Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines / “Dietary Supplements”:
TGA Publishes Online Catalogue of Permitted Ingredients for Use in Listed Medicines
The TGA is pleased to announce that an online catalogue of ingredients approved for use in listed medicines has been finalised and is now available. Listed medicines can only contain certain low risk ingredients in acceptable amounts that are approved by the TGA. The ingredients available for use in listed medicines and requirements associated with their use are specified in the Permissible Ingredients Determination. Source: Permiited ingredients
TGA – CMA Bilateral MeetingThe Therapeutic Goods Administration bilateral meeting with Complementary Medicines Australia was held on Friday 24 February. The annual bilateral meeting is a chance for industry associations to meet with TGA executives to discuss the business performance and financials of the previous year, the budget forecast and proposed increases to fees and charges. This meeting also provides a chance for CMA to provide an industry update on its strategic outlook, achievements and issues. A summary of the main updates is provided here: TGA - CMA meeting
TGA Safety Advisories -
Australia Kangaroo Essence Tablets; & Africa Black Ant capsules; & Nangen Zengzhangsu capsules - The Therapeutic Goods Administration (TGA) has tested these products and found that the tablets and capsules contain the undeclared substance sildenafil (active in Viagra) Sources: Jump! & Bite! & Rise!
Counterfeit Tadalafil 100mg Tablets - The TGA has tested a product labelled Tadalafil 100mg tablets and found that the tablets contain trace amounts of the undeclared substances sildenafil (active in Cialis) and dipyrone (an analgesic, no longer sold in Australia due to links to a rare but sometimes fatal condition called agranulocytosis. Source: Fake Cialis
Placebo Tablets - The TGA has tested a product labelled Placebo and found that the tablets contain the undeclared substance clenbuterol (bronchodilator). Source: Fake Placebo
Change Me Herbal Slimming capsules; & Ultimate & Herbal Slim Weight Loss Capsules; & Lose Weight Capsules - The TGA has tested these products and found that they contain the undeclared substance sibutramine (active ingredient in Reductil, that was withdrawn in October 2010 after a study showed an increased risk of major cardiac events). Sources: Slim chance & Fat chance & Lose it caps
TGA Releases Medical Devices Safety Update
Health facilities may have justifiable reasons for not following advice given by a medical device sponsor during a product recall, but it is important to document the risk assessment leading up to the decision. A facility declining to implement a recall should complete a well-reasoned risk assessment that is endorsed by the appropriate executive within the facility and stored for future reference. Suppliers may be surprised to learn that some topical creams are classed as medical devices, while others are classed as medicines. According to the Australian medical devices guidance document number 35 'emollient and moisturising preparations, formulated and presented for therapeutic use' are classed as medicines, whereas 'uncompounded emollients, moisturisers presented for therapeutic use' are classed as medical devices. The essential difference is that those topical creams classed as devices achieve their intended action in ways that do not primarily rely on 'pharmacological, immunological or metabolic means'. Source: Medical device’s
New Zealand Expert Fears Health Product Causes 'Life-Threatening Allergic Reactions'
An Auckland specialist is convinced an over-the-counter health product (herbal ingredient – andrographis) is causing "life threatening allergic reactions" - and her fears have been backed by Medsafe. She skin-tested one patient to determine whether the herb had caused their anaphylactic reaction, but it came up negative. "But that doesn't exclude that it was the ingredient they reacted to - skin testing doesn't exclude a clinically significant allergy. "She reported the drug reactions to New Zealand's Centre for Adverse Reactions Monitoring. Source: Nicole Barratt, NZ Herald Herb reaction
Read the NPNZ response to the Andrgraphis allergy story here: NPNZ reaction
Healthy Products to Shine at Industry Trade Show in Sydney, June 2017
As all of our readers will be aware, RFA Regulatory Affairs has played a vital role in providing compliance advice internationally for suppliers of complementary medicines, foods and cosmetics in Australia.
Having participated in tradeshows around the world, including last year’s huge SupplySide West Expo, we’re continually asked about similar events in the Australia market, and for years there hasn’t been anything for the industry.
Rewind to 2015, and the launch of Naturally Good Expo has finally created an event in Australia that brings together the entire supplier and buyer ecosystem to do business and network. The event has seen phenomenal growth, and this year doubles in size, moving to the brand new ICC Sydney Exhibition Centre @ Darling Harbour.
Thousands of buyers attend from a wide variety of channels, including pharmacy, all major supermarket health category buyers, practitioners, 70% of the countries health food stores, as well as distributors, agents and brokers.
RFA Regulatory Affairs will again have a stand at this year’s event on the 4th and 5th June in the new Complementary Medicines Pavilion – dedicated to the growth of complementary medicines through all Australian channels. Complementary Medicines Pavilion Come and see us at Stand B43!
We encourage our overseas and local clients to consider the exciting opportunity of attending this industry event!
Naturally Good Expo
ICC Sydney Exhibition Centre
Sunday 4th – Monday 5th June, 2017
Open daily 10am – 5pm
When an Australian Grown Product Doesn’t Count as an Australian Ingredient
With mandatory compliance with the new Country of Origin Food Labelling Information Standard approaching next year, the food industry is discovering all manner of discrepancies and unforeseen negative impacts for their products. This article explores the situation where, if 100% Australian almonds are ground and strained overseas, the resulting almond milk is required to identify the product as “Made in” the country where it was ground and strained. Source: Charles Fisher, Food-Legal CoO Labelling
Application A1135 – Beta-galactosidase as a Processing Aid (Enzyme) - The purpose of the Application is to permit the use of a new source of beta-galactosidase from a genetically modified strain of Bacillus licheniformis to be used as a processing aid during the production of reduced lactose or lactose free milk and dairy products. Source: Beta-galactosidase
A1117 – Extension of Use of L-Cysteine as a Food Additive - The purpose of this Application is to extend the use of the food additive, L-cysteine, to limit enzymatic browning of cut avocado and banana and so extend the shelf life. Source: L-cysteine
A1119 – Addition of Water to facilitate Wine Fermentation - The purpose of the Application is to permit the addition of water to dilute high sugar to aid fermentation in the production of wine, sparkling wine and fortified wine. Source: Water & wine
A1128 – Food derived from reduced Acrylamide Potential & Browning Potato Line E12 - The purpose of the Application is to seek approval for food derived from a genetically modified potato line, E12 which has reduced acrylamide potential and reduced browning (black spot). Source: Acrylamide
A1126 Pectins & Carrageenan as Processing Aids in Wine (Fining Agent) - The purpose of the Application is to seek permissions for pectins and carrageenan as processing aids to remove heat-unstable proteins from Australian produced wine. Source: Wine fines
Department of Agriculture Notice IFN 01-17 - Date Marking and Other Labelling Requirements for Imported Food
The purpose of this notice is to provide detail to importers about some of the labelling non-compliances that are regularly identified by the department regarding imported food. For the period from January to June 2016, there were 17,464 labelling assessments conducted under the IFIS, with 366 labelling related non-compliances detected. Source: Food labels
Department of Agriculture Releases Latest ‘Failing Food Report’
This report details food that was found to fail under the Imported Food Inspection Scheme during the month. The ‘failed food’ was not distributed for sale in Australia. It was destroyed by the importer or re-exported to the country of origin under department supervision. Where a product is found to be noncompliant because the label does not have the mandatory allergen declaration, the product must be destroyed, re-exported or re-labelled to include the mandatory declaration. Future consignments continue to be targeted at 100 per cent until a history of compliance is established. Typical causes for ‘food failure’ are Microbiological / Allergen contamination (mostly cheeses and sea-foods), and, Toxin / Chemical presence (processed foods and nuts). Source: Food fails
Country of Origin Training Videos
Australia's new Country of Origin Labelling laws have changed. An amendment in November 2016 to the scheme means there are different requirements for overseas food that is packed in Australia. This series of 8 video modules, incorporates these changes to provide a comprehensive, up-to-date way for you to understand the labelling requirements and obligations under the new laws. The training videos explain concepts such as "substantial transformation", "priority foods", "varying Australian content", the new definition of "Made in Australia", and more. Watch the FREE first video by clicking here! Source: Food-Legal CoOLL videos
Watchdog Revises Standards, Begins Regulatory Process for Online Sales
Beijing was a hive of activity last week as regulators revised standards on an extensive range of food lines, and released draft regulations on online food services for public comment. Source: RJ Whitehead, Food navigator-Asia China online
Drinkers on the Pulse: Australia Gets Its First Lentil Craft Beer
A craft brewery in the Adelaide Hills has released Australia’s first beer made with lentils. Source: By RJ Whitehead, Food Navigator-Asia Lentil beer
MEDICINES (Dietary Supplements):
TGA Responds to Claims of Poor Oversight of Sunscreens
After many recent reports of people becoming sunburned, even after use of sunscreen products, concerns have been expressed concerning the safety and efficacy of various sunscreen products and the testing process carried out by TGA on sunscreens available on the market. The TGA does require sponsors to undertake SPF (efficacy) testing of sunscreens but because of the highly specialised nature of the testing the TGA does not do it in house. All testing is done under an international ISO standard. If there was a problem with the SPF testing then all samples of that product would be affected and we would see much greater numbers of sunburn. The Cancer Council and medical colleges have emphasised the importance of applying sunscreen liberally and regularly, as these products are commonly under-applied. Source: Sunscreens
TGA Completes Investigation on Homeopathic Teething Products
As reported in previous newsletters, the USA Food and Drug Administration published a safety alert and media release in late 2016, stating that homeopathic teething tablets and gels may pose a risk to infants and children. The TGA has completed its testing of samples of teething gels and has not identified any quality issues. Levels of atropine, the primary alkaloid present in belladonna, were found to be well below the cut off for this type of product of 300 parts per billion. Based on these results, no further regulatory action will be taken. Source: Teething troubles ; Further information by Chloe Booker, SMH Teething tribulations
Widespread Adulteration of Korean Ginseng Extract in the European Food Supplements Market
Analysis of commercial Korean ginseng (panax ginseng) root extract samples obtained from the European market revealed adulteration in more than half of the products tested. Adulteration of botanicals is a substantial threat to the natural products industry worldwide. It diminishes the quality and efficacy of food supplements and introduces potential safety hazards. On occasion, adulteration can be unintended however in the clear majority of cases the practice is deliberate and intentionally fraudulent. Source: Network Nutrition Ginseng adulteration
Publication of TGA Laboratory Testing Outcomes
From mid-2017 the Therapeutic Goods Administration will begin publishing additional information about their laboratory activities, including outcomes of laboratory testing, on the TGA website. The TGA tests approximately 2000 samples of therapeutic goods annually. While many products tested by them meet required quality standards, they currently provide very little information to the Australian public about the testing activities undertaken. Source: Lab tests
TGA Consultation - Reforms to the Regulatory Framework for Complementary Medicines
The Therapeutic Goods Administration is seeking comments from interested parties on a range of reforms to the regulatory framework for complementary medicines to address Government-agreed recommendations from the Review of Medicines and Medical Devices Regulation. Consultation closes 28th March 2017. Source: CM consultation
TGA Safety Advisories:
Chao Jimengnan Super Powerful Man Tablets; Zhen Gongfu Tablets; Impeous Man capsules - The Therapeutic Goods Administration has tested these products and found that the tablets / capsules contain the undeclared substance sildenafil (active in Viagra) Source: Superman tabs 1 ; Superman tabs 2 ; Superman tabs 3
COSMETICS & Personal care:
Accord Australasia Launches Sunsible Website
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. Please visit this site to learn more about the what, the why and the how of sunscreens. You can also take the Sunsible quiz! Source: Sunsible