aid.   Source: Trichoderma enzyme

Application A1184 – Glucoamylase from GM Aspergillus niger (donor Trametes cingulata): The purpose of the application is to approve the use of glucoamylase sourced from GM Aspergillus niger containing the gene from Trametes cingulata.   Source: GM aspergillus

Application A1185 – Alpha-amylase from Aspergillus niger as a Processing aid (enzyme): The purpose of this application is to approve the use of Alpha-amylase sourced from Rhizomucor pusillus in GM Aspergillus niger.  Source: Alpha amylase

Application A1186 – Soy Leghemoglobin in meat analogue products: The purpose of the application is to allow the use of soy leghemoglobin derived from P.pastoris as a component in meat analogue products.   Source: Meat analogue

Application A1188 – Gibberellic Acid as a Processing Aid: The purpose of the Application is to allow Gibberellic Acid to be used as a processing aid for all cereal grain germination and retain the limit of GMP.   Source: Gibberellic acid

Functional Foods and Supplements to Contribute Towards $25bn Australian Market by 2030

Australian ‘health and wellness’ products including functional foods, supplements and personalised nutrition, along with more sustainable products such as alternative protein, will become a AU$25bn billion market by 2030, according to new data.   Source: (Copyright) Guan Yu Lim, Food Navigator-Asia Functional foods market

How to Read Australian Food Labels

When it comes to food labelling in Australia, it is a legal requirement for all packaged foods to have a food label containing important safety and nutrition information which helps consumers compare one food item with another and find high-quality foods with high nutritional value. Food Standards Australia and New Zealand [FSANZ] says there should be 12 components to a food label – including dates, ingredients, vitamins, certain allergens, instructions for storage and preparation, and advisory and warning statements - with the nutrition information panel [NIP] and the ingredients list being the most important information for consumers.   Source: Amy Mills, New Idea Understanding food labels   (Please also compare with French food labelling regulations)

Aussies Willing to Pay More for Sustainable Products

Australian shoppers are willing to pay more for environmentally-friendly products from sustainable companies, according to new findings by Salmat and ACRS. The research found that a third of Australian shoppers (34 per cent) will buy sustainable products, but 31 per cent said they don’t purchase a brand or product that doesn’t adhere to their values, ethics or sustainability practices. Almost three quarters (72 per cent) of shoppers rank ethical brand behaviour among their top three priorities in shopping for products.    Source: Remedios Lucio, Inside FMCG Fair trade

Aussie Plant-Based Meat Could be Worth $3b to Economy

Recently released world-first modelling shows Australia’s plant-based meat industry is projected to add up to $3 billion a year into the economy by 2030. It would appear an outrageous proposition given Australia's alternative meat market only contributes 265 jobs and $30 million at present. But the new research suggests otherwise. Under the most favourable scenario, one of three outlined by global firm Deloitte, thousands of jobs would be created and customer expenditure would rise to $4.6 billion per annum. But Food Frontier, an alternative plant protein group which commissioned the report, is warning the nation could miss out on the prospective boom.    Source: Callum Godde, AAP via PerthNow Plant-based meat projections

These Food Movements are Aiming to Change the Way We Eat

Australians of all ages and cultural backgrounds are getting together to change the world - and they're doing it using food. Youth Food Movement Australia (YFMA) is a volunteer-run, non-profit organisation that engages people aged 18-35 years and educates them about food sustainability issues. The movement, which is mostly online, runs blogs, events and campaigns that focus on the reduction of food waste, creating culturally inclusive food communities, how to use ‘ugly food’ and community eating. Grow Free is a grassroots movement that that aims to share free, healthy food with all members of the community. The organisation’s philosophy is all about ‘growing and giving’. The movement centres around the existence of physical carts, placed in various locations that are shared with members of the public online. These carts display free produce that people can pick up, and vegetable, herb and flower seedlings for people to take and plant in their garden. You can also use the cart to drop off produce and seedlings to give away to others. The global Slow Food movement, which was founded in Italy in the 1980s, is now a 30-year-strong organisation that’s working hard to protect local food cultures and traditions across 160 countries, including Slow Food Australia. The movement focuses on a concept of food that is ‘good, clean and fair’, and aims to bring international and Indigenous gastronomic traditions to the community. There is also the Right to Food Coalition - the nationwide food movement – made up of organisations, practitioners, researchers and community workers – aims to advocate for vulnerable people who don’t have access to healthy food.    Source: Yasmin Noone, SBS Food movements

RFA Provides Comprehensive Training In Regulatory Affairs - Spring Special! 20% discount on September and October bookings

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 www.rfaregulatoryaffairs.com/training-courses . 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. We are offering a special 20% discount on all courses if you enrol in the month of September or October. 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:

“I am building a fire and every day that I train, I add more fuel”    Mia Hamm