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

 


VITAMIN K2 NOW APPROVED FOR LISTED MEDICINES IN AUSTRALIA

20th June

Vitamin K (K1 and K2), including ‘menaquinone 7’, has been approved for use in complementary medicines in Australia, and is now effectively on the Australian Register of Therapeutic Goods (ARTG).

The TGA has not yet published the Compositional guidelines for the use of Vitamin K2 however we expect these to be released shortly.

K2 has a long history of safe use and there are many clinical studies available to support specific health claims of this product.

 Please contact us if you would like more information or assistance with listing new products containing K2 for sale in Australia.

Source: http://www.comlaw.gov.au/Details/F2014L00746

 

 

TGA Releases Consumer Based Video to Explain its Regulation of Therapeutic Goods

June 24

Watch this video to find out how TGA weighs the potential benefits of a product against the risks; the different processes associated with lower risk and higher risk goods; what TGA does if a problem is identified after a product has been released to the market; and, how the public can help to monitor safety by reporting problems with therapeutic goods.

Source: http://tinyurl.com/ly5wr9j

 

 

ACCC discovers that 'Victoria Honey' not from bees and not from Victoria

23 June 2014

Basfoods (Aust) Pty Ltd (Basfoods) has paid penalties totalling $30,600 following the issue of three infringement notices by the Australian Competition and Consumer Commission (ACCC) in relation to Basfoods’ “Victoria Honey”.

The ACCC considered that Basfoods had misrepresented that its “Victoria Honey” was honey produced by honey bees on product labelling and on its website, when it was mainly comprised of sugars from plants including corn and sugar cane.

In addition, the ACCC also considered that by naming and labelling its product “Victoria Honey”, Basfoods had represented the product as originating from Victoria, Australia when in fact it was a product of Turkey.

Source: http://tinyurl.com/kxdt2g2

 

 

Warning to Food Companies About Product Stories After Federal Court Finding Against Coles

June 19

“Freshly baked” Coles bread products were partially baked and frozen off-site by a supplier. Bread from the “Cuisine Royale” and “Coles Bakery” range advertised as “fresh, baked today and sold today” included one product from Ireland first baked months earlier. Other loaves that the company claimed were “freshly baked” were found to have been made in Denmark and Germany before being frozen and transported to Australia to be ‘finished’ at in-store bakeries within Coles supermarkets.

These bread products were promoted at Coles’ supermarkets with in-house bakeries as ‘Baked Today, Sold Today’ and in some cases ‘Freshly Baked In-Store’.  In addition, some of these products were offered for sale at Coles’ supermarkets close to prominent signs which stated ‘Freshly Baked’ or ‘Baked Fresh’.

The Court found that the “Baked Today, Sold Today”, “Freshly Baked” and “Baked Fresh” claims made by Coles amounted to a misleading representation that the par-baked bread products had been baked on the day of sale, or baked in a fresh process using fresh not frozen product.

According to several Australian news agencies, Coles is facing more than $3 million in fines after losing a court battle over the freshness of its bread.

A hearing will be held in the Federal Court in Melbourne at a later date to determine the relief that will be ordered. The ACCC is seeking penalties, declarations, injunctions, costs and other orders.

Full story, courtesy of Australian Food News: http://tinyurl.com/p7cjunu

 

 

New Foodlegal Symposium: Breakthroughs in Making and Marketing Healthier Products

June 18

The Symposium explores latest breakthroughs, regulations and developments in healthy products and provides insight into scientific developments and marketing opportunities for your products.

Pre-booking is required. Places are limited and are likely to fill quickly.

Source: http://tinyurl.com/klkutga

 

 

FSANZ Examines Chemical Migration from Packaging into Food

June 18

The purpose of this Proposal is to assess the public health and safety risk of chemicals which may migrate from packaging materials into food, and to identify and manage any risks.

Source: http://tinyurl.com/l9j8j24

 

 

TGA Required Advisory Statements for Medicine Labels (RASML) and the Labelling Order (TGO 69)

June 13

Information for consumers, health professionals and industry:

The labels of over-the-counter and complementary medicines are often required to contain particular advisory statements about specific risks related to use of the medicines. These advisory statements are compiled into the Required Advisory Statements for Medicine Labels (RASML).

The newly revised RASML and the amendment to the Labelling Order (Therapeutic Goods Order No. 69D) has commenced on 12 June 2014.

Source: http://tinyurl.com/phg37kq

 

 

The Truth About Your Painkillers: Generic Vs Brands

June 12

Drug companies have convinced consumers to pay much more for paracetamol and ibuprofen than they need to. Read this revealing story from CHOICE online here: http://tinyurl.com/krat2k6

 

 

NICNAS Announces Training and Outreach Sessions—Nationwide

June 11

National Industrial Chemicals Notification & Assessment Scheme’s (NICNAS's) preferred approach to ensuring compliance with legislation is to work with industry—providing advice to help them understand their regulatory obligations and assistance in finding the most practical way to meet those obligations.

As part of their commitment to raising industry awareness, NICNAS will be conducting stakeholder training and awareness sessions in major capital cities and selected regional areas in coming months, and are seeking expressions of interest from those wishing to attend.

NICNAS training sessions are approximately 1.5 to 2 hours in duration, and there is no cost to attend.

Source: http://tinyurl.com/kdbxfk3

 

 

TGA Explains Target Evaluation Times for OTC Medicine Applications

June 10

The TGA aims to complete the OTC medicine evaluation process within a specified target time.

Read about the total evaluation and standard request for information response times here: http://tinyurl.com/movrj6h

 

 

TGA Draft OTC Medicine Monographs for Topical Imidazole Antifungals, Topical Nasal Decongestants and Pholcodine

June 10

There were a total of four submissions received. Read all of these plus a complete TGA response here: http://tinyurl.com/l85jh2a

 

 

TGA Issues Statement on Liquid Nicotine and Personal Importation for use in Electronic Cigarettes

June 4

Some recent media reports about electronic cigarettes suggest that the importation of nicotine in personal amounts is exempt from regulation. This is not always the case.

The media reports appear to be in reference to the personal importation scheme for therapeutic goods under the Therapeutic Goods Act 1989.

Source: http://tinyurl.com/nawrvad

 

 

Robert Forbes, Founder & Manager of RFA Regulatory Affairs Interview

June 2

Mr. Forbes has been involved in the complementary medicine industry for over 35 years. His expertise lies in regulatory affairs for non-prescription and complementary medicines.

Read more about this fascinating man in this personal and insightful interview by Sheldon Baker of Nutralink, in this June edition of Nutraceuticals World.

Source: http://tinyurl.com/ncl5j7r

 

 

TGA Issues Guidance on Colourings Used in Medicines for Topical and Oral Use

May 30

Colourings are inactive substances that may be used in topical or oral formulations of medicines, for various reasons such as to distinguish between strengths, indications or markings; to assist with identifying the medicine; or, to distinguish between other medicines.

Source: http://tinyurl.com/mmgwaft

 

 

MEDSAFE - Important Changes to the Definition of Medicines and Medical Devices

May 28

New Zealand Medicines & Medical Devices Safety Authority (MEDSAFE), modernises the definitions of medicine, medical device and therapeutic purpose in order to better align the boundary between medicines and medical devices with international norms. These changes come into effect on 1 July 2014.

Source: http://tinyurl.com/nm7zp5e

 

 

World Health Organization Releases Traditional Medicine Strategy 2014-2023

May
New strategy for traditional and complementary medicine includes the development and use of herbal medicinal preparations. This updated document builds on work the WHO has undertaken over the past decade to identify further and strategize on the future of traditional medicines (TM) around the world.

Source; American Botanical Council: http://tinyurl.com/k9t644a

 

 

Department of Agriculture Lists Latest Failing Food Report

May

This report details food that was found to fail under the Imported Food Inspection Scheme during the month. The Department of Agriculture targets and monitors food determined to pose a high or medium risk to public health. Risk food is targeted at 100 per cent until a history of food safety compliance is established. Failed foods are not distributed for sale in Australia, they are destroyed by the importer or re-exported to the country of origin under department supervision. Future consignments continue to be targeted at 100 per cent until a history of compliance is established.

RFA suggests that food importers pay particular attention to the APRIL 2014 results and look under the heading “Random monitoring of food for compliance”, and note the number of foods seized for regulatory reasons, especially ingredients not permitted in that class of food

Source: http://tinyurl.com/oszh7h3

 

 

BOOK REVIEW: Smoke Signals: A Social History of Marijuana

Smoke Signals: A Social History of Marijuana – Medical, Recreational, and Scientific by Martin A. Lee. New York, NY: Scribner; 2012. Hardcover, 519 pages. ISBN: 978-1-4391-0260-2. $35.00. Reviewed by Mariann Garner-Wizard for the American Botanical Council.

“The wrongheadedness of the US-driven war on drugs, particularly the prohibition of cannabis (marijuana; Cannabis sativa, Cannabaceae), has become so obvious that at times it seems the end must be near…. Smoke Signals casts a broad net over recent events and hauls it up full; if not everything within passes historical muster in 50 years, it is a lively, provocative read today.”

Read the entire Herbalgram book review: http://tinyurl.com/oun5uke

 

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