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CMEC Meeting 63, 12 October 2007

Complementary Medicines Evaluation Committee

12 October 2007

Extracted ratified minutes

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CMEC Meeting 63 extracted ratified minutes (pdf,96kb)

Public recommendation summary

This summary is posted shortly after the CMEC meeting to give quick advice 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.

Item 2 Confirmation of Draft Minutes of CMEC 62 (8 June 2007)

Recommendation 63.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 62, 8 June 2007), as amended, are a true and accurate record of that meeting.

Item 6.1 Evaluation of a New Substance - Rhodiola rosea

Recommendation 63.4

CMEC recommends to the TGA that R. rosea dried root (powdered), its aqueous extract and its hydroethanolic extracts (up to 70% ethanol v/v) are suitable for use as ingredients in Listed medicines, following finalisation of a compositional guideline.

Item 10.1 Review of Selenium label statement

Recommendation 63.9

CMEC recommends to the TGA that the following statement be included on the labels of all preparations for oral use containing selenium with a recommended daily dose of 150 µg or less of selenium:

"This product contains selenium which is toxic in high doses. A daily dose of 150 microgram, for adults, of selenium from dietary supplements should not be exceeded."

Item 10.2 Review of Vitamin A label statement

Recommendation 63.10

CMEC recommends to the TGA that the following statement be included on the labels of preparations for internal use containing 3 000 µg retinol equivalents or less of vitamin A other than those containing:

  1. 33 µg retinol equivalents or less of vitamin A per dosage unit of a divided preparation; or
  2. 33 µg retinol equivalents or less of vitamin A per gram of an undivided preparation.

"1. The recommended adult daily intake of vitamin A from all sources is 700 µg retinol equivalents for women, and 900 µg retinol equivalents for men.

2. WARNING - When taken in excess of 3 000 µg retinol equivalents, vitamin A may cause birth defects.

3. If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist."

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