TGA Advises on Using 'Natural' Claims When Advertising to the Public

The TGA has released guidance on the use of 'natural' and related claims when advertising medicines and medical devices to the public. It is recognised that If the advertising does not explain what the term 'natural' (as well as related claims such as 'naturally occurring', 'sourced from nature' and 'naturally derived') means in relation to the particular product being promoted, interpretations by consumers will vary, especially if 'natural' is used as a stand-alone claim. When advertisers use a 'natural' claim, they will either have to provide sufficient information to explain the claim or use it in accordance with the definitions set out in the TGA's guidance. Specific information for consumers on the use of 'natural' claims in relation to medicines and medical devices will be published in coming weeks. Stay tuned!    Source: 'Natural' claim    (Please also read the TGA’s humorous take on this topic, Bee Aware: what’s the buzz on natural claims?)

TGA Provides Summary of Fees and Charges Effective from 1 July 2019

The Therapeutic Goods Administration is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. A fee is charged for a service, such as a product evaluation. A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year. This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation.     Source: TGA fees & charges

Changes to Ingredient Names: End Of Transition Period - Are You Ready?

The transition period for updating medicine ingredient names ends on 30 April 2020. This means that from 1 May 2020 all medicines released for supply in Australia must use the new ingredient names. The four year transition period has provided sufficient time for sponsors to move over to using the new names. With less than 12 months left, consumers and health professionals are expecting to see the new ingredient names on medicine labels and relevant documentation. Questions that listed medicine suppliers need to ask themselves should be: “Do I have a medicine that contains an ingredient on the affected ingredients list?”; “If the ingredient is used as an active ingredient, is the right ingredient name displayed on my medicine labels?”; “If the ingredient is used as an excipient and I include the names of excipients on my labels, is the right ingredient name displayed?”; “If the medicine has an associated product information or consumer medicine information document, is the right ingredient name used in those documents?”; and “If I have advertising materials for my medicine that include ingredient names, is the right ingredient name used in those materials?”.    Source: Ingredient naming deadline

TGA Answers FAQs on Issues Raised by Industry in Relation to Permitted Indications for Listed Medicines

As regular readers of this newsletter are now well aware, the TGA has revised the guidance related to indications for listed complementary medicines in Australia. 'Indications' are statements that describe the specific therapeutic use for a medicine, i.e. a medicine's claimed purpose or health benefit. Indications can be specific (e.g. refer to a named non-serious condition); or non-specific (e.g. refer to general health maintenance). Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination. The list of permitted indications is maintained by the TGA and provides a comprehensive list of indications currently accepted for listed medicines, provided appropriate evidence is held by the medicine sponsor. Since this new standard has been implemented there have been many questions raised by stakeholders and these are addressed here: Permitted indications FAQs . Also, the TGA has announced the introduction of the ability to use the "TGA Assessed" claimer for complementary medicines that are either ‘registered’ or ‘listed assessed’. Information regarding ‘TGA assessed’ claims for assessed listed and registered complementary medicines can be read here: 'TGA assessed' claims  

TGA Updates the Permissible Ingredients Determination for Listed Medicines

An updated version of Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019 has added 4 new ingredient entries and changed 19 existing ingredient entries to make requirements clearer and less restrictive. Two of the new active ingredients are only available with written authorisation provided by DSM Nutritional Products Pty Ltd (until 30 June 2021). There is also an expansion of the permissible concentration of menthol for dermal application to 25%.    Source: Permissible ingredient update

TGA Seizes Bloodroot Salve (Black Salve) and Bloodroot Capsules on the Gold Coast

The Therapeutic Goods Administration, in conjunction with Queensland Police Services and the Australian Taxation Office, executed a search warrant at a business premises on the Gold Coast, Queensland. During the search, the TGA seized various items. This included 27 jars of suspected Bloodroot Salve (commonly known as Black Salve), 84 bottles of product suspected to be Triple Strength Bloodroot Capsules and 30 bottles of suspected Double Strength Bloodroot Capsules. The operation was part of an investigation into the alleged importation, advertising and unauthorised supply of unapproved therapeutic goods, including scheduled medicines. A number of items and devices were also uncovered and seized, allegedly relating to manufacturing of therapeutic goods. Enquiries are still underway and further action will be dependent upon the outcome of investigations. (Bloodroot Salve, more commonly known as Black Salve, is a topical paste. It is commonly classified as an 'escharotic', as it is corrosive and can destroy skin tissue, causing disfigurement. Application can result in dead skin tissue and a thick dark scar. Bloodroot capsules may contain several of the same ingredients as Black Salve).    Source: Bloodroot salve raid

TGA Seizes SARMs and Nootropics Using Search Warrants

The Therapeutic Goods Administration (TGA) executed four search warrants connected to a business operating in the Sutherland Shire, Sydney. This was undertaken in conjunction with NSW Police, the Australian Federal Police (AFP), the Australian Taxation Office (ATO) and NSW Health. During the search, various items were seized. These items allegedly include raw materials and finished Selective Androgen Receptor Modulators (SARMs), and Nootropic products. The products are not included in the Australian Register of Therapeutic Goods (ARTG) and therefore cannot be supplied in Australia. The operation was part of an investigation into the alleged importation, advertising and supply of unapproved therapeutic goods, including scheduled medicines.   Source: TGA SARM bust    (Please also see related story (copyright) by Cheryl Tay, NutraIngredients-Asia SARMs harm )

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Receives NutraIngredients-USA Editors Award for Industry Initiative of the Year

RFA Regulatory Affairs congratulates the American Botanical Council - American Herbal Pharmacopoeia – and the National Center for Natural Products Research on being awarded the 2019 Industry Initiative of the Year for their Botanical Adulteration Prevention Program. This newsletter has repeatedly run stories on this excellent industry initiative and we are delighted that this group has been recognised within the industry. The BAPP focuses on educating herb and natural product industry members to identify unethical sellers of adulterated and fraudulent raw botanical materials, botanical extracts, and essential oils. This is achieved via the publication of 50 (to date) credible and authoritative peer-reviewed documents; plus interviews with trade media; speeches at industry, scientific and professional conferences; and direct consultation with members of the industry.    Source: BAPP award

Aloe Vera Bulletin Published by Botanical Adulterants Prevention Program

The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) announces the publication of a new Botanical Adulterants Prevention Bulletin (BAPB) on aloe vera (Aloe vera) leaf gel- and juice-derived ingredients. This new publication documents adulteration of aloe vera leaf gel and juice with undeclared maltodextrin and ingredients from other Aloe species.    Source: Aloe vera adulteration

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