5 de setembro de 2019

TGA NEWS: Consultation: Proposed clarification that goods are therapeutic goods - goods containing folate substances in certain circumstances

From: www.tga.gov.au

The TGA is seeking comments from interested parties on the making of an order under subsection 7(1) of the Therapeutic Goods Act 1989 ('the Act') to declare a particular class of goods, when used, advertised or presented for supply in a particular way, to be therapeutic goods ('the proposed declaration').

Specifically, the class of goods that is proposed to be declared comprises goods containing folate substances in circumstances where these goods are represented as being food for special medical purposes, or being for dietary management of a disease, disorder or medical condition.

The proposed declaration is to the effect that when these goods are used, advertised, or presented for supply for therapeutic use (including but not limited to therapeutic use relating to depression, an inborn error of metabolism, or folate deficiency) the goods are therapeutic goods for the purposes of the Act.

Interested parties should respond by close of business Wednesday 18 September 2019.

How to participate?

Complete the online consultation submission form to upload your submission in either pdf or word format.

Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:

Regulatory Compliance Section
Regulatory Compliance and Education Branch
Therapeutic Goods Administration
PO Box 100


In Australia, foods are permitted to be supplied to consumers without prior regulatory approval by state and territory food authorities. Therefore, goods may be brought to market as foods without prior regulatory assessment as to whether those goods are indeed foods or therapeutic goods under law. 

The TGA has become aware that some goods, which are purported to be foods for special medical purposes (‘FSMP’), are being marketed and supplied to consumers in circumstances where there may be an issue as to their characterisation as therapeutic goods. This situation may arise due to misunderstandings regarding the interpretation of the definition of FSMP in Food Standard 2.9.5, which is a legislative instrument made under the Food Standards Australia New Zealand Act 1991. 

If a declaration of the proposed kind is made under the Act, the effect would be to clarify that goods described by the terms of item 1 in Schedule 2 to the proposed declaration are subject to regulation as therapeutic goods, specifically a medicine (and not subject to the separate regulatory scheme for foods). Consideration is being given by the respective delegate as to the making of the proposed declaration in order to provide certainty for industry and other stakeholders that such goods are indeed therapeutic goods despite any representation purporting otherwise. 

Regulation under the Act ensures that goods, which are represented in any way to be, or that are, whether because of the way in which those goods are presented, or for any other reason, likely to be taken to be for therapeutic use, are subject to the national system of controls in place to ensure those goods are of appropriate quality, safety and efficacy. 

Any goods affected by the making of the proposed declaration would need to be registered or listed (as required) on the Australian Register of Therapeutic Goods (‘ARTG’). Continued supply of goods subject to the proposed declaration (if made) without any such controls is incompatible with the intended use of those goods and the independent systems of regulation for foods and therapeutic goods. 

If the proposed declaration were to be made, any patients that may be affected, for example, by unavailability during the period following the commencement of the declaration prior to registration or listing (as required) on the ARTG, may seek to access those affected goods via the Authorised Prescriber or Special Access Schemes under the recommendation of their treating physician.