Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines (“Dietary supplements”):
TGA Assessed Listed Medicines Evidence Guidelines
The assessed listed medicines pathway provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG). The new pathway sits between the current listed (lower risk) and registered (higher risk) pathways. It enables sponsors to list products with higher level indications than permitted in standard listed medicines without having to meet the extensive requirements for full registration. This is provided that assessed listed medicines have robust scientific evidence to support the efficacy of the product, and this evidence is pre-market assessed by the TGA. Medicines that have undergone pre-market assessment and approval by the TGA have a unique AUST L(A) number, and may carry a claim that the product's efficacy has been assessed for the approved indications. There are three application categories for assessed listed medicines which have different evidence requirements depending on the level of efficacy evaluation This document provides guidance for the evidence requirements for all application categories, however a majority is dedicated to L(A)3 applications as these products require a de novo evaluation of efficacy. Source: Assessed LM guidelines
TGA Conducts Review of Listed Medicines With Traditional Indications
The Therapeutic Goods Administration will be initiating targeted compliance reviews of a selection of listed medicines that use traditional indications. (Traditional indications are statements that describe the specific therapeutic use for a medicine based on evidence of a history of medicinal use). If you are a consumer, please be aware that this is part of TGA’s normal review process and there is no immediate concern associated with the use of listed traditional medicines. TGA recommends that If you are a sponsor of a listed medicine with traditional indications, you are encouraged to re-evaluate the evidence you currently hold; and to reconsider the indications made for your medicines with reference to the ‘evidence guidelines for listed medicines’. TGA will be conducting desktop compliance reviews for a selection of listed medicines with traditional indications in the second half of 2018. Some will be selected randomly and others will be selected on the basis of regulatory intelligence. Source: Traditional indications review
Submissions Received: Discontinuing Pre-Market Evaluation f Herbal Component Names (HCNs)
The TGA has published submissions made in response to the November 2017 public consultation paper, “Consultation: Discontinuing pre-market evaluation of Herbal Component Names (HCNs)”. A total of 7 submissions were received. All respondents that gave permission to be published on the TGA website are now available in PDF format. Source: Herbal component names
Discontinuing Pre-Market Evaluation of Herbal Component Names
Where a herbal ingredient comprises of chemical constituents, these chemical constituents are referred to as "herbal components". A Herbal Component Name (HCN) for use in listed medicines is a name for a herbal component of its parent herbal ingredient. HCNs are not standalone active ingredients for use in listed medicines. Certain herbal components are mandatory to declare in listed medicine applications. These mandatory herbal components are identified in the Therapeutic Goods (Permissible Ingredients) Determination, and are mandated by the Poisons Standard or for safety reasons. There is no legislative requirement to use non-mandatory herbal components for listing a medicine on the ARTG. Sponsors will no longer be able to submit new HCN applications for pre-market evaluation effective immediately. After 1 October 2018, sponsors will not be able to select HCNs from the TGA list of approved HCNs for use in new listings. The TGA will continue to work with industry to discontinue pre-market evaluation of HCNs. Source: Herbal component names
TGA Consultation on Proposed Therapeutic Goods Advertising Code Guidance
The Code is the key advertising compliance standard that sets out minimum requirements and underpins the regulatory framework for the advertising of therapeutic goods to the public. The Code addresses several recommendations from the Expert Review of Medicines and Medical Devices Regulations that were agreed by Government. The TGA is seeking input from interested parties on the revised version of the guidance to support the Code. This consultation closes on 4 October 2018. Source: Advertising code consultation
TGA Updates Compositional Guideline Template
A compositional guideline is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in listed medicines as either an active substance or an excipient. This template is for prospective sponsors and substance manufacturers to supply with their applications. Source: Compositional guidelines
TGA Announces Final Decisions Amending The Current Poisons Standard for Cannabis Products
The final decision of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Schedule 4 entry for cannabidiol, and the Schedule 8 and Appendix K entries for tetrahydrocannabinols and cannabis in the Poisons Standard. Source: Cannabis regulation
TGA Updates on GMP Clearance Application Forms
These notices are for sponsors who make GMP clearance applications. Following updates to the GMP clearances forms, the TGA is continuing to monitor and review them to ensure improved user experience. The TGA has become aware of several issues, and fixes are scheduled to be implemented in August 2018. Source: GMP clearance
TGA Recall - Durex Real Feel Condoms (6 pack)
Reckitt Benckiser (RB), in consultation with the TGA, is conducting a recall of one batch of Durex Real Feel polyisoprene (non-latex) condoms as testing has found this batch will likely not meet specifications at the end of its shelf-life in 2021. The affected condoms come from batch number 1000432443 (expiry January 2021). No other batches are affected by this issue. The recall followed RB's in-house durability testing during which the affected batch was heat treated to simulate three years of shelf-life ageing and failed subsequent pressure tests. There is no immediate safety concern for consumers and there have been no adverse events reported in Australia regarding this batch of condoms. Source: Condom fail
TGA Safety Advisories— Source: https://www.tga.gov.au/current-year-alerts
Fairy capsules: the capsules contain the undeclared substance sibutramine
G Female Oral Tablets: the tablets contain the undeclared substance sildenafil
Liangzern Dietary Supplements: the tablets contain the undeclared substance sildenafil
Germany Niubian tablets: the tablets contain the undeclared substance sildenafil
Rhino 8 Platinum 8000 capsules: the capsules contain the undeclared substance sildenafil
TGA Expands List of Comparable Overseas Regulators for Medical Device Applications
The TGA is expanding the range of international assessments and approvals from comparable overseas regulators that sponsors can choose to provide when submitting their applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG). TGA is also increasing the use of assessment reports as the basis for abridgement of the assessment of an application for a TGA conformity assessment certificate. Source: Medical devices 1(See also related story: Application Requirements for Medical Devices - Preliminary Assessment Medical devices 2 )
TGA Updates Status of Essure Contraceptive Device
The Essure contraceptive device was cancelled from the Australian Register of Therapeutic Goods (ARTG) on 9 February 2018. Since the device began supply in Australia in 1999 until 6 August 2018 the TGA has received 59 adverse event reports relating to women implanted with the Essure device. Source: Medical device scandal
Vitamin Supplementation Comes Under Scrutiny
Dr. Derek Muller is the creator of popular YouTube channel Veritasium and has investigated vitamins and whether they really are good for humans. In a recent documentary Vitamania: The Sense And Nonsense Of Vitamins televised on SBS, Dr Muller said there were about 85,000 vitamin products on the market and people spent about $100 billion on vitamin supplements around the world. “We are looking at one billion people who regularly take vitamins or supplements — that’s a lot,”. Dr Muller is not out to debunk vitamins and he said they can improve people’s health in some cases. “I want us to be more nuanced in our understanding of these substances.” His new documentary, was screened in sessions around Australia between July 28 and August 3. Sources: Charis Chang, News.com.au Vitamin scrutiny ; Vitamania (Editor’s note: Robert Forbes was invited to contribute to Vitamania and his comments can be read here: RFA backgrounds Vitamania )
TGA Responds to Vitamania
On the evening of 12 August 2018, the documentary Vitamania premiered in Australia. The documentary explores the role of vitamins and vitamin purchases around the world. To provide context for the film, the TGA describes here how they regulate vitamins in Australia. Source: TGA Vitamania
Botanic Adulterants Prevention Program
Three leading nonprofit organizations—the American Botanical Council (ABC), the American Herbal Pharmacopoeia(AHP), and the University of Mississippi's National Center for Natural Products Research (NCNPR)—have initiated a large-scale program to educate members of the herbal and dietary supplement (complementary medicines) industry about ingredient and product adulteration. Responsible parties in the herbal and dietary supplement community have become increasingly concerned about the suspected and confirmed practice of adulteration of numerous ingredients. The existence of adulteration raises questions about the identity and quality of some popular herbal ingredients sold in dietary supplements in the United States and in other botanical products (e.g., medicines, cosmetics, etc.) in global markets. For a complete summary of all activities of this programme, please visit Botanical Adulterants Index page (Editor’s note: For the most recently published example of this programme, please read the “Bulletin on Boswellia Resin Adulteration - adulteration and substitution of boswellia with resins from related species” Boswellia adulteration )
Foods:
Heinz to Pay $2.25 Million Fine for 'Deceptive' Peddling of Toddler Snack
Food giant Heinz has been ordered by the Federal Court to pay $2.25 million in penalties after being found guilty of "misleadingly and deceptively" targeting sugar-heavy snacks at toddlers. But the Australian Competition and Consumer Commission (ACCC), which initiated the legal battle, remains unsatisfied with the result, having sought $10 million in penalties. Earlier this year, the Federal Court found Heinz had misled the public about the nutritional content of its Little Kids Shredz range, aimed at children aged one to three years. It found the statements and pictures of fruit and vegetables on the packaging "conjured up impressions of nutritiousness and health", even though the sticky snack was two-thirds sugar. Source: Esther Han, SMH Heinz penalty
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. A summary of submissions will be produced and published on the Food Regulation website. Submissions close at 11:59pm on 19 September 2018 Australian Eastern Time. Source: Sugar labelling (Editor’s note: Please see also related story “Food Standards Agency Survey Highlights Sugar Fears”, courtesy of Rod Addy, Food Manufacture Sugar worries ).
FSANZ Called for Comment on Draft Cost Recovery Arrangements
Food Standards Australia New Zealand has 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 was 2 August 2018 and results will be published when they come to hand. Source: Cost recovery
Review of Fast Food Menu Labelling Schemes
The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) is conducting a review of fast food menu labelling schemes in Australia. The review will consider the effectiveness of the fast food menu labelling schemes including implementation and emerging issues since the release of the endorsed National Principles for Introducing Point-of-Sale Nutrition Information in Standard Food Outlets in 2011. At its meeting of 29 June 2018, the Forum agreed that further targeted consultation is to be undertaken to develop policy options that aim to improve and strengthen fast food menu labelling in Australia. A broader range of stakeholders will be engaged in the next stage of consultation. Source: Fast food labelling
FSANZ Notifications—
Application A1129 – Monk Fruit Extract as a Food Additive: The purpose of the Application is to permit monk fruit extract as a food additive, specifically as an intense sweetener. Source: Monk fruit sweetener
Application A1144 – Re-categorising Coconut Milk for Food Additive Permissions: The purpose of the Application is to consider whether the food category for food additive permissions for coconut milk products is more appropriate under fruits, rather than beverages. Source: Coconut milk
Application A1146 – Thermolysin (Protease) as a Processing Aid (Enzyme): The purpose of this Application is to permit the use of thermolysin (protease) from Anoxybacillus caldiproteolyticus as a processing aid in protein, dairy, egg, meat and fish processing and flavour production. Source: Processing aid
Application A1151–Beta-Galactosidase from Papiliotrema terrestris as a Processing Aid (Enzyme): The purpose of the Application is to amend Schedule 18 of the Australia New Zealand Food Standards Code to include ß-Galactosidase from Papiliotrema terrestris as a Processing Aid. Source: B-Galctosidase
Application A1153 – Endo xylanase from T. reesei as a Processing Aid: The purpose of the Application is to include a genetically modified strain of Trichoderma reesei as a permitted source for Endo-1,4 (3) - ß -xylanase (E.C.3.2.1.8) Source: E-xylanase
Application A1154 – Food derived from insect-protected cotton line MON88702: The purpose of the Application is to seek approval for food derived from a genetically-modified insect-protected cotton line, MON88702 Source: GM cotton food
Application A1157 – Enzymatic production of Rebaudioside M: The purpose of this Application is to seek approval for a new specification for rebaudioside M produced by an enzymatic biosynthesis method. Source: Rebaudioside enzyme
Application A1158 – Rosemary extract as a food additive: The purpose of this Application is to seek approval to permit the use of rosemary extract as a food additive (antioxidant). Source: Rosemary antioxidant
Application A1168–Glucoamylase from GM Aspergillus niger as a Processing Aid (Enzyme): The purpose of the Application is to permit the use of glucoamylase produced from a genetically modified strain of Aspergillus niger as a Processing Aid. Source: GM aspergillus
Proposal M1015 – Maximum Residue Limits (2017): The purpose of this proposal is to consider varying certain maximum residue limits (MRLs) for residues of specified agricultural and veterinary chemicals that may occur in food commodities. Source: MRL food
Australian (NSW) Food Authority Recalls – Source: Current recalls
Frozen Vegetable Product Recalls: Contain a ‘particularly dangerous strain’ of Listeria monocytogenes (Full list: Frozen food recall )
Woombye Cheeses: due to microbial (high E.coli count) contamination
Gary Gumball (Ice cream): due to the potential presence of foreign matter (glass)
Rafferty’s Garden Organic Baby Rice Cereal: due to incorrect packaging information and the presence of an undeclared allergen (gluten / oats)
Lactose Free Whole Milk Powder: due to the presence of foreign matter (metal)
White Mill Pancake Shake: due to the presence of an undeclared allergen (egg)
Lotus Certified Organic Millet Meal: due to the presence of an undeclared allergen (gluten).
Food Allergen Portal
Food allergies can be life threatening. For people who have a food allergy the only way to manage the allergy is to avoid the food allergen. For this reason there are laws in place, for example mandatory labelling to help people who have a food allergy avoid food allergens. Many sectors in the community also have a role in assisting in managing food allergies including the food industry, health professionals, and schools. This food allergen portal was created by the Allergen Collaboration to provide different sectors in the community with links to best practice food allergen resources and key messages to promote in the different sectors. Source: Food allergen portal
July 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 July. Among the pathogenic organisms detected in these imported foods were, Salmonella, Bacillus cereus and E. coli as well as the toxins Aflatoxin, Histamine, caffeine, betel nut and more. Source: July Failing foods
Marketing News:
Chinese Millenials Key Demographic for Aussie Supplements
Australian supplement firms should target Chinese millennials if they want to maximise their growth opportunities in the country, the founder and president of the Australia-China SME Association has argued. Source: Cheryl Tay, Nutraingredients-Asia Marketing in China
Quote for the month:
“The entry point for desktop internet is the search bar. The entry point for the mobile internet is the QR code” WeChat founder, Allen Zhang
*************************************************************************************************************************************************************
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 Product Design Project Management Regulatory Support 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 E: This email address is being protected from spambots. You need JavaScript enabled to view it.
Cosmetics (& Household cleaning products):
To Be or Not To Be—‘Natural’. What’s in a Name?
A naturally-occurring chemical is one of the following: Either, an unprocessed chemical occurring in a natural environment — chemicals obtained from plants, microorganisms, the earth, sea or animals without any processing at all, for example blood and milk from animals, minerals, ores, crude oil, coal and natural gas obtained without any processing; OR, a chemical occurring in a natural environment that is extracted using a process that does not cause a chemical change in the substance — this refers to chemicals that occur in nature but which have been extracted using certain processes without changing their chemical composition. If introducers and suppliers extract a chemical by some other means, such as steam distillation or solvent extraction, it will not be a naturally-occurring chemical. Source: Natural chemicals (See also: Examples of naturally occurring chemicals)
New Service From RFA Regulatory Affairs - New Product Development
Details at the bottom of this newsletter.
Please wait...
