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current affairs

Issue 116 

April 2013

Published by Robert Forbes & Associates Pty Ltd. www.robert-forbes.com

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Latest Regulatory News

ACCC takes action over potentially misleading vaccine claims.

The Australian Competition and Consumer Commission has instituted Federal Court proceedings over allegedly misleading claims on a homeopathy website regarding the effectiveness of the whooping cough (pertussis) vaccine. The ACCC has taken proceeding against Homeopathy Plus! Australia Pty Ltd and against the owners of the Homeopathy Plus! website. The claims on the Homeopathy Plus! website include statements that the whooping cough vaccine is “unreliable” and “largely ineffective” in preventing whooping cough and that homeopathic remedies are a safe and effective alternative for the prevention and treatment of whooping cough. The ACCC alleges that these claims are misleading and deceptive, in breach of the Competition and Consumer Act 2010. The ACCC is seeking an injunction to have the claims removed, as well as penalties against the company and individuals. Whooping cough is a highly infectious respiratory disease which is most serious in young children. The Australian Government Department of Health and Ageing recommends children receive the whooping cough vaccine as part of routine childhood immunisation.

EU horse meat substitution.

In the light of the horse meat substitution affecting the European Union (EU), the NSW Food Authority advises that the Department of Agriculture, Fisheries and Forestry, which controls quarantine, advises Australia does not import any lasagna from Europe or beef patties from the UK or Ireland. There is a low risk of the EU substitution issue being experienced here, as Australia imports negligible amounts of raw meat. Horse meat is not processed for human consumption in NSW. Strict laws are in place that require knackeries to stain horse meat with a bright blue dye and to prevent it from entering the human food supply chain. The Authority conducts random species testing of meats sold at butchers in NSW. There are significant penalty provisions under the Food Act 2003 for substitution and deceptive labelling of food.

Sydney Harbour fish and seafood

The NSW Food Authority advises that elevated levels of dioxins have been detected in some fish and seafood in Port Jackson and its tributaries. (Long-term, high-level exposure to dioxins can sometimes cause a range of ill effects, including reproductive disorders and cancer). No fish or seafood caught west of the Sydney Harbour Bridge should be eaten. All commercial fishing in Sydney Harbour has been banned since 2006. Recreational fishing is not closed but eating of Harbour fish and seafood caught east of the Sydney Harbour Bridge should be limited; generally no more than 150 grams per month should be consumed. Recreational fishers should consult the recommended maximum intake for fish species. Fish can also be caught and released.

OneTouch Verio IQ blood glucose meter recall.

Johnson & Johnson Medical Pty Ltd, after consultation with the TGA, has recalled its OneTouch Verio IQ Blood Glucose Meter, used mainly for self-testing by patients with diabetes. At extremely high blood glucose levels (56.8 mmol/L and above), the device would turn off rather than display the intended warning "EXTREME HIGH GLUCOSE above 33.3 mmol/L". Johnson & Johnson Medical Pty Ltd has initiated a consumer-level recall and is replacing all devices free of charge.

Compositional guideline: Deer velvet antler powder – amendment

Deer velvet antler powder is pulverised, dried deer antler, including velvet, which has been obtained from the stags of the red deer (Cervus elaphus), elk/wapiti (Cervus canadensis) or a crossbreed of the two. The stags from which the substance is obtained must have been bred and raised in New Zealand and fulfill the requirements for animals suitable for human consumption and antlers must be removed according to the National Velvetting standards Body Code of Practice.The TGA received a request to amend the acceptance criterion for the test parameter 'Ash' in the compositional guideline for 'deer velvet antler powder' and the TGA has stated it has no objection to this request and has amended the  compositional guideline for 'deer velvet antler powder'.

Role of the sponsor of therapeutic goods.

A sponsor is a person or company who exports, or imports, or manufactures therapeutic goods for supply in Australia. TGA has published a brief guideline to these responsibilities at http://www.tga.gov.au/industry/basics-role-of-sponsor.htm

All recall actions

The System for Australian Recall Actions (SARA) is a searchable database of therapeutic goods product recalls. Search the System for Australian Recall Actions

7 million hits on Name and Shame register.

The popular Name and Shame register operated by the NSW government which publicly names businesses that fail to meet food safety standards has received more than 7 million hits online, NSW Minister for Primary Industries Katrina Hodgkinson said. "This sends a clear message to food businesses that consumers expect high standards and are scanning the list of restaurants and other food outlets before deciding where to dine out," Ms Hodgkinson said."A penalty notice on the register not only acts as a potential deterrent to would be diners it also serves as a deterrent to food businesses against making food safety breaches." There were almost 1.25 million views on the Name and Shame register in 2012 alone and more than 7.1 million since the register was established in 2008. The most common food safety breaches under the Food Act 2003 are: cleaning and sanitation (35%), temperature control (13%), pest control – infestations, droppings (13%), hand washing offences (13%) and protection from contamination - storage, personal hygiene (11%). "The number of food businesses appearing on the register has almost halved in 3 years which shows the campaign is having the desired effect with more food outlets adhering to the rules," Ms Hodgkinson said.

OTC medicines reforms.

On 13 March 2013, Medsafe and the TGA published the outcomes of the consultation on the reform of the over the counter (OTC) medicines business processes. The publication also announced that a staged implementation of new implementation procedures would begin on 15 April 2013, and foreshadowed the release of detailed guidance documents.

More contaminated products seized.

The Therapeutic Goods Administration (TGA) has tested imported products My Slimmer Me (MSM) soft gel capsules, MSV Strong Version, ESV Extra Strong Version and RL Rapid Loss soft gel capsules and found that they contain the undeclared prescription substance sibutramine - despite the products’ label claims that they are made of herbal ingredients and contain no medicines. Consumers are advised that sibutramine is a prescription-only medicine (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. They also contain a sibutramine impurity with unknown health risks. The supply of these products is illegal. TGA investigations have shown that a number of people in Australia have bought the product online. In addition, Paiyouji Natural Slimming Capsules have similarly been found to contain sildenafil (an undeclared prescription substance marketed as Viagra and used to treat erectile dysfunction) as well as the undeclared substance phenolphthalein which was previously used as an oral laxative, but is no longer available in Australia due to serious safety concerns associated with its long term use. These ingredients were added despite the product label claim that it is made of herbal ingredients only.

Nature's Child internet advertising complaint.

The Complaints Resolution Panel found that "Nature's Child" internet advertisement breached the Therapeutic Goods Advertising Code and the Therapeutic Goods Act. The Panel found that the representations made for the "Amber Necklaces", "Bottom Balm" and "Wonder Balm" products were therapeutic claims either stated directly or implied through customer testimonials. Nature's Child did not provide any evidence in support of the representations in the advertisement and acknowledged that the claims they had made had not been scientifically validated. The panel found that the advertisement as a whole conveyed unwarranted and unrealistic expectations of product effectiveness and was misleading through the unverified representations that the necklaces (and amber bracelets) could 'help relieve inflammation associated with teething', was a 'side-effect free remedy for the pain or complication of teething', could 'have an analgesic effect', or that 'recent scientific research had also proven its (amber) benefits’. Likewise, representations that the Wonder Balm and Bottom Balm had benefits in relation to inflammation, bites, burns, haemorrhoids and had 'healing properties' would foster unrealistic, unwarranted expectations of the products effectiveness and were likely to mislead consumers. The Panel also determined that the language used in the advertisement would exploit the lack of knowledge of consumers, especially those parents seeking to alleviate the pain, suffering and distress associated with teething or with skin inflammations in their child. It was apparent to the Delegate that the use of words such as "...miracle results.." and "...any redness, inflammation, bite, rash is history when bottom balm is part of your daily nappy changing/ baby care routine..." were representations implying that the product was a certain or sure cure, which is in breach of the Code.

CPSC and ACCC warn of poison dangers with liquid laundry packets.

The U.S. Consumer Product Safety Commission (CPSC) and the Australian Competition and Consumer Commission (ACCC) are urging parents to take immediate action to ensure their family is not exposed to the hazards posed by liquid laundry packets or capsules. Young children who are exposed to the highly concentrated, toxic detergent are at risk of serious injury. Reports of incidents in the United States and Australia have prompted the product safety agencies to warn parents about what can happen if these products are not used safely. Children who have ingested detergent from the packets have required medical attention and hospitalization for loss of consciousness, excessive vomiting, drowsiness, throat swelling, and difficulty breathing. Eye contact has also resulted in reports of injury, including severe irritation and temporary loss of vision. “Poison call centers across Australia have received more than 85 calls in the last 18 months relating to exposure to these laundry capsules,” said ACCC Deputy Chair Delia Rickard. “The experience in Australia is consistent with an international trend, where most cases have involved a child aged five years or younger.” The number of incidents, in a relatively short period of time, suggests that children are highly attracted to the packets, which can resemble play items. The soft and colorful product can be easily mistaken by a child for candy, toys, or a teething product. Water, wet hands, and saliva can cause the packets to dissolve quickly and release their highly concentrated toxic contents. Parents and caregivers are urged always to handle the product carefully and with dry hands. For more information about product safety in Australia, visit www.productsafety.gov.au, follow the ACCC on Twitter at http://www.twitter.com/ACCCProdSafety, or call the ACCC Infocentre on 1300 302 502. You can also find product safety information via the ACCC’s Product Safety Facebook Page and YouTube channel, ACCC Product Safety.

ACCC institutes proceedings against Luv-a-Duck for false, misleading and deceptive conduct.

The Australian Competition and Consumer Commission has instituted proceedings in the Federal Court against Luv-a-Duck Pty Ltd alleging false, misleading and deceptive conduct in relation to the promotion and supply of its duck meat products. The ACCC alleges that Luv-a-Duck engaged in false, misleading or deceptive conduct by use of one or more of following statements on its packaging, website and brochures: a statement that its ducks were ‘grown and grain fed in the spacious Victorian Wimmera Wheatlands’, and other promotional statements of a similar nature; and,  a statement that its ducks were ‘range reared and grain fed’. The ACCC alleges that the duck meat products sold or offered for sale by Luv-a-Duck were in fact processed from ducks that did not have substantial access to the outdoors, or access to spacious outdoor conditions. “Consumers must be able to trust that what is on the label is true and accurate. Businesses need to make sure they are not misleading consumers into paying a premium for products that don’t match the claims made on the label,” Ms Court said. The ACCC is seeking: declarations, injunctions, pecuniary penalties, orders that Luv-a-Duck implement a trade practices compliance program, orders that Luv-a-Duck publish corrective notices on its website and business premises and provide a corrective notice to its customers, and costs.

Summary of outcomes from NICNAS consultation on proposal to adopt the revised Australian/New Zealand sunscreen standard for cosmetic sunscreen products.

This consultation opened on 4 December 2012 and closed on 25 January 2013. A notice advertising the consultation was published in the Chemical Gazette of 4 December 2012, on the Australian Government Business website, and also on the Australian Government public consultation website. A reminder notice was also published in the Chemical Gazette of 2 January 2013. A total of fourteen responses were received, with thirteen from industry (including three industry associations) and one from a community association. A summary analysis of results is published on the Consultations section of the NICNAS website at: http://www.nicnas.gov.au/Consultations/Proposal_To_Adopt_Sunscreen_Standard.asp

Compositional guideline: Calcified Lithothamnion tophiforme

Calcified Lithothamnion tophiforme was recently added to the list of ingredients permitted in listed complementary medicines and the TGA has published the compositional guidelines. The substance, a source of calcium and magnesium, is the skeletal deposits of Lithothamnion tophiforme sourced from Arnarfjordur in Iceland.

Two more products cancelled from ARTG

A further two products have been cancelled from the Australian Register of Therapeutic Goods (ARTG). Blooms Curcumin 600 Plus with enhanced BioP absorption AUST L 169976 – due to unacceptable presentation and advertising issues; and Swisse Ultiboost Appetite Suppressant AUST L 175898 – due to insufficient evidence to support product claims.


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