Report - Omega-3 Long-Chain Polyunsaturated Fatty Acid Content and Oxidation State of Fish Oil Supplements in New Zealand

Forty-seven fish oil products available on the New Zealand market were analysed for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) content, as well as for oxidative status in a collaborative effort by several analytical laboratories. The results are in stark contrast to the very low percentage of fish oil products reported to be in compliance with primary oxidation limits and EPA/DHA content by a recently published assessment of fish oil supplements in New Zealand. Possible reasons for this discrepancy are evaluated and discussed.    Source: Nature.com NZ fish oils

Three E-Cigarette Companies Cop Fines Over Misleading Health Claims in World-First

Three e-cigarette companies have been ordered to pay a total of $175,000 in penalties for making false and misleading health claims, following legal action launched by the consumer watchdog. In separate proceedings against online retailers Jostick, Social-Lites and Elusion, the Federal Court found all three companies misled consumers by claiming their products did not contain harmful carcinogens and toxins, when this was not the case. The Australian Competition and Consumer Commission says it is the first time any regulator globally has successfully taken action for false and misleading claims about the presence of carcinogens in e-cigarettes.    Source: News.com Vape penalty

TGA Consultation – Proposed Amendments to the Poisons Standard  The TGA is seeking comments from interested parties on proposed amendments to the Poisons Standard concerning Chloroacetamide CAS Number 79-07-2; Docusate sodium CAS Number 577-11-7; Vinyl acetate CAS Number 108-05-4; amongst other substances.    Source: New substances

TGA Presentation - Regulatory Reforms at the Therapeutic Goods Administration (TGA)

Speaking at the recent ARCS webinar, Dr Mark McDonald presented an overview of recommendations from the Review of Medicines and Medical Devices Regulation relating to low risk therapeutic goods. Slides and a complete transcript can be read here: TGA - ARCS webinar;  National Institute of Complementary Medicine (NICM) response: NICM response

TGA Recalls –

Span-K (potassium chloride) 600 mg tablets - bottles supplied without child-resistant caps   Source: Span-K

Hyland's Baby homeopathic teething tablets - Hyland's homeopathic teething tablets are complementary medicines marketed to provide temporary relief of teething symptoms in children. This recall is being undertaken following an investigation by the United States Food and Drug Administration that products supplied in the US contained inconsistent amounts of belladonna alkaloids, a toxic substance, which may differ from the calculated amounts listed on the products' labels.   Source: Teething troubles

TGA Safety Advisories –

Editor's note: This month, a record 19 different products claiming to be “natural” and aimed at erectile dysfunction have been listed on TGA website. There are too many to list individually here, but they mostly contain undeclared sildenafil and/or tadalafil and other prescription-only drugs.   Source: TGA safety alerts

Slim-Vie Slimming Capsules -the capsules contain the undeclared substances sibutramine, sildenafil and phenolphthalein.   Source: Slimming caps

TGA Code of Practice for Tamper-Evident Packaging of Therapeutic Goods

The purpose of tamper-evident packaging is to alert consumers of possible safety concerns before they purchase or use goods. This code of practice provides guidance on tamper-evident packaging for therapeutic goods. Compliance with the code improves the security of therapeutic goods supplied in Australia and increases the likelihood that consumers can identify when a product has been tampered with. These guidelines are not currently mandatory.    Source: Tamper evident

NHMRC Undertakes Homeopathy Review

National Health & Medical Research Council has reviewed the scientific evidence for the effectiveness of homeopathy in treating a variety of clinical conditions with the aim of providing Australians with reliable information about its use.  The evidence identified in this assessment of the evidence has been summarised in a NHMRC Information Paper, which informed the development of NHMRC’s position on homeopathy. A NHMRC Statement has also been developed, based on the assessment of the evidence.    Source: Homeopathy review;   Read also the response from NICM: NICM reviews homeopathy

GOED Study Shows New Zealand Fish Oil Supplements Meet Label Claims

The Global Organization of EPA and DHA Omega-3s (GOED), in conjunction with several of its members, has published a paper in Scientific Reports that shows the results of oxidation and EPA/DHA content testing on 47 fish oil supplements purchased at retail in New Zealand. The paper concluded that nearly all products met the regulatory limits for oxidation and label claims about EPA and DHA content, and compliance with stricter voluntary industry standards was also high. The study was carried out in response to a report published in January 2015 by Albert et al that stated that nearly all fish oil supplements in the New Zealand market did not contain the EPA and DHA stated on the label and were excessively oxidized.    Source: Fish oils

NPNZ Issues Warning for Suppliers of Iron Supplements

Natural Products New Zealand warns that if you have an iron supplement in your range please check it meets regulatory requirements in New Zealand as some companies are being asked to recall stock. The Dietary Supplements Regulations 1985 state that products must not contain more than 24mg daily dose, however the Medicines Regulations 1984 has additional requirements regarding restrictions on the dose units and the pack sizes. Dietary supplements must not contain more than 24mg per recommended daily dose, and as well, the tablets cannot contain more than 5 mg per dose unit, and, as well, the pack size cannot be more than 750mg in total.    Source: NPNZ Iron supplements

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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