Senator Allison asked the Minister representing the Minister for Health and Ageing, upon notice, on 2 March 2004:

(1) What nutritional supplements for use by health professionals have been denied listing by the Therapeutic Goods Administration over the past 10 years and for what reasons.

(2) Which of these products is currently available in New Zealand and the United States of America.

(3) What is the appeal process when a nutritional supplement is denied listing.

Senator Ian Campbell (Minister for Local Government, Territories and Roads) —The Minister for Health and Ageing has provided the following answer to the honourable senator's question:

(1) and (3) In Australia, nutritional supplements are classified and regulated as `complementary medicines'. Most complementary medicines are considered to be lower risk medicines and are Listed in the Australian Register of Therapeutic Goods (ARTG).

Listed medicines may only contain ingredients approved by the Therapeutic Goods Administration (TGA) as being suitable for use in low risk medicines. New ingredients for use in Listed medicines are evaluated by the TGA in response to an application from a sponsor. Based on the data supplied by the sponsor and other data, a comprehensive evaluation report is prepared by the staff of the Office of Complementary Medicines. The evaluation report is also put forward for consideration by the Complementary Medicines Evaluation Committee (CMEC), an independent, expert committee.

The key factors considered when evaluating a new complementary medicine substance are quality and safety. Adequate quality control ensures that products contain the correct amounts of specified ingredients and do not contain unsafe amounts of ingredients or contaminants. The safety evaluation determines whether the substance is of sufficiently low risk so as to allow its inclusion in lower risk complementary medicines.

Since its establishment in 1998, the CMEC has recommended to the TGA that, based on the data available at the time of review, eleven substances are not suitable for use in Listed medicines. These substances are as follows:

- Arginine;

- Conjugated linoleic acid 75%;

- Conjugated linoleic acid 60%;

- Chemically treated petroleum ether extract of conifer needles;

- Tryptophan;

- Calcium glucarate;

- Potassium chloride;

- Red yeast rice;

- Isobutylene-isoprene copolymer (butyl rubber);

- Commiphora mukul oleo-gum resin ethyl acetate extract; and

- Active hexose correlated compound.

All therapeutic goods must be included in the ARTG prior to entering the marketplace. The TGA does not evaluate Listed complementary medicines prior to inclusion in the ARTG. Rather, they are automatically included in the ARTG following on-line application to the TGA by the sponsor and self-certification that the product is eligible for Listing, provided the required fees have been paid. If an application to List a product does not conform with particular requirements it will not be accepted by the on-line Electronic Listing Facility. Following Listing, a statistically significant proportion of these medicines undergo post-market review on a random or targeted basis, to ensure they conform with the legislative requirements for Listed medicines. Regulatory action may be taken against products that do not conform, such as cancelling or proposing to cancel a product from the ARTG.

Decisions by the TGA in relation to certifications made for Listed medicines are reviewable under Section 60 of the Therapeutic Goods Act 1989.

(2) This information is unavailable, as neither New Zealand nor the United States maintains a national register of such products. In addition, the name of a product available in Australia may not be the name used for the same product in other countries.