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Issue 112

September 2012

Published by Robert Forbes & Associates Pty Ltd. www.robert-forbes.com

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Latest Regulatory News

Australian Indigenous (bush foods) added to Nutrition Panel Calculator

FSANZ has added 14 new indigenous foods to the Nutrition Panel Calculator (NPC), used by industry to provide nutrition information on food labels. The addition of these new foods will allow food manufacturers to calculate the average nutrient content of their bush food products and prepare a Nutrition Information Panel (NIP) based on up-to-date nutrient data. The 14 new foods added include Kakadu plum, considered to be the world’s richest natural source of vitamin C.

Cough and cold medicines may cause harm to children

The TGA has published the following advice: “Parents have been alerted to take note of important changes in the latest advice on dispensing cough and cold medicines to their young children. While the review concluded there are no immediate safety risks with these products, it found there was evidence that they may cause harm to children and that the benefits of using them in children have not been proven. As a result parents are advised that: (a) Cough and cold medicines should not be given to children under 6 years of age. (b) Cough and cold medicines should only be given to children aged 6 to 11 years on the advice of a doctor, pharmacist or nurse practitioner. Labels on these products will now be changed to reflect this new advice. Federal Parliamentary Secretary for Health and Ageing, Catherine King, said “.... while a baby or child may appear to have a cold, it could actually be suffering from a much more serious illness such as asthma, influenza, pneumonia, bronchitis, middle ear infection or another infection that requires early medical attention and treatment. Cough and cold medicines offer only temporary relief of common symptoms such as runny nose, cough, nasal congestion, fever and aches. They do not affect the severity of the viral infection or shorten the time the infection lasts. An overdose of these medicines can lead to serious harm.”

Recommendation to permit betaine and betaine monohydrate as active ingredients in listed medicines

At the December meeting of the ACCM the following recommendation was made: “ACCM advises the TGA that, at an appropriate dosage level (as determined by the TGA), betaine and betaine monohydrate have demonstrated the appropriate level of safety for an ingredient considered suitable for use in listed medicines.”

Stability requirements explained

The TGA recently presented a talk providing clarification and examples of stability testing requirements and how these relate to “Product Quality Reviews”. The talk was given to members and guests of the Royal Australians Chemical Institute and is available on the TGA website.

Adulteration of male enhancement products

More products imported from overseas, but not legally listed in Australia, have been found to contain undisclosed amounts of prescription medicines, even though they are labelled with claims statements such as “natural” and “drug free”. Consumers are warned not to order over the internet, Extra Power Powder, Ultra Men for Men, MMC Maxman IV Erection Enhancer, and Rock Hard for Men.

New evidence guidelines for listed medicines revised

The TGA has issued a revised draft of the proposed guidelines for evidence claims for listed medicines, responding to industry concerns over some aspects of the proposal. The requirement for an expert to conduct evidence reviews has been removed. The TGA has called for comment on the proposal, with the cut-off date for submissions being Monday 22nd October. Revised document is on TGA website’s newsroom.

Mobile phone app launched to help consumers access data on recalled goods

The ACCC has launched an app for Android mobile phones which allows consumers to easily find information on recalled products. There were 500 recalls in Australia in 2011. Using the app, consumers can also take photos of goods they believe could be unsafe so they can report them to the ACCC. An iPhone version of the app has already been released. Information on recalls is available from http://www.productsafety.gov.au/

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Disclaimer: Whilst Robert Forbes & Associates has made every effort to be accurate,
errors may appear and are inadvertent.

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