TGA Fact Sheet: Folate and Folic Acid for Use in Listed Medicines

This fact sheet has been created for sponsors who wish to list folate products on the ARTG. It is intended to provide general information on the most commonly used folates and answer the most frequently asked questions. Folate, or vitamin B9, is an essential vitamin required by the human body for normal growth and development as it plays a critical role in the synthesis of DNA and RNA, and in the metabolism of certain amino acids. The term "folate" is actually a generic name for a group of related compounds with similar nutritional properties. The three most commonly used forms are folic acid, calcium folinate and levomefolate salts. All three forms can be incorporated into the body's metabolic pathways and may provide sources of the same biologically active form of folate – a compound known as 5-methyltetrahydrofolate (5-MTHF) or levomefolic acid.   SourceFolate

'Painful' Sunscreen Burn Cases Ignite Call for Review of Product Testing in Australia

More stories are emerging of people being left "red raw" despite using popular sunscreen products, prompting calls from a leading public health advocate for a review of the way Australia regulates sunscreens. Michael Moore, chief executive of the Public Health Association of Australia, said the reports were extremely concerning. He said it was time for the Therapeutic Goods Administration (TGA) — Australia's sunscreen regulator — to examine its processes to make sure sunscreens were being adequately tested before going on the market. The director of the only company carrying out independent laboratory testing of sunscreen in Australia wants an overhaul of international testing standards. John Staton runs Dermatest, a Sydney laboratory which tests the SPF factor of sunscreens. He said the problem is that many sunscreens sold in Australia are tested in the United States and Europe.   Source: Amy Bainbridge, ABC News Sunburn

TGA Approves Permissible Ingredients (26BB) Determination No.1 of 2017

Complementary Medicines Australia advises that The Therapeutic Goods Administration (TGA) has approved the new Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017. TGA anticipates that the updated Determination will be published and available on the Federal Register of Legislation (FRL) after 30 January 2017. The new Determination includes a total of 293 changes to ingredients available for use in listed medicines including the addition of 11 new ingredients and the deletion of one ingredient.   Source: via CMA, Permissible ingredients

TGA Consultation: Scheduling Medicines and Poisons

The Therapeutic Goods Administration is seeking comments from interested parties on proposed amendments to the Poisons Standard. The TGA has expanded the scheduling proposals for selected substances to be considered by the Advisory Committees on Chemicals and Medicines Scheduling (ACCS, ACMS) to promote relevant public submissions. This consultation closes on 10 February 2017.   SourceSUSMP consultation

TGA Reviews Scientific Literature on Sunscreen Actives

This scientific review report is limited to the review of safety concerns surrounding zinc oxide (ZnO) and titanium dioxide (TiO2) nanoparticles (NPs) present in sunscreens. The two main issues considered in this review are the evidence for the ability of these NPs to penetrate the skin to reach viable cells and the potential toxicity exerted by them. The TGA has been continuously monitoring the emerging scientific literature in this area and working cooperatively with international regulatory agencies to ensure that appropriate regulatory action is undertaken if any unacceptable risk of harm/toxicity is identified.   SourceSunscreen lit-review

TGA Recalls:

Chinese Sports Injuries Pill (Zhong Guo Die Da Wan) - Consumers and health professionals are advised that Beijing Tong Ren Tang Australia, in consultation with the TGA, is recalling one batch of its Chinese Sports Injuries Pill (Zhong Guo Die Da Wan) due to the presence of aristolochic acid. There is no established safe exposure level to aristolochic acids.   Source: Sports pill

The Cider Lab (assorted beverages) - Asahi Premium Beverages Pty Ltd has recalled The Cider Lab assorted beverages sold by liquor stores nationwide due to the presence of an undeclared allergen (sulphites)   Source:CiderLab

 

RFA Breaking News

Training Course Update:

NEW COURSE NOW AVAILABLE Pharmacovigilance Obligations Training. For details see foot of this newsletter

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Complementary Medicines (“Dietary supplements”):

  Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 Update. This far reaching bill has implications for those involved in the supply of Listed Medicines, or Medical Devices, as…

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Foods:

  New NZ Government Pulls NHP Bill Regular readers of this newsletter will have noticed the tortuous path of the Natural Health Products bill as it slowly makes its way…

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Cosmetics (& Household cleaning products):

  Correction of an Error on AICS The National Industrial Chemical Notification Scheme (NICNAS) has corrected a listing error on the Australian Inventory ofChemical Substances (AICS), after an entry that…

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Marketing News:

The Seismic Shifts in Marketing’s Role in Direct Selling “Marketing doesn’t matter for a direct selling company.” Have you ever heard this one before? If you’ve been working in direct…

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RFA Training Courses for Listed Medicines, Foods, Cosmetics – Now Available

Are you new to the Australian market? Are you unsure about how to comply with recent changes to TGA regulations such as the new TGA Order 92? Do you have…

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