March April 2010 Newsletter

Issue 99 - March-April 2010	Published by Robert Forbes & Associates Pty Ltd http://www.robert-forbes.com/
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RFA News
Medicines
- TGA News
Foods
- FSANZ Update
Cosmetics
- NICNAS News
Association News
Conferences and Meetings
RFA Training Courses

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Changes to New Zealand dietary supplement regulations
There have been major changes to New Zealand's regulations which will affect companies supplying dietary supplements in New Zealand, and those companies who import these products into Australia via New Zealand. Please refer to the article from Natural Products New Zealand (NPNZ) in this newsletter. In addition, clients of RFA will be sent a detailed explanation by separate email.

TGA News

Product recall
On 27 March 2010, AMLO 10 tablets (10mg amlodipine)Blister packs of 30 tablets (Batch AR169 EXP NOV11)(ARTG 96962), were issued a Class II recall due to the possibility of this batch containing AMLO 5 tablets (5mg amlodipine). (Sponsor ? Spirit Pharmaceuticals Pty Ltd)
Read more ...

[Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.]

Product cautions
The TGA is aware that some Australian consumers may have purchased a product known as Botanical Slimming 100% Natural Soft Gel (or "Meizitang") over the internet. TGA laboratory analyses have detected the presence of sibutramine, an undisclosed prescription-only substance. The consumption of this product may be harmful if taken without the supervision of a medical professional. Consumers are advised to exercise extreme caution when purchasing medicines over the internet. Products purchased in this way may not meet the same standards of safety, efficacy and quality as those approved by the TGA for supply in Australia, and may contain unauthorised ingredients.
Read more ...

Medicines safety update ? fish oil The TGA has released safety information for healthcare practitioners relating to the anticoagulant properties of fish oils. Despite the lack of evidence of a systematic safety concern, it would appear reasonable to be mindful of the theoretical risk of bleeding with fish oil when monitoring patients treated with fish oils and anticoagulants. Bays (2007) in an article entitled 'Safety considerations with omega-3 fatty acid therapy', suggests:
•	discontinuing high-dose fish oil consumption or supplementation during an acute bleeding illness, such as during and immediately after a haemorrhagic stroke, or in patients with or at high risk for haemorrhagic stroke
•	discontinuing fish oil therapy 4-7 days before elective procedures with a high risk for bleeding complications, as often occurs with aspirin, warfarin, and clopidogrel, even though infusion of fish oils after major abdominal surgery through parenteral nutrition does not appear to result in clinically significant bleeding and has been suggested to be safe with specific regard to coagulation and platelet function
•	considering the potential antithrombotic and cardiovascular benefits of restarting fish oil therapies postoperatively, given that thrombotic and cardiovascular events may occur following major surgery.
Read more ...

Fourth bill to enhance the therapeutic goods act 1989 On Wednesday 17 March 2010, the fourth Bill, the Therapeutic Goods Amendment (2009 Measures No 3) Bill 2009, was debated and passed by the House of Representatives. The Bill is now expected to be debated in the Senate. The Bill makes a number of key amendments, principally to:
•	Implement a new framework for the regulation of human cellular and tissue based therapy products
•	Provide more flexible arrangements to recall batches of goods
•	Enable information to be sought from past sponsors of medicines and therapeutic devices but only for the 5 year period before the request is made, and
•	Improve the operation of the Act through a range of minor technical amendments.
Read more ...

Fifth bill to enhance the therapeutic goods act 1989 On Wednesday 17 March 2010, the fifth Bill, the Therapeutic Goods Amendment (2010 Measures No 1) Bill 2010, was introduced to the House of Representatives. The Bill is now expected to be debated by the House. The Bill makes a number of key amendments, principally to:
•	Provide for the supply of unapproved medical devices to substitute for approved devices that are in short supply or unavailable
•	Enable listing of export-only variants of registered or listed medicines
•	Clarify the provisions that allow the Minister to determine a list of permitted ingredients for listed medicines, and
•	Improve the operation of the Act through a range of minor technical amendments.
Read more ...

Manufacturing quality program presentation
A presentation on the Australian GMP requirements for bacterial contamination testing of cell and tissue products presented by Katherine Clark (GMP Auditor, Office of Manufacturing Quality) is available to download. The requirements for testing cell and tissue products and the applicable standards are discussed.
Read more ...

CMEC meeting 74 ? extracted ratified minutes
The ratified minutes of the 74th Complementary Medicines Evaluation Committee meeting held on 4 December 2009 included a recommendation to the TGA that seven Zanthoxylum species remain suitable for use as ingredients in Listed medicines, restricted to traditional plant parts and dosages
Read more ...

Draft compositional guidelines The following draft compositional guidelines are now available:
•	Quercetin Read more ...
•	Rutin Read more ...
•	Hesperidin Read more ...
•	Citrus bioflavonoids extract Read more ...
•	Fish oil ? natural Read more ...

TGA issues further guidance for manufacturers
The TGA's Office of Manufacturing Quality has released two guidance documents to assist complementary medicines manufacturers to comply with the requirements of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products 2009.
Read more ...

NICNAS call for information: chemicals in cosmetic products previously regulated as therapeutics
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is seeking information on certain ingredients in cosmetic products that were previously regulated as therapeutics by the Therapeutic Goods Administration and were in commerce prior to the introduction of reforms to the therapeutic-cosmetic interface in September 2007. NICNAS is seeking to identify those chemicals that meet the criteria for recognition as an industrial (cosmetic) chemical and that may be eligible for listing on the Australian Inventory of Chemical Substances (AICS). The call for information is open from 2 February ? 2 May 2010.
Read more ...

Updated advice to consumers regarding hydroxycut products
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 in light of these media reports. The TGA had not received any reports of liver injury prior to these media reports, and has yet to receive detailed information about the particular case. As a result the TGA has been unable to ascertain whether the patient who was reported in the media to have suffered liver toxicity took the Australian or the US product.
Read more ...

Therapeutic listing notice no. 1 (2010)
Oral preparations, that contain 'Omega-3 fish oil phytosterol esters' as a therapeutically active ingredient can be included on the ARTG for listed goods, the product label must include statements: "There is no benefit from taking more than 3g/day of phytosterols from all sources" and "Not suitable for pregnant or lactating women".
Read more ...
Draft compositional guidelines for phytosterol esters ...

Office of manufacturing quality (updated)
The Office of Manufacturing Quality (OMQ) operates within a defined quality management system, striving towards continuous improvement in efficiency, consistency, quality and timeliness in the delivery of regulatory services to industry.
Read more ...

Technical working groups Technical Working Groups (TWG) have been established by the TGA's Office of Manufacturing Quality (OMQ) to bring together manufacturing technical expertise from industry and the regulator to address the grey areas or vagaries of the code of GMP as it relates to manufacturing. Read more ... Two working documents from the complementary medicine TWG include:
•	Draft guidance for the interpretation of manufacturing standards for product quality review for Listed complementary medicines
•	Draft guidance for the interpretation of manufacturing standards for on-going stability testing for Listed complementary medicines
Read more ...

Updated membership for national coordinating committee on therapeutic goods
Read more ...

Therapeutic goods (multi-site manufacturing licences) guidelines
Read more ...
Consultation outcomes
Read more ...

NDPSC Feb 2010 post meeting gazette notice
Read more ...
NDPSC Feb 2010 record of reasons
Read more ...

European union guidelines ? newly published
Read more ...
Adoption/non-adoption of European Union guidelines in Australia
Read more ...

FSANZ (Food Standards Australia New Zealand) update

Amendment 115 gazetted Amendment No. 115 was gazetted on 8 April 2010 in Australia and published in the New Zealand Gazette on the same day. The Applications under which these amendments are as follows:
•	Application A1015 ? Ethyl Lauroyl Arginate as a Food Additive
•	Application A1019 ? Exclusive Use of Phytosterol Esters in Lower Fat Cheese Products
•	Application A1024 ? Equivalence of Plant Stanols, Sterols & their Fatty Acids Esters
Read more ...

FSANZ considers approving two GM foods
FSANZ released a consultation document for two applications to approve the sale of genetically modified (GM) foods in Australia and New Zealand and one for a processing aid obtained from a GM source. The applications being considered are for foods derived from insect-protected soybean and drought-tolerant corn, respectively, and an engineered enzyme produced from a strain of Aspergillus niger.
Read more ...

COAG independent review of food labelling law and policy
The committee conducting the independent review of food labelling law and policy has released the issues consultation paper via the website. The consultation paper summarises the issues that have been raised in the first round of submissions to the review, as well as issues in the literature and media in recent years. The paper also elaborates on the review?s terms of reference and has been prepared to stimulate thinking and debate. All stakeholders are encouraged to take this opportunity to make a written submission by 14 May 2010.
Read more ...

NICNAS News

Chemical gazette March 2010
Read more ...

Chemical gazette April 2010
Read more ...

Complementary Healthcare Council of Australia (CHC)

Herbal remedies scare report: CHC responds
Consumers need not panic over media reports stating multivitamin use increases the risk of developing breast cancer after a study published this month claimed there may be an association with the commonly consumed product.
The Swedish study carried out in over 35,000 women, was conducted via a self-administered questionnaire that provided information on multivitamin use and incidence of breast cancer with a follow-up period of 10 years.
Whilst the study has been published in the American Journal of Clinical Nutrition, the Complementary Healthcare Council (CHC) has some concerns over limitations to the study. "The manner in which the study was conducted means that key factors such as the bioactivity of the ingredients within the multivitamin has not been evaluated, thus, not giving a complete picture of the overall results" said Dr Wendy Morrow, Executive Director of the Complementary Healthcare Council (CHC). Throughout the study, dietary supplement use was solely assessed through a self-administered questionnaire which may have resulted in individuals being incorrectly classified based on answers provided and may have skewed results. "Of further concern is that information on the brands of multivitamins taken by the participants was not collected; therefore the study was unable to determine whether there may be an association with one particular dietary supplement product or ingredient(s) at certain doses which has resulted in the assumption of multivitamins being the risk factor." Dr Morrow said.
The CHC highlights that in the study, 'multivitamin users' were noted to have greater breast density (this is when the breasts have relatively less fat and more glandular and connective tissue) than 'non-users'. This is important to consider in relation to the outcome, as greater breast density is well known to be associated with a relatively higher risk of developing breast cancer. The CHC would also like to reinforce that Swedish dietary supplements are not regulated to the same high standard as those in Australia. Without knowing which brand or combination of ingredients were being consumed it is difficult to conclude whether there may have been other factors contributing to the suggested association such as the manufacturing methods used or excipients (an inactive substance used as a carrier in complementary medicines) within the supplements.
"The CHC believes that more detailed information is needed before any strong association can be made between an increased risk of breast cancer and multivitamin consumption." said Dr Morrow.
The CHC advises consumers who are concerned or have questions about the research to seek information from their healthcare professional.

www.chc.org.au

Natural Products New Zealand (NPNZ)

New guidance on NZ dietary supplements The new guidance about dietary supplements is now available on Medsafe?s website. There is a brief explanation about the changes introduced through the recent amendments to the DSR and advice on:
•	how to tell if a product is regulated under the Medicines Act or the Food Act (as a supplemented food or dietary supplement)
•	what a company needs to do if they want to sell a dietary supplement containing more than 300mcg of folate
•	obtaining an export certificate from Medsafe
Read more ... www.naturalproductsnz.org

TGACC Advertising Seminars
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 ...

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 ...

ASMI Conference & AGM
November 18, Australian Technology Park, Redfern, Sydney
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 12:06

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.

March April 2010 Newsletter

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