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The latest news is posted on our website on a regular basis. Visit us often to keep informed. www.robert-forbes.com

Complementary Medicines (‘Dietary supplements’):

When Does Disease Education Stray Into Product Promotion?

This TGA guidance is to assist providers of disease education activities (including sponsors, health professionals, pharmacies, peak organisations and community educators) to ensure that disease education activities do not inadvertently become advertisements for therapeutic goods. While a disease education activity may legally make reference to a range of treatment options, if the information provided is likely to encourage consumers to seek to obtain a particular good, or seek a prescription for a particular medicine, then it will be considered an advertisement.    Source: Education V Promotion

Are You A Business Involved with Medicinal Cannabis Products but Unsure How to Advertise?

This TGA guidance aims to assist providers of medicinal cannabis products and therapies (including sponsors, manufacturers, importers, pharmacists, health professionals and marketers) to comply with the therapeutic goods advertising restrictions. The focus of this guidance is to help providers understand how to promote their business or service without advertising medicinal cannabis products to the public, which is prohibited.   Source: Medicinal cannabis advertising

TGA Provides Consent to Supply Therapeutic Goods that Don’t Comply With New Label Laws

The TGA has established a process for sponsors of non-prescription medicines (which include complementary and OTC medicines) to request consent for non-compliance with the new TGO No. 92 - Standard for labels of non-prescription medicine, relating to the presentation of the name of the medicine on product labels. This is an interim measure to assist industry to transition to the requirements for TGO 92. This new order includes requirements to ensure easy readability and identification of key health information such as active ingredients.   Source: TGO 92 consent for non-compliance

Advertising of Complementary Medicines: Update

The Complementary Healthcare Council of Australia (CHC) is no longer accepting any new applications for advertising pre-approvals of complementary medicines (CMs). Applications received by CHC before 14 November 2019 will continue to be processed and decided, with final decisions for all these applications to be made by 27 January 2020. From 19 November 2019, all new applications for approval of medicines advertising in any specified media (broadcast, print, cinema or public display) should be lodged with Consumer Healthcare Products Australia (CHP Australia), which was previously known as the Australian Self Medication Industry. These new arrangements will apply until the pre-approval process is disbanded on 30 June 2020. Application fees will not change from those already published on the website.   Source: CM advertising update

Summary: Therapeutic Goods Determinations

Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Registration) Determination 2018: (Sets out the kind of information which must accompany an application for the registration of a complementary medicine, and the form in which the application must be submitted).

Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Section 26AE Listing) Determination 2018: (Sets out the kind of information which must accompany an application for the listing of a complementary medicine under section 26AE of the Therapeutic Goods Act 1989 and the form in which the application must be submitted).

Therapeutic Goods (Permissible Indications) Determination (No.2) 2019: (Specifies the indications that are permitted for use in a medicine listed in the Australian Register of Therapeutic Goods under subsection 26BF of the Therapeutic Goods Act 1989 and any requirements associated with their use in such medicines).

Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019: (Determines those ingredients that may be contained in a medicine that is listed in the Australian Register of Therapeutic Goods ("the Register") under section 26A or 26AE of the Therapeutic Goods Act 1989, and requirements in relation to the inclusion of those ingredients in such medicines).  

Update to Listed Medicine Ingredients

Therapeutic Goods (Permissible Ingredients) Determination (No. 3) has recently been registered on the Federal Register of Legislation. A total of 40 changes have been made in the updated Determination. These changes include: Addition of 6 new ingredient entries; and changes to 34 existing ingredient entries to make requirements clearer and less restrictive.    Source: TGA updates LM ingredients

Consultation: Are Sports Supplements Foods or Therapeutic Goods? CMA Responds

In the October 2019 edition of this newsletter we ran a story with the heading ‘Consultation: Are Sports Supplements Foods or Therapeutic Goods?’. Complementary Medicines Australia has released a major Position Statement regarding this proposed change to legislation, highlighting concerns that may force some current ‘foods’ to be reclassified as ‘medicines’. CMA believes that probably 40% of ‘foods’ in the specialty sports supplement sector may be affected, with a possible cascading or “domino” effect of around 60-80% of products due to other factors such as inability to access manufacturing lines that are licensed under the TGA requirements.    Sources: TGA sports food consultation; &   CMA position statement; & Media comment

Communique: Therapeutic Goods Advertising Consultative Committee

The fourth meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC) was held in Canberra on 17 October 2019. TGACC members represent a diverse range of stakeholders with an interest in the advertising of therapeutic goods, including consumer, industry and health professional bodies. Topics covered included: work on improving granularity of complaints data against Key Performance Indicators; guidance documents on advertising requirements (specifically for providers of medicinal cannabis products), human cell and tissue products and disease education activities; testimonials and endorsements (including the role of social media influencers); and the role product samples.    Source: TGACC communique

The Importance of Approved Terminology for Therapeutic Goods

The TGA develops and maintains approved terminology to ensure the accuracy and consistency of information on the Australian Register of Therapeutic Goods (ARTG). This provides a consistent and standardised method for naming of: ingredients; components; routes of administration; dosage forms; container types; units of expression; and proportion.    Source: Approved terminology

TGA Rules on Products Containing Folate

Clarity has been provided that certain goods containing folate, which are represented as being foods for "special medical purposes" or dietary management, are considered to be therapeutic goods. This is due to the high likelihood that these goods may be used for a therapeutic purpose, i.e. to prevent, cure or alleviate folate deficiency or depression, or an inborn error of folate metabolism. This means they must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) and regulated accordingly.   Source: Folate substances

Changes Made to Propolis and Royal Jelly in Listed Medicine Applications

The TGA has changed the listed medicine application system to allow equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the Australian Registry of Therapeutic Goods (ARTG). Sponsors can now enter propolis and royal jelly preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. This guidance does not apply to ‘Export Only’ medicines. Sponsors of existing listed medicines should review this information before 31 March 2020 to check if they are eligible for a free correction to their ARTG entry.    Source: Propolis & royal jelly

Beware the ‘Barbie Drug’: The Dangers of Using Melanotan

The TGA urges consumers to steer clear of products containing 'melanotan'. These products are usually marketed as injectable tanning products. They are not included on the Australian Register of Therapeutic Goods (ARTG) and have not been assessed for quality, safety or efficacy by the TGA. It is illegal to advertise and supply these products, and their use has proven serious side effects that can be very damaging to one's health (darkened skin, increased moles and freckles, nausea, vomiting, loss of appetite, flushing of the face, involuntary stretching and yawning, and spontaneous erections!). Melanotan and melatonin (which is commonly used as a sleep aid) are different substances, and the above warnings do not apply to melatonin.    Sources: TGA melanotan warning & Lauren Golman, A Current Affair: ACA melanotan story

TGA Safety Advisories- Source: TGA current year alerts

Grakcu capsules: The capsules contain the undeclared substances Sildenafil and Tadalafil

Me2Shape capsules: The capsules contain the undeclared substance Fluoxetine

De2Xy capsules: The capsules contain the undeclared pharmaceutical substance Bisacodyl.

Ying Da Wang tablets: The tablets contain the undeclared substance Sildenafil.

 

Foods:

Proposal to Prohibit the Retail Sale of Pure and Highly Concentrated Caffeine Products

As previously reported in the July and September 2019 editions of this newsletter, there has been considerable concern over the health dangers of concentrated caffeine products. Food Standards Australia New Zealand (FSANZ) is now calling for public comment on an urgent Proposal to prohibit the retail sale of pure and highly concentrated caffeine food products in Australia and New Zealand.   Sources: Caffeine regulation & Caffeine regulation 2

Allergy Information for Food Manufacturers, Retailers and Importers

Food manufacturers, retailers and importers are responsible for ensuring their imports are properly labelled and for providing clear, up-to-date and accurate information about the allergen status of their product.    Source: Food allergen portal

FSANZ Releases Regulatory Science Strategy 2019–2023

This Food Standards Australia New Zealand report details the global challenges, trends and emergent risks in a dynamic food system. It describes how FSANZ will continue to align their work to Ministerial priority areas, and sets out a plan to grow scientific and risk analysis capabilities, scientific evidence base and risk assessment methodologies to underpin their standards setting activities. Through the new strategy they aim to build stronger links with academia and industry, further leverage resources through strategic partnerships and communicate the science to meet the needs of stakeholders.   Source: FSANZ regulatory strategy report

Food Recall - Core Powerfoods Frozen Meals

The recall is due to potential microbial (Salmonella Weltevreden) contamination.   Source: Core powerfoods recall

September 2019 Failing Food Report

This latest report details food that was found to fail under the Imported Food Inspection Scheme during the month of September. Among the usual pathogenic organisms detected in these imported foods are such organisms as Staphylococci E coli, Listeria, and Salmonella, and assorted toxins such as arsenic, aflatoxin and others.  Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals and also irradiation. There is also a failed ‘formulated supplementary sports food’ that contained an ‘unapproved novel food’ (Acacia rigidula).   Source: September 2019 food fails  

FSANZ Notifications—

Application A1182 – Glucose Oxidase from Trichoderma reesei as a Processing Aid (Enzyme): The purpose of this application is to approve a Glucose Oxidase enzyme preparation from Trichoderma reesei for use as a processing aid in cereal based products (baking) and egg processing.    Source: Glucose enzyme

Application A1191 – Mono- and diglycerides of fatty acids (471) as a surface coating: The purpose of this application is to extend the permission of the food additive mono- and diglycerides of fatty acids (INS 471) as a surface coating on fruit & vegetables to increase postharvest shelf life.    Source: Food coating

Proposal P1054 – Pure and highly concentrated caffeine products: This urgent proposal is to amend the Code to prohibit the retail sale of pure and highly concentrated caffeine food products.    Source: Caffeine fix

Sticky Situation: Australia-New Zealand Tensions Rise Over Million-Dollar China Manuka Honey Battle

Australia and New Zealand have been involved in a battle over the latter’s bid to trademark the term ‘Manuka’ in China for months, with no end in sight and increasingly terse accusations flying back and forth across the Tasman Sea.    Source: (Copyright) Pearly Neo, FoodNavigator-Asia Manuka monopoly

The Lantern Project: Improving Nutrition and Food Choices for Elderly Australians

One way to enhance agency and ensure that residents of aged care facilities have access to adequate choice of nutritious foods would be to implement a mandatory legislative instrument for a nationally consistent approach to the interpretation of food laws that apply to aged care facilities. This legal requirement should have an emphasis on providing stimulating food choices even though the food safety definition of the elderly consumer is as a “vulnerable person”. The Lantern Project is a non-profit organisation with a vision to improve the quality of life of older Australians through good food and nutrition.     Source: Joe Lederman, FoodLegal The Lantern Project

The Countries with the Best and Worst Food Systems

The Netherlands is the best place to eat overall, Chad the worst. The USA has the cheapest food in the world compared to the price of other goods, but falls down for food-related health problems. Cambodia has the healthiest food, but a lot of malnourished people as well. Best Places To Eat: The Netherlands, followed by France, Switzerland (equal score); then, Denmark, Sweden, Austria, Belgium (equal score), and Ireland, Italy, Portugal, Luxembourg, Australia (equal score).     Source: Ben Schiller, Fast Company Food countries

Cosmetics and TGA Listed Sunscreens:

There is no news to report this month, but if you haven’t already seen it, you might like to view: RFA Regulatory Affairs You Tube Video (Cosmetics Regulation)

Marketing News:

General Interest: Vaccines - Inoculating Against Fear

Along with good nutrition and public sanitation, vaccination is one of the most effective ways to prevent diseases. In Australia, the Therapeutic Goods Administration regulates vaccines, and we have been lucky enough to be the recipients of one of the most robust and well-regulated childhood vaccination programs in the world. Australia has played its part in the scientific advances in vaccine medicine, being world leaders in the research to advance the science of vaccines, with some of the best known medical scientists being Sir Frank McFarlane Burnet, Sir Gustav Nossal, Professor Ian Frazer and most recently, Dr Laura Mackay. So with all the evidence before us, we now face a new question – why are people in Australia and across the developed world demonstrating a growing scepticism in some small pockets of the community, about the value of vaccination? The WHO has named vaccine hesitancy as one of its top 10 threats to global health for 2019. Australia is leading the way on an international level to address the issue of vaccine hesitancy through the International Coalition of Medicines Regulatory Authorities.   Source: Vaccine education

AHPA Webinar: Roadmap to Climate Action & Collaboration in the Herbal & Supplements Industry

The American Herbal Products Association is hosting an important webinar scheduled for 10 AM Wednesday, December 11 10 AM *PT (*Pacific Daylight Time is 18 hours behind Australian Eastern Summer Standard Time, so webinar would commence December 12 at 4am if you were in Sydney). The Climate Collaborative, AHPA, and American Botanical Council Sustainable Herbs Program are partnering to host a special introductory webinar for herbal and supplement companies on how you can join in creating a collaborative industry pathway to reversing climate change, and get access to free resources that can support your own climate action journey. The webinar includes an overview of the Climate Collaborative’s work to date, and brings together a panel conversation on how companies of all sizes in the industry are making their supply chain and sourcing practices integral to their overall approach to climate action.    Source: Webinar for climate action

Training: RFA Provides Comprehensive Training in Regulatory Affairs

Are you looking to expand your knowledge or are you new to Australian regulations related to the supply of foods, cosmetics and/or complementary medicines? Then check out the full list of courses we offer on the Robert Forbes & Associates website www.rfaregulatoryaffairs.com/training-courses . There are 20 courses to choose from and any of these can be undertaken either singly or in groups, from within our Glebe, Sydney office, at your office or remotely via Skype. Contact our training manager Kate Durey This email address is being protected from spambots. You need JavaScript enabled to view it.  to receive the latest information on these training courses at this discount offer. See you in the classroom!

Quote for the month:

“A diamond is a chunk of coal that did well under pressure”    Anonymous

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