Advertising - testimonials and endorsements. This is a new TGA guidance document that explains the difference between testimonials and endorsements, and which types of each are permitted. For example, testimonials: Testimonials made by anyone engaged in the production, marketing or supply of the advertised therapeutic good, along with others as described in the Code, are not permitted. Advertisements for therapeutic goods must not contain a testimonial from anyone who has received ‘valuable consideration’ for making the testimonial or for marketing the goods. This includes social media influencers, bloggers and brand ambassadors. What is valuable consideration? This guidance provides many hypothetical examples of testimonials and endorsements and shows which are compliant and which are not permitted. A must-read guidance. Read it here.

 

Training course in advertising: RFA offers a one hour training course on advertising. Information is here.

 

Risks of intentional self-poisoning with paracetamol. (TGA) has commissioned a report on the risks of self-harm from intentional paracetamol misuse.    Source: TGA

 

Poisons schedules: final decisions including chromates and chromium trioxide.    Source: TGA

 

Public consultation on proposed amendments to the Poisons Standard

Item 1.1 - Cetirizine

Item 1.2 - Budesonide

Item 1.3 - MDMA

Item 1.4 - Psilocybine

Item 1.5 - Apronal (allylisopropylacetylurea)

Item 2.1 - Helional

Item 2.2 - Hydroxypinacolone retinoate

Item 2.3 - MDMA and MDA

Item 3.1 - Dichloromethane (methylene chloride)

Item 3.2 – Ipflufenoquin

Source: TGA

 

Product recalls

Swisse Beauty Collagen Glow Gummies.    Source: TGA

Medtronic Implantable Defibrillators - Implant Hazard - software update required.    Source: TGA

Multiple Sunscreens Recalled - Low levels of benzene detected. Updated list of products here.

 

Comparable overseas bodies for complementary medicines. An updated list is here.

 

Export of medicines. A guidance document including recent updates.    Source: TGA

 

Compliance enforcement

15 infringement notices totally $39,960 issued to a NSW person for alleged unlawful importation of ivermectin and doxycycline.  2,500 ivermectin tablets and nearly 10,000 doxycycline capsules were imported over the course of one month, far exceeding what is allowable under the Personal Importation Scheme.    Source: TGA

FatBlaster Max (AUST L 348163) cancelled from the Australian Register of Therapeutic Goods. The TGA considers that the name 'FatBlaster', would be understood to represent that the medicine causes loss of body fat and therefore weight loss, neither of which are indications listed for the product. Cat Media is appealing.    Source: TGA

Infringement notice of $2,664 issued to a Sydney based individual for alleged unlawful importation of unregistered anaesthetic products. The individual was previously a general practitioner but surrendered their registration in 2019 and did not have approval or authority to import the goods into Australia.    Source: TGA

Aussiewhip Pty Ltd fined $39,960 for alleged unlawful advertising of disposable nicotine vaping products which are prescription-only medicines and must only be dispensed by pharmacies to consumers who hold a valid prescription. After being contacted by the TGA the company shut down the website but reinstated the content on a new website.    Source: TGA

Three infringement notices totalling $39,960 issued to New South Wales company Khazanah Nasional Pty Ltd for alleged unlawful advertising of disposable liquid nicotine vaping products.    Source: TGA

TMF Cosmeceuticals Pty Ltd fined $26,640 for alleged unlawful importation of ivermectin.    Source: TGA

FuturePro convicted and its director was convicted and fined $25,000 for unlawful conduct relating to alternative medicines. In particular for the banned substance Sanguinaria canadensis (bloodroot) which is used to make black salve, a corrosive topical paste, and unregistered gumby gumby. Claims were being made for the prevention and treatment of cancer.    Source: TGA

Individual fined $2,664 for unlawful importation of nicotine vaping pods.    Source: TGA

 

NSW Health has seized more than $1 million worth of illegal e-cigarettes and liquids containing nicotine since January 2022.    Source NSW Health

 

Approved COVID-19 rapid antigen self-tests. This list is regularly updates by the TGA.    Source: TGA

 

Unique device identification. A TGA presentation of “real world experiences”.    Source: TGA

 

Personalised medical device framework. Overview of medical device regulations. A TGA presentation available here.

 

Medical devices or surfaces with anti-viral or anti-microbial claims. A TGA presentation on what anti-viral claims can be made, evidence required, advertising requirements and documentation required.    Source: TGA

 

Regulation of software based medical devices. A factsheet for digital mental health: Software based medical devices is here.

RFA Breaking News

Cosmetic, Personal Care and TGA Listed Sunscreens:

Useful resources for labelling of products Label your products.    Source: business.gov.au Labelling, SDS and packaging.    Source: Australian Industrial Chemicals Introduction Scheme (AICIS) Cosmetic labelling.    Source: ACCC Product Safety Australia  …

Readmore..

Foods:

Research into vitamin D levels in the population A number of FSANZ staff recently contributed to a journal article investigating vitamin D in Australian diets. This study showed that vitamin…

Readmore..

Complementary Medicines and Medical Devices:

Advertising - testimonials and endorsements. This is a new TGA guidance document that explains the difference between testimonials and endorsements, and which types of each are permitted. For example, testimonials:…

Readmore..

Cosmetic, Personal Care and TGA Listed Sunscreens:

Guide to categorising your chemical importation and manufacture. Updates to the guide.    Source: AICIS   Draft evaluation of a chemical with CAS number 1428963-39-6. Call for comment, deadline 3rd…

Readmore..

Foods:

Imported kava – update to the definition of permitted kava products and labelling requirements for retail ready packs and bulk imported kava not for immediate retail sale.    Source: Dept…

Readmore..

Complementary Medicines and Medical Devices:

Pharmacovigilance – important reading for all suppliers/sponsors and manufacturers of complementary medicines! This is an often overlooked responsibility and the TGA is now issuing fines for non-compliance - see next…

Readmore..

Go to top