March 2003 - The Essential Technical & Regulatory E-News - Local & International

TGA News

Regulation of Colloidal Silver and Related Products
The Therapeutic Goods (Excluded Goods) Order has been amended so that products containing substances like colloidal silver, which are used in the purification or treatment of drinking water, but which make therapeutic claims, are no longer excluded from therapeutic goods legislation. This means that colloidal silver products making therapeutic claims are now therapeutic goods under the Therapeutic Goods Act 1989. The TGA has not approved any colloidal silver medicines and most of the products currently being marketed will become illegal therapeutic goods. The TGA will take action to stop the supply of these illegal therapeutic goods.

Suppliers wishing to market colloidal silver products as therapeutic goods will need to submit either an application to have colloidal silver approved as a new Listable substance (on the basis of demonstrated safety and quality) or an application to have products containing colloidal silver included on the Australian Register of Therapeutic Goods (on the basis of demonstrated safety, quality and efficacy). TGA update can be found at

New List of Ingredients with Restrictions & Conditions
A list of ingredients and the restrictions and conditions that apply when used in listable medicines, as at December 2002 is available at This is a rather daunting document at 360 pages. Clients of Robert Forbes & Associates may find it easier to refer to our document “Listed Actives” available on our website in the “Client Entry” section (you will need your client password)

Difference Between Elf 2.5 and Elf 2.6
The differences between Elf 2.5 and 2.6 in terms of restricted ingredients, coded warnings, and coded indications for use are explained at (ELF - Electronic Lodgement Facility – for submitting applications to the TGA for listing of medicines)

Sunscreen Agents Permitted As Actives in Listable Products
Effective 28 January 2003 a revised list of sunscreening agents permitted as active ingredients in listed products is available. The list was amended to remove a number of ingredients that were not included in any products currently authorised for sale in Australia and were no longer commercially available. If sponsors want to market a product with an active ingredient not on the list they must submit data to establish the safety of the ingredient under its proposed conditions for use. Isopropylbenzyl salicylate, benzophenone, benzophenone-2 and salicylic acid salts have been flagged for review. These substances are not approved for use in the US, EC or Canada. New products containing any of these ingredients will not be approved pending a safety review of these substances.


On 21st January Travacalm Original Tablets Blister pack was issued a Class I Recall following a number of reports of excess side effects related to the active ingredient.
(Batches 77164, 78586 and 79954) (Sponsor – Key Pharmaceuticals Pty Ltd)

On 30th January Travacalm HO hyoscine hydrobromide 300 micrograms tablets strip pack was issued a Class 1 Recall because the tablets do not conform to the uniformity of content specification. This means that some tablets contain the active ingredient in doses much higher than should be there, creating the risk of unintentional overdosing.
(Batch #’s: 77163, 79376) (Sponsor: Key Pharmaceuticals Pty Ltd)

On 31st January Sunsense Sports Milk sunscreen was issued a Class II Recall following the product being associated with a number of significant skin reactions.
(All batches) (Sponsor: Ego Pharmaceuticals Pty Ltd)

On 4th February Difflam - C Alcohol Free Solution was issued a Class II Recall due to possible microbial contamination in some bottles.
(All batches) (Sponsor - 3M Pharmaceuticals Pty Ltd)

[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.]

Food Standards

Currently there are two food standards under development by Food Standards Australia New Zealand (FSANZ). Proposal P242 - Medical Foods is close to finalisation and Application A470 for Formulated Beverages has recently commenced assessment and is now open for initial comment.

Medical Foods : The final comment period for this proposal closed in early February. The standard is intended to regulate foods that are used under medical supervision for the dietary management of people with medical conditions, disabilities or diseases. It includes Very Low Energy Foods for the medical management of obesity. Advertising of these foods to the general public is prohibited but allowed in health professional publications. Labelling is also tightly controlled, requiring warning statements and advice on precautions, side-effects, and contraindications and potential interaction with drugs. The Assessment Report and Draft Standard can be found on the FSANZ Website at

Formulated Beverages : It is now some time since Energy Drinks were regulated and able to be produced in Australia. They were originally only available in Australia as imports from or via New Zealand where they were compliant with the Dietary Supplements Regulations. A successful application by the manufacturers of Red Bull resulted in the Standard for Formulated Supplementary Caffeinated Drinks.

The Australasian Soft Drinks Association has applied for the category to be broadened to formulated drinks without the specific need to add a caffeine. Again such products can be legally sold in Australia if they come into the country from or via New Zealand as they are also covered by the Dietary Supplements Regulations.

FSANZ is considering this application in conjunction with the existing proposal for Food-Type Dietary Supplements (P235) and the yet to be released proposal P260-Medicinal Herbs, since New Zealand Dietary Supplements often contain herbal substances.

A470 is currently open for initial comment until 26th February, and the Initial Assessment report can be found at the FSANZ Website at

Global Nutrition Industry Worth $US150 Billion

Global nutrition industry sales grew to $150 billion in 2001 according to research recently published by the American Nutrition Business Journal. In the US, sales equated to $53 billion for the dietary supplement, natural personal care and natural, organic and functional food markets - making the U.S. the largest single nutrition market in the world.

However, 65% of global sales were registered outside the US. This new research, presented in the August/September 2002 issue of Nutrition Business Journal, shows that European markets grew 7.6% to $48 billion in consumer sales. This was followed by Japan with 9.1% growth and $27 billion in nutrition sales.

The $50-billion global supplement industry (which includes vitamins, minerals, herbs, sports, weight-loss and specialty supplements) saw slow or declining growth in mature markets, punctuated by pockets of positive growth in emerging markets. High growth countries included Malaysia and The Philippines in Asia, Spain and Italy in Southern Europe, and Poland and Russia in Eastern Europe.

New Clinical Guide to Herbs

The American Botanical Council (ABC) has announced the availability of its latest in-depth, therapeutic guide The ABC Clinical Guide to Herbs. This is a comprehensive study of 29 of the most commonly used herbs. Each of the herbs is presented with a comprehensive monograph, a clinical overview for quick reference to key issues regarding safety, therapeutic use, and a simplified information sheet for consumers and patients that includes descriptions, uses, cautionary information, adverse effects, drug interactions, and dosages. A separate chapter covers 13 proprietary herbal products that have undergone clinical studies. Visit the ABC website for information. Also ABC's exclusive worldwide trade distributor, Thieme New York Cost is US$49.95 plus shipping and handling.

FSANZ Phases out Ethylene Oxide

Food Standards Australia New Zealand (FSANZ) has reminded importers and retailers of herbs, spices and dried vegetables used in seasonings that residues of ethylene oxide, a sterilising agent, will not be permitted in Australia from 1st October 2003.From this date there will be no "stock-in-trade" exemptions and any products containing residues must be removed from retail shelves. Ethylene oxide has in the past been used to control bacterial pathogens such as Salmonella in herbs, spices and dried vegetable seasonings for many years, however, tests have shown that ethylene oxide residues may pose a risk to human health.

New Chief for FSANZ

Graham Peachey has been appointed as the new Chief Executive Officer of Food Standards Australia New Zealand (FSANZ). Graham Peachey's current position is Executive Head of the Trans-Tasman Group of the Therapeutic Goods Administration. He has also been Director of the Chemicals and Non-Prescription Medicines Branch of the Therapeutic Goods Administration. In 1993 Mr Peachey was appointed to the then National Food Authority where he played a major role in the development of the Treaty between Australia and New Zealand to establish a common food standards system and a new bi-national food regulator, the Australia New Zealand Food Authority. He continued as a General Manager with ANZFA until 1998.

Baseball Players Death Linked to Ephedra Supplement

A Florida coroner has linked the use of an ephedra supplement to the death of 23 year old pitcher Steve Bechler and has urged baseball to ban the herbal stimulant. Whilst toxicology results weren't available at the time the Chief Medical Examiner stated they had enough to make this preliminary determination. Ephedra supplements are used to boost energy and promote weight loss - however several sporting groups have banned its use including the international Olympic Committee. The FDA is reported to have linked ephedra 1,400 "adverse events" -- including at least 80 deaths. Bechler complained of dizziness on Sunday after a training workout and was taken to a Medical Centre, where he was treated for heat exhaustion. His organs began failing as his temperature rose to 108 degrees. He died Monday morning. Click here for news article

Lancet Study Highlights Hazards of Supplementation

Researchers of a study published in the Lancet Medical Journal on January 11th 2003, claim research into the hazards and risks of taking dietary supplements should be a priority, after they assessed the adverse events caused by natural supplements.

The report looked at the role played by dietary supplements in adverse events recorded by 11 poison control centres in the US during 1998. The researchers said that out of more than 2,300 calls about dietary supplements, almost 500 people had symptoms probably caused by a supplement. The researchers urged that a better surveillance system be set up, and a register of all supplement ingredients be available to the poison centres. (Lancet 2003:361:101-6, January 11)
For pdf file of study click here.

International News

European Parliament Introduces a Ban on Animal Testing of Cosmetics from 2009
A new directive (seventh amendment of Directive 76/768/EEC on cosmetics) covering products including shower gels, shampoos and creams, aims to improve animal welfare without jeopardising consumer safety and the protection of human health. On January 15 2003, Parliament agreed a 2009 deadline for the complete ban on animal testing of cosmetics where alternative non-animal tests are currently unavailable. The industry managed to secure a 2013 ban date for the case of three tests that are particularly difficult to replace. As an internationally debated element in the decision, the animal testing ban includes a ban on imports into the EU of beauty and hygiene products produced outside the bloc. The Council's final approval of the new legislation is expected shortly.

European Commissions Draft Proposal on Addition of Vitamins & Minerals to Foods
The European Commission has published a draft proposal for a directive on the addition of vitamins, minerals and other substances to food. Adding nutrients to foods remains a largely unregulated area and rules between European states differ greatly. The proposal will result in a list of permitted vitamins, minerals and vitamin formulations, with a further list for substances subject to conditions (these will remain on the list for three years during which time businesses may submit scientific data demonstrating that the substance is safe). Certain substances will be restricted or prohibited for use, such as the Kava Kava and St John's Wort and levels of caffeine and quinine in soft drinks, and certain products, including fresh produce (meat, fish and fruit and vegetables) and alcoholic drinks, will not be open to additives. In addition there will be strict labelling laws so that consumers are not mislead as to the merit of added nutrients.

New Task Force in Us to Look Into Health Claims on Foods
The FDA Commissioner has announced the formation of a new Task Force to look into Health claims on foods. The group will develop scientific guidance for establishing standards for qualified health claims in foods.

Principal aims of the task force for the next six months include a report on how the agency should apply the "weight of the evidence" standard established under the consumer health information initiative for qualified health claims on conventional foods and to develop a framework of regulations that will give these principles the force and the effect of law.

In addition the group will examine the most effective way to present scientifically based information to consumers in a truthful and non-misleading manner, and to identify the kinds of information known to be misleading to consumers.

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