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

4 September 2019

This consultation closed on 18 September 2019.

Invitation to comment

The TGA sought 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.

For more detail, please refer to item 1 of Schedule 2 to the proposed declaration attached.

Consultation documents

How to access a pdf or Word document


Document released for consultation on Wednesday 4 September 2019.

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

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

The TGA sought comments from interested parties on item 1 of Schedule 2 to the proposed declaration to inform the delegate's considerations as to whether or not the proposed declaration should be made.

Any decision as to the making of the proposed declaration remains under consideration pending this consultation process and associated deliberations.


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.


Submissions may address any, or all, aspects of item 1 of Schedule 2 to the proposed declaration.

Submissions might include:

  • suggested improvements
  • an assessment of how the proposed change will impact on you.
  • what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits. This is important - the TGA is required to quantify the regulatory impact (burden and/or savings) of any proposed changes.


Any questions relating to submissions should be directed to Sasha Barclay, Director, Regulatory Compliance by email to or by telephone to 02 6289 5150.

What will happen

It is proposed that all submissions received in response to this consultation will be published in full on this website in the interests of transparency. Accordingly, please ensure that the entirety of your submission is appropriate for publication.

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

A decision about making the declaration will be taken after submissions have been considered.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.