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current affairs

Issue 117

May 2013


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

Your one stop shop for regulatory advice for your complementary medicines, foods and cosmetics. Contact us to see how we can help you.

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Latest Regulatory News

Department of Agriculture, Fisheries & Forestry (DAFF) – Biosecurity

The Department of Agriculture Fisheries and Forestry (DAFF), monitors imported food at the border for compliance with Australian standards. If you import food, you are responsible for meeting the standards that apply to your products to ensure they are safe and suitable for their intended use.

DAFF provides tables to list the test type and tests that apply to specific food types and the standard against which the test results are assessed. Where there are no analytical tests the food will still be subject to a visual and label assessment.

Tests applied to surveillance category foods                          PDF [758.9 KB]

 

Lend a hand for food safety on World Hand Hygiene Day

NSW Food Authority got behind the World Health Organisation’s World Hand Hygiene Day on Sunday, May5th.

The NSW Food Authority has identified hand washing as one of its golden food safety rules. It’s one of the simplest, most important and easiest ways to prevent illness.

The NSW Food Authority’s Name and Shame website, which allows consumers to view businesses that have failed to meet food safety standards, had a number of businesses on the register for hand washing offences. Hand washing offences are up there in the top five most common food safety breaches under the Food Act, accounting for 13% of breaches in 2010-11.

The Authority is also committed to encouraging and promoting training and learning through programs like Food Safety Supervisor. This is a training initiative designed to improve skills and knowledge in the industry - with close to 50,000 people in NSW having completed the training. There is a fact sheet available outlining the correct method for hand washing at

www.foodauthority.nsw.gov.au/_Documents/industry_pdf/hand_washing.pdf

 

Food Standards Australia & New Zealand (FSANZ) opens “Food allergen portal”

This portal acts as a gateway for both consumers and professionals. This email address is being protected from spambots. You need JavaScript enabled to view it.

Food allergies can be life threatening. For people who have a food allergy the only way to manage the allergy is to avoid the food allergen. For this reason there are laws in place, for example mandatory labelling requirements to help people who have a food allergy avoid food allergens.

This food allergen portal was created by the Allergen Collaboration to provide different sectors in the community with links to best practice food allergen resources and key messages to promote in the different sectors such as: Information for food industry (manufacturers and retailers, food service and importers) ; Information for consumers; Information for childcare centres and schools; Information for health professionals; and Information for government organisations

 

Complementary Medicine registered with TGA.

NeuroTabs have been successfully registered on ARTG (209079 - AFT Pharmaceuticals Pty Ltd) .

Whilst complementary medicines are routinely ‘Listed’, it is rare that a complementary medicine is ‘Registered’.

Background information on registered complementary medicines is available on the TGA website.

NeuroTabs are potassium iodate (253 micrograms tablet bottle) and used for the prophylaxis and treatment of iodine deficiency disorders.

 

BSN Hyper Shred capsules

BSN Hyper Shred capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested BSN Hyper Shred capsules and found that they contain the substance oxedrine (aka synepherine) at levels that require a prescription.

Consumers are advised that oxedrine is a prescription-only medicine. There are currently no products on the Australian Register of Therapeutic Goods (ARTG) containing the substance oxedrine.

(Oxedrine may pose health risks which may be seriously increased if taken with interacting drugs by people consuming this product). The supply of BSN Hyper Shred capsules is illegal.

BSN Hyper Shred capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

The TGA is working with Australian Customs and Border Protection Services (Customs) to help stop future shipments of BSN Hyper Shred capsules from entering Australia.

 

The following advice is for health professionals and cosmetic/beauty clinics who advertise services that involve therapeutic goods containing Schedule 4 (prescription-only) substances.

Advertising of prescription-only products to consumers is illegal. Generally, it is an offence the Therapeutic Goods Act for a person to publish or broadcast an advertisement about therapeutic goods that contains a statement referring to goods, or substances or preparations containing goods, included in Schedules 3, 4 or 8 of the Poisons Standard. This offence attracts a maximum penalty of $10,200 for an individual and $51,000 for a body corporate.

The Act broadly defines an advertisement in relation to therapeutic goods as including any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

Some health professionals and cosmetic/beauty clinics are advertising, to the general public, therapeutic goods or substances that are designated 'prescription-only' items. These products include cosmetic injections such as: “Restylane, Perlane, Hylaform Collagen, Botox, Newfill, Sculptra, Aquamid” and others. These products are generally administered for the purpose of temporarily removing/reducing wrinkles and lines on the face, around the eyes, forehead, lips and neck.

To enable health professionals and cosmetic/beauty clinics to continue promoting their businesses and services to consumers, while also complying with the regulatory advertising requirements for therapeutic goods, the Therapeutic Goods Administration (TGA) advises that there should be no reference in advertisements to individual Schedule 4 items. However, the following acceptable general terms and phrases may be used in advertising:

“cosmetic injections; (anti-) wrinkle injections/treatments;injections/treatments for lips/ fine lines/folds/age lines; wrinkle and lip enhancement/fulfillment/augmentation; injections to enhance pouting of the lips; and/or injections which reduce the depth of fine lines/wrinkles around the face/lips”.

Other words and phrases with similar meaning may also be used, provided that they do not refer to specific products or ingredient names. It is not acceptable to use acronyms, nicknames or abbreviations of the medicine’s name, which may be taken by a consumer to be a "reference" to a specific medicine or substance.

 

Three people diagnosed with Listeriosis in Sydney

NSW Health advisory. 3 people, all public hospital patients during early April, have been diagnosed with listeriosis. An investigation by public health epidemiologists and the NSW Food Authority has confirmed all 3 patients tested positive to the same strain of the infection and all had been in hospital for treatment of pre-existing serious conditions. The investigation into the possible cause of infection in the patients is ongoing. Preliminary results suggest that the cases may be linked to consumption of profiteroles served to patients in March and early April. As a precaution, profiteroles were immediately withdrawn from all patient meals. People at risk include pregnant women, newborns, the elderly and people with weakened immune systems. The NSW Food Authority is working with the food suppliers to ensure there is no ongoing risk to public health. The supplier immediately ceased production of all foods when informed of a possible link to the listeriosis cases.

 

Mojo Risen capsules

Safety advisory. Mojo Risen Capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested Mojo Risen Capsules and found that it contains the undeclared prescription substance tadalafil - despite the product label claim that it is 100% Safe and Natural and contains no medicines. Consumers are advised that tadalafil is a prescription-only medicine (which is the active ingredient in Cialis).The supply of Mojo Risen Capsules is illegal.

Mojo Risen Capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

Action the TGA is taking

The TGA is working with Australian Customs and Border Protection Services (Customs) to help stop future shipments of Mojo Risen Capsules from entering Australia.

Please also read Buying medicines and medical devices over the Internet, and Counterfeit medicines and devices.

 

Maxman III capsules; Ziyinzhuangyang tablets

Safety advisory. Maxman III capsules and Ziyinzhuangyang tabletsboth pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested Maxman III Capsules andZiyinzhuangyang tabletsand found that they both contain the undeclared prescription substances sildenafil(despite the product label claims that they are 100% Natural and contain no medicines). Consumers are advised that sildenafil is a prescription-only medicine (which is the active ingredient in Viagra).The supply of bothMaxman III Capsules and Ziyinzhuangyang tablets are illegal.

Neither Maxman III Capsules nor Ziyinzhuangyang tablets have been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.TGA investigations have shown that a number of people in Australia have bought the products online.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites. Products purchased over the Internet may contain undisclosed and potentially harmful ingredients and may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

 

New approach to evaluation of over the counter medicines in Australia and New Zealand

A new streamlined process for assessing medicines sold over the counter takes effect week starting 15 April 2013, marking a major step towards establishing a single Trans-Tasman regulatory agency for therapeutic products.

The media release by The Hon Shayne Neumann MP, discussing the new assessment system can be read here:

New approach to evaluation of over the counter medicines in Australia and New Zealand

 

OTC medicines reforms: Information forums

Phase 1 of the staged implementation plan commenced in Australia and New Zealand on 15 April 2013. Hence the specific guideline documents and tools that were recently posted on the Medsafe and TGA websites have become 'operational'.

To assist OTC industry stakeholders to submit applications, a series of information forums will be held to explain the new streamlined processes and use of the guidelines and tools.

Forums will be held in Auckland, Melbourne and Sydney. Dates and venues are detailed on the TGA website.http://www.tga.gov.au/newsroom/events-otc-reforms-130430.htm

These forums should be very useful to any stakeholder that wishes to make an application to register, or to change the registration of an OTC medicine in Australia or New Zealand.

 

TGA releases Australian regulatory guidelines for OTC medicines (ARGOM)

These Guidelines describe the information to be supplied with an application for registration of OTC (over-the-counter) medicines in the Australian Register of Therapeutic Goods (ARTG). These medicines will be subject to evaluation by the Therapeutic Goods Administration, in accordance with Section 25 of the Therapeutic Goods Act 1989.

This information will enable the determination of the application for registration and, accordingly, the Guidelines are approved for the purposes of subsection 23(2) of the Therapeutic Goods Act 1989 with effect from 1 July 2003.

The Guidelines also give guidance on the information required to be submitted for consideration of applications to vary information about therapeutic goods included in the Register, which are made under subsection 9D(1), (2) or (3) of the Therapeutic Goods Act 1989.ARGOM guidelines

 

Alligator Brand Veal Ravioli: product recall

Australasian Fresh has recalled Alligator Brand Veal Ravioli from Costco stores in Sydney, Canberra and Melbourne.

The reason for the recall is the presence of an undeclared allergen (soy) due to a labelling error.

The recalled product is : Alligator Brand Veal Ravioli available in 1kg (2x500g packets) vacuum-sealed plastic tray with ALL ‘use by’ dates up to and including ‘8/05/13’ The recall only applies to the product with these details.

People with an allergy or intolerance to soy should not consume this product as they may have a reaction if the product is consumed.For more information contact Australasian Fresh Pty Ltd: 03 9687 0870

 

Macro Vegetarian Bites: product recall

Woolworths Ltd is recalling Macro Vegetarian Bites from all Woolworths Supermarkets, Safeway, Food for Less, and Flemings Supermarkets nationally.The recall is due to the possible presence of foreign matter (metal fragments)

Macro Vegetarian Roasted Vegetable Split Pea & Spinach Bites available in a 225g resealable plastic pouch with ALL ‘best before’ dates up to & including ’29 APRIL 2013’.The recall only applies to product with the details above.

Food products containing metal fragments may cause injury if consumed.

Consumers can return the product to the place of purchase for a full refund.

For more information contact The Woolworths Consumer Enquiries Hotline 1800 103 515

 

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