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TGA Releases Updated List of Compositional Guidelines 

The following is a list of current compositional guidelines for ingredients that have been evaluated for use in listed medicines. Read the latest list and for information on what compositional guidelines are, when they are used and how they are generated.



Product Recall - Counterfeit Durex Branded Condoms Purchased From Groupon Website 

It has been identified that the condoms sold are counterfeit goods and may have defects such as holes in the latex. Defects may result in the condoms failing to prevent pregnancy and protect users against sexually transmitted infections.



ACCC Authorises Medicines Australia Code Subject to Strengthening Individual Reporting 

The Australian Competition and Consumer Commission is requiring Medicines Australia to strengthen its public reporting as a part of authorising edition 18 of its Code of Conduct (the Code) for five years. The Code sets the standards for the marketing and promotion of prescription pharmaceutical products in Australia by member companies.



Wet Wipes Causing Havoc in Australia's Sewage and Water Systems 

Australians are flushing thousands of kilograms of incorrectly labelled wet wipes down their toilets every year, causing havoc in the country's water and sewage systems. Many products are advertised as being "flushable", which the country's peak water industry body, the Water Services Association of Australia, says is wrong. Labelling on products needed to be consistent and accurate and that people should be encouraged to put wet wipes in the rubbish, not the toilet.

Source: Patrick Hatch, The Age;  ... Read also related article from NYTimes:


Australia Updates Guidance on Bovine Spongiform Encephalopathy (BSE) 

 Under the Imported Food Control Act 1992, beef and beef products for human consumption are considered a risk food for the likely presence of BSE agent. The beef can only be sourced from countries that have had their BSE food safety risk assessed and a satisfactory BSE risk status assigned by Food Standards Australia New Zealand (FSANZ) and BSE certificates negotiated and agreed between the Department of Agriculture and competent authorities of the exporting country.



Amphetamine-Like Substance Found in Weight Loss, Sports Supplements 

Researchers have identified a number of weight loss and athletic performance supplements that contain an amphetamine-like substance that has not been proven to be safe. The findings were published in the journal Drug Testing & Analysis (2015 March 1; DOI 10.1002/dta.1793). Of the 21 brands labelled as containing Acacia rigidula, a shrub native to Texas, 11 brands or 52.4 percent contained an amphetamine isomer known as or ß-methylphenylethylamine (BMPEA). While BMPEA was synthesized in the 1930s as a potential substitute for amphetamine, its efficacy and safety were never studied, the article noted.

Source: Josh Long, Natural Products Insider


Federal Court Finds Advanced Medical Institute Engaged In Unconscionable Conduct 

The Federal Court today declared that Advanced Medical Institute (AMI), NRM Corporation and NRM Trading Pty Ltd (NRM) had engaged in unconscionable conduct in promoting and supplying medical services and medications for men suffering from sexual dysfunction. ACCC Chairman Rod Sims welcomed the Court’s decision. “This case provides a clear message that businesses must not take advantage of consumers who are vulnerable or disadvantaged. Consumer issues in the health and medical sector are a priority for the ACCC and we will not hesitate to hold businesses and responsible individuals to account for the actions,” Mr Sims said.  



Coles to Pay $2.5m For Misleading "Baked Today" And "Freshly Baked In-Store" Bread Promotion 

The Federal Court has ordered Coles Supermarkets Australia Pty Ltd (Coles) to pay penalties of $2.5 million for making false or misleading representations and engaging in misleading conduct in relation to the promotion of its par-baked bread products, in proceedings brought by the Australian Competition and Consumer Commission. The products were promoted as “Baked Today, Sold Today” and in some cases “Freshly Baked In-Store”, when they were in fact partially baked and frozen off site by a supplier, transported and ‘finished’ at in-store bakeries within Coles supermarkets.



ACCC Acts on Chinese Made 'Aussie Beer' 

The Independent Liquor Group (ILG) has paid a penalty of $10,200 following the issue of an infringement notice by the Australian Competition and Consumer Commission in relation to its “Aussie Beer” product. From March 2014 to August 2014, ILG supplied a product named “Aussie Beer”, with labelling that incorporated the statement “100% owned” within a map of Australia and the statement “Australia’s finest malt”.  The packaging also featured green and gold colours, which are colours closely associated with Australian sporting teams.



Canadian Politicians Take Action on Microbeads 

The Canadian government has been urged to take immediate action to designate microbeads plastics as “toxic” under the Canadian Environmental Protection Act (1999), which would then allow the federal government to regulate, phase out, or eliminate the use of microbeads in products used or produced in Canada.

Source: Megan Leslie, MP . . Related: Australia survey of microbeads


TGA Releases Complementary Medicines - Compliance Reviews Outcomes 2014 

Each year the Therapeutic Goods Administration reviews a proportion of listed complementary medicines to check for compliance with regulatory requirements. They undertake a review at any time after a medicine is listed on the Australian Register of Therapeutic Goods (ARTG) and vary the proportion of random and targeted reviews to ensure efficient use of resources and maintain a risk benefit approach. Read the detailed results here.



FSANZ Proposal P1038 

– Vitamin & mineral claims & sodium claims about food containing alcohol



FSANZ Proposal P1025 

– Code Revision to revise the Australia New Zealand Food Standards Code to improve legal efficacy



TGA Releases Draft Compositional Guidelines for Squid Oil ; Menaquinone 7 

Source: ;


TGA Safety Advisories Concerning Illegal Erectile Dysfunction Medicines 

Numerous products are seized at Australia's borders every month; examples over last few weeks include - Enhanced Vegetal Vigra capsules; Gold Viagra capsules; Kangaroo Sexually Invigorating Essence; Xzen 1200; Strong-SX capsules; Black King Kong capsules; North West Wolf capsules; USA Gold Ant capsules; Strong Horses capsules; Niu Mo Wang Bull Monster tablets; Majestic Lovezone tablets; MMC USA Blue Shark capsules, and many others. The Therapeutic Goods Administration (TGA) has tested these products and found that the capsules contain the undeclared substances sildenafil (Viagra) &/or tadalafil (Cialis).

Sources: ; ; ; ; ; ; ; ;


A USA Update on False Advertising Insurance 

There is a widespread perception that a commercial general liability policy provides defence and settlement costs for false advertising lawsuits. Further, class action lawsuits against dietary supplement companies for false advertising are becoming increasingly popular among plaintiffs’ attorneys. Another coverage area of a standard liability policy, called Personal and Advertising Injury (PAI), has created some confusion among many people. To some, the name itself implies coverage for any and all kinds of advertising activities, including false advertising. However, this is not the case—not by a long shot. What is covered by PAI? In two words: not much!

Source: Greg Doherty, for Nutraceuticals World


Australia’s National Heart Foundation Reviews Dietary Fish & Fish Oil Supplement Data 

Using the National Health and Medical Research Council's evidence assessment framework, conclusions were made in relation to dietary intake of fish and omega-3 LCPUFA for cardiovascular health. Dietary intake of fish was found to be mostly consistent with respect to protection from heart disease and stroke. In relation to omega-3 LCPUFA supplementation, neither a beneficial nor adverse effect was demonstrated in primary or secondary prevention of coronary heart disease (CHD).

Source: Heart, Lung & Circulation


Kakadu Plum Wins Editor’s Choice Award - Most Novel Ingredient 

The 3rd annual Functional Ingredients “Editor’s Choice Awards at Engredea / Natural Products Expo West, highlighted the best-in-class raw material ingredient suppliers across a range of disciplines. Voted “Editors Choice Award - Most Novel Ingredient” GoWild Australia's, Kakadu Plum - Terminalia ferdinandiana extracts and powders - the world's richest source of vitamin C, has a history of use as a traditional food and medicinal agent by indigenous Australians for treatment of numerous ailments. Also, as a good topical for skin care, hair care, cosmetics, supplements, and as a natural preservative due to its high antibacterial activity. This is a unique native Australian super-fruit that boasts the highest Vitamin C content of any citrus, even acerola, and yet is not acidic.



What Australian Food Labels Don't Tell You 

An overhaul of country of origin food labels is not likely to hit the shelves until at least the end of the year, with the Australian government considering a system that would use a graph to indicate the percentage of Australian-grown produce in food. According to Foods Standards Australia and New Zealand, country-of-origin labelling also needs to be displayed alongside fruit, vegetables, fish and meat. This is a mandatory requirement that is often flouted, more so in Victoria than in NSW, where there are public "name and shame" registers.

Source: Richard Cornish, GoodFood . . . Related - A Guide to Understanding the Nutritional Label   &   Country of Origin Labelling


Outcomes of the Review to the Vendor Qualification Questionnaires and Good Supplier Practice

Complementary Medicines Australia (CMA) outlines the outcomes of the review to the standard format Vendor Qualification Questionnaires (VQQ) (a shared suite of documents developed by CMA in collaboration with the Australian Self Medication Industry (ASMI)). The revised documents are now published to the CMA and ASMI websites, respectively. The revisions made to the documents resulting from the review are summarised here.



New TGA Business Services Site Launches 28th April 2015 

The TGA will be launching the first of a series of upgrades to its existing eBusiness Services (eBS) site. The new site will be launched on Tuesday 28th  April 2015 and will be called TGA Business Services.



TGA Announces Changes to Sponsorship of Therapeutic Goods 

Changes to the sponsorship of therapeutic goods in an entry in the ARTG must be notified to the TGA within 3 months.



TGA Releases Half-yearly Performance Report July to December 2014 

This report details overall TGA performance. Of particular interest to RFA Newsletter readers is the table ‘Listed medicine reviews Table 69, New and completed reviews’ on page 57.



TGA Presentation Given at the Capsig NSW - Complementary Medicines – Revival 

On 25 March, 2015 Yasmin Mollah, Assistant Director, Listing Operations and Angeliza Querubin, Pre-Market Assessment Section, Complementary medicines branch, TGA provided an overview of the regulation of complementary medicines in Australia.



Department of Agriculture Releases Failing Food Report for March 2015 

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 department also operates a five per cent random surveillance program to monitor a range of food imported into Australia for compliance to some standards in the Australia New Zealand Food Standards Code.



Department of Agriculture Updates Tests Used for Imported Foods 

The Department has reviewed tests applied to some surveillance food under the Imported Food Inspection Scheme. Residue testing in fruit, vegetables and juices has been expanded and will assess a wider range of chemicals for compliance to the Australia New Zealand Food Standards Code maximum residue levels. A list of the residues to be included in the screen and a summary of changes effective from 22 April 2015 are now available.



Student Dies After Consuming Toxic ‘Diet Pills’ in UK 

The mother of a student thought to have taken "highly toxic" diet pills bought online has appealed to others not to consume them. "Two tablets was a lethal dose - and she had taken eight”. Police said the tablets were believed to contain dinitrophenol, known as DNP, an industrial chemical which is sold illegally in diet pills as a fat-burning substance. Users experience a metabolism boost, leading to weight loss, but taking even a few tablets can be fatal.



TGA Releases Compliance Review for Krill Oil 

The Therapeutic Goods Administration (TGA) has informed Complementary Medicines Australia (CMA) of the outcomes of compliance reviews for medicines containing the ingredient, Euphausia superba (Krill) Oil. It is CMA’s intention that by highlighting the information contained in this alert it may assist sponsors to review the evidence to support indications for krill oil and voluntarily make any corrective actions that may be required.

Source: CMA member alert


New Zealand Plans New Rules For Natural Health 

Upcoming bill controls claims which can be made about non-prescription items such as vitamins. Claims made about the benefits of natural health products such as vitamins will need to be backed by evidence under a new system. Health officials have told the local industry that a new regime, separate from those for food and medicines, will likely be in place next year.

Source: Nicholas Jones, NZ Herald


ASMI Complaints Panel Ruling – Pitfalls for Advertisers of Therapeutic Goods 

A recent decision by the Australian Self-Medication Industry (ASMI) Complaints Panel reminds advertisers of therapeutic goods to think carefully about proposed advertising or risk conducting a second-round campaign of corrective advertising. Key messages included - Do not make claims that are broader than the product specification, consumer medicine information and product information, even if there is some supporting scientific evidence for the broader claim; Think carefully before grouping claims, particularly in relation to the relief of symptoms; and, Do not give the impression that a product approved for the relief of long-term symptoms may also relieve short-term symptoms.

Source: Kim O’Connell, International Law Office


Addisons Releases Direct Selling Legal Update 

This is the latest edition of the Addisons Direct Selling Legal Update. In this edition, this prominent legal firm takes a look at some developments which may impact on those in the direct selling sector. Of particular interest is the latest on ACCC Compliance & Enforcement policy.



CRN Webinar • APRIL 29, 2 – 4 pm EDT (USA) 

Testing, Testing 1-2-3: Product and Ingredient Testing in Today's Climate. "What You Need to Do and How to Do It - Navigating from Regulatory through Technical"



SPECIAL FEATURE – Now is the Time to Start Planning Your Sunscreen Products 

We’ve only just started to enjoy autumn after our hottest Australian summer ever, but if you’re planning on introducing a sunscreen range at the end of the year, now is the best time to start working for launch.

Did you know that there’s a wide variety of options in respect to sunscreen products? Depending on your budget and the claims you wish to make sunscreen products can be either cosmetics or medicines.

Cosmetic sunscreen products don’t require any applications to the Therapeutic Goods Administration (TGA) and don’t need to be manufactured in a GMP facility. Typically these moisturisers, tinted bases, creams, foundations and lip type products provide the sunscreen as a secondary benefit. Depending on what type of cosmetic secondary sunscreen product you’re thinking about, you could potentially claim up to an SPF 50+ on your product label.

The other types of sunscreen products are considered primary sunscreens (but you can also have secondary sunscreen products in this category). Whilst these require an application to the TGA and to be manufactured in a GMP facility, the benefits of this option include a greater variety of product claims including making claims pertaining to skin cancer risk.

RFA Regulatory Affairs can assist in helping you get ready for your 2015 cosmetic and medicinal sunscreen launch. We have expertise and experience in assessing ingredients, submitting applications to the TGA , working with manufacturers and ensuring label and advertising (websites, brochures, etc.) compliance and to help you meet your launch deadline. Contact us now to discuss your plans for your next sunscreen product launch.



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