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: https://www.tga.gov.au/current-year-alerts

Li Da Weight Loss Capsulesthe 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

RFA Breaking News

Complementary Medicines (“Dietary supplements”):

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Foods:

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Cosmetics and TGA listed sunscreens:

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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…

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Complementary Medicines (“Dietary supplements”):

  TGA Revamps Complaints Handling for the Advertising of Therapeutic Goods The Therapeutic Goods Administration (TGA) is responsible for ensuring that therapeutic goods available for supply and use in Australia…

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Foods:

  Honey Scandal Rolls on: Almost 20 per cent of Australian Honey Samples Found to Not be Pure As reported by this newsletter in September 2018, Australia’s honey is not…

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