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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

 

TGA Publishes Updated List of Registered Complementary Medicines 
Registered complementary medicines are considered to be of relatively higher risk than Listed medicines, based on their ingredients or the indications made for the medicine. Unlike listed medicines, registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to being accepted on the Australian Register of Therapeutic Goods (ARTG) and able to be marketed. The following list sets out the registered complementary medicines on the ARTG. Source: http://tinyurl.com/ntrhgts
 
CONUSBAT Conference to Highlight Challenges Associated With EU Animal Test Ban
Since March 2013, the Animal Test Ban for cosmetics has been implemented in the EU. The ban applies irrespectively of the availability of test alternatives for most of the hazard areas of interest in human safety assessments and a derogation mechanism is not in place. Dr. Annelie Struessmann, Regulatory Director, CONUSBAT will be speaking on 24-25. November 2015 at the InterContinental Hotel, Düsseldorf, Germany.  Source:http://tinyurl.com/n9cm8vw
 
Department of Agriculture & Water Resources Releases Latest Failing Food Report
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. The following table details where results were detected in excess of food safety limits. The food was not distributed for sale in Australia. It was destroyed by the importer or re-exported to the country of origin under department supervision. Source: http://tinyurl.com/nhujz4q
 
FSANZ Accepts Delay in Commencement of Dietary Fibre Claim Provisions
Food Standards Australia & New Zealand has accepted Application A1101 made by the Australian Food and Grocery Council to delay the requirement to comply with the qualifying criteria for nutrition content claims about dietary fibre in Standard 1.2.7 – Nutrition, Health and Related Claims, for 12 months, from and including 18 January 2016, until and including 17 January 2017.  Sourcehttp://tinyurl.com/pujfxjt
 
FSANZ Application A1103 – Citric & Lactic Acids as Food Additives in Beer and Related Products 
The purpose of this Application is to permit the extension of use of citric and lactic acids as food additives in beer (under food category 14.2.1 Beer and related products). Source: http://tinyurl.com/omxlelk
 
FSANZ Announces Proposal P1035 - Gluten Claims About Foods Containing Alcohol
The purpose of the Proposal is to permit nutrition content claims about gluten in relation to foods (including beverages) containing more than 1.15% alcohol by volume. Sourcehttp://tinyurl.com/k3hk7pu
 
FSANZ Calls for Submissions on Voluntarily Adding Vitamins and Minerals to Nut-And-Seed-Based Beverages
Food Standards Australia New Zealand (FSANZ) has called for submissions on an application seeking permission to voluntarily add vitamins and minerals to nut-and-seed based beverages. FSANZ Chief Executive Officer Steve McCutcheon said that under the current Food Standards Code, vitamins and minerals can be added to legume-based and cereal-based beverages. Submissions are invited from government agencies, public health professionals, industry and the community. The closing date for submissions is 16 October 2015. Source: http://tinyurl.com/ogbqc79
 
Cost-Effective, Soy-Based Solution Developed for Use in Metal Food and Beverage Cans
The Ohio Soybean Council (OSC) and researchers at Battelle have developed a soy-based, BPA-free coating for use in the lining of metal food and beverage cans and other coating applications. This breakthrough will help food producers develop packaging solutions that meet increasing consumer health and safety demands while providing excellent performance and food safety. Dr. Bhima Vijayendran, a partner at Redwood Innovation Partners who collaborated on the development of the coating, sees great promise for applications in food and beverage packaging - “By offering a soy-based, BPA-free alternative coating for cans, this technology offers a natural alternative to improve imperishable food distribution and eliminates consumer concern of harmful chemicals leaching into food and beverages".  Source: http://tinyurl.com/pypavtg
 
Australian Organic Farmer Loses GM Appeal
Organic farmer, Steve Marsh has suffered a major defeat in a landmark legal battle over the growing of genetically modified canola in WA. Mr Marsh and his supporters were devastated when the Supreme Court upheld an earlier ruling dismissing his $85,000 damages claim against GM canola-growing neighbour Mike Baxter. In a split decision, the three appeal court judges rejected claims that Mr Marsh lost organic certification on most of his farm near Kojonup in 2010 because it was contaminated with GM canola which blew over the fence from Mr Baxter's property. Mr Marsh sued his childhood friend in a case that has attracted worldwide attention and which has implications for the State Government's plans to repeal laws allowing it to prevent the growing of GM crops approved by Commonwealth authorities.  Source: The West Australian http://tinyurl.com/o8yeflm
 
European Parliament Opposes National Bans on Imports of GM Food and Feed 
The European Parliament's (EP) agriculture committee has rejected the European Commission's draft law that would give European Union (EU) member states the power to restrict or prohibit the use of EU-approved genetically modified (GM) food or feed on their territory. It fears that arbitrary national bans could distort competition on the EU's single market and jeopardize the EU's food production sectors which are heavily dependent on imports of GM feed. Sourcehttp://tinyurl.com/nbxp545
 
Chipotle Sued for Using GMOs After Declaring Its Food GMO-Free
Popular burrito chain Chipotle, which proudly declared it is completely GMO-free in April, is being sued over alleged use of GMOs. According to CBS, a class action lawsuit has been filed in San Francisco against the Colorado-based company claiming that Chipotle has been using GMOs — or genetically modified organisms — in its food “despite advertising that it is GMO-free.” Chipotle plans to contest the lawsuit.  Source: FoodService.com News  http://tinyurl.com/ovyqypt
 
Celebrities and Senators Hold News Conference to Discuss Opposition to H.R.1599 
USA Senator, Patrick Leahy (D-VT), together with actresses Blythe Danner and her daughter Gwyneth Paltrow, spoke at a news conference to discuss opposition to H.R. 1599. Known as the "Deny Americans the Right to Know (DARK)," which would "take away the right of states to label Genetically Modified Organisms, stop the Food and Drug Administration from ever using its authority to craft a national GMO labelling standard, and add to consumer confusion by allowing 'natural' claims on GMO foods."  Source: Zimbio http://tinyurl.com/och8n3z
 
Vemma Nutrition Shut Down for Running Pyramid Scheme
The USA Federal Trade Commission (FTC) on Wednesday announced that Vemma Nutrition — a multilevel marketing firm that relies on independent salespeople, called affiliates, to buy and sell its energy drinks, diet shakes and supplements — has been shut down for engaging in “deceptive and unlawful acts and practices.” The announcement followed an Aug. 17 suit filed against the company, in which the FTC accused it of operating as an illegal pyramid scheme. Source: America-Aljazeera http://tinyurl.com/pjolls7
 
TGA – Safety Advisory: Hongkong Tianli Biological 'Power' Tablets
Hongkong Tianli Biological 'Power' tablets pose a serious risk to your health and should not be taken.  The Therapeutic Goods Administration (TGA) has tested a product labelled Hongkong Tianli Biological 'Power' tablets and found that the tablets contain the undisclosed and prescription only substance Sildenafil (the active ingredient in Viagra).  Source:http://tinyurl.com/n9olz55
 
American Botanical Council: Investigation on Devil’s Claw Ignores Expert Evaluations 
The non-profit American Botanical Council (ABC) says that the New York Attorney General’s (NY AG’s) investigation on the herb, devil’s claw(Harpagophytum) has reached an incorrect conclusion based on its too-narrow interpretation of botanical classifications. The NY AG sent cease-and-desist letters to 13 companies that sell devil’s claw herbal dietary supplements informing them that their products containing devil’s claw material were tested at the New York Botanical Garden using DNA technology. The results showed that the devil’s claw was a different botanical species than what was labelled, and what the NY AG termed a “less desirable” species of the herb. Source: ABC http://tinyurl.com/owcpm7f
 
TGA Issues Listing Notice for 10 New Ingredients Permitted for Use in Listed Medicines
The Therapeutic Goods Administration has declared the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods (subject to certain individual conditions): Ribose; Calcium and Magnesium pyruvate; Octanoic acid; Terminalia arjuna (Arjun tree); Berberis aristata (Indian Barberry); Co-Methylcobalamin; Choline dihydrogen citrate; Lepidium meyenii (Maca); Trachyspermum ammi (Ajwain); & Dimethylglycine hydrochloride.  Source: http://tinyurl.com/oondaxb  ...  See full list of current compositional guidelines for ingredients that have been evaluated for use in listed medicines here: http://tinyurl.com/lonndpd
 
TGA Issues Advertising Guidance for Extemporaneously Compounded Medicines
In Australia, advertisements for *extemporaneously compounded medicines must comply with the Therapeutic Goods Act 1989 (the Act) and other relevant laws. Extemporaneously compounded medicines, although exempt from some parts of the Act, are not exempt from the advertising provisions of the Act. Generally, it is unlawful to publish or broadcast an advertisement to the general public for an extemporaneously compounded medicine, that: refers to a substance (any ingredient of a medicine) or a good containing a substance classified in the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard) as a "Pharmacist Only Medicine" (Schedule 3), "Prescription Only Medicine" (Schedule 4) or "Controlled Drug" (Schedule 8) (some exceptions apply); or has not been pre-approved by the Secretary of the Department of Health, if that advertisement is for a 'designated therapeutic good'  published or broadcast in 'specified media'. Source:http://tinyurl.com/qal5tjr  ...  * A working definition of 'extemporaneous' dispensing or compounding is the mixing together of the ingredients of a prescription or drug formula performed for individual orders by the dispenser or clinician.
 
Australia’s Department of Agriculture Updates Tests Applying to Foods (Honey & Seafood)
The Department of Agriculture has completed a review of the tests applied to imported honey. The testing of imported honey for the antimicrobials, chloramphenicol, nitrofurans, streptomycin, sulphonamides and tetracyclines has demonstrated high levels of compliance for a prolonged period. The testing of imported honey for these antimicrobials will cease. Consignments of imported honey will now be inspected, sampled and tested for evidence of the addition of cane sugar or corn syrup (C4 sugar adulteration), reducing sugar content and moisture content. The department is currently reviewing the antimicrobial testing of imported seafood. Once completed, a further Imported Food Notice will be published to advise of any changes.  Source: http://tinyurl.com/oqz9vbz
 
Food Legal Conference on ‘Clean-est Labelling and Marketing Strategies’
With the support of Osborne Richardson, FoodLegal announce the clean labelling workshop that will take place in Sydney and Brisbane on 8th and 21st October respectively.  Sourceshttp://tinyurl.com/q4cxwvx & http://tinyurl.com/qa5tlrj
 
FSANZ Application A1114 – Food Derived From High Yield Corn Line 
The purpose of the Application is to seek approval for food derived from a genetically modified corn line MON87403 modified for increased yield.  Source:http://tinyurl.com/odzvbp7
 
Chinese Formula Company Snaps up Australian Nutrient Manufacturer, Swisse in A$1.5bn Deal
Australian vitamins and supplements manufacturer, Swisse has reportedly been bought by Hong Kong-listed infant formula maker, Biostime. Source: Food Navigator-Asiahttp://tinyurl.com/qfkytb3
 
FSANZ & NSW Food Authority Recall Coconut Milk Drinks
Food Standards Australia New Zealand (FSANZ) & NSW Department of Health have urged consumers with a dairy allergy to be aware of recent recalls. In these recalls, dairy products were present in the product but were not declared on the product label, as required under the Food Standards Code. FSANZ is aware of two reported cases of anaphylactic reactions associated with the consumption of coconut milk drink.  Sources: http://tinyurl.com/nr4dequ &http://tinyurl.com/qa8ez3q & http://tinyurl.com/ngvsavu
 
TGA Safety Advisory - New Queen Slimming Soft Gel Capsules
New Queen Slimming soft gel capsules pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled New Queen Slimming soft gel capsules and found that the capsules contain the undeclared and prescription-only substance sibutramine. Sibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke. Source:http://tinyurl.com/nc9gu96
 
University of Sydney Reorganises the Way it Teaches Complementary Medicines
In 2015 The University of Sydney reorganised the way it teaches complementary medicines (CM). Associate Professor Parisa Aslani and Dr Joanna Harnett from U/Syd Faculty of Pharmacy outline the changes.  Source: http://tinyurl.com/nwq27on
 
FSANZ Application A1111 – Bacteriophage S16 & F01a as a Processing Aid
The purpose of the Application is to seek approval for a preparation of two bacteriophages (S16 and FO1a) (Salmonelex™) as a processing aid to reduce Salmonella contamination in specific foods. Source:  http://tinyurl.com/lfx9mkn
 
FSANZ Application A1112 – Food Derived from Herbicide-Tolerant Corn Line
The purpose of the Application is to seek approval for food derived from a genetically modified corn line MZHG0JG that is tolerant to the herbicides glyphosate and glufosinate ammonium. Source: http://tinyurl.com/o5r24sf

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Upcoming Trade Expo – Supply Side West October 5 – 9 Las Vegas, USA.
As part of this massive annual trade expo the managing director of RFA Regulatory Affairs, Robert Forbes, will be giving a short public talk on the regulatory guidelines surrounding the supply of complementary medicines into Australia. Titled, “What! No Dietary Supplements in Australia?” this presentation will be conducted under the auspices of the Consultants Association for the Natural Products Industry (CANI) in the USA, of which Robert is Vice-President. It will be held in the afternoon of October 8th.  Sourcehttp://west.supplysideshow.com/central.aspx     Robert will also be available to meet with any suppliers wanting to enter the Australian & New Zealand markets. Please contact this office directly at http://www.robert-forbes.com/ or visit Stand #323, Ask The Experts, at the expo and have an informal face-to-face chat.
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