This news is posted on our website on a regular basis. Visit us often to keep informed.www.robert-forbes.com
RFA Regulatory Affairs is looking for a regulatory affairs associate to join our team.
Please see the bottom of this Newsletter for details.
The Australian and New Zealand Governments have agreed to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
The Federal Court has ordered Dateline Imports Pty Ltd to pay penalties of $85,000 following action by the Australian Competition and Consumer Commission for false or misleading representations.
“Consumers must be able to trust claims that are made about the ingredients and benefits of beauty products. Credence claims are a current enforcement priority for the ACCC” ACCC Commissioner Sarah Court said.
- A1104 – Voluntary Addition of Vitamins & Minerals to Nut- & Seed-based Beverages
Food Standrads Australia & New Zealand to seek permission for the voluntary addition of a range of vitamins and minerals to nut- and seed-based beverages that provide a milk alternative for consumers with allergic / intolerant conditions.
- A1102 – L-carnitine In Food
To permit the sale of L-carnitine in a variety of food categories including dairy products (excluding butter and butter fat), confectionery, cereal and cereal products, food intended for particular nutritional uses, non-alcoholic beverages and gels.
- P1029 – Maximum Level for Tutin in Honey
The purpose of this Proposal is to develop a permanent maximum level for tutin in honey
The purpose of the Proposal is to permit nutrition content claims about gluten in relation to foods (including beverages) containing more than 1.15% alcohol by volume.
- P1034 – Chemical Migration from Packaging into Food
The purpose of this Proposal is to assess the public health and safety risk of chemicals which may migrate from packaging materials into food, and to identify and manage any risks.
An ACT Legislative Assembly committee conducting an inquiry into the use of medical cannabis in the community has called for public submissions. Public hearings are planned for early 2015 and a report is due to be presented to the Assembly and considered by the ACT Government in June.
Source: Canberra Times (Tom McIlroy) http://tinyurl.com/mdy6au8
Supporters of marihuana use have had their day in the push to legalise cannabis for recreational use. Now, consumers and patients are in increasing numbers turning to the plant’s beneficial properties to bring about a “wellness revolution”, according to the owner of the biggest hemp foods producer in the southern hemisphere.
Source: Food Navigator – Asia (RJ Whitehead) http://tinyurl.com/pdvlmdt
After years of calling for changes in Australia’s supremely tight regulatory framework, Australian complementary medicine manufacturers might just get some of the things they’ve been asking for, even if the process will only be a “quiet revolution”, according to the top regulator.
Source: Food Navigator – Asia (RJ Whitehead) http://tinyurl.com/m98fcny
Healthfarm Fine Foods Pty Ltd has recalled 29 various peanut, tree nut and seed spreads sold in Woolworths and health food stores nationally.
The products are being recalled due to the presence of allergens at levels in excess of the amount expected on a product carrying a "May Be Present" warning statement.
The National Institute of Complementary Medicine’s executive director, Professor Alan Bensoussan has received the complementary medicine industry's most prestigious award, the Lady Cilento Award, recognising his life-time achievements and outstanding contribution to the industry and community. Alan was caught completely off-guard on the night!
The award acknowledges the recipient's professionalism, contribution of outstanding merit and reflection of high aspirations benefiting the complementary healthcare ethos.
Coordinating international cooperation among medicines regulatory authorities …, will avoid duplication of efforts and promote informed risk-based allocation of authorities' resources. These efforts and others would strengthen the quality, safety and efficacy of medicinal products globally. In this context, regulators must act globally and domestically, and collaboratively.
The American Botanical Council, American Herbal Pharmacopoeia and the National Center for Natural Products Research have just released their second issue of the “Botanical Adulterants Monitor,” an e-newsletter intended to provide relevant stakeholders with the latest news and information regarding the adulteration, identity, and quality of botanical raw materials, extracts, essential oils, and related plant-based materials used in consumer products.
Source: ABC Herbalgram http://tinyurl.com/mddgqfh
Nearly 50 stakeholders, including international regulators, industry scientists and academics, attended the 2014 Council for Responsible Nutrition - International event. CRN-I will submit a summary of the symposium proceedings to an international journal for publication, adding to the catalogue of CRN-I symposium proceedings published every year since 2010. RFA Regulatory Affairs was also represented at this symposium by one of its senior regulatory affairs associates,Samantha King. By all accounts it was a fascinating and very valuable get-together.
Source: Nutraceuticals World http://tinyurl.com/m58n5wr
The Therapeutic Goods Administration has recently released the latest version of the Standard for the Uniform Scheduling of Medicines and Poisons, otherwise known as ‘The Poisons Standard’. One example of the many significant changes is that, ‘phenoxyethanol’, a commonly used cosmetic ingredient, is now included as a ‘Schedule 6. Poison’. In this case, this means that if a cosmetic formula contains more than 1% of phenoxyethanol, additional packaging labelling restrictions may be applicable to the cosmetic product packaging.
The Therapeutic Goods Administration is aware of reports relating to the safety of Miracle Mineral Solution (MMS), including a report that four people were hospitalised in Victoria after using the product. MMS is marketed as water purification drops and may be offered under different names, including Miracle Mineral Supplement. It contains 28% sodium chlorite, which is a chemical used as a textile bleaching agent and disinfectant. MMS is not approved by the TGA for any therapeutic use.
In Australia, products that are used in the purification or treatment of drinking water, and which do not make therapeutic claims, are not considered therapeutic goods. However, based on the media reports, the TGA is concerned that some people may be using MMS to treat illnesses or for other therapeutic purposes.
Wednesday December 24 – a half day – open, morning until midday.
Thursday December 25 to Friday January 2, 2015, RFA office will be closed.
Returning to work Monday January 5, 2015
RFA Regulatory Affairs is looking for an experienced Regulatory Affairs Associate who has at least 2 years' experience, to join our team at Robert Forbes and Associates in Glebe. We work with companies who supply personal healthcare products including complementary medicines, foods, cosmetics and household goods, NZ Dietary supplements, and some medical devices, in Australia and New Zealand.
Our preference is for a candidate with experience in cosmetic and household goods.
- Review product formulations, labels, advertising against relevant legislation, and ensure regulatory compliance with relevant Australian and New Zealand legislation and guidelines
- Research claims and evidence as per relevant legislative guidelines.
- Organise applications and lodge submissions with associated Regulatory Bodies such as the TGA (Listed Medicines), NICNAS, FSANZ, AQIS
- Assist in the development and checking of ingredient reviews, manufacturing, packing, labelling, advertising and product specification documentation for products sold in Australia and/or New Zealand
- Keep up to date with regulatory changes and variations
- Relevant tertiary qualification (e.g. Health Sciences)
- A minimum of 2 years' experience in Regulatory Affairs role
- Proven understanding of Australian and New Zealand regulations
- Experience using online lodgement systems NICNAS, AICS, TGA eBus, AQIS, etc.
- Complementary Medicines, Food and/or Cosmetic Industry experience
- Well-developed communication skills; both written and verbal
- Self-motivated team player with an ability to work to monthly targets