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CMEC Meeting 03, 12 March 1998

Complementary Medicines Evaluation Committee

12 March 1998

Extracted ratified minutes

How to access a pdf document

CMEC Meeting 3 extracted ratified minutes (pdf,32kb)

Public recommendation summary

Item 3.1.4 Royal jelly safety review - item 3.4 of CMEC2 refers

Recommendation

CMEC agreed to recommend to the TGA:

  • that, in relation to the royal jelly label warning, a short warning attracting the attention of those most needing the warning was necessary in conjunction with a longer warning giving the same information as the current warning ie:
    • "not to be taken by asthma and allergy suffers' in letter 3 mm high followed by a longer warning in standard type of 1.5 mm covering the remaining information in the present warnings".

Item 3.2.1 Safety of herbal ingredients - item 3.3 of CMEC1 refers

Recommendation

CMEC agreed to recommend to the TGA:

that the document titled 'Therapeutic Goods Administration - Proposal for Public Comment: Identifying Low Risk Herbal Ingredients' to be circulated for comment with section 7 of the TGA paper titled 'Arrangements for Complementary Medicines and Related Matters' attached.

Item 4.1 Starch sodium octenyl succinate

Recommendation

CMEC agreed to recommend to the TGA:

that, having evaluated the safety of starch sodium octenyl succinate, this substance is suitable for use as an excipient ingredient in therapeutic goods listed in the ARTG for supply in Australia.

Item 5.1.2 Piper methysticum, kava - safety review

Recommendation

CMEC agreed to recommend to the TGA:

To maintain kava, Piper methysticum, as a substance permitted with certain conditions to be included in products listed in the ARTG for supply in Australia and to recommend to the National Drugs and Poisons Schedule Committee not to include kava in Schedule 4 of the Standard for the Uniform Scheduling of Drugs and Poisons.

Recommendation

CMEC agreed to recommend to the TGA:

to impose the following list of restrictions on therapeutic goods containing kava, Piper methysticum, listed in the ARTG for supply in Australia:

  1. a maximum recommended daily dose of 250 mg of kavalactones
  2. a maximum amount of kavalactones per tablet or capsule of 125 mg and a maximum amount of dried rhizome per tea bag of 3 g.

Item 5.2 Harmala alkaloids

Recommendation

CMEC agreed to recommend to the TGA:

to work towards a legal means of excluding nominated species such as Passiflora incarnata, which include harmala alkaloids, from poisons scheduling and prohibition of importation.

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