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current affairs

Issue 122

October 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

and here: http://www.seek.com.au/job/25334689

 

Latest Regulatory News

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

 

 

Direct Selling Association of Australia (DSAA) October activities

The Direct Selling Association of Australia is holding a number of briefings across the country in the next few weeks to keep its members up to date with industry issues and learn about DSAA initiatives. These briefings are open to all DSAA members on will be held on 23 October in Sydney, 24 October in Brisbane, 25 October in Melbourne, 29 October in Adelaide and 30 October in Perth. Further information can be obtained from This email address is being protected from spambots. You need JavaScript enabled to view it..

 

 

ACCORD initiative

Accord Australasia Limited is the national industry association for the Australasian hygiene, cosmetic and specialty products industry. Its latest initiative is the launching of www.furphies.org.au , billed as “Clarifying misconceptions about Cosmetics, Personal care &Household products”.

Here you can find out more about some of the most persistent cosmetics and personal care product misconceptions by clicking on the headings. Follow the links to such topics as:

Baby products; Deodorant - and breast cancer?; Perfumes; Hair colorants; Lead in lipstick?; Mouthwash - and oral cancer?; and Sunscreens - more harm than good?

Source:   http://www.accord.asn.au/

  
  
National Industrial Chemicals Notification & Assessment Scheme (NICNAS) revamps website

NICNAS website now provides clear and comprehensive update on all things Cosmetic.

General information on cosmetics:

Ingredients in cosmetic products, even those described as naturally-occurring, are regulated as industrial chemicals.

To make sure that these products are safe for use by consumers, workers and for the environment, the Australian Government assesses the risks associated with the ingredients used in the manufacture and importation of cosmetic products in Australia.

Companies and/or individuals who are introducing (importing or manufacturing) cosmetic ingredients or importing cosmetic products must be registered with NICNAS. All cosmetic products and their ingredients must also comply with relevant legislative requirements. New cosmetic ingredients (not on the Australian Inventory of Chemical Substances - AICS) are subject to notification and assessment unless they qualify for an exemption.

Cosmetics must be labelled in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991. This legislation prescribes the Mandatory standard—Cosmetics & toiletries—ingredients labelling which sets out the standards, the responsibilities of suppliers and retailers, and the Australian Competition and Consumer Commssion's (ACCC) role in enforcing cosmetic and toiletries ingredients labelling.

Amendments to the Industrial Chemicals (Notification and Assessment) Act 1989 (in September 2007) introduced a Cosmetics Standard 2007 which sets specific standards for six cosmetic product categories. The NICNAS Cosmetics Guidelines are a plain English guide to the legislative requirements that apply to all cosmetics.

The Cosmetics Standard was amended with effect from 1 August 2013 to adopt the revised Sunscreen Standard AS/NZS 2604: 2012. Under the amended Cosmetics Standard 2007, two categories of cosmetic sunscreen products (face/nail and skin care) will have five years within which to comply with the Sunscreen Standard AS/NZS 2604: 2012.

This website also includes a very helpful list of Frequently Asked Questions about Cosmetics;

anda fact sheet on the adoption of the Sunscreen Standard AS/NZS 2604: 2012

Source: http://tinyurl.com/nagm7y9

  
  
Pain-killers containing dextropropoxyphene - Di-Gesic and Doloxene

10 October 2013

New conditions on the registration and supply of dextropropoxyphene-containing pain-killers Di-Gesic and Doloxene will take effect from 10 October 2013.

On 12 September 2013, the Administrative Appeals Tribunal (AAT) imposed certain conditions on the registration of Di-Gesic and Doloxene to ensure the safe use of these products. This allows them to remain on the Australian Register of Therapeutic Goods (ARTG), and therefore continue to be marketed in Australia.

Full report: http://tinyurl.com/leta2zq

  
  
2nd International Congress on Naturopathic Medicine - 2014

October 2013

ICNM 2014 is a rare opportunity to learn directly from the opinion leaders that are shaping the future of Natural Medicine practice.Following the success of ICNM 2013, The 2nd International Congress on Naturopathic Medicine (ICNM 2014) will take place in Paris, France, July 4-6 2014.

  
  
America’s Largest Professional Society of Medicinal Plant Research Experts Endorses Botanical Adulteration Education Program

3 October 2013

The American Society of Pharmacognosy (ASP) has announced its endorsement of the ABC-AHP-NCNPR Botanical Adulterants Program. This is an educational program designed to increase the herb, dietary supplements, and natural products industries’ awareness of the need for enhanced scrutiny via laboratory analysis of herbal raw materials, extracts, and essential oils that may be accidentally or purposefully adulterated with lower-cost, non-disclosed ingredients. ASP is North America's leading organization of scientists involved with research on medicinal plants, fungi, marine organisms, and other natural materials used in the production of new medicines, comprising the essence of the science of pharmacognosy. Founded in 1959, ASP consists of more than 1,100 pharmacognosists, natural products chemists, botanists, molecular biologists, and other medicinal plant research experts from around the world. The ABC-AHP-NCNPR Botanical Adulterants Program is a consortium of independent nonprofit organizations whose mission relates to education, scientific research, and quality of botanical dietary ingredients and related plant-derived materials.

Companies, organizations, foundations, and/or individuals interested in supporting this program are invited to contact Ms. Denise Meikel, ABC Development Director, at (512) 926-4900, ext. 120, or by email.

  
  
Complementary medicines: Cancellations from the ARTG following compliance review

2 October 2013

Two recent Listed medicines have been removed from ARTG:

  1. Total Care (AusBioMed) #L177226
  2. GanoMax (Koda International Pty Ltd) #L74449

To read full list of cancellations from 1 July 2012 go to: http://tinyurl.com/pocr8wo

  
  
University of Alberta researcher wins $250,000 prize in complementary medicine

27 September 2013

The 42-year-old founding director of Canada’s first academic paediatric integrative medicine program is the recipient of the 2013 Dr. Rogers Prize for excellence in complementary and alternative medicine.

Dr. SunitaVohra, of the University of Alberta, was named as the winner of the $250,000 award at a gala dinner Thursday at the Fairmont Waterfront Hotel. The Dr. Rogers Prize is the largest cash prize of its kind in North America.

Read the whole story at: http://tinyurl.com/o33xn8r

  
  
Book Review: Chromatographic Fingerprint Analysis of Herbal Medicines

Chromatographic Fingerprint Analysis of Herbal Medicines: Thin-Layer and High Performance Liquid Chromatography of Chinese Drugs, 2nd edition, revised and enlarged by Hildebert Wagner, Rudolf Bauer, Dieter Melchart, Pei-Gen Xiao, and Anton Staudinger (eds.). New York: Springer; 2011. Hardcover, 1024 pages (Vols. 1 & 2). ISBN 9783709107621. $319.00

“...this is a monumental body of work, representing over a decade of collaborative efforts, and I applaud the new addition of other chromatographic fingerprinting techniques in addition to the traditional TLC methods. Overall, the monographs and the supplemental information provided in the appendices and beginning chapters of this work provide an excellent foundation from which methodologies can be tested and developed. Essentially, these volumes serve—in both research and industrial settings—as a useful laboratory manual for the analysis of Chinese herbs using commonly employed analytical techniques and readily available equipment”.

Read all of Paula N. Brown’s, (PhD) review here: http://tinyurl.com/k8s239z

  
  
Dept. Agriculture, Fisheries & Forestry (DAFF) releases latest Failing-Foods report

29 September 2013

This report details food that was found to fail under the Imported Food Inspection Scheme during the month of August.

The table in the following link, details where results were detected in excess of food safety limits.

These foods were not distributed for sale in Australia. They were destroyed by the importer or re-exported to the country of origin under DAFF supervision.

Future consignments continue to be targeted at 100% until a history of compliance is established. The full story can be read here: http://tinyurl.com/p9kb9qk

  
  
NZ Fonterra milk scare turns out to be storm in a tea cup as false-positive result confirmed.

19 September 2013

Warren Buffett famously once warned: “It takes 20 years to build a reputation and five minutes to ruin it. If you think about that, you'll do things differently.”

After repeated reports of milk product contamination, New Zealand gets a second life after recent declarations of milk contamination prove to be false alarms.

Read more at: http://tinyurl.com/pov5nok

  
  
USA Experts Advise Manufacturers on How to Avoid a Fraudulent 'Dry Lab'

16 September 2013

The US Food and Drug Administration’s (FDA) dietary supplement rules and regulations for current Good Manufacturing Practices requires supplement manufacturers to be highly diligent in compliance. This is especially true when selecting contract analytical laboratories to verify the authenticity and quality of raw materials and finished products. Three highly qualified experts present a comprehensive review of this process in the current issue of HerbalGram, the peer-reviewed, quarterly journal of the non-profit American Botanical Council (ABC). Since many herb and other dietary supplement manufacturers do not have — and are not required to have — analytical laboratories on site, they must outsource required analyses of raw materials to third-party laboratories.

“Determining the proper identity, authenticity, and lack of adulteration of all botanical materials that are known to be adulterated is an important part of maintaining proper Good Manufacturing Practices, as required by federal law,” said Mark Blumenthal, founder and executive director of ABC, and editor-in-chief of HerbalGram. “ABC is grateful to the authors for their article, which can help herbal manufacturers and others understand the key issues in choosing analytical services from contract laboratories.” Included in the HerbalGram article is a table of seven basic tips for selecting a contract laboratory. Of particular concern is the possibility of contracting with an illegitimate “dry lab,” which provides fabricated yet plausible testing results without actually analysing the supplied material.

Source:here.

 

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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 31st October 2013.

 

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Business Opportunity 

One of RFA's longest standing clients is offering his business for sale.

The business revolves around a "grand-fathered' registered over-the-counter medicine that has been on sale since the early 1900's.

Please contact Robert at This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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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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