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Complementary medicines:

TGA Results Confirm Effectiveness After Sunscreen Testing

In response to reported concerns during the past Australian summer that sunscreens were failing to provide adequate sun protection, the TGA undertook laboratory testing of 31 commonly used products, including lotions, creams and aerosol sprays, sourced from pharmacies and supermarkets. Between 1 January and 31 December 2016 the TGA received a total of 27 reports of adverse reactions to sunscreens. Of these 15 were reports of allergic reactions (rash) and 12 reports of a product not being effective. It was found that all products tested contained the correct levels of ingredients, as specified on their labelling, and complied with the Australian regulatory guidelines for sunscreens for content of sun protection ingredients (90-120% of the labelled claim).    Source: Sunscreen testing

TGA Changes Policy on Vitamin A – Betacarotene Naming

For many years, it has been generally understood that early TGA advice indicated that suppliers could not refer to betacarotene as provitamin A or state the equivalent IU of Vit A. However, the TGA seems to have changed this policy, and now betacarotene may be stated in retinol equivalents. Furthermore, the NHMRC Nutrient Reference Values for Australia and New Zealand note that the term vitamin A includes provitamin A carotenoids that are dietary precursors of retinol and retains 6 µg all-trans ß-carotene as being equivalent to 1 RE (retinol equivalents). When Vitamin A is declared as an equivalent of Betacarotene and the medicine is for oral or sublingual use in adults the medicine also requires specific warning statements on the medicine label.    Refer: Vitamin A

TGA Form Update - Notification of a New Proprietary Ingredient

The role of the 'Notification of a new proprietary ingredient' form is to allow the TGA to enter formulation details and other relevant information relating to a proprietary ingredient into the Proprietary Ingredient Table in TGA Business Services. This allows for the capture of complex formulation details and other relevant information, and the provision of a unique name and number for each proprietary ingredient. Applications for new therapeutic goods that are to be included on the Australian Register of Therapeutic Goods (ARTG) can then include these complex formulations in a single step using the allocated proprietary ingredient number (rather than the full formulation details of the proprietary ingredient).    Source: New ingredient

TGA Targets Macular Degeneration Claims

Macular degeneration is a restricted representation and not permitted in listed medicines. The TGA will examine the unauthorised reference of macular degeneration in listed medicines. If a supplier’s medicine is included in the targeted project, the TGA will write to you in July 2017 and request information such as your product label and the evidence you hold to support claims and indications. Be Prepared!   Source: Macular degeneration

TGA Q&A on the Code of Good Manufacturing Practice for Medicinal Products

Everything that you wanted to know about how and why the TGA regulates Good Manufacturing practice in Australia.    Source: GMP Q&A

Regulatory Battle: New Zealand Manufacturers Hit Out at Health Bill ‘Detractors’

Five major New Zealand manufacturers – backed by trade body Natural Products New Zealand (NPNZ) – have hit out at a "small group of detractors” which they claim is creating "misinformation" about the country's proposed Natural Health Products Bill.    Source: Gary Scattergood+, Nutraingredients-Asia NZ Health Bill

TGA Safety Advisories:   SourceAlerts

Dragon Power (Yong Gang Tablets) - the tablets contain the undeclared substance sildenafil.

Slimming Capsule - Reduce Fat - the capsules contain the undeclared substances sibutramine and phenolphthalein.

7-Days Herbal Slim-Extra capsules - the capsules contain the undeclared substance sibutramine.



CHOICE Makes Weighty Argument to Leave Food Labelling Alone

Consumer group CHOICE has turned its attention to the weight of your favourite supermarket items as the government initiates a review. The group has “weighed in”, so to speak, on an unfolding scenario that could see product weights removed from the front of packaging. That’s what the food industry wants but the government says it will canvas views of all consumers before making a decision. For CHOICE, the decision is simple: Do nothing.    Source: Weighty choice

Health Department Consults on the 'As Prepared' Rules for the Health Star Rating System

The Health Star Rating (HSR) Advisory Committee (HSRAC), responsible for overseeing the implementation, monitoring and evaluation of the HSR system, is reappraising the form of the food (‘as prepared’) rules in The Guide for Industry to the HSR Calculator . On 28 April 2017 the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) noted suggestions from stakeholders to improve the HSR system, including the ‘as prepared’ rules, and asked the HSRAC to address these concerns as a matter of priority. Consultation closes June 30th 2017    Source: As Prepared

Media in Overdrive as Health Star Rating System Goes From Sweet to Sour

Opinions swirl on all sides as the Australian Government announces that it will be reviewing its controversial Health Star Rating System. Typical of the complaints against the current HSRS is this from Peter FitzSimons: “(Recently) the government announced it would be conducting a review of its Health Star Rating System on food products, which, as you know, is meant to be the official guide as to just how healthy a product is, by virtue of the number of stars it displays on the package… The system is predicated on the notion that these stars are not handed out in a measure of overall health, but only how they measure up against other products in their food group. Say no more. And if your product doesn't measure up, no worries. You don't have to play because The Health Star Rating System is not mandatory. You can just opt out!”    Sources: SMH, Peter FitzSimons Health Star Rating ; Big Sugar; Read also from HSR2; and also from HSRS Homepage HSRS Gov.

Raw Milk Conviction Sweet Success for Food Safety

A woman has been fined a total of $28,000 and ordered to pay professional costs of $25,000 after she pleaded guilty to four charges relating to the sale of unpasteurised or ‘raw’ milk in Goulburn Local Court. She was fined under section 104 of the Food Act 2003 for selling milk which was not pasteurised in contravention of Food Regulation 2010, and for conducting a food business without a licence as required by the Regulation. She also pleaded guilty to two charges under section 21 of the Act for selling unpasteurised milk that exceeded acceptable microbiological limits for standard plate counts and Listeria.    Source: Raw deal

Biosecurity Officials Seize Concerning Amount of Contraband at Gold Coast Airport

Biosecurity officers seized more than 6760 items of biosecurity concern from the Gold Coast Airport in 2016, up 15 per cent from 2015. The increase in seizures at the airport was a concern for all Australians because exotic pests and diseases have the potential to hurt our way of life. Coolangatta isn’t the only airport to have increased seizures in 2016. About 273,000 items of biosecurity concern were seized across Australia’s international airports in 2016, up by more than 6 per cent from 2015.    Source: Biosecurity

Department of Agriculture Releases Latest ‘Failing Food Report’

This report details food that was found to fail under the Imported Food Inspection Scheme during the month of April. The following link details where noncompliant food was detected. The noncompliant food was not distributed for sale in Australia. It was destroyed by the importer or re-exported to the country of origin under department supervision. Where a product is found to be noncompliant because the label does not have the mandatory allergen declaration, the product must be destroyed, re-exported or re-labelled to include the mandatory declaration. Future consignments continue to be targeted at 100 per cent until a history of compliance is established. The source of ‘food fails’ were either microbiological contamination (e-coli, listeria, salmonella), toxins detected (histamine, aflatoxin), or illegal chemical additives (various).    Source: Food fails

NSW Food Authority Recalls –

Hershey's Chocolate Products -A & W Hollier Wholesale Distributors Pty Ltd has recalled assorted Hershey’s chocolate products from Aldi stores in NSW, ACT, QLD, VIC, SA and WA, due to the potential presence of allergens (peanuts and tree nuts) which are not declared on the allergen statement.    Source: Hershey's

Creative Gourmet Frozen Mixed Berries - Entyce Food Ingredients Pty Ltd is conducting a precautionary recall of Creative Gourmet Frozen Mixed Berries. The recall is due to potential Hepatitis A virus contamination.    Source: Hep Berries

Lupin: New Requirement for Mandatory Allergen Labelling

Last month lupin was added to the list of nine allergens that must be declared on food labels. The changes mean all food businesses will need to declare lupin on food labels whenever it is present as an ingredient or as a component of food additives or processing aids. Australia and New Zealand have one of the highest rates of allergic disorders in the world, so it’s critical that food businesses get their allergen labelling right. Food business will have 12 months from 25 May 2017 to meet these requirements.    Source: Lupin allergy    

Consultation on Draft Guidance to Food Regulators in Conducting Their Compliance, Monitoring and Enforcement Activities

The Implementation Subcommittee for Food Regulation (ISFR) is updating its guidance on compliance, monitoring and enforcement. This updated material will provide guidance to food regulators in conducting their compliance, monitoring and enforcement activities. The updated guidance will establish expectations for industry stakeholders on the approach taken by food regulators to compliance, monitoring and enforcement. In this context, ISFR is now seeking comments from stakeholders on the draft revised guidance on compliance, monitoring and enforcement. Submissions close at COB 28 July 2017    Source: Food regulators

Consultation Paper Released: New framework for Regulation of Nutritive Substances and Novel Foods

Food Standards Australia New Zealand (FSANZ) today released a consultation paper on a framework for regulating nutritive substances and new (or novel) foods. The proposed new framework was developed following feedback from stakeholders on Proposal P1024: Revision of the Regulation of Nutritive Substances & Novel Foods. The consultation paper is available from the Food Standards website and is available for comment until 6:00pm (Canberra Time) 28 July 2017.    Source: Novel foods



NICNAS Reforms

The reforms to NICNAS aim to reduce regulatory burden on the industrial chemicals sector by streamlining assessment processes and refocusing assessment effort on higher risk industrial chemicals, while also ensuring that Australia's robust safety standards are maintained. Consultation period closes on 12 July 2017. Have your say here:

Health Department Updates Ban on Cosmetic Testing on Animals

As part of the 2017-18 budget package, the Australian Government will implement a ban on cosmetic testing on animals by introducing legislation to enable a national ban on the use of new animal test data to support the introduction of chemicals used exclusively as cosmetic ingredients. The aim will be to work with the cosmetics industry, in consultation with key animal welfare stakeholders, to develop a voluntary code of practice on the sale of cosmetic products.    Source: Animal testing


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