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Issue 121

September 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.

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Latest Regulatory News

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



Upcoming Expo Notification – SupplySide West, Las Vegas USA November 12 -16, 2013

Gathering Ingredient Buyers and Sellers from Around the World.

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.

Please Note: Robert Forbes & Associates will be attending SupplySide West in Las Vegas and will be available for personal meetings. If you would like to meet us, please let us know what time is suitable, or alternatively, you could find Robert and the team at the “Ask the Experts” booth (#34064) sponsored by the Consultants Association for the Natural Products Industry (http://www.cani-consultants.org/)

What happens in Vegas is your business!

Check out - http://west.supplysideshow.com/



Conference announcement - International conference on Consumer Product Safety

October 9 - 10, 2013   Outrigger Surfers Paradise Hotel,   Queensland, Australia

The International Consumer Product Health and Safety Organisation (ICPHSO)

The two day event will take place at the Outrigger Resort in Surfers Paradise on the Gold Coast and is the first international consumer product safety conference to be held in Australia.

Further information: http://www.recalls.gov.au/content/index.phtml/itemId/1049469



Non-profit Collaboration Addresses Adulteration of Botanical Dietary Ingredients

Three leading non-profit organisations—the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the University of Mississippi's National Center for Natural Products Research (NCNPR)—have initiated a large-scale program to educate members of the herbal and dietary supplement industry about ingredient and product adulteration. Responsible parties in the herbal and dietary supplement community have become increasingly concerned about the suspected and confirmed practice of adulteration of numerous ingredients. The existence of adulteration raises questions about the identity and quality of some popular herbal ingredients sold in dietary supplements in the United States and in other botanical products (e.g., medicines, cosmetics, etc.) in global markets. The ABC-AHP-NCNPR Botanical Adulterants Program is a long-term, multi-party coalition of herb quality and identity experts in university research groups, third-party analytical laboratories, government agencies, trade associations, and industry companies to examine the extent of suspected adulteration of herbal materials, particularly adulteration that is economically motivated. The intention is to confirm the extent of adulteration in the United States and global markets, determine which official or unofficial analytical methods are currently available to help detect the presence (or absence) of a suspected or known adulterant, and to provide comment and guidance on the relative strengths and/or weaknesses of differing analytical methods. The results of this investigation will be published in a series of reports (white papers) and will be made available on the ABC website.

Source- http://abc.herbalgram.org/site/PageNavigator/About_Adulterants_Program.html



TGA - Safety advisory

6 September 2013

Prosolution tablets pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested Prosolution tablets and found that they contain the undeclared prescription substance tadalafil, consumers are advised that tadalafil is a prescription-only substance (which is the active ingredient in the medicine Cialis). They also contain the undeclared prescription substance sildenafil. Consumers are advised that sildenafil is a prescription-only substance (which is the active ingredient in the medicine Viagra).

The supply of Prosolution tablets is illegal.

Prosolution tablets have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.



NSW Food Authority Award

30 August 2013

NSW seafood industry excellence recognised

The NSW seafood industry was celebrated last night at the 2013 Sydney Fish Market Seafood Excellence Awards. The Coffs Harbour Fishermen’s Co-operative Ltd was awarded Best Supplier (NSW) award. The Bermagui Fishermen’s Co-operative Limited and The New Zealand King Salmon Company Pty Limited were also highly commended in this category. The award was sponsored by the NSW Food Authority.

The Seafood Excellence Awards recognise suppliers as well as NSW seafood retailers and restaurants across eight award categories. They include two People’s Choice Awards where customers were able to vote for the NSW Best Seafood Restaurant and Best Seafood Retailer.

Fish Café by Balgowlah Seafood in Balgowlah won NSW Best Seafood Restaurant and Claudio’s Quality Seafoods was awarded Best Seafood Retailer at Sydney Fish Market.



Australian Government Department of Agriculture, Fisheries and Forestry (DAFF) Notification

22 August 2013

The Failing Food Report for July 2013 is now available to view on the website.

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.

Source - http://www.daff.gov.au/biosecurity/import/food/failing-food-reports



FSANZ Notifications

August - September 2013

This Notification Circular includes notices that are required to be given to the public, submitters and appropriate government agencies, under the Food Standards Australia New Zealand Act 1991 (FSANZ Act).

FSANZ has completed an administrative assessment of the following Application. An opportunity to comment will be available at a later date which will be publicly notified.

A1055 – Short-chain Fructo-oligosaccharides

A1083 – Maximum Residue Limits for Blueberries & Raspberries

A1090 – Addition of Vitamin D to Breakfast Cereal: to permit the addition of vitamin D to breakfast cereal.

Source - http://www.foodstandards.gov.au/code/changes/gazette/Pages/default.aspx



FSANZ Publishes "Agents of Foodborne Illness”

August 2013

Agents of Foodborne Illness is a technical publication for the food industry, food safety consultants and food regulators.

The publication contains information about pathogens that cause foodborne illness. The sections contain information about growth and survival characteristics, symptoms of disease, virulence factors, epidemiological data, occurrence in food, susceptible populations, and dose-response relationship.

This publication is not intended as a comprehensive reference source. Each section also contains a list of recommended reading, such as the US Food and Drug Administration’s Bad Bug Book

The second edition of Agents of Foodborne Illness contains updated information and additional chapters. The series has also been expanded to consider parasites and infectious prion particles in addition to bacteria and viruses.

Agents of Foodborne Illness - download the full publication (pdf 1255 kb)



UN Launches GM Database

August 2013

The FAO GM Foods Platform - A platform for all

The FAO GM Foods Platform is a simple online platform to share information on safety assessment of foods derived from recombinant-DNA plants authorized in accordance with the CodexGuideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants (CAC/GL 45-2003, annex III adopted in 2008) ". This Platform also facilitates the effective utilisation of food safety assessment in situations of Low Level Presence of r-DNA plant materials in food.The FAO GM Foods Platform is freely accessible for those who want to browse the information. Registration is required for those who need to upload information.

Please note: the FAO GM Foods Platform was officially launched on 1 July 2013 and the database will gradually expand as Member countries upload their information over the coming weeks and months.

The launching event was convened on 1 July 2013 at FAO headquarters in Rome, Italy. Meeting report is available for download and some photos of the event can be viewed here.



TGA Advisory Committee on Complementary Medicines Meeting statement - Meeting 14

2 August 2013

The ACCMM provides advice when requested on a wide range of TGA concerns. The committee report may not become publicly available for sometime after a committee has provided that advice. The purpose of this Meeting Statement is to describe in general terms the matters considered by the committee at each meeting and for it to be available as soon as reasonably practical after the relevant meeting.

Topics discussed included:

  • The committee’s advice was sought previously in relation to an application for a new registered complementary medicine, NeuroTabs (AUST R 209079)
  • The committee’s advice was sought on two applications before the TGA, both being new substances for use in listed medicines (specifically whether submitted data are sufficient to establish safety of the substances)
  • Members were provided with background information and a comparison between the current regulatory schemes for food and medicines in Australia, noting the particular relevance of these issues to the regulation of complementary medicines
  • Members were provided with an update on the complementary medicines regulatory reforms. In this context, members noted progress on the implementation of the recommendations made by the Auditor General in respect to complementary medicines
  • Members were provided with an update on a previously discussed item – ‘Bioavailability enhancing effects of excipients’ .

The next meeting of the ACCM is scheduled for 6 December 2013.



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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