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current affairs

Issue 123

November 2013

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

Your one stop shop for regulatory advice for your complementary medicines, foods and cosmetics. Contact us to see how we can help you.

This newsletter is sent to clients of RFA at no charge. You are welcome to forward this to any colleagues who may find it useful. Click here to view this newsletter in your web browser

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We need a Regulatory Affairs Manager

RFA is looking for a Regulatory Affairs Manager.

For details, see details towards bottom of this page.


Latest Regulatory News

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



Trade Expo – SupplySide West (Las Vegas, USA) November 12 -16, 2013

SupplySide West brings together the suppliers and buyers that drive the dietary supplement, food, beverage, animal nutrition, personal care and cosmetic marketplace. Key professionals and thought leaders from executive management, R&D, QA/QC and marketing teams will meet in Las Vegas November 12-16.

Their goal? To explore and discover innovations from around the world to develop the next product that will drive revenue, market share and consumer loyalty.

Reminding all our readers that RFA-Regulatory Affairs will be attending this Trade Show and you can catch us at the Consultants Association for the Natural Products Industry (CANI), Booth # 34064. We’d love to see you there and catch up face to face while we discuss business opportunities in Australia and New Zealand.



Food Standards Australia and New Zealand (FSANZ)  -  Stakeholder Engagement Strategy 2013-2016.

This strategy seeks to help inform people about the food regulation system more broadly, and in doing this, references Engaging inthe Australian and New Zealand Joint Food Regulation System; a stakeholder engagement strategy for the entire food regulation system, that was developed for the Food Regulation Standing Committee. Full details can be obtained at :http://tinyurl.com/k5zjyfm



Science Group Says Article on DNA Barcode Analysis of Herbs Is Flawed, Contains Errors, Creates Confusion, and Should Be Retracted

5 November

A recently published articlethat presents research conducted using DNA barcode technology to analyse various herbal products in North America contains numerous flaws, calculation errors, taxonomic anomalies, and unreliable conclusions, and should be retracted by the journal and appropriately corrected before it is republished. So says the American Botanical Council (ABC), that recently published a critique of the paper co-authored by five herb quality control experts. The paper, based on DNA technology, was published in October in the journal BMC Medicine. It has been cited by various media outlets, including the November 5 “Science Times” section of the New York Times in an article that raises questions about the quality of dietary supplements.

Read more at:http://tinyurl.com/m7bvk63



The American Botanical Council Celebrates 25 Years of Herbal Medicine Education

31 October

Award-Winning Non-profit with Passion for Plant-Based Medicine Has International Impact and Reputation

(AUSTIN, Texas, Oct. 31, 2013) On November 1, the American Botanical Council (ABC) celebrates a quarter century of promoting the responsible, science-based use of herbal medicine. The independent non-profit’s 25th anniversary is a major milestone for the Austin, Texas-based organization and speaks to its enduring message of informed, research-supported healing through nature — one that has resonated with thousands of members and supporters both locally and in many countries around the world.

More details about the ABC available in this story: http://tinyurl.com/mp3gs8u



TGA publishes latest data from European Commission on PIP silicone gel breast implants

30 October

The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published an updated opinion on the safety of PIP silicone gel filled breast implants.

Full report can be read here: http://tinyurl.com/og9olw6



Summary of presentations given at the TGA complementary medicines road shows, July - August 2013

29 October

In late July and early August the TGA conducted road shows in Sydney, Brisbane and Melbourne to inform interested parties of the TGA's progress on complementary medicine reforms, the review of evidence to support indications and an update to the listed medicines application software. Summaries on the following topics are now available:

TGA blueprint reforms for complementary medicines - http://tinyurl.com/lkpfqm3

Evidence supporting indications for consumers and industry - http://tinyurl.com/my73vzz

Changes to the listed medicines online application form - http://tinyurl.com/lku3wqx



Food Standards Australia New Zealand (FSANZ) consumer alert

23 October

FSANZ Chief Executive Officer Steve McCutcheon said the FDA has advised consumers not to use OxyELITE Pro supplements because they are potentially linked to an outbreak of acute non-viral hepatitis in Hawaii.

Australian health authorities have been alerted to be on the lookout for acute cases of non-viral hepatitis.

FDA details can be read here: USFDA advice on investigation into OxyElite Pro



TGA Consultation Notification inviting public submissions

17 October

The Secretary of the Department of Health hereby gives notice that the proposed amendments to the current Poisons Standard contained in this notice will be referred for scheduling advice to relevant expert advisory committees. Accordingly, the following scheduling proposals are open for public submissions. Persons wishing to make a submission are strongly encouraged to submit them in electronic format (word or unsecured PDF) to the email address provided by 14 November 2013.

Documents can be read at http://tinyurl.com/l97z8hk



Australians want more Government regulation, says survey

15 October

People in at least one Australian state would welcome more government regulation on food matters for a better public health environment, a new survey has revealed.

Originally published at Food-Navigator Asia - http://tinyurl.com/msxbnuz



TGA announces review of Caffeine and Oxedrine containing products

13 October

Consumers and health professionals are advised that the TGA is undertaking a comprehensive review of the safety of therapeutic goods containing both caffeine and oxedrine. Oxedrine is found in the herb Citrus aurantium (also known as bitter orange). Caffeine and oxedrine (along with some other herbal stimulants) are found in a range of health products currently available in Australia. These goods are variously marketed as energy supplements, appetite suppressants and weight loss products.

Read more at: http://tinyurl.com/lxy654v



Department of Agriculture, Fisheries & Forestry (DAFF) release September Failing Food Report

25 October

When food is inspected under the Imported Food Inspection Scheme (IFIS), it may be subject to analytical testing for particular hazards. Failing food reports identify foods that have been found to fail analytical testing or do not meet the compositional requirements of the Australia and New Zealand Food Standards Code.

The report does not list foods that have failed for non–compliant labels as the responsibility for the correct labelling of imported food lies with the importer of the food. In these cases, the importer has an opportunity to bring the label into compliance with Australian food labelling standards.

Find out who failed and why at: http://tinyurl.com/nxr9myz



Regulatory Affairs Manager Wanted

Robert Forbes and Associates (RFA) is looking for a Regulatory Affairs Manager who has at least 5 years’ experience in Australian regulatory affairs relating to complementary medicines, foods and cosmetics.

This position is based in our offices in Glebe, Sydney, and is a full-time position. The Manager will be supervising a team of 7 in-house regulatory associates plus several external consultants. Three of our associates have previously held this position but are now working part-time. These experienced and dedicated associates are well versed in all aspects of the company’s services and will be very supportive of the new manager.

The Regulatory Affairs Manager reports to the Director, Robert Forbes. The manager will have responsibility for oversight of all Regulatory Affairs advice provided to clients of the Company and will delegate work to our Regulatory Affairs Associates and external consultants. The Manager is the prime point of contact for all clients and regulatory agencies including TGA, NICNAS, FSANZ, and AQIS. The Manager also represents the Company at National or international forums

Tasks most commonly undertaken by RFA are detailed on our website www.robert-forbes.com

Included as part of the remuneration package are daily lunches, extensive staff amenities and a secure car parking space.

If this role is of interest to you and you meet the requirements mentioned above, please send your resume to:  This email address is being protected from spambots. You need JavaScript enabled to view it.

Applications close early November 2013.



The original Vitamin Converter, created by RFA, has now received nearly a quarter of a million hits. You are welcome to use this useful tool.

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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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