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TGA Webinar on International Harmonisation of Ingredient Names

On 10th June 2016, Jola Samoc of the Therapeutic Goods Administration, delivered an online webinar on the topic of ‘Updating Medicine Ingredient Names’. This PDF summary outlines in a very clear format, all the issues surrounding the use of Australian Approved Names (AAN) and how they match up against the WHO’s International Non-proprietary Names (INN).   Source: TGA June webinar

TGA Latest Fee & Charge Summary as of 1 July 2016

The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. A fee is charged for a service, such as a product evaluation. A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year.   Source: TGA costs

TGA Annual Charge Exemption Scheme: Q & A

On 10th June 2016, Jola Samoc of the Therapeutic Goods Administration, delivered an online webinar on the topic of ‘Updating Medicine Ingredient Names’. This PDF summary outlines in a very clear format, all the issues surrounding the use of Australian Approved Names (AAN) and how they match up against the WHO’s International Non-proprietary Names (INN).   Source: TGA June webinar

TGA Puts Spotlight on Listed Medicines With Blood Glucose And Cholesterol Indications

The TGA will be initiating targeted compliance reviews for Listed medicines that have indications relating to blood glucose or cholesterol biomarkers. They will be focusing on medicines that have a statistically higher possibility of having non-compliance issues. If a medicine is found to be non-compliant, the medicine’s entry may be cancelled from the ARTG.

NB: If you are a sponsor of a listed medicine containing indications relating to the blood glucose and/or cholesterol biomarkers, you are encouraged to re-evaluate the evidence you currently hold; and reconsider the indications made for your medicines.   Source: > Latest News 12/07/16

TGA Progress Stalls on MRA GMP Clearance Application Processing Times

As of 7 June 2016, the average processing time taken to complete an MRA GMP clearance application was 6.6 weeks. 90% of the finalised MRA GMP Clearance applications were within 7.5 weeks. (As of 9 May 2016, the median processing time taken to complete an MRA GMP clearance application was 5.0 weeks and average processing time was 6.5 weeks).   Source: Clearance times

TGA Safety Advisories for July:

Black Storm tablets  The Therapeutic Goods Administration (TGA) has tested product labelled Black Storm tablets and found that the tablets contain the undeclared substances sildenafil and vardenafil (actives in Viagra and Levitra)   Source: Black Storm

Golden Ant tablets The TGA has tested a product labelled Golden Ant tablets and found that it contains the undeclared substances sildenafil and chloramphenicol. (Active in Viagra and an antibiotic)   Source: Golden Ant

How to Understand Those Tricky Sugar Labels

Have you ever bought a packet of lollies and eaten the whole thing after seeing "all natural" or "no added sugar" on the front? You're not alone. Understanding the sugar content of a product can be confusing and difficult, and it's not made any easier by misleading claims like "no added sugar" plastered on foods we might otherwise be wary of. Once you know the tips and tricks, reading sugar labels can be easy -- you just have to know what you're looking for.   Source: Huffington Post, Juliette Steed Sugar sugar

NSW Food Authority Recalls July 2016:

Hillcrest Chewy Choc Squiggle Muesli Bars ALDI has recalled this product due to the presence of an undeclared allergen (peanut).   Source: Muesli bar

Bakers Life Hot Dog Rolls - 6 Pack ALDI has recalled this product due to the presence of foreign objects (metal shavings).   Source: Hot dog rolls

New Australian Country-Of-Origin Labelling 'Doesn’t Go Far Enough'

Australia’s new country-of-origin food labels are a good start, though there is plenty of scope to go even further, according to a leading food systems specialist.   Source: Food Navigator-Asia, RJ Whitehead CoOL critique

ACCC Takes Action Against E-Cigarette Suppliers

The Australian Competition and Consumer Commission has commenced separate proceedings in the Federal Court against two e-cigarette online retailers alleging that they made false or misleading representations and engaged in misleading conduct by making statements on their websites that their e-cigarette products did not contain toxic chemicals. The ACCC alleges that the two companies, Social-Lites Pty Ltd (Social-Lites) and Elusion New Zealand Limited (Elusion), breached the Australian Consumer Law (ACL) by making representations on their websites from at least August 2015 that the e-cigarette products being sold did not contain carcinogens or toxic chemicals, and did not contain any of the chemicals found in conventional cigarettes. The ACCC alleges, based on independent testing it commissioned, that the e-cigarette products sold by Social-Lites and Elusion did in fact contain carcinogens and toxic chemicals found in conventional cigarettes, including formaldehyde, acetaldehyde and acrolein.   Source: e-cigarettes

Paddle Pop and Sakata Snack Makers Fined by ACCC for Misleading Health Claims

The makers of Streets Paddle Pop ice-creams and Sakata rice snacks have each paid a penalty of $10,800 after exploiting school canteen guidelines to create a "health halo" around their processed products. The Australian Competition and Consumer Commission issued an infringement notice to Unilever, owner of Streets Paddle Pop, and Smith's, maker of Sakata snacks, after it found their "school canteen approved" logos were making shoppers assume the products had been approved or were suitable as healthy options for school canteens.   Source: SMH, Esther Han Unhealthy snacks

ACCC Comes Down Hard on Unsafe Products

Editor’s Note: Although this story is not directly related to the everyday business of RFA Regulatory Affairs, we thought it worth including as an indication of the wide-reaching and often used powers of Australia’s consumer regulator. The Federal Court has ordered Online Dealz Pty Ltd (Online Dealz) to pay a penalty of $100,000 for supplying a household cot, portable cot and stroller that did not comply with safety standards, and for making misleading representations in advertisements for the household cot, in proceedings brought by the Australian Competition and Consumer Commission. The Court also ordered Online Dealz’ sole director, Janet Lucas, to pay a penalty of $20,000 after finding that she was knowingly concerned in the conduct of Online Dealz in relation to the household cot.   Source: ACCC penalty

ACCC Agreement to Restrict Advertising of Infant Formula

The Australian Competition and Consumer Commission has re-authorised an agreement between manufacturers and importers of infant formula that prohibits them from advertising and promoting formula for babies under 12 months of age directly to the public. This five-year agreement is designed to promote breastfeeding in Australia, which has significant public health benefits.   Source: Infant formula

FSANZ Notifications July 2016:

Application A1113 – Extension of Use of Propionates in Processed Meats

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

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.   Source: Berries

Application A1117 – Extension of Use of L-Cysteine as a Food Additive

​The purpose of this Application is to extend the use of the food additive, L-cysteine, to limit enzymatic browning of cut avocado and banana and so extend the shelf life.   Source: L-cysteine

Application A1119 – Addition of Water to facilitate Wine Fermentation

The purpose of the Application is to permit the addition of water to dilute high sugar to aid fermentation in the production of wine, sparkling wine and fortified wine.   Source: Wine water

Application A1090 – Voluntary Addition of Vitamin D to Breakfast Cereal

The purpose of this Application is to permit the voluntary addition of vitamin D to breakfast cereal.   Source: Vit D

Application A1132 – Broaden Definition of Steviol Glycosides (Intense Sweetener)

The purpose of this Application is to expand the definition of steviol glycosides for use as an intense sweetener to include all steviol glycosides present in the Stevia rebaudiana leaf.   Source: Stevia

Application A1109 – Glutaminase from Bacillus amyloliquefaciens as a Processing Aid (Enzyme)

The purpose of the Application is to permit glutaminase derived from Bacillus amyloliquefaciens as a processing aid in the production of certain seasoning ingredients or foods used for seasoning as an alternative to the use of monosodium glutamate.   Source: Glutaminase

Application A1116 – Food derived from Herbicide-tolerant & Insect-protected Corn Line MZIR098

The purpose of the Application is to seek approval for food derived from a genetically modified corn line MZHIR098 that is tolerant to the herbicide glufosinate ammonium and protected against corn rootworm.   Source: GM Corn

Application A1120 – Agarose Ion Exchange Resin as a Processing Aid for Lactoferrin Production

​The purpose of this Application is to seek permission for the use of agarose ion exchange resin as a processing aid in the production of high purity lactoferrin from bovine milk and milk-related products.   Source: Agarose

Application A1134 – Phytosterols in Portion-controlled Breakfast Cereals

The purpose of the Application is to amend current novel food permissions for phytosterols added to breakfast cereals to allow increased concentrations for portion controlled breakfast cereals, in either individually wrapped portions or portions that can be easily divided.   Source: Phytosterols

Proposal P1042 – Low THC Hemp Seeds as Food

The purpose of this Proposal is to permit the addition to food of products from the seeds of low tetrahydrocannabinol varieties of Cannabis sativa.   Source: Cannabis

Food Expiration Dates Everyone Should Know

Do you know the difference between 'use by' and 'best before'? "There's basically three types of expiration dates in Australia," Rachelle Williams, Chair of the Food Safety Information Council, told The Huffington Post Australia. "There's 'use by', 'best before' and 'baked on'. Read this article to discover the meanings of these terms and how they apply to a range of particular foods.   Source: Huffington Post, Juliette Steen Food dates

CMA Reports on Medicinal Cannabis Consultation Session

Complementary Medicines Australia was recently invited to attend an information session held by the Department of Health’s Office of Drug Control (ODC) regarding licensing for the domestic cultivation and manufacture of medicinal cannabis products. This follows on from recent amendments to the Narcotic Drugs Act 1967, enabling the domestic cultivation of cannabis for medicinal and related research purposes that will come into operation later in the year. Domestic cultivation of medicinal cannabis will enable sufficient quantities of raw materials to be available to meet the needs of local manufacturers, and will ensure that quality control measures on medicinal cannabis-derived products can be enforced to protect patient safety.  Source: CMA Technical Alert Cannabis cultivation

CMA Technical Alerts on Curcumin and on ‘Export Only’ Products

Complementary Medicines Australia puts the spotlight on Curcumin products and also, Export-only medicines and their conditions of listing.   Source: CMA alerts

ABC Announces that Complete Digital Archive of HerbalGram Issues is Now Available

The American Botanical Council (ABC) is excited to announce that every issue of HerbalGram, the non-profit’s quarterly, peer-reviewed journal, is now available online. Going back to issue 1 from the summer of 1983, the newly updated archive includes 21 issues that have never been available in a digital format. The complete HerbalGram collection is available to ABC members at all levels.   Source: HerbalGram

Botanicals Added To EFSA Data Warehouse

The European Food Safety Authority has taken the first step in releasing a web-based version of its Compendium on Botanicals. The searchable database, which is still under development, will be expanded to include non-European botanical species. The complete version of the Compendium will be released early 2017.   Source: EFSA data

EFSA Permits Glycaemia Control Claim

The European Food Safety Authority, in article 13.5 on health claims, allows for products to use a “induces a lower blood glucose rise” claim, when using non-digestible carbohydrates as sugar replacers. The claim was fully authorized by the European Commission on the 20th June 2016. Non-digestible carbohydrates are neither digested nor absorbed in the small intestine. For the health claim to be applicable, the products (food and drinks) should contain at least 30 % less sugars than the reference product.   Reference paper: EFSA opinion

FDA Issues Final Rule Amending Food Facility Registration Regulations

Domestic and foreign facilities that provide food for human or animal consumption in the United States are generally required to register with FDA. The food facilities registration database provides FDA with information necessary to address actual and potential safety concerns and determine to whom certain FSMA provisions, including hazard analysis and risk-based preventive controls and mandatory recall authority, apply. On July 13, 2016, FDA issued the final rule, “Amendments to Registration of Food Facilities.”   Source: AHPA FDA food regs


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