Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

 

Australians Rewrite Complementary Medicine Rulebook

Times are changing in the world of Australian complementary medicine regulations and New Zealand producers will need to act fast or risk losing out to their competitors for sales across the ditch. That is the advice Australian regulatory consultant Robert Forbes gave the audience at the Natural Health Products New Zealand Suppliers Day in Auckland. Recent TGA changes include removal of the free text option when making product claims/indications (applicants will need to select their product claims/indications  from a drop-down list of over 1000 approved indications) and changes to regulations related to new ingredient assessments. There is a new approval pathway for non-prescription medicines to be sold in Australia (called Aust L Assessed; AUST L A whichsits in between Listed and Registerd medicine categories and allows manufacturers to make slightly more powerful claims about their products’ health effects if they have the supporting evidence.   Source: Jonathan Chilton Towle, pharmacytoday.co.nz (Subscription) Australian V NZ regulations

TGA Rules on the Implementation of a ‘Claimer for Efficacy Assessed Non-Prescription Medicines’

The TGA has ruled on a proposal to allow sponsors to claim (‘the claimer’) that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market evaluation by the TGA. Eligible products will be ableto carry higher level health claims than current Listed (AUST L) products, including health benefits for more serious health conditions. Government-recognised status of the efficacy of Complementary Medicines (CMs) which hold higher level health claims puts Australia at the cutting edge of global regulation of CMs. The claimer, to be applied voluntarily by the sponsor of the approved product, will appear in the form of a diagram on the product label. The optional statement on the label will be: ‘Evidence for the approved indications has been assessed by the TGA’). The claimer will be introduced for assessed listed medicines (which may include complementary and OTC medicines) and registered complementary medicines only.    Source:  Efficacy claimer ruling  

TGA Publishes Current List of  Evaluated Registered Complementary Medicines

Registered complementary medicines are considered to be of relatively higher risk than listed medicines, based on their ingredients or the indications made for the medicine. Registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to being accepted on the Australian Register of Therapeutic Goods (ARTG) and able to be marketed. Medicines registered on the ARTG are assigned a unique AUST R number, which must be displayed on the medicine label. The following link sets out the registered complementary medicines on the ARTG that have been evaluated by the TGA for safety, quality and efficacy: Registered comp meds

TGA Considers 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 ARTG. As soon as legislation is finalised, the number of comparable overseas regulators and assessment bodies will be expanded to include peak European, Canadian and Japanese regulatory agencies.   Source: Medical device regulation

TGA Updates Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in September 2018. A total of 10 changes have been made in the updated Determination. These changes include: the addition of 5 new ingredients; changes to 5 existing ingredient entries; and, correcting the approved ingredient name.   Source: Permissible ingredients update

TGA Recalls NET Remedies Homeopathic Products

Consumers and health professionals are advised that NET Remedies, in consultation with the TGA, is recalling all unexpired aqueous-based products currently in the supply chain due to possible microbial contamination. It has been identified that a fault in the water filtration system from the North Carolina manufacturer resulted in four batches being contaminated by Pseudomonas spp.   Source: Homeopathic recall

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

For the first time, in many years, this month there have been no reported illegal medicines containing Viagra / Cialis like substances imported into Australia!

Weight-Loss 'Shredder' Drugs Containing Toxic DNP Linked to Deaths

Health authorities are warning the public against weight-loss products containing a toxic chemical that have caused multiple deaths in Australia and overseas. The drugs containing the chemical 2,4 dinitrophenol (DNP) are marketed as "shredders" to the fitness, weight-loss and body-building communities. The toxic substance used to make herbicides and explosives causes serious illness and death. Several young people have died after taking the drugs in Australia and internationally according to NSW Health. DNP prevents energy from being stored as fat; instead it releases energy as heat, which increases body temperature. That can damage the cells of organs including the kidney and brain.    Source: Kate Aubusson, SMH Weight-loss shredder

TGA Provides Update on the Compliance Verification (CV) GMP Clearance Applications Backlog

In 2017-18 a total of 5,327 GMP Clearance applications were received. This compares with over 5,400 applications in 2016-17 and over 5,600 in 2015-16. This has created a backlog of applications and has extended the processing times for CV clearance applications. To address the backlog, in September 2017 the TGA implemented a range of GMP Clearance process improvements and a streamlined compliance verification process. Analysis of the CV GMP Clearance applications shows that there has been a substantial reduction in the number of CV applications across the board.    Source: GMP backlog

TGA Facebook Has Officially Launched

Facebook is a popular forum for consumers to discover and share information, with 60% of Australians being users of social networks including Facebook. The TGA Facebook page extends its reach with these consumers, increasing awareness of its role as Australia’s regulator of medicines, medical devices, blood, cell and tissue products. Consumers can use the page to find information and tips on the safety of medicines and medical devices, while health professionals can use it to follow the latest news and guidance on the regulation of therapeutic goods.    Source: TGA Facebook

TGA Publication of Interim Decisions Proposing Amendments to the Current Poisons Standard

Affected substances include: Sildenafil; Budesonide; Alkyl nitrites; Codeine; Cannabidiol and tetrahydrocannabinols (THCs); Paracetamol combined with ibuprofen; 2-Butoxyethanol; Dimethyl sulfoxide (DMSO); Aliphatic allyl esters; &, Astodrimer sodium. Further comments are due to the TGA by 11 October 2018.    Source: SUSMP scheduling

The Rhetoric Around What Constitutes 'Good' Evidence Has Become Increasingly Polarising

The debate about what constitutes 'good evidence', always a controversial point, has recently become even more heated, writes complementary medicines consultant Michael Smith.   Source: Gary Scattergood, Nutraingredients-Asia  'Good' evidence

 

Honey Scandal Continues to Grow

As reported by this newsletter in December 2014, Australia’s consumer watchdog, the ACCC, fined two companies for selling “Turkish Sugar Syrup” labelled as honey.. The official test in Australia to check if honey is pure is called the “C4 sugar test.” Plants have different ways of producing sugars, using different chemical pathways depending on the plant and the conditions in which it is grown. Bees collect nectar mostly from flowers of plants in the “C3 cycle”, and much less from plants using C4 pathways to make sugars. The C4 test picks up most fake honey, because most of the cheap sugar syrups used to make fake honey came from C4 plants, like corn and sugar cane. But newer substitutes, like rice, wheat, and beet syrups, come from C3 plants, and so won’t be picked up. The fake honey in this most recent scandal was identified by a method called “Nuclear Magnetic Resonance” (NMR for short). which measures how the nuclei in the sample respond to different magnetic fields, it providing a fingerprint of what is in the sample. This means it isn’t restricted to just testing for C4 sugars, and it can detect non-honey sugars from any source. This is why some honeys may pass the standard test, but not pass an NMR test.   Sources: What is Fake Honey and Why Didn’t the Official Tests Pick it Up?   Emma Beckett, The Conversation Honey testing ;   Department of Agriculture Responds to Honey Furore   Govt. honey testing ;   Fake Honey Imports Could Lead to a Humanitarian Disaster   Robert Costa, SMH Honey disaster;   Honey…how to Shrink the Frauds? Australian Experts Respond to 'Adulterated' Product Claims Gary Scattergodd, Food Navigator-Asia 'Funny' honey

Food Fraud Affects Many Supermarket Staples, so how do you Choose the Good Stuff?

Food fraud is essentially the sale of an inferior product represented as a more valuable one. This could be through substitution, dilution, tampering, or misrepresentation of food, ingredients or packaging. Because it is designed to be undetected, it is difficult to know the true reach of food fraud, but the potential profits and complexities of the modern food supply chain mean it is likely becoming more common. The substitutes aren't always harmful but, they may have different nutrient profiles and biological properties to the original product. Often, it would be completely legal to add these products to food, provided they were labelled correctly.    Source: Emma Beckett, ABC Food frauds

Australian (NSW) Food Authority RecallsSource: Current recalls

Glendenning Farms eggs: due to potential microbial (Salmonella) contamination.

Rhuby Delights and Rhuby Creations Chocolate Products: due to an undeclared allergen (dairy).

G J Wholesale Alcohol Products: due to potential chemical contamination

YouFoodz Clean Paprika Chicken: due to the presence of undeclared allergens (fish, gluten, egg, milk)

Mahroum Sesame Halva: due to the presence of an undeclared allergen (pistachio nut)

Schweppes Lemonade 1.1 litre: due to an incorrect label (Schweppes Lemonade Zero Sugar) being applied to the rear of the bottle.

Fresh Stawberry Contamination

The NSW Police Force is warning the community following reports of contaminated strawberries. On 12 September 2018, Queensland Police Service announced an investigation into the contamination, which appears to have originated at a Queensland-based supplier. The contamination relates to what appears to be sewing needles and pins inserted in strawberries. Police are urging anyone who has purchased contaminated product to take the punnet to their local police station immediately for triage and forensic examination. Any customer who has purchased strawberries is urged to cut the fruit before consuming.   Source:  Strawberry contamination

(Beaking News:  As the ‘Strawberry Crisis’ escalates with multiple copy-cat incidents, sewing needles get removed from supermarket shelves: SMH Supermarket strawberry reaction;, QLD Health update 6)

Compendium of Microbiological Criteria for Food September 2018

Food Standards Australia New Zealand have recently published a comprehensive guide to the whys and hows of food testing. Microbiological criteria are established to support decision making about a food or process based on microbiological testing. Criteria can be developed and applied for different purposes across the food supply chain, with different consequences if the limits are not met. An important principle is that a microbiological criterion is established at a specified point in the food chain for a particular purpose. In general, this is to establish the safety of a food or to verify that the food safety control system or elements of it are working as intended.     Source: © Food Standards Australia New Zealand Food compendium

FSANZ Notifications—

Application A1137 – Polysorbate 20 as a Food Additive: The purpose of the Application is to permit the use of polysorbate 20 as an emulsifier.   Source:  Polysorbate 20

Application A1170 – Rebaudioside MD as a Steviol Glycoside from Saccharomyces cerevisiae: The purpose of the Application is to seek approval for a steviol glycoside mixture (Reb MD) for use as an intense sweetener, produced from a genetically modified Saccharomyces cerevisiae.   Source: Steviol glycoside

Proposal P1046 – L-amino acid acetate in Food for Special Medical Purposes: This proposal has removed a negative impact on trade by enabling the sale of food for special medical purposes (FSMP) containing L-arginine acetate.   Source: L amino acid

Proposal P1048 – Code revision 2018: The purpose of the Proposal is to make minor amendments including the correction of typographical errors, inconsistencies and formatting issues and updating of references.   Source: Code rvision 2018

Why the FDA is Updating What “Healthy” on a Food Label Means

The United States Food and Drug Administration (FDA) recently announced new steps to advance health through improvements in nutrition. Modernising labels to make them simpler and understandable by implementing a new Nutrition Facts label – an item that hadn’t been refreshed in more than 20 years – reflect recent scientific developments as part of an initiative designed to empower consumers to choose healthful diets. Today, almost 40 percent of U.S. adults are obese and poor nutrition plays a part in this epidemic.    Source: Randall Popelka, Herbalife FDA food label

Portal for all Things Food Related

BiaBiz is a comprehensive directory of free technical knowledge & trainings for food producers, entrepreneurs, scientists, technologists & advisers. This useful aggregator is a handy go-to site when you are searching for global food facts and resources including a link to RFA’s popular vitamin converter.       Source: BiaBiz

 

CMA Provides an Industry Snapshot into Australia’s Complementary Medicines for 2018

Complementary Medicines Australia (CMA) is the peakbody for the complementary medicines industry, representing members across the supply chain, including manufacturers, importers, exporters, raw material suppliers, wholesalers, distributors and retailers. Regulated in Australia as medicines, complementary medicines include vitamins, mineral and nutritional supplements, homeopathic, aromatherapy products and herbal medicines. The term ‘complementary medicines’ also comprises traditional medicines, which includes traditional Chinese medicines, Ayurvedic, Australian Indigenous and Western herbal medicines. This fascinating snapshot of the current Australian market points out, among other things, that Australia’s Complementary Medicines Industry has annual revenue of AU$4.9 billion which represents a $2.0 billion growth over the last 5 years.   Source: CMA industry snapshot

 

Quote for the month:

“Be not afraid of going slowly; be afraid only of standing still”   Anon.

 

NICNAS Annual Reporting Due by 28 September

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) governs the safe use of a broad range of chemicals including those used in cosmetics, soaps and many other personal care products. If you have introduced new chemicals that are exempt from notification, under permit or self-assessed certificate for the 2017/18 registration year, you must submit an annual report or online declaration to NICNAS by 28 September 2018.    Source: NICNAS reporting

Thinking of Supplying Soap in Australia? Here are the Rules

If you’re planning to sell soap that you import or make, you will probably need to register with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). This is because most soap ingredients are regulated as industrial chemicals in Australia. If you want to sell soap you need to register (your business, not your products or ingredients) with NICNAS.  You don’t need to register your business with NICNAS if you only re-sell soap that you bought from an Australian supplier or manufacturer; and/or, make soap from ingredients that you bought in Australia and the process you use doesn’t involve a chemical reaction (such as melting and blending).   Source:  Selling soap

 

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 )

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