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Complementary Medicines (“Dietary supplements”):

Summary of Changes to the Therapeutic Goods Advertising Code 2018

The Therapeutic Goods Advertising Code (No.2) 2018 (the No.2 Code 2018) will commence from 1 January 2019. Key changes include: delaying commencement of certain health warnings; streamlining definitions; providing transitional arrangements for pre-approved advertisements; streamlining general requirements for advertisements; clarifying requirements for scientific or clinical claims; and, clarifying requirements relating to consistency with public health campaigns.   Source: Advertising code update

Complying with the Therapeutic Goods Advertising Code (No. 2) 2018

Advertising of therapeutic goods requires a higher ethical standard than may apply for ordinary consumer goods. Determining the appropriateness of a therapeutic good can be difficult for a consumer and it is important that promotional material is truthful, balanced and not misleading. Advertising should give adequate information on the risks and cautions around a product and recommend to seek health professional advice where appropriate. As a result there is specific legislation that applies to the advertising of therapeutic goods to consumers (over and above Australian Consumer Law, which regulates advertising generally). The regulation of advertising reflects the importance of consumers being properly informed so that they can select treatment options appropriately for use in their own and their family's healthcare.   Source: Advertising to the public

TGA Advertising of Therapeutic Goods: Education, Training and Events

A suite of educational materials is being developed to help advertisers understand the legislation relating to advertising therapeutic goods. These materials include online learning modules, videos, webinars and presentations and will be updated as new information and training materials become available.   Source: TGA training   (See also: RFA Regulatory Affairs training courses)

TGA Advertising Guidance: Sample Social Media Acceptable Use Policy

The TGA acknowledges that social media provides a valuable platform for sharing views about products, but there are important considerations around therapeutic goods. To help advertisers comply with the Therapeutic Goods Advertising Code, the TGA has provided a social media acceptable use policy that advertisers can use on their digital platforms. This policy sets out guidelines to ensure any comments, endorsements or testimonials are not misleading or encourage the inappropriate use of a product. To use the policy, suppliers can simply copy and paste into the 'About' tab on their own social platforms and be sure to moderate any comments that may result in them breaching the Code.   Source: Acceptable use policy

TGA Updates Medicine Ingredient Names

In different countries, different names are used to describe the same medicinal ingredient. Over the years, some medicine ingredient names in Australia have become out of date. This can be confusing for Australian consumers and healthcare professionals who travel internationally, as well as people like doctors who have trained overseas or people trying to access medicine information online. The TGA is updating some medicine ingredient names used in Australia to align with names used internationally. The four year transition period for these changes has started and will end in April 2020.   Source: Medicine ingredient naming

TGA Safety Advisories—   Source:

Li Da Weight Loss Capsules: the capsules contain the undeclared substance sibutramine.

Chapter Plus+ By Backslim Capsules: the capsules contain the undeclared substance sibutramine.

Canberrans Warned of Dangerous and Unknown Substances in Sport Supplements

Australian Capital Territory Chief Health Officer Dr Paul Kelly, said ACT Health is currently investigating the sale of sports and other supplements in the ACT, following complaints to the Health Protection Service. “The products are being sold locally and primarily through sports supplement stores, which is why this is so concerning and why Canberrans need to be warned. These substances are banned for a reason. They pose a significant health risk and for the majority of these substances there is no legitimate medical use”. The sport supplement products that have been found as part of the investigation, are labelled to contain substances, such as selective androgen receptor modulators (SARMs), cardarine, tadalafil, oxedrine, melatonin and phenibut.   Source: Sports supplements warning . (Editor’s note: Seems that USA has similar problems, especially with ‘phenibut’ Phenibut warning )

Medical Devices: Hearing Aid Retailers Fined $2.5 Million for Misleading Pensioners

The Federal Court has ordered hearing aid retailers Oticon Australia Pty Ltd (Oticon) and Sonic Innovations Pty Ltd (Sonic) to pay penalties totalling $2.5 million for misleading pensioners through newspaper advertisements for hearing aids sold by AudioClinic and HearingLife clinics. In addition to paying penalties of $2.5 million, the Court ordered by consent that Sonic and Oticon offer refunds to customers who purchased ConnectLine and SoundGate3 accessories, publish a corrective notice in a nationally circulated newspaper, and establish an Australian Consumer Law compliance program.   Source: Hearing aid penalty

NZ Natural Health Products Back on Political Agenda

In June 2018, New Zealand First MP, Mark Patterson, submitted a member’s bill to replace the Natural Health and Supplementary Products Bill which lapsed shortly before last year’s election and was not reinstated when Parliament resumed. Mr Patterson has since withdrawn his bill, after he was contacted by the minister’s office and told the ministry was already working on new rules for natural health products. Health minister David Clark has asked for advice on new legislation for natural health products. Currently, natural health products are controlled as medicines or under Dietary Supplements Regulations 1985. Industry group Natural Health Products NZ has been a vocal proponent of the need to update the legislation, which it sees as an impediment to business. Dr Clark was not available for an interview, but, in a statement to Pharmacy Today, confirms: “The Government has agreed to develop legislation of its own on this matter.”   Source: NHPNZ, NZ NHP Bill

Renewed Warning of Liver Harm from Artemesia annua

The New Zealand Director General of Health is renewing a public warning following more reports of serious liver harm from taking Arthrem and other products containing Artemisia annua extract. An initial alert in February this year was a result of 14 reports of liver harm linked to the use of Arthrem, a natural product available for sale and other similar products. Since then there have been an additional 11 reports, some showing serious harm. Some of these new reports may have been from people taking these products earlier, but they may also have been from people continuing the take the product. Artemisia annua extract (also known as Sweet Wormwood, Sweet Annie or Qing hao) is marketed as a natural dietary supplement for maintaining and supporting joint health and mobility. Several products containing Artemisia annua extract are available in New Zealand.   Source: NZ liver warning

New Technique to Eliminate Adulteration of Ginkgo Biloba Leaf Extracts

Network Nutrition, a division of IMCD and supplier of specialised plant derived natural-healthcare ingredients, has recently published its scientific research into the numerous mechanisms for the adulteration of Ginkgo biloba leaf extracts. The research includes careful examination of the latest and most sophisticated mode of adulterating this popular herbal material, being the inclusion of an entirely different plant species; Styphnolobium japonicum (syn. Sophora japonica). The paper, published in the journal Fitoterapia, involved a comprehensive independent analytical screen of 22 finished products purchased in the European, Australian and New Zealand retail sectors. It was discovered that 14 out of 15 (93%) of the finished products purchased in Europe contained adulterated Ginkgo extract, whilst this was true for 2 out of 7 (28.5%) of those purchased in the Australian and New Zealand markets. The research discusses the hotly debated presence or absence of genistein; an isoflavone compound, and whilst some scientific circles elude to the natural occurrence of this compound in Ginkgo leaf, the research provides expanded analytical tools to determine the source of any genistein present.   Source: Elsevier Gingko study

Botanical Adulterants Prevention Program Publishes Cranberry Laboratory Guidance Document

The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of nonprofit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The program advises industry, researchers, health professionals, government agencies, the media, and the public about the various challenges related to adulterated botanical ingredients sold in commerce. This new publication evaluates analytical methods to authenticate cranberry fruit materials and detect adulteration with anthocyanin- or proanthocyanidin-rich extracts from other plant species.   Source: ABC Herbalgram Cranberry adulteration




Not Meeting Honey Rules Costs Auckland Businessman

An Auckland businessman has been fined more than NZ$26,000 for offences related to making false therapeutic claims about honey and failing to ensure he was a registered exporter. Jonathan Paul Towers, 43, has been sentenced in the Auckland District Court and fined $26,300 after earlier pleading guilty to one charge under the Food Act and one charge under the Animal Products Act. A Ministry for Primary Industries (MPI) investigation found that Towers exported honey worth approximately $30,000 while not being registered between March 2014 and November 2016.   Source: NZ honey fine

Honey Investigation Concludes Due to Testing Uncertainty

The Australian Competition & Consumer Commission has concluded its investigation into allegations Capilano Honey Limited (Capilano) breached the Australian Consumer Law in relation to representations about its ‘Allowrie’ honey and other products. The investigation followed allegations in the media that a number of honey products including Capilano’s ‘Allowrie’ honey, labelled ‘pure’ and ‘100% honey’ were adulterated with sugar syrup. The allegations were based on results arising from a testing process known as Nuclear Magnetic Resonance (NMR) testing. NMR testing can be used for a variety of applications, but has only recently emerged as a testing method for honey adulteration. The ACCC is advised NMR testing is not yet reliable enough to determine whether honey is adulterated and therefore should not be used as a basis to support legal action. This is consistent with the approach of regulators in the UK, US and the EU.   Source: Honey is now OK ; See also Nutra Ingredients-Asia, Honey investigation loses sting

Food Regulation: Getting Your Claims Right

The Australian and New Zealand joint food regulation system is based on scientific evidence and expertise that protects the health and safety of consumers. It is a complex system that involves all levels of the Australian and New Zealand governments. Different roles are met by local, state and national government, and international obligations are respected. Here is a guide to complying with the Nutrition, Health and Related Claims Standard of the Australia New Zealand Food Standards Code (the Code). This guide was developed by the Implementation Subcommittee for Food Regulation (ISFR) to provide advice on how to comply with the Nutrition, Health and Related Claims Standard (Standard 1.2.7) in the Code.   Source: Food regulations guide

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

Application A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40: The purpose of this Application is to seek approval for food derived from SHO safflower lines 26 and 40, genetically modified to produce high levels of oleic acid in the seed.   Source: GM safflower

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 M

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 A1162–Triacylglycerol lipase preparation from Trichoderma reesei as a Processing Aid (Enzyme): The purpose of this Application is to seek approval to permit the use of the enzyme Triacylglycerol lipase from Trichoderma reesei as a processing aid in the manufacturing of cereal-based products.   Source: Trichoderma enzyme 1

Application A1165 – Lysophospholipase from Trichoderma reesei as a Processing Aid (Enzyme): ​The purpose of the Application is to permit the use of lysophospholipase enzyme from Trichoderma reesei as a processing aid for use in starch processing.   Source: Trichoderma enzyme 2

Application A1172 – Enzymatic production of Rebaudioside D: The purpose of this Application is to seek approval for a new specification for rebaudioside D produced by an enzymatic conversion method.   Source: Rebuadioside

Application A1173 – Minimum protein in follow-on formula: The purpose of the Application is to seek approval to vary the minimum protein requirement in follow-on formula.    Source: Infant formula

Proposal P1050 – Pregnancy warning labels on alcoholic beverages: The purpose of the proposal is to consider a mandatory labelling standard for pregnancy warning labels on packaged alcoholic beverages.   Source: Alcohol in prgnancy

Hemp Seed Can be Sold as Food in New Zealand

Amendments to regulations to allow the sale of hemp seeds as food came into affect on 12th November 2018. Head of New Zealand Food Safety, Bryan Wilson, says there was wide support for changes to introduce hemp seed into the New Zealand food supply. "Hemp seeds are safe to eat and nutritious. They don't produce a psychoactive or therapeutic effect. "Earlier this year, New Zealand Food Safety and the Ministry of Health jointly consulted on proposed changes to the Misuse of Drugs (Industrial Hemp) Regulations 2006 and the Food Regulations 2015 to allow the sale of hemp seed as food. Sixty-four submissions were received from industry groups, growers, businesses, and consumers, with the majority of respondents strongly in favour of changes to allow hemp seed and hemp seed products to be sold as food. Submitters also requested more guidance surrounding the Misuse of Drugs (Industrial Hemp) Regulations 2006.     Source: NZ hemp seeds

[Related content: Cannabis Cosmetics Crusader Celebrates Year on From Aussie Hemp Food Legalisation - Almost exactly a year ago, changes to the Australian Food Standards Code finally permitted the sale of low-psychoactive hemp seed as a food, after years of lobbying by producers and industry groups. Hemp skincare’s popularity has trickled down from last November’s food legalisation buzz.   Source: J. Whitehead, Cosmetic Designs-Asia Oz hemp regulation ]

History Spot: Dr Harvey Washington Wiley & his ‘Poison Squad' who Pioneered USA Food Safety

In major US cities in the late 19th century, dairy producers looking to cut costs would dilute milk using pond water, plaster dust and some yellow lead to give a golden hue. Once the manufacturer was satisfied with the aesthetic of the product, the toxic chemical formaldehyde could be added to give the so-called "embalmed milk" a longer shelf life. Milk was only one of a long list of commonly adulterated foods that included lead in cheese, brick dust in cinnamon, sawdust in ground coffee, and brown sugar spiked with crushed insects. Unchecked by government regulation, basic safety or even labelling requirements, food manufacturers put profit before the health of their customers. After briefly serving in the Civil War, Harvey Washington Wiley became a chemistry professor, and in 1883 was named the Department of Agriculture's chief chemist. The department, traditionally concerned with agribusiness, became the vehicle for Wiley’s 30-year campaign for safe food and proper labelling. Eventually, the government legislated and the Meat Inspection Act was passed, followed a week later by the Pure Food and Drug Act. Commonly known as 'the Wiley Act', it required that a drug's active ingredients be written on its packaging, and meant unsafe products could be outlawed. Gradually food safety standards were expanded and exported internationally and by mid-century became the rule rather than the exception throughout the developed world. Consumers today, who value their breakfast free of borax, have Wiley to thank.   Source: ABC News History: The Wiley Act

October 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 latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of August. Among the pathogenic organisms detected in these imported foods were, Listeria monocytogenes, Vibrio cholera, & Salmonella, as well as the toxins Aflatoxin, Lead, Dimethoate and more.   Source: Latest failed foods


Cosmetics and TGA listed sunscreens:


Why You Should Always Buy Australian Made Sunscreen

Sunscreen experts are pleading with Australian consumers to steer clear of so-called "sunscreen pills" and buy Australian-made products over imported ones. In a crackdown on the burgeoning sun protection industry, the US Food and Drug Administration earlier this year warned four companies to stop claiming their dietary supplements could protect people from sun damage. Australia produces the most effective sunscreens in the world and consumers should opt for local products over highly marketed ones from overseas. A TGA spokeswoman said sunscreen pill products were not approved for sale in Australia and sun-screening claims can only be made for products applied to the skin, meet the official standard and have been registered.   Source: Sunscreen pills

National Transport Commission (NTC) Removes Aerosols from Personal Care Products in Consumer Packaging Exemption Clause

In a September update of the ‘Australian Code for the Transport of Dangerous Goods by Road and Rail’, edition 7.6 (ADG 7.6) by the NTC ‘aerosols’ were excluded from the “Personal Care Products in Consumer Packaging” exemption clause (section 3.4.12). The original version of the ADG 7.6 published on the NTC website exempted all personal care products in consumer packaging from the requirement to mark and label packages, and from documentation requirements if they were correctly classified and packed. This permitted personal care aerosols to be transported by road and rail as “general freight”. An additional new clause has now been added by the NTC to remove aerosols from this exemption.   Source:  Aerosol transport

Event: Accord Cosmetic & Personal Care Conference, Sydney 6th December 2018

Accord is the national industry association representing manufacturers and suppliers of hygiene, cosmetic and specialty products, their raw material suppliers and service providers. RFA Regulatory Affairs is a proud sponsor and we look forward to meeting you at the upcoming conference. Bring your ideas and enthusiasm and we will show you how to get your cosmetic products to market.   Source: Accord conference


Marketing News:


A Product Registry in USA Would Go a Long Way Toward Weeding Out Bad Actors

The low barriers to entry in the dietary supplement industry create the risk that the good deeds of the many will be besmirched by the transgressions of the few. Fortunately, there is something that can be done about it, given enough collective will.     Source: Hank Schultz, Nutraingredients-USA USA supplements regs

(Editor’s note: Compare and contrast the situation in the USA, where dietary supplements are regulated as foods; and there is no pre-market registration requirements, with Australia. Down under, these types of products are regulated as ‘complementary medicines’ and as such, are regulated as medicines requiring strict manufacturing standards. Therapeutic claims, or indications for use, must be based on scientific or traditional evidence).

What is the Difference Between Public Liability Insurance & Professional Indemnity Insurance?

It is often asked “isn’t Public Liability Insurance and Professional Indemnity Insurance the same thing?” The short answer is ‘no’ they are not. Find out more here… Insurance Made Easy

Quote for the month:

“Honesty is the fastest way to prevent a mistake from turning into a failure”.   James Altucher

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