Robert Forbes & Associates Additional Services – Evidence to Support Claims

Robert Forbes and Associates can help you by:

• Highlighting the evidence (or possibly lack of) to support your product claims.
• Researching and sourcing acceptable ‘levels of evidence’ for the ingredients in your product.
• Providing hard copies of literature searches.
• Providing advice on reformulation if necessary so that ingredients are present in the right doses to support the claims made.

If you wish to utilize this service or if you have any questions please contact Robert Forbes on forbes@robert-forbes.com.au

New Substances

Trametes versicolor hyphae aqueous extract – powder has been approved by the TGA as suitable for use as an active ingredient in listable medicines.

A draft Compositional Guideline has been made available by TGA for comment and can be found at http://www.health.gov.au/tga/docs/pdf/compguid/drtrametes.pdf
Note - Compositional Guidelines are intended to provide clarity to the specific form or type of substances that the TGA approves for use in listed medicines, as either an active substance or an excipient, where there is no standard in the British Pharmacopoeia (BP) or other acceptable monographs.

Neem (Azadirachta indica)
CMEC rescinds a previous recommendation in regard to the suitability of cold-pressed neem (Azadirachta indica) seed oil for use in listable medicines and recommends that cold-pressed neem seed oil be permitted for use in listable medicines consistent with the decision of the National Drugs and Poisons Scheduling Committee (Decision 2002/36-15), as follows:

• at concentrations up to 1 % for topical application; and
• at concentrations greater than 1 % for topical application when in a container fitted with a child resistant closure and labelled with the statements: "Not to be taken"; "Keep out of the reach of children"; and "Do not use if pregnant or likely to become pregnant."

Calcium Sodium Caseinate
CMEC recommends that calcium sodium caseinate is suitable for use as an ingredient in listable medicines, subject to the provision of a label statement indicating that products containing calcium sodium caseinate contain cow's milk protein (or words to that effect).

TGA News

Australian Regulatory Guidelines for Complementary Medicines (ARGCM)
The ARGCM was commenced in August 2001 by the TGA in consultation with ASMI (Australian Self-Medication Industry) and CHC (Complementary Healthcare Council of Australia) (See Current Affairs Issue 23 for full story) Draft documents available for comment are -

• Proposed ARGCM Structure and Content
• DRAFT ARGCM Appendix - 'Quantified by Input'
• DRAFT ARGCM Part III - Evaluation of Complementary Medicine Substances
  
  http://www.health.gov.au/tga/docs/html/argcm.htm

Audits of Medicine Manufacturers
Detailed information on all aspects of Audits on Medicine Manufacturers including Audit Frequency and Scheduling; Audit Duration; Audit Team; What happens at a typical Audit; Follow-up after the Audit and Appeals and Complaints is available at http://www.health.gov.au/tga/docs/html/auditmed.htm
Background - The Manufacturer Assessment Section (MAS, formerly GMP Auditing and Licensing Section) of the TGA is responsible for licensing of Australian manufacturers and audits of Australian and overseas manufacturers wishing to supply therapeutic goods in Australia. In general, manufacturers of therapeutic goods in Australia are required under the Therapeutic Goods Act 1989 to hold a licence. To obtain a licence to manufacture therapeutic goods, a manufacturer must demonstrate compliance with manufacturing principles including Codes of Good Manufacturing Practice (GMP). GMP auditors monitor compliance with the Codes by carrying out regular on-site audits.

Overseas manufacturers that supply therapeutic goods to Australia are also required to meet at least an equivalent standard of GMP as Australian manufacturers. To avoid the need for an on-site TGA audit, sponsors may submit an acceptable form of evidence of the standard of manufacture for assessment (GMP clearance) when applications are lodged for listing/registration of medicines - see the Guidelines on Standard for Overseas Manufacturers.

Review of Therapeutic Product Advertising In Australia and New Zealand
The final report of a proposed Trans-Tasman Advertising Scheme for advertising therapeutic products in Australia and New Zealand is now available. Consultation with stakeholders will take place before a final proposal for the Scheme will be presented.
http://www.health.gov.au/tga/docs/html/advrev.htm

Draft Code of Practice for Tamper Evident Packaging
A draft Code of Practice for Tamper-Evident packaging (TEP) of Therapeutic Goods is available for comment (before 19th May). The draft was developed under the direction of the Industry Government Crisis Management Committee (IGCMC) through its Subcommittee on Tamper-Evident Packaging. It is proposed that the Code will become mandatory early in 2004 under the therapeutic goods legislation. Sponsors will be given a 12-month transition period in which to comply. http://www.health.gov.au/tga/docs/html/tepcopdr.htm

Drug Company Convicted of Counterfeiting

Curacel International Pty Ltd has become the first Australian pharmaceutical manufacturer to be convicted of manufacturing counterfeit medicines.
Curacel was fined $84,000 for manufacturing counterfeit medicines, carrying out unlicensed steps in the manufacture of medicines and manufacturing and supplying unapproved medicines. Company Director, Mr Karim Rouan Cham, was also fined $12,000 for label swapping of medcines.
TGA investigations revealed the presence of the Schedule 4 Poisons Dimethyl Sulfoxide (DMSO) and Hydroquinone in some products. Another product had been re-labelled with a fictitious batch number in an attempt to extend the shelf life of the product by two years beyond the original expiry date.

Australian Government Acts to Prevent Sale of Opium Drink

The Commonwealth Government has taken urgent action to prevent the sale of a formulated drink that claims to contain opium. As opium is a prohibited substance under the Food Standards Code it cannot be added to any food or drink. Urgent discussions with State and Territory officials are underway and arrangements have been made to have this product tested. If the drink is found to contain opium, then full enforcement action will be taken. The Australian Competition and Consumer Commission (ACCC) has also been contacted by the Commonwealth Government as should the product contain opium, then the producer could be prosecuted under the Trade Practices Act for misleading labelling.

Food Ministers Agree to Range of Policy Initiatives

The newly expanded Australia and New Zealand Food Regulation ministerial council recently agreed to a number of policy decisions.

• Country of Origin Labelling of Food
  The Ministerial Council agreed to a policy direction on mandatory country of origin labelling of food, on the grounds of enabling consumers to make informed choices.
• Added Caffeine in Foods
  The Ministerial Council agreed, until further evidence becomes available, to maintain the status quo for caffeine regulation by: maintaining the current additive permissions for caffeine; and restricting the use of new products containing non-traditional caffeine rich ingredients (including guarana) to boost the caffeine content in other food, beyond the current provisions for caffeine.
  In addition, further investigations would be called for on the use of guarana and guarana extract as well as the definition of kola drinks.
• Review of GM Labelling
  The Ministerial Council agreed to proceed with a review of the labelling requirements for genetically modified food. The review will include a review of legislation in place around the world.
• Consultation Mechanism
  The Ministerial Council has endorsed new Principles for Operating Protocols for Stakeholder Consultation, The Ministerial Council has asked that these Principles be reviewed in 12 months time.
• Maximum Residue Levels for Ceftiofur (for Australia only)
  The Ministerial Council had previously agreed to adopt draft variations to the Food Standards Code to include maximum residue levels (MRLs) for Ceftiofur except for edible offal and fat (cattle). The Ministerial Council agreed to the MRLs for Ceftiofur for cattle, edible offal of 2mg/kg and cattle fat of 0.5mg/kg for Australia.
• Bovine Spongiform Encephalopathy Risk Assessment and Management (for Australia only)
  The Ministerial Council has asked FSANZ to review the latest scientific evidence on BSE and TSE contamination and transmission risks and international regulatory measures for managing these risks, and report to the Ministerial Council in 12 months time.
• Soy Based Infant Formula
  Ministers agreed that FSANZ should continue to monitor developments relating to soy-based infant formula and to advise the Council of any significant issues.

Sigma Purchases Herron for $123million

According to a recent report in the Australian Financial Review, Sigma will purchase privately owned Herron Pharmaceuticals in a $123 million deal that will create Australia’s largest drug manufacturer. The purchase comes just 7 months after the ACCC rejected a $1.4 Billion merger of Sigma and Australian Pharmaceutical Industries.

Useful Links

The following links are provided as useful websites for you. The views expressed may not necessarily be the views of Robert Forbes & Associates. Click on name to jump direct to websites.

American Botanical Council (Education and Research Organisation)
Australian Self Medication Industry (ASMI) (Industry Association)
Complementary Healthcare Council of Australia (CHC) (Industry Association)
Consultants Association for the Natural Products Industry (USA Professional Group))
Direct Selling Association of Australia
Food Standards Australia New Zealand
Medical Industry Association of Australia (MIAA) (Medical Device & Diagnostics Industry Association)
Medsafe(New Zealand Medicines and Medical Devices Safety Authority)
National Herbalists Association of Australia (NHAA)
Natural Products Industry Center (Information Service)
Therapeutic Goods Administration
Weaver & Amin Attorneys at Law (US)
Weekes Preston Attorneys (Australian Consumer Goods Lawyers)

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

Copyright © 2002Robert Forbes & Associates Pty Ltd. All rights reserved.

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