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Current Affairs
Issue 104 - January-February 2011 Published by Robert Forbes & Associates Pty Ltd
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RFA News
Nordoff-Robbins Music Therapy
Clients of RFA would be aware that some years ago we decided that instead of sending Christmas cards to our clients, we would instead donate funds to the Nordoff-Robbins Music Therapy Australia. The Nordoff-Robbins Music Therapy Centre at the University of Western Sydney averages 234 clients each week, and registered music therapists provide programmes for children and adults with physical and intellectual disabilities and mental health issues; adults with acquired brain injury; senior Australians in aged care programs; and school students experiencing learning and behavioural problems. This pioneering work by the Nordoff-Robins organisation is successfully building bridges of communication and literally giving people something to sing about. This link takes you to a letter from the foundation in appreciation of our support over the years. We recommend this foundation to our clients as a worthy recipient of your charity dollars.

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TGA News

Therapeutic goods listing notice (No. 4)
In 2010 the following can be included for oral preparations for use as therapeutically active ingredients in listed goods:
-   Docosahexaenoic acid (DHA)-rich oil derived from microalgae Schizochytrium sp. as a therapeutically active ingredient in combination with other ingredients.
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TGA internet site redevelopment
The TGA invited responses from interested parties on options for the redevelopment of the TGA website and their preferred methods of receiving communications from the TGA, consultation closed on 1 December 2010. After consideration of the responses, the TGA will include the preferred options as part of the redeveloped TGA website. The site is expected to be launched in April 2011.
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Counterfeit medicines
Counterfeit medicines or medical devices are often packaged or marketed to mimic a genuine item. Products are considered counterfeit if the labeling, presentation, advertising, formulation or source of the goods is false.
The TGA, with cooperation from State and Territory Governments, closely monitors the supply chain in Australia to prevent counterfeit medicines or medical devices from entering the market. All therapeutic goods are potential targets for counterfeiters. Importation, manufacture and supply of counterfeit therapeutic goods are subject to specific criminal and civil penalty provisions in the Therapeutic Goods Act 1989. Producing counterfeit therapeutic goods is also a breach of intellectual property.
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To avoid purchasing counterfeit products, consumers should exercise caution when buying medicines on the Internet.
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Q&A relating to the additional default standards legislation
A series of Q&As are presented in relation to questions such as; What does 'default standard' mean in relation to medicines? What are the current 'default standards'? What are the definitions of various Pharmacopoeias?
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Draft compositional guideline for steviol glycosides
The product is obtained from the leaves of Stevia rebaudiana Bertoni. The leaves are extracted with hot water and the aqueous extract is passed through an adsorption resin to trap and concentrate the component steviol glycosides. The resin is washed with a solvent alcohol to release the glycosides and product is recrystallised from methanol or aqueous ethanol. Ion exchange resins may be used in the purification process. The final product may be spray-dried.
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Transparency review of the TGA
On 16 November, Parliamentary Secretary for Health and Ageing, Catherine King announced a comprehensive review of the way in which the TGA communicates its regulatory processes and decisions. The review will focus on improving the TGA's transparency. The TGA reforms are consistent with the Government's policy of reducing unnecessary regulatory burden, and its increased transparency agenda, particularly its changes to the Freedom of Information Act 1982 to improve public access to decision-making.
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National Coordinating Committee on Therapeutic Goods
Updated membership list.
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Determining if your product is a food or therapeutic good
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FSANZ (Food Standards Australia New Zealand) update

Government welcomes study on folic acid
News that adding folic acid to bread flour is improving levels of folate in the Australian population is extremely welcome, Parliamentary Secretary for Health and Ageing Catherine King said. Ms King said the results of the study, published in the Medical Journal of Australia, showed blood folate levels have significantly improved since mandatory fortification was introduced.
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Australia and New Zealand Food Regulation Ministerial Council
The health implications of caffeinated energy drinks, improvement of public awareness of the nutrition content of take away food and recent international developments and efforts made by Australian and New Zealand industry in phasing out the use of Bisphenol A (BPA) chemicals in baby bottles and food containers were among a range of food and beverage topics discussed at a recent meeting of the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) held in Adelaide.
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FSANZ sets up high- level consumer and public health group
A new consultative forum to facilitate more effective engagement between consumer and public health groups and Food Standards Australia New Zealand (FSANZ) has been established.
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FSANZ proposes changes to food standards code
FSANZ released details of proposed changes to the Food Standards Code. Among the changes under consideration are the approval of a GM corn, steviol as a high intensity sweetener, and food for special medical purposes.
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Food regulator joins the social media sphere
Consumers can now get the latest information about food recalls and other food regulation information through the use of Facebook and Twitter.
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Final report of the review of food labelling law and policy
Recommendations to improve food labelling law and policy in Australia and New Zealand are contained in a report presented to Federal, State and Territory Governments. A copy of the report is on the site.
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Peanut contamination of imported crumbed fish and seafood
FSANZ advised Australians with peanut allergies not to eat imported crumbed fish and crumbed seafood products that could be contaminated with undeclared peanuts.
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Food standards news – spring edition No77
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Chemical gazette February 2011
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Association News
Complementary Healthcare Council of Australia (CHC)

International Trade: Making Global Achievable
Date: 8 March 2011
Time: 9am - 5pm
Venue: The Marriott Hotel, Hyde Park, Sydney
RSVP: Registrations closed 18 February 2011
Cost: $395 CHC Members, $495 Non member, $100 Full-time Students*
Do not miss out on this exclusive opportunity to hear from industry leaders about how to turn international trade opportunities in the complementary healthcare products industry into a reality.
This one day seminar will provide delegates with the opportunity to hear from Business and Government experts on how to make international trade achievable – helping to break down barriers and translate requirements.
Speakers include Robert Forbes of Robert Forbes and Associates, Richard Henfrey of Blackmores and Jason Luchi of Commonwealth Bank, as well as Tim Harcourt from Austrade, Mohammed Ali from the TGA and Rob Williams from AQIS.
To find out more or to register for the event, please visit
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Conferences & Meetings
CONFERENCE WRAP: Sheldon Baker covers brand marketing at Nutra India Summit 2011
Sheldon Baker, senior vice president of Baker Dillon Group, the award-winning nutraceutical brand marketing firm presented at the India Summit 2011, in Mumbai, India. He told the audience that "Many companies from India, as well as parts of Asia, who want to enter the North American supplement marketplace from abroad must recognise that there are cultural distinctions that can impact the marketing approach both short and long term. Furthermore, most companies have limited knowledge or experience about how supplement ingredients and retail products are distributed and sold in the US. In the end, a lot of time and money is invested, only to fall short of expectations on successful new marketplace expansion."
"It is imperative for companies that say they want to be a supplement leader to take the necessary and strategic steps to position themselves correctly with the proper look and feel in order to move to the North American forefront," says Baker.

Natural Health Expo
March 4 – 5, 2011 AJC Convention Centre, Randwick Sydney
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Natural & Organic Products Europe
April 3 - 4, 2011 Olympia, London
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Australian Fitness & Health Expo
April 15 – 17, 2011 Sydney Convention Centre Darling Harbour Sydney
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Supply Side East
May 2-4, 2011 Meadowlands Exposition Centre, Secaucus, New Jersey
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Vitafoods International
May 10 – 12, 2011 Geneva Palexpo, Switzerland
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Natural Products Asia
August 25 – 27, 2011 Hong Kong Convention & Exhibition Centre
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Natural Products Expo East
September 21-24, 2011 Baltimore Convention Centre, Baltimore Massachusetts
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RFA services
We are very flexible … whatever your regulatory needs we can help

With 30 years of regulatory experience and a network of industry contacts, RFA can provide expert regulatory advice – whether it’s checking your in house regulatory work, training your regulatory staff, up-skilling new employees, checking a label, setting up stability protocols, handling entire product listings or responding to a section 31 so you can keep your product on the market. Whatever the regulatory job we can work with you, no matter how small or large the job is.

RFA can help you put extra regulatory checks in place to safeguard your business. And there are no regular monthly commitments or long term contracts, you brief us on what you want done and we complete each task accurately and promptly.
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