Section 7 declarations - food or therapeutic good?
Background
Section 7 declarations are made under the Therapeutic Goods Act 1989 (the Act) 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. Goods or classes of goods that are declared to be therapeutic goods via a section 7 declaration must be included on the Australian Register of Therapeutic Goods (ARTG).
A declaration does not necessarily mean that a product, or class of products, is approved for supply in Australia. It is the responsibility of sponsors to make an application to have particular products included on the ARTG if they have not already done so.
It should be noted that the Act was amended, with effect from 27 November 2002, to stipulate that 'therapeutic goods' include goods that have been declared to be therapeutic goods under section 7 of the Act, even if they are also goods for which there is a prescribed standard in the Australia New Zealand Food Standards Code.
Declarations made
The following section 7 declarations that relate to complementary medicines have been made prior to the November 2002 amendment:
- the product "Cellasene" and any products containing "Cellasene" were declared to be therapeutic goods on 3 December 1998. Order No 1, gazette no S568 refers;
- fibre in capsule, tablet or pill form was declared to be a therapeutic good on 8 February 1999. Order No 1 of 1999 <http://www.tga.gov.au/legis/ogtg9901.htm>, gazette GN9 refers;
- goods labelled and promoted for cosmetic purposes when presented for oral consumption packed and labelled for cosmetic use, were declared to be therapeutic goods on 1 March 1999. Order No 2 of 1999, gazette S88 refers;
- shark cartilage, when presented in the form of capsules, pills, tablets or powder, other than as a wholesale product in powdered form for use as an ingredient in food, was declared to be a therapeutic good on 14 April 1999. Order No 3, gazette GN 15 refers; and
- goods containing, or promoted as containing, isolated HMB (including b-hydroxy-b-methylbutyrate) or its salts, when presented in the forms of powders, tablets, capsules or pills were declared to be therapeutic goods on 14 April 1999. Order No 4, gazette GN 15 refers.
An amendment was made to Schedule 4 of the Therapeutic Goods Regulations, with effect from 1 January 1999, to provide for products containing shark cartilage to be listed on the ARTG. An amendment was also made on 25 June 1999 to provide for products containing HMB to be listed on the ARTG. No amendment to the regulations was necessary for the first three declarations.
For further information on this topic contact the TGA Information Officer by telephone on 1800 020 653 or email to info@tga.gov.au.