Latest News

This news is posted on our website on a regular basis. Visit us often to keep informed. www.robert-forbes.com

Complementary Medicines (“Dietary supplements”):

Listed Medicine Compliance Rating Scheme Has Begun

The TGA’s Listed Medicine Compliance Rating Scheme commenced on 28 November 2018 as part of its existing compliance review process. As listed medicines are not evaluated by the TGA before they are included on the Australian Register of Therapeutic Goods (ARTG), they conduct post-market compliance reviews on a proportion of those on the ARTG each year to ensure their ongoing safety, quality and efficacy. To support the publication of review outcomes on the TGA website, they have developed a Listed Medicine Compliance Rating Scheme (the Scheme). The Scheme is intended to aid consumers in interpreting the outcomes of compliance reviews after they get published on the TGA website. This will enable consumers to make informed choices about their use of self-selected medicines and provide an incentive for sponsors to improve overall compliance of their products.   Source: Compliance rating scheme

TGA Fines Company Over $25,000 for Alleged Importation of Unapproved Therapeutic Goods

Australian company ESCHOICE Pty Ltd will pay penalties of over $25,000 after the Therapeutic Goods Administration (TGA) issued infringement notices for the alleged importation of unapproved therapeutic goods, namely medicines and medical devices for use in cosmetic procedures. Australian Border Force officers seized the imported therapeutic goods as part of Operation Antlia, a compliance initiative of the TGA. The TGA initiated Operation Antlia to target the illegal use of therapeutic goods in the cosmetics industry after a woman died from a cosmetic procedure at a Sydney clinic last year.   Source: Operation Antlia

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 in December 2018. A total of 6 changes have been made in the updated Determination. These changes include changes to 5 existing ingredient entries, including making requirements clearer and less restrictive; and, removal of 1 ingredient that was a proprietary formulation and incorrectly classified as being appropriate for use in listed medicines during the drafting of the original Determination. The removed ingredient is not currently used in any listed medicines in Australia.    Source: Permissible ingredients

TGA Consultation: Remaking Therapeutic Goods Order No. 78

The TGA is seeking comments from interested parties on the proposed remaking of Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules and reintroducing pills into the remade Order. This consultation closes on 8 February 2019.    Source: TGA 78 consultation

TGA Reviews the Narcotic Drugs Act 1967

The Narcotic Drugs Act establishes a framework to both prevent abuse and diversion of controlled narcotics and to ensure the availability of such drugs for medical and research purposes, in accordance with the Single Convention on Narcotic Drugs. Since October 2016, the Act was extended to provide for the regulation of cannabis cultivation and production in Australia, to enable a sustainable supply of safe medicinal cannabis products for therapeutic purpose.    Source: Narcotics review

TGA Takes Action Against Peptide Clinics Pty Ltd for Alleged Advertising Breaches

The Secretary of the Department of Health has begun Federal Court proceedings against Peptide Clinics Pty Ltd, trading as Peptide Clinics Australia, alleging breaches of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2015 (the Advertising Code). This legal action follows an investigation by the Therapeutic Goods Administration. Peptide Clinics Australia is alleged to have advertised compounded prescription only therapeutic goods, including 'peptides', on its website and other social media platforms, accessible to both registered customers and the public. It included references to serious forms of diseases, and to conditions such as anxiety and depression.    Source: Peptide Clinics busted

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

THAN YOU tablets: the tablets contain the undeclared substance sibutramine.

NZ Therapeutic Products Regulatory Scheme Consultation

New Zealand’s Ministry of Health is seeking feedback on the draft Therapeutic Products Bill. The Therapeutic Products Bill would replace the Medicines Act 1981 and establish a new regulatory scheme for therapeutic products. Please note that Natural Health Products (including rongoā Māori) will be excluded, as far as possible, as the Government is considering options for how these could be regulated as a separate process.   Source:  NZ Therapeutic products bill

AHPA Issues Status Report on Hemp and CBD After USA Farm Bill Passage

The American Herbal Products Association has produced a Status Report after working with legal and industry experts to develop a new, free resource titled Status Report: Marketing of hemp and cannabidiol (CBD) products in the United States, following passage of the 2018 Farm Bill. This document provides concise and up-to-date information on the status of such operations and products as soon as this legislation is adopted as federal law. Because of the herbal product industry’s broad interest in the impact of this legislation on hemp and CBD, AHPA is distributing this information before the bill has been signed into law. The 2018 Farm Bill has been passed by the Senate and House, but still needs to be signed into law by the President. AHPA is not aware of any indications that successful and timely completion of this is in doubt.   Source: 2018 Farm Bill passage

 

Foods:

Are All Foods That Contain “Traces” of Allergens Now Considered Unsafe?

(This article by Charles Fisher details and analyses an actual case study where FoodLegal represented a food manufacturer against enforcement action by the Victorian Department of Health. Names and dates have been removed to protect client confidentiality. Should the position taken in this instance become nationwide policy, it would trigger sweeping changes across the food industry in allergen management and labelling in Australia). Briefly, an Australian company marketed a product with the warning that it may contain traces of a specific allergen. After a reported health incident the same product was shown to contain 0.06% of the allergen and the Victorian Department of Health ruled that the label should have stated that the allergen was ‘present’ in the product, rather than ‘may contain traces’. The product was declared ‘unsafe’ and had to undergo a public recall.   Source: Food Legal A trace of allergen

Australian Bio-Security Finds Spicy Rabbit Heads Destined for Human Consumption

Biosecurity officers at the Sydney Gateway Facility had the hares on the back of their necks stand up when they found this spicy package earlier this year. An X-ray of goods entering the country found a package containing spicy rabbit heads, destined for human consumption. Biosecurity officers conducted a thorough inspection of the parcel and contents, and the items were destroyed. (If an item does not meet Australian import conditions it must be treated, exported or destroyed at the importer’s expense. Certain food, plant material and animal items from overseas could introduce serious pests and diseases into Australia, devastating our valuable agriculture, tourism industries and unique environment).   Source: Food security

Sydney Food Importer Fined for Undeclared Allergens

Sydney company Tek Shing Trading Pty Ltd has been fined $48,400 and professional costs of $17,034 after its director pleaded guilty to nine offences under the Food Act 2003 in the Downing Centre Local Court on Tuesday 11 December 2018. The charges pertained to labelling offences relating to the Kingsgrove company’s imported ‘Hot Pot Sauces’ and failure to comply with the company’s recall process as required by the Australia and New Zealand Food Standards Code.   Source: Hot sauce in hot water

Cruise Ship Fines Start in New Zealand

Biosecurity New Zealand officers now have the ability to fine cruise ship passengers who bring ashore foods or other items that could carry dangerous pests or diseases. The new fines came into place this month, allowing officers to issue infringement notices of $400 to cruise ship passengers who unintentionally break New Zealand's biosecurity rules. Biosecurity New Zealand already has the power to prosecute passengers who intentionally smuggle risk goods ashore. He says fines can currently only be issued to travellers who are permanently leaving a vessel. Biosecurity New Zealand is working to extend the infringement notices to passengers who temporarily come ashore.   Source: Cruise ship control

Cargo Ship Ordered to Leave New Zealand

Biosecurity New Zealand has directed a vehicle carrier to leave New Zealand waters following the discovery of stink bugs and other regulated pests. Biosecurity officers intercepted 3 live and 39 dead brown *marmorated stink bugs and 69 other dead regulated stink bugs after the Carmen arrived in Auckland from Europe on Wednesday morning.   Source: Stink bugs      (*The term "marmorated" means variegated or veined like marble)

FSANZ Notifications—

Application A1137 – Polysorbate 20 as a Food Additive: The purpose of the Application is to permit the use of polysorbate 20 as an emulsifier.   Source: Polysorbate 20

Application A1168–Glucoamylase from GM Aspergillus niger as a Processing Aid (Enzyme): ​​​The purpose of the Application is to permit the use of glucoamylase produced from a genetically modified strain of Aspergillus niger as a Processing Aid.   Source: Aspergillus niger

 

Cosmetics and household cleaning products:

Australian Ministers Confirm Phase-out of Microbeads in Cosmetics

The Meeting of State Environment Ministers (MEM) recently took place and as part of an overall action plan on waste management have reaffirmed their commitment to the complete phase-out of solid plastic microbeads in cosmetics and personal care products.    Source:  Plastic microbeads

 

Marketing News:

Australia, New Zealand and Pacific Island Beauty Brands Capitalise on Indigenous Ingredients

Australia and New Zealand may be saturated markets for the cosmetics and toiletries industry, but consumers’ willingness to buy a variety of complex formulated and premium green products is continually expanding revenue. Millennial consumers especially are contributing to rising demand for independent and green brands.     Source: Excerpt article from Barbara Barkhausen, Cosmetics Business Cosmetics downunder

 

Quote for the month:

“Christmas is not a date. It is a state of mind”   Mary Ellen Chase

 

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