The Therapeutic Goods Administration
("TGA") is proposing changes to the
Therapeutic Goods Act 1989
("Act") that would result in the form of
a product being a key factor in determining whether it constitutes
a medicine or a food.
Currently, the regulatory regimes relating to foods and
medicines often overlap. For example:
there are food standards for many substances that may be
marketed as medicines, such as formulated products categorised as
supplementary sports foods and edible oils (for example fish oil,
flaxseed oil); and
there are some medicines which have the properties of
The TGA and the Food Standards of Australia and New Zealand
("FSANZ"), consider that confusion
exists for importers, manufacturers, consumers and government
regulators as to which regulatory regime (and legislation) applies.
In other words, it is necessary for relevant parties to determine
the product is classified as a medicine, in which case the
product will require listing or registration with the TGA and must
comply with the Act; or
the product is classified as a food, in which case the product
will need to comply with the FSANZ Code (and the relevant State and
Territory Food Acts).
These authorities take the view that the confusion that exists
between foods and medicines increases where certain foods are
packaged in capsule, tablet or pill form. This view is reached on
the basis that the form of the packaging/presentation of the
product creates the impression that the product is a medicine and
consumers may consider that such foods have been assessed by the
TGA when, in fact, this has not occurred.
Proposed Section 7 Declaration
The proposal to issue a declaration (under Section 7 of the Act)
will attempt to resolve many of the issues and clarify regulatory
requirements in relation to the food/medicine interface issue.
This will result in any products packaged in capsule, tablet or
pill form being deemed to be classified as a medicine.
How this may affect you?
If you are manufacturing, importing, marketing or selling
certain food products in capsule, tablet or pill form, the proposed
Section 7 Declaration will cause those products to be classified as
medicines (unless they are unmedicated confectionary): they will
require listing or registration with the TGA and compliance with
This will result in many products sold currently as foods in
capsule, tablet or pill form which are not currently listed by the
TGA being required to be listed by the TGA in order to be marketed
and sold in Australia. This will impact on suppliers of various
products, including food products and sports supplements.
Any submissions to the TGA on this issue must be made by
30 November 2009.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
What happens if a patient, particularly a mental health patient,.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).