ACCC Sues Voltaren Makers GlaxoSmithKline and Novartis for Misleading Consumers

The Australian Competition and Consumer Commission watchdog is taking GlaxoSmithKline and Novartis to the Federal Court, alleging the global pharma giants misled consumers about their Voltaren Osteo Gel and Voltaren Emulgel pain relief products. GSK and Novartis marketed Osteo Gel as a specific osteoarthritis medication more effective at treating the condition than Emulgel, when the two products had in fact the same pain-relief ingredient, the Australian Competition and Consumer Commission claims. In a similar case, in December 2016, the Full Federal Court ordered the Australian branch of Reckitt Benckiser to pay a $6 million penalty for making false representations that Nurofen Specific Pain products were each formulated to specifically treat particular types of pain.    Source: Voltaren charge

USA Industry Rallies Behind FDA’s Warning on SARMS

The FDA has recently issued a consumer warning about the use of SARMs, or selective androgen receptor modulators, in bodybuilding products. The administration warns against the potentially dangerous ingredients that pose serious health concerns to consumers, including (but not limited to) increased risk of heart attack, stroke, and life-threatening liver toxicity. Five major trade associations serving the natural products industry have banded with the U.S. Anti-Doping Agency (USADA) in solidarity with the FDA. The trade associations in support of the FDA’s consumer warning include the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), the United Natural Products Alliance (UNPA), and the USADA.    Source: WholeFoods Magazine SARMS warning

TGA Updates the Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in November 2017. A total of 85 changes have been made in the updated Determination. These changes include: The addition of 32 new ingredients; &, Changes to 53 existing ingredient entries (including: making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use; making requirements for ingredients more restrictive, such as the inclusion of additional warning messages; and making minor changes to make a number of entries clearer. A complete list of changes to ingredient availability can be found here: Permissible ingredients

TGA Presentations: Complementary Medicine Reforms Information Sessions, November-December 2017

The TGA held a series of information sessions on reforms to the complementary medicines framework. The presentation topics included: Background and progress of complementary medicine reforms; Permitted indications for listed medicines; &, The assessed listed medicines pathway.    Source: Listed medicine presentations

Update on Child-Resistant Packaging Requirements for Medicines 2017 (TGO 95)

TGO 95 makes minor changes, of which there are no perceived changes for complementary medicines.    Source: Child-proof 

TGA Safety Advisories –

Editor’s Note: It has been a big year for Australian Customs (AQIS) & the Therapeutic Goods Administration (TGA) after a record number of bogus medications have arrived on Australian shores in 2017. Far and away the most common offenders are fake-medicines containing varying undeclared amounts of Viagra-like chemicals. The next most common category violators are weight-loss medicines containing undeclared amounts of often banned stimulants and prescription drugs. For this year’s full list go to: 2017 alerts  

 

RFA Breaking News

Christmas Greetings

  Robert Forbes & Associates, T/A RFA Regulatory Affairs wishes all of our clients a Happy and Holy Christmas Holiday break. Our office will be closed from end of business…

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Complementary Medicines (“Dietary supplements”):

  ACCC Sues Voltaren Makers GlaxoSmithKline and Novartis for Misleading Consumers The Australian Competition and Consumer Commission watchdog is taking GlaxoSmithKline and Novartis to the Federal Court, alleging the global…

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Foods:

  Food Regulation in Australia and New Zealand This website provides information about the activities and processes in the joint Australia and New Zealand food regulation system, including roles and…

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Cosmetics (& Household cleaning products):

Aerosol Sunscreens May Leave You Burnt This Summer After a string of consumer complaints about the mists offering no protection, the Cancer Council has changed its tune and says it…

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Marketing News:

What Are The Latest Trends In The Personal Care Sector? Bans, restrictions, ingredient disclosure: these are the key chemical issues the personal care industries in Europe, the US and the…

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Training Course Update:

  NEW COURSE NOW AVAILABLE! Pharmacovigilance Obligations Training In September this year, the TGA released guidance on the pharmacovigilance responsibilities of sponsors.  Newly developed, this training course is for sponsors…

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