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CMEC Meeting 28, 27 July 2001

Complementary Medicines Evaluation Committee

27 July 2001

Extracted ratified minutes

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CMEC Meeting 28 extracted ratified minutes (pdf,107kb)

Public recommendation summary

This summary has been posted immediately after the CMEC meeting to give quick advice of the recommendations made by CMEC to the TGA. This summary does not represent the decisions of TGA. Reasons underlying these recommendations will be available after Members ratify the Minutes at the next CMEC meeting.

Item 2 Minutes of CMEC's 27th meeting

Recommendation 28.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 27, 14-15 June 2001), as amended, are a true and accurate record of that previous meeting.

Item 6 Evaluation of new substances

Item 6.1 Chemically treated petroleum ether extract of conifer needles

Recommendation 28.2

CMEC recommends to the TGA that a chemically treated petroleum ether extract of conifer needles is not suitable for use as an active or excipient ingredient in listable therapeutic goods as insufficient evidence has been presented to support its long-term safety for human use.

Item 7 Safety or efficacy reviews

Item 7.1 Quercetin

Recommendation 28.4

CMEC recommends to the TGA that quercetin is suitable for use as an active ingredient in listable therapeutic goods.

Item 7.2 Tryptophan

Recommendation 28.5

CMEC recommends to the TGA that tryptophan is not suitable for use as an active or excipient ingredient in listable therapeutic goods as there is insufficient evidence to support its safety in listable goods.

Item 7.3 Kava

Recommendation 28.6

CMEC recommends that the TGA continue to monitor adverse effects associated with the use of kava and that no action be taken at this stage.

Item 10.4 Royal jelly

Recommendation 28.10

CMEC recommends to TGA that royal jelly-containing products should continue to carry the warning statements:

"This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers" (in 3 mm type)
OR
"Not to be taken by asthma and allergy sufferers" (in 3 mm type), combined with "Royal jelly may cause severe allergic reactions and in rare cases, fatalities" (in 1.5 mm type).

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