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CMEC Meeting 72, 22 May 2009
Complementary Medicines Evaluation Committee
Extracted ratified minutes
Public recommendation summary
This summary is posted shortly after the CMEC meeting to give quick notification of certain recommendations made by CMEC to the TGA. The TGA is yet to consider these recommendations and so this summary does not represent final decisions of TGA and should not be taken as such.
Reasons underlying these recommendations will be available after ratification of the Minutes at the next CMEC meeting. Other recommendations may be made at CMEC meetings but, because they concern confidential matters, or matters requiring further consideration by the TGA, they are not available for public disclosure.
CMEC confirms that the draft Minutes of its previous meeting (CMEC 71 March 2009), as amended, are a true and accurate record of that meeting.
CMEC endorsed the following coded indications, as acceptable for medicines making claims in relation to cholesterol:
- 'May help maintain normal [and/or healthy] cholesterol levels'.
- 'May help maintain cholesterol within the normal [and/or healthy] range and improve the HDL/LDL ratio'.
CMEC endorsed the following label advisory statement, for use when making indications/claims in relation to blood cholesterol levels:
- 'Not for the treatment of high cholesterol. Blood cholesterol levels should be regularly checked'.
CMEC recommends to the TGA that 'Calci-Tab 600' (tablets) is suitable for Registration in the Australian Register of Therapeutic Goods, subject to the appropriate labelling requirements.
CMEC recommends to the TGA that any herbal species confirmed as containing aristolochic acids is not suitable for inclusion in Listed medicines, as there is insufficient justification for any cut-off to be applied to preparations of such species.
The CMEC recommends to the TGA that Asarum spp. are no longer suitable for inclusion in Listed medicines, due to the increased potential for preparations of this genera to contain aristolochic acids.
CMEC recommends to the TGA that there is currently insufficient evidence to warrant a change to the current regulation and labelling of products containing preparations of Cimicifuga racemosa.
|Complementary Medicines Evaluation Committee meeting 72 (pdf)||152KB|