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

Published

27 November 2019

Further comments received

27 November 2019

Following the close of the public consultation, the TGA separately provided interested parties with an opportunity to comment on information before the TGA. This information concerned a complaint made by one party to the TGA about a particular product presently marketed as a food for special medical purposes and associated correspondence, along with reference to particular scientific articles and clinical practice guidelines.

The comments provided in response by interested parties ('respondents') included personal information (as defined under the Privacy Act 1988) and information provided in confidence. The following summary is provided regarding the comments made:

The general view was that the extra material did not change the respondents' position. The respondents reiterated views made during the public consultation (noting the majority of submissions received in the public consultation objected to the proposed declaration).
Respondents disagreed with the views of the complainant and provided a critique of those views.
Respondents provided an analysis of (or commentary on) the scientific articles and the clinical practice guidelines, and referenced other scientific articles. The general consensus was that one scientific article (included in the opportunity to comment) was considered not to be relevant.
Some respondents noted there is a place for a food for special medical purposes to include folate for dietary management of some conditions.

Submissions

31 October 2019

The TGA thanks individuals and organisations who provided submissions in response to the public consultation paper: Proposed clarification that goods are therapeutic goods - goods containing folate substances in certain circumstances.

On 4 September 2019, the TGA undertook public consultation on the 'Proposed clarification that goods are therapeutic goods – goods containing folate substances in certain circumstances'. Comment was sought by 18 September 2019.

As part of the public consultation, the TGA published a draft order proposed to be made under subsection 7(1) of the Therapeutic Goods Act 1989. The proposed declaration (if made) would have the effect of declaring that certain goods containing folate substances, when used, advertised, or presented for supply for therapeutic use (including but not limited to therapeutic use relating to depression, inborn error of metabolism, or folate deficiency) are therapeutic goods for the purposes of the Act.

Twenty-five submissions were received from a range of respondents.

The majority of the submissions received objected to the proposal. Objections were mainly due to:

financial and other impacts on a particular entity (and its investors and staff), which currently supplies goods that may be affected by the proposed declaration; and
the potential loss of access to the relevant goods by consumers and the hardship those consumers might face as a consequence of the goods being therapeutic goods (some respondents were concerned that relevant schemes under the Act for alternative access would not be effective).

One submission from an industry representative advocated that goods used, advertised or presented for supply for therapeutic use should be regulated as therapeutic goods.

All submissions have been provided to the delegate responsible for determining whether or not the proposed declaration should be made.

All submissions that gave permission to be published on the TGA website are now available below in PDF format.