Complementary Medicines and Medical Devices:

Update to remote GMP inspections during the pandemic.

This includes a summary of the options for the Compliance Verification (CV) pathway and the Mutual Recognition Agreement (MRA) pathway.    Source: TGA

 

Amendment to the independent report on the therapeutic use of psilocybin and MDMA

A final decision may be published the first week of December 2021.    Source: TGA

  

Compliance enforcement

Criminal cartel charges - a follow up to last month’s story about an individual pleading guilty to criminal cartel charges: on the 16th November the company itself, Alkaloids of Australia Pty Ltd, also pleaded guilty to criminal cartel conduct. Alkaloids of Australia produces and supplies SNBB (scopolamine N-butylbromide, also known as hyoscine butylbromide). SNBB is manufactured from the Duboisia plant, which is native to Australia.    Source: ACCC

Ivermectin – A chiropractor in New South Wales has been issued an infringement notice for $2,664 for alleged importation of ivermectin product not included on the Australian Register of Therapeutic Goods.    Source: TGA

Counterfeit erectile dysfunction medicines - Performance Online Services Pty Ltd fined $53,280 for exporting, supplying and advertising Xcalibur XXX Gold 8000 and Wicked Triple Platinum – products that were not entered in the Australian Register of Therapeutic Goods (ARTG). The products contained the undeclared ingredient sildenafil, a prescription only substance.    Source: TGA

Adulterated products seized and destroyed by customs

S.W.A.G II Platinum 33K - undeclared substance sildenafil.    Source: TGA

Panther Power Platinum 11000 – same as above.   Source: TGA

777K – as above.    Source: TGA

One Night Love tablets – as above.    Source: TGA

COVID – Queensland individual issued infringement notice for $2,664 for advertising a homeopathic product for the treatment and prevention of COVID-19.    Source: TGA

Nicotine vaping products (Source for items below: TGA):

Australia Utopia issued with 7 infringement notices totalling $93,240 for alleged advertising breaches of nicotine vaping products on its website

RV Global Ecommerce Pty Ltd fined $39,960 – same as above

Sydney company Mason Online Pty Ltd fined $106,560 for alleged advertising breaches – as above

Melbourne individual responsible for the Vapespot website has been issued seven infringement notices totalling $18,648

Melbourne-based individual fined $7,992 for alleged unlawful importation of nicotine vaping products

 

Reclassification of some medical devices

On the 25th November a number of medical devices were re-classified, including active medical devices for therapy with a diagnostic function; spinal implants for motion preservation; devices in direct contact with the heart, central circulatory system, central nervous system; devices that administer medicines or biologicals by inhalation; active medical devices; and substances introduced into the body, body orifice or applied to the skin.    Source: TGA

 

Medicinal cannabis

Regulations are being refined. Here some links to various relevant topics:

New streamlined process for medicinal cannabis applications

Changes to Special Access Scheme (SAS) and Authorised Prescriber applications

Changes to sponsor requirements for supplying unapproved medicinal cannabis products in Australia

Importation, manufacture and supply of unapproved medicinal cannabis products

Information for health professionals

 

 

Foods:

 Failing food reports for September 2021

Risk food test results – aflatoxins, Salmonella and histamine continue to be commonly detected.    Source: Dept of Agriculture, Water and the Environment

Surveillance food tests includes random inspection of imported foods. Includes non-permitted ingredients such as vitamins and minerals and prohibited plants.    Source: Dept of Agriculture, Water and the Environment

 

Branded Food Database

FSANZ along with GS1 Australia are preparing a database that will enable consumers easy access to product information for thousands of foods and beverages, including nutrition information panel, listed ingredients, pack and serve size and health star rating along with dietary fibre and fruit, vegetable, nut and legume content.    Source: FSANZ

 

Energy labelling of alcoholic beverages

Options are being considered. Unlike most other packaged food and beverages, labels on most packaged alcoholic beverages do not provide information about energy content.   Source: FSANZ

 

Call for comment on Very Low Energy Diets

An application has been received to modify this standard to bring it into line with other international regulations for similar products.    Source: FSANZ

 

Call for comment - new source for an enzyme processing aid

The enzyme beta-fructofuranosidase has a long history of safe use and is already sourced from microorganisms. This application is to seek approval to produce the enzyme from a strain of bacterium known as Aspergillus fijiensis. FSANZ's safety assessment found no health and safety concerns for Australian and New Zealand consumers.    Source: FSANZ 

 

Hemp

An application has been submitted to FSANZ to permit the sale of low-delta-9 tetrahydrocannabinol (THC) hemp leaf, seed sprout and root as food and food ingredients in Australia and New Zealand.    Source: FSANZ

 

National food recalls

This month, two were due to undeclared allergens (milk in Fresh Food Enterprises IQ Bars, and egg in YBC Picola Strawberry), and three were due to contaminants (Vibrio parahaemolyticus in raw Pacific oysters from Coffin Bay, Listeria monocytogenes in Snackers Market Tasty Cheese and Mini Crackers and Pretzels, and also in Good to Go Tasty Cheese Salami and Cabanossi).    Source: FSANZ

 

 

Cosmetics, Personal Care and TGA Listed Sunscreens:

Cosmetic or therapeutic?

When does a cometic get regulated as a medicine, or a medical device? A new guidance document goes some way to clarifying this often grey area. You may think a product is a cosmetic, but it could be regulated as a therapeutic based on its primary use, the ingredients, the claims made and overall presentation and context. What is a cosmetic? How to advertise it?    Source: TGA.

 

Draft evaluation of chemicals – comments invited

This includes a list of draft evaluations. Comment period closes on 17 December 2021.    Source: AICIS

 

Chemicals of low concern that may not require further regulatory controls to manage risks to the environment

AICIS is seeking use and hazard information. Comment period closes 17th December 2021.     Source: AICIS

 

Chemicals unlikely to need further human health risk management controls

AICIS is seeking use and hazard information. Comment period closes 17th December 2021.    Source: AICIS

 

Reporting and record-keeping obligations and annual declarations for importers of chemicals

Relevant to importers of cosmetics and other personal care products. This is a comprehensive summary of reporting and record keeping obligations.    Source: AICIS and also here.

 

 

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