January-February 2010 Newsletter

Issue 98 - January-February 2010	Published by Robert Forbes & Associates Pty Ltd http://www.robert-forbes.com/
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Topics

RFA News
Medicines
- TGA News
Foods
- FSANZ Update
Cosmetics
- NICNAS News
Association News
Conferences and Meetings
RFA Training Courses
Course available for
marketing executives

Jenny Morris OA
RFA was delighted to hear Jenny Morris was recently awarded an Order of Australia medal. The award recognises Jenny's amazing contribution to the music industry and her extensive charity work with Nordoff-Robbins Music Therapy Australia – an organisation which RFA supports. Jenny, who has two ARIA awards for best female artist and multiple platinum awards, is an avid supporter of Nordoff-Robbins http://www.nordoff-robbins.com.au – who funds music therapists at children's hospitals and a training centre at the University of Western Sydney.

TGA News

Child-resistant packaging requirements for medicines
The TGA is seeking comment on a number of proposed amendments to Schedule 1 to TGO No 80 Child-Resistant Packaging Requirements for Medicines. Submissions close 19 March 2010. These amendments to Schedule 1 would update the list of substances which, if present in a medicine, require the medicine to have child-resistant packaging.
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Advice to consumers regarding hydroxycut products
In May 2009, the US Food and Drug Administration issued a warning to consumers to cease using US hydroxycut products due to reports of adverse reactions, including liver toxicity. Recent media reports have claimed that a case of liver toxicity in Australia is linked to the use of Hydroxycut Hardcore. Further investigations are being conducted and the TGA will continue to monitor the situation and take regulatory action as appropriate.
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Therapeutic Goods Committee (TGC) – expressions of interest for membership The TGA is seeking expressions of interest from persons with relevant expertise to fill two new positions on the TGC. These positions, which will supplement the current membership, are for:
•	A person with expertise in pharmaceutical science; and
•	A person with expertise in community or hospital pharmacy practice.
Read more ...

TGC 35th meeting, 14 October 2009
Key recommendations made by the TGC at the 35th meeting include recommendations that involve an annual review of TGO No 80 Child-resistant packaging requirements, medicine labelling, TGO No 78 Standard for tablets and capsules, orders relating to exclusion of certain USP monographs, product standards for the new regulatory framework for biologicals, manufacturing principles for medicinal products and the draft TGO standard for heparin.
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Use of the term 'quantified by input'
Submissions from industry on the use of the term 'Quantified by Input' for Listed Complementary Medicines are available.
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Regulation impact statement on TGA and NICNAS proposed regulation of disinfectants
In response to a recommendation in the Report of the Commonwealth Government's Taskforce on Reducing the Regulatory Burden on Business (the Banks Report), the TGA and the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) have released a consultation regulatory impact statement for public comment. The submission deadline for this consultation was extended to February 2010.
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CMEC public recommendation summaries and minutes
A new process is in place for announcing recommendations made by CMEC to the TGA. CMEC recommendations will be posted on the TGA website only after ratification by the Committee (at their next meeting). On some occasions, portions of minutes and recommendations may not be made public due to ongoing deliberation by CMEC or TGA. In this instance, when the final CMEC recommendation is published, the relevant CMEC Minutes relating to this item may be published retrospectively.
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Update to the manufacturing principles for medicinal products
In July 2010, the TGA will adopt the PIC/S Guide to Good Manufacturing Practices for Medicinal Products as the applicable Code of GMP under Manufacturing Principles. The adoption reflects the TGA's intention to maintain standards in line with international best practice. A series of seminars were arranged to provide industry with an introduction to the major changes introduced in the PIC/S Guide. The presentation is available to view.
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Registering as a small business with the TGA
The TGA is changing its banking systems to comply with recent Commonwealth Government changes to policy that will support small business. The TGA is asking all of its vendors to identify whether they should be considered as a small business by the TGA in making payments.
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Section 7 declarations - food or therapeutic good?
Section 7 declarations are made to provide greater clarity for consumers, the food and medicines industries and regulators in determining whether a product is a food or a therapeutic good. Essentially, a section 7 declaration enables the Secretary to the Department of Health and Ageing to declare that particular goods or classes of goods are or are not therapeutic goods.
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Proposed Section 7 declaration: that products in capsule, tablet and pill form are therapeutic goods
Submissions from organisations are available for review.
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Reductil product information
In December 2009 the TGA was informed of the interim results of a clinical trial known as the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, conducted by Abbott Laboratories, which showed higher rates of cardiovascular events such as heart attack and stroke in patients using sibutramine than in those receiving a placebo. While prescribing of the product (Reductil) has not been restricted and it has not been withdrawn from the market, the TGA's review of the safety of the product is ongoing, to determine if any further regulatory action is warranted.
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NDPSC pre-meeting gazette notice February 2010
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Questions and answers relating to the additional default standards legislation
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Updated recall coordinators' contact details (Dec 09)
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CMEC meeting dates for 2010
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FSANZ (Food Standards Australia New Zealand) update

Thinking about becoming pregnant fact sheet
A multi-media information package outlining seven tips for safe eating and drinking before and during pregnancy has been launched by FSANZ.
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Bisphenol A (BPA) and food packaging
FSANZ has assessed the studies that led to the USFDA decision to undertake a review and further research and their view remains that BPA in baby bottles and food packaging in Australia and New Zealand is still safe.
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National product recall Bonsoy milk
A consumer-level recall for Bonsoy soy milk was voluntarily instigated by the importer in December 2009. FSANZ has advised people not to consume Bonsoy soy milk. This follows a cluster of nine adults and one child, who have recently presented in NSW with thyroid problems. Subsequent testing of samples of Bonsoy soy milk revealed unusually high levels of iodine.
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Food standards news – summer edition is now available
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Food surveillance news – summer edition is now available
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NICNAS News

Call for comment on ingredients previously regulated as therapeutic goods
Reforms to the cosmetic-therapeutic interface took effect on 17 September 2007 with the introduction of the Cosmetic Standard 2007. Chemicals in some products that were previously regulated by TGA are now regulated by NICNAS. This includes chemicals in some: secondary sunscreens of SPF up to 15, anti-bacterial skin products, anti-acne products, anti-dandruff products and anti-perspirants. Comment from companies or individuals affected by these reforms has been requested by 2 May 2010.
Read more ...

Chemical gazette February 2010
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Complementary Healthcare Council of Australia (CHC)

Herbal remedies scare report: CHC responds
Setting the record straight on the recent scare report on herbal medicines by a South Australian academic, the Complementary Healthcare Council of Australia (CHC) said that much of the report was ill-informed, misleading and irresponsible — and most importantly, not relevant to complementary medicine (CM) products sold in Australia, which are among the most tightly regulated in the world.

CHC Executive Director Dr Wendy Morrow said: 'the report looks mainly at the sale of herbal products in the United States, where the standard of regulation is considerably lower. The report also states that access to such products is largely unrestricted, ignoring the fact that Australia has one of the most highly regulated environments in the world for CM products, and operates under strict safety and quality regulations set by the Australian Government's TGA.' Dr Morrow says GPs and other healthcare practitioners should make the effort to climb the tree of knowledge on CMs and urges consumers to take responsibility for the medicines they take and seek advice from their healthcare practitioners before combining these with other medicines — and ensure they disclose their use to their healthcare professional.

Upcoming regulatory changes in the complementary healthcare industry
A Complementary Healthcare Council forum

Ensure your business is prepared for 2010!
Don't miss out on crucial presentations by TGA, OCM, OMQ, FSANZ, NPNZ, CRC & CRP plus a special opening speech by The Hon Mark Butler, Parliamentary Secretary.
Dates: 25 – 26 March 2010
Venue: Citigate Central, 169 – 179 Thomas St Sydney
Registrations and full program details are now available online, please visit www.chc.org.au/Events and follow the links.
Please contact Jess Schnitzler on 02 6260 4022 or This e-mail address is being protected from spambots. You need JavaScript enabled to view it with any queries.

www.chc.org.au

Natural Products New Zealand (NPNZ)

Changes to dietary supplements regulations The previously proposed changes to the Dietary Supplements Regulations 1985 (DSR) have now been approved and will take effect from 31 March 2010. The changes provide for:
-	Foods to be taken out of the DSR, leaving therapeutic-type products to be administered under the DSR. The DSR will exclude products that most people would recognise as foods from coverage under the regulations. The administration of the DSR will then be provided by Medsafe rather than NZFSA.
-	Increase in the permitted maximum level of folic acid in dietary supplements from 300mcg to 500mcg for products made in accordance with the New Zealand Code of Good Manufacturing Practice.
NPNZ welcomes the increase in permitted level of folic acid – the NZ industry have sought this change for over a decade; and the changes to the administration of the DSR are also welcomed as an interim measure until a new regulatory system for the manufacture and supply of natural health products in NZ can be put into place. Further information will be available at www.nzfsa.govt.nz REMINDER: 2010 Natural Products Summit Natural Products New Zealand has set the date for the 2010 Natural Products Summit. Mark 22 April 2010 in your diary now! www.naturalproductsnz.org

Nutracon Conference
March 10 – 11, Hilton Anaheim, California, USA
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Natural Products Expo West
March 11 – 14, 2010 Anaheim Convention Centre, California, USA
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Supply Expo
March 12 – 14, Anaheim Convention Centre, Anaheim, California, USA
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DSAA Expanding Horizons Conference 2010
March 14 – 16, RACV Royal Pines Resort, Gold Coast, Queensland
Read more ...

CHC 'upcoming regulatory changes in the complementary healthcare industry'
March 25 – 26, Citigate Central, Sydney
Read more ...

TGACC Advertising Seminars
March 31, Wesley Conference Centre, Sydney (fundamentals – full day)
April 21, Wesley Conference Centre, Sydney (advanced – half day)
May 14, Novotel, Melbourne (fundamentals – full day)
June 18, Novotel, Brisbane (fundamentals – full day)
June 23, Wesley Conference Centre, Sydney (fundamentals – full day)
Read more ...

New Zealand Natural Products 2010 Industry Summit
April 22 – 23, Nelson, New Zealand
Read more ...

Natural Health Conference and Expo
April 29 – 30, Eagle Farm Racecourse, Brisbane
Read more ...

Nutricosmetic Summit
June 10, Renaissance Hotel, Las Vegas, Nevada, USA
Read more ...

NBJ Summit
July 20 – 23, St Regis Resort, Dana Point, California, USA
Read more ...

Nutracon Asia
August 26 – 27, Hong Kong Convention & Exhibition Centre, Hong Kong
Read more ...

Natural Products Expo Asia
August 26 – 28, Hong Kong Convention & Exhibition Centre, Hong Kong
Read more ...

Third Australian Food Safety Conference
September 7 – 9, Crown Conference Centre at Crown Promenade, Melbourne
Read more ...

Natural Health Conference and Expo
September 16 -17, Aotea Centre, Auckland, New Zealand
Read more ...

The Organic Summit
October 13, Seaport Hotel, Boston, Massachusetts, USA
Read more ...

Natural Products Expo East
October 13 – 16, Boston Convention & Exhibition Centre, Boston, Massachusetts, USA
Read more ...

CHC 2010 National Conference
October 28 – 29, Crowne Plaza, Surfers Paradise, Queensland
Read more ...

GMP Management Course
ASMI in partnership with the Advanced Manufacturing Centre and the University of NSW has created a course on GMP management which culminates in a graduate certificate. This course is open to members and non-members of ASMI.
Read more ...

New course now available for marketing staff – an overview of the TGA regulations including advertising regulations for foods, medicines and cosmetics.
Details at www.robert-forbes.com/training-courses.html

Half day (4 hour) courses
•	Overview of the food/therapeutic/cosmetic interface
•	Cosmetic regulation
•	Medicines - advertising code
•	Medicines - product claims and indications
•	Listed complementary medicines - TGA eBS online applications
•	Medicines – the sponsor's finished product specifications

Full day course
•	Food Standards

For more information visit the RFA website

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Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants
Phone: 61 2 96608027 - Fax: 612 96608106 Postal: PO Box 123, Annandale NSW 2038 AUSTRALIA
Office: 335 -341 Glebe Point Road (Entrance Ferry Rd - Level 1), Glebe SYDNEY, NSW AUSTRALIA

Last Updated on Tuesday, 17 August 2010 12:05

robert-forbes.com.au - Robert Forbes and Associates - Regulatory and technical advice to suppliers and manufacturers of complementary medicines, dietary supplements, OTC medicines, cosmetics, personal care products and foods.

January-February 2010 Newsletter

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