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Courts Gag Campaigner After ‘Toxic’ Capilano Honey Remarks

A Victorian beekeeper who accused a leading Queensland honey manufacturer of selling “toxic” foreign products has been gagged by the courts ahead of legal action. (Capilano defends product safety but is slow to respond to misleading country of origin labelling after accusations of using imported Chinese honey with the local product).   Source: RJ Whitehead, Food Navigator-Asia 'Toxic' honey


Australian Firm Launches ‘World’s First Clinically Tested’ Prebiotic Honey

Australian manufacturer Capilano has launched what it states is the world’s first clinically tested prebiotic honey.   Source: By Gary Scattergood, Food Navigator-Asia Prebiotic honey


TGA Provides Compliance Advice and Education for Listed Medicines

The following information is aimed at providing sponsors with a better understanding of common compliance issues and how they can be avoided. The Therapeutic Goods Administration believes that sponsors want to do the right thing and hopes that this information will provide clarity around regulatory requirements so that sponsors can more easily comply with the law.   Source: TGA education


TGA Updates List of 'Permissible Ingredients' for Use in Listed Medicines

The Therapeutic Goods Administration has listed the changes to ingredient availability in the amended Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016. The list includes new allowable ingredients, Removal of one previously allowed ingredient, and, Changes to ingredient requirements.   Sources: Permissible ingredient update 1 ; Permissible ingredient update 2


TGA Issues Australian Regulatory Guidelines for Complementary Medicines (ARGCM). Version 6.0

The Australian regulatory guidelines for complementary medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia. If you want to supply a complementary medicine in Australia, you may choose to employ a regulatory affairs consultant.   Source: CM guidelines


TGA Safety Advisories:

Bee Sexy Slimming capsules - The Therapeutic Goods Administration has tested a product labelled Bee Sexy Slimming capsules and found that the capsules contain the undeclared substance sibutramine. Consumers are advised that sibutramine is a prescription-only substance in Australia. Sibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke.   Source: Bee sexy

Vigour 300 tablets - The TGA has tested a product labelled Vigour 300 tablets and found that the tablets contain the undeclared substance sildenafil (active ingredient in Viagra).   Source: Vigour 300


TGA Safety Warning: Homeopathic Teething Products

Consumers and health professionals are advised that the TGA is aware of overseas safety concerns relating to homeopathic teething products, which are potentially harmful for infants and children,and is investigating the issue. The USA Food and Drug Administration published a safety alert and media release stating that homeopathic teething tablets and gels may pose a risk to infants and children. The TGA is conducting urgent laboratory testing of homeopathic teething products currently marketed in Australia to ascertain whether any action is required here.   Source: teething troubles 


NSW Food Authority Recalls:

Quality Bakers Australia Various Bread Rolls - has recalled multiple bread roll products due to the potential presence of foreign matter (metal pieces).   Source: Bread roll metal

Woolworths Singleton Australian Mince (various) - Woolworths Limited has recalled Australian pork, beef and lamb mince sold from its Woolworths Singleton store in NSW due to a packaging fault resulting in the presence of metal fragments.   SourceMince metal

Pandaroo Sushi Ginger - G & L YUEN Pty Ltd trading as YUEN’S MARKET TRADING CO. has recalled Pandaroo Sushi Ginger due to the presence of foreign matter (glass).   Source: Sushi ginger


FSANZ Notifications:

Application A1135 – Beta-galactosidase from Bacillus licheniformis as a Processing Aid (Enzyme)

The purpose of the Application is to permit the use of a new source of beta-galactosidase from Bacillus licheniformis to be used as a processing aid during the production of reduced lactose or lactose free milk and dairy products.   Source:Bacillus enzyme

Application A1113 – Extension of Use of Propionates in Processed Meat

The purpose of the Application is to request the extension of use of propionates as anti-microbial preservatives in processed meat products.   Source:Meat propionates

Application A1115 – Irradiation of Blueberries & Raspberries

The purpose of the Application is to seek permission to irradiate blueberries and raspberries for phytosanitary purposes against fruit flies and other critical plant pests, at levels between 150 Gray (Gy) and 1 kGy.   Source: Berry irradiation

Proposal P1027 – Managing Low-level Ag & Vet Chemicals without Maximum Residue Limits

The purpose of this Proposal is to manage low-level agricultural and veterinary chemicals without MRLs (i.e. the food is not listed in Schedule 20, but the chemical is).    Source: Residual levels


AIHW Reports on Health Expenditure Australia 2014–15

Australia's spending on health remains slow, but health now represents a greater proportion of the economy than ever before, according to a new report from the Australian Institute of Health and Welfare (AIHW).   Sources: Health report; &, Health report 2016


"Incidental DNA Fragments" May be Misinterpreted Using Next Generation Sequencing (NGS)

DNA testing of botanical ingredients continues to be a white hot topic in the herbal products industry, with far more questions than answers and controversy than consensus. You will want to read a paper that the American Herbal Products Association has just published on its website: A caution to industry and regulators -  ‘Incidental DNA fragments’ may be misinterpreted using Next Generation Sequencing  (NGS).  Sources: Herbal DNA; &,  NextGen sequencing


Requirements for Foreign Companies Entering U.S. Market

International companies looking to enter the dietary supplement market in the U.S. have a long and winding road to navigate. Negotiating the maze of laws and regulations enforced by federal and state agencies can be a daunting proposition. A subset of these difficulties involves securing the insurance—product liability, principally—that will satisfy potential U.S. customers and let company principals sleep at night, knowing our litigious system. This article examines the insurance and regulatory challenges companies face.   Source: Greg Doherty et al, Nutraceuticals World USA product liability


TGA Warned by FDA re. Japanese Chemical Manufacturer

The US FDA recently issued a warning letter to the Nippon Fine Chemical Company, an API and chemical substance manufacturer. The warning letter was issued due to the site’s personnel physically obstructing FDA inspectors and refusing to hand over documents for review. FDA was concerned about reports of contamination with glass, hair, cardboard, metal, product discoloration, and a black spider. The FDA has also placed the site on import alert. Australia’s TGA is concerned that some incipient ingredients, potentially sourced from this company, may find their way into Australian medicines.   Source: Nippon alert


Is The 2015 Nobel Prize a Turning Point for Traditional Chinese Medicine?

Half of the 2015 Nobel Prize in Physiology or Medicine went to a researcher who spent her entire career researching traditional Chinese medicine. Scientist Youyou Tu, is based at the Chinese Academy of Traditional Chinese Medicine in Beijing (now the China Academy of Chinese Medical Sciences) since 1965. Traditional medical knowledge anywhere in the world has not even been on the radar for Nobel Prize prospects. Until 2015, that is. So how should we interpret this arguably seismic shift in international attention on traditional Chinese medicine?   Source: The Conversation Nobel Laureate, Youyou Tu 


Marketing News:


Australia to Get Single Food Labelling Brand to Seize China Growth Under Twiggy Forrest Plan

Australia's beleaguered farmers are poised to unlock vast new export markets as producers, peak bodies and both sides of politics prepare to bury their differences to sell products into China under a "one brand, one logo" approach for the first time. The new strategy – under wording and a trade symbol designed for maximum Chinese impact – would pitch Australia in a head-to-head race against the gold-standard in export marketing, "100% Pure New Zealand".   Source: Mark Kenny, SMH Brand Australia


How to Best Prepare Your Company for a Cyber Attack

With more and more high profile cyber security incidents being made public, awareness of the importance of cyber security continues to steadily increase. The Australian Government, via its Australian Cyber Security Centre (ACSC), has released a comprehensive report highlighting the threats faced and what we should be doing about them. We thought it could be of interest if we provide you with a summary of it. (The Australian Government has defined cyber attack as: "a deliberate act through cyberspace to manipulate, disrupt, deny, degrade or destroy computers or networks, or the information resident on them, with the effect of seriously compromising national security, stability or economic prosperity").   Source: Cyber threat


Quote of the Month:

“Cyber war takes place largely in secret, unknown to the general public on both sides”.     Noah Feldman

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