Proposed Section 7 Declaration: that products in capsule, tablet or pill form are therapeutic goods
Call for comment
This consultation closed on 30 November 2009.
6 October 2009
Document
Written submissions are invited on the following document:
Background
In Australia, it has long been recognised that there is a legislative 'interface', or overlap, between foods and medicines for human oral consumption. As the food and complementary medicine sectors have evolved over recent years, a 'grey area' has unintentionally developed at this food-medicine interface. The confusion is due to certain areas of food legislation and therapeutic goods legislation overlapping in such a way that makes it difficult to determine which legislation should be applied in many cases.
Currently, some orally consumed products fall under the definition of both a food and a therapeutic good. This situation is creating uncertainty for many people and organisations, including importers, manufacturers, consumers, and government regulators. There is particular concern regarding the potential for this confusion to prevent the consumer from making an informed choice. There is also a potential public health and safety risk arising from this situation, particularly if the products in question have not been manufactured to an acceptable standard or are found to be contaminated and/or to include a prescription-only substance.
The Therapeutic Goods Administration (TGA) and Food Standards Australia and New Zealand (FSANZ) have recognised that the food-medicines interface confusion is heightened by the practice of presenting certain foods in capsule, tablet or pill form. This form of presentation, except in the case of unmedicated confectionary, gives the impression that the product is a medicine. The impression that a product is a medicine carries consumer expectations that the product has been assessed by the TGA and that the claims on the label have been approved.
The current proposal to declare (under Section 7 of the Therapeutic Goods Act 1989) that goods presented for oral consumption in tablet, capsule or pill form are therapeutic goods, aims to resolve many of these issues and clarify regulatory requirements for industry. Should this initial consultation indicate that the Section 7 Declaration is warranted, a full regulatory impact statement would be prepared.
Enquiries
Enquiries should be directed via email to Section7consultation@tga.gov.au.
Notes on submissions
All submissions received will be placed on the TGA's website, unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.
For submissions made by individuals, all personal details, other than your name, will be removed from your submission before it is published on the TGA's website. In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.