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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.
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Item 2 Minutes of CMEC's 40th Meeting
Recommendation 41.1
CMEC confirms that the draft Minutes of its previous meeting (CMEC 40, 30 May 2003), are a true and accurate record of that previous meeting.
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Item 7.1 Safety Review of Kava (Piper methysticum)
Recommendation 41.2
The CMEC endorses the following four recommendations made by the Kava Evaluation Group (KEG), and recommends to the TGA:
Recommendation 1
That:
- aqueous dispersions of whole or peeled rhizome of Piper methysticum;
- aqueous extracts of whole or peeled rhizome of Piper methysticum; and,
- dried whole or peeled rhizome of Piper methysticum
are suitable for use as ingredients in Listed medicines for oral use, subject to the following conditions:
- the preparation does not contain, for its recommended daily dose, more than 250 mg of kavalactones; and
- if the preparation is in a tablet or capsule - the amount of kavalactones does not exceed 125 mg for each tablet or capsule; and
- if the preparation is in a tea bag - the amount of dried whole or peeled rhizome does not exceed 3 g for each tea bag; and
- if the preparation contains more than 25 mg of kavalactones per dose - the label on the goods includes the following warnings (or words to the same effect):
- Not for prolonged use. If symptoms persist, seek advice from a healthcare practitioner;
- Not recommended for use by pregnant or lactating women; and
- May harm the liver.
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Recommendation 2
That Piper methysticum may be used in homoeopathic preparations more dilute than a thousand fold dilution of a mother tincture.
Recommendation 3
That:
- aqueous dispersions of whole or peeled rhizome of Piper methysticum;
- aqueous extracts of whole or peeled rhizome of Piper methysticum; and,
- dried whole or peeled rhizome of Piper methysticum
are suitable for use as ingredients in Listed medicines for topical application to the rectum, vagina and by spray to the throat.
Recommendation 4
That Piper methysticum may be used as an ingredient in Listed medicines for topical application to the skin.
Recommendation 41.3
The CMEC recommends to the TGA that products containing Piper methysticum must be Registered prior to their supply, other than:
- aqueous dispersions of whole or peeled rhizome of Piper methysticum;
- aqueous extracts of whole or peeled rhizome of Piper methysticum;
- dried whole or peeled rhizome of Piper methysticum;
- products for topical application to the skin; and
- homoeopathic preparations more dilute than a thousand fold dilution of a mother tincture.
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Item 7.2 Safety review of Chelidonium majus (Greater Celandine)
Recommendation 41.4
CMEC notes the safety review conducted by the TGA and recommends that the TGA maintain Chelidonium majus as an ingredient for use in Listed medicines, but with a warning statement to be included on the label of oral products. The statement is to advise consumers to use products containing the herb under the supervision of a healthcare practitioner, to caution consumers who have a history of liver disease, and to warn consumers to discontinue use of the herb if particular symptoms indicative of liver problems occur.
Item 7.3 Safety review of chromium (III) picolinate
Recommendation 41.5
CMEC notes the safety review conducted by the TGA and recommends that the TGA maintain chromium picolinate for use as an active ingredient in Listed medicines with a maximum daily dose of chromium of 50µg, as specified in Schedule 4, Part 5, Division 2, Subdivision 2 of the Therapeutic Goods Regulations.
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Item 7.4 Safety review of betacarotene
Recommendation 41.6
CMEC notes the preliminary safety review undertaken by the TGA, and recommends that a full safety review of betacarotene for use as an ingredient in Listed medicines be undertaken.
Item 10.4 Proposal for label warning regarding chewable tablets
Recommendation 41.10
CMEC recommends to the TGA that an advisory statement be included on the label of products where the dosage form is a chewable tablet, emphasising the need to chew the tablet, and including the statement “Not to be swallowed whole”.
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