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

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

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 Recalls – Source: 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.