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CMEC Meeting 09, 29 October 1998

Complementary Medicines Evaluation Committee

29 October 1998

Extracted ratified minutes

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CMEC Meeting 9 extracted ratified minutes (pdf,73kb)

Public recommendation summary

Item 3.1.2 Harmala alkaloids - request by NDPSC

Recommendation 1

CMEC recommends that CMS submit the scientific report on the relevance of Dr Bourke's research to human health to NDPSC and advise NDPSC that Dr Bourke's papers are not relevant to the proposed descheduling of herbs or therapeutic goods containing 0.1% or less, or 2 mg or less per recommended daily dose, of harmala alkaloids.

Recommendation 2

CMEC recommends that TGA Laboratories Branch analyse herbal products in the ARTG containing Tribulus terrestris and other herbs suspected of containing harmala alkaloids for the presence and levels of harman and norharman, at least, as a matter of priority.

Recommendation 3

CMEC recommends that TGA contract a consultant neurotoxicologist to review further the possible role of β-carboline derivatives in the pathogenesis of Parkinson's disease, and to examine the safety implications for people taking herbal medicines containing these alkaloids.

Recommendation 4

CMEC recommends that CMS conduct a fuller review of the safety of Tribulus terrestris, including its potential to increase testosterone concentrations in the body and to have toxic levels of nitrates, when time permits.

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Item 3.2.1 Shark cartilage

Recommendation 5

CMEC recommends that the following declaration be made under section 7 of the Therapeutic Goods Act, of goods to be therapeutic goods:

  • Shark cartilage in forms such as powders, capsules, tablets and pills.

Item 3.2.2 Probiotic organisms

Recommendation 6

CMEC recommends that all species and strains of probiotic bacteria currently in use in products included in the ARTG as at 31 July 1998 be permitted in listable therapeutic goods, other than Bifidobacterium dentium, Bacillus coagulans (also called Lactobacillus sporogenes), Bacillus laterosporus, Enterococcus faecium and Enterococcus faecalis, for which significant safety concerns exist.

Item 4 Evaluation of new substances

Item 4.1 Glucosamine

Recommendation 7

CMEC recommends that glucosamine, and its hydrochloride and sulfate salts, are suitable for use in listable therapeutic goods, provided the appropriate warning statements are included.

Item 5 New product registration evaluation

Item 5.1 Kunzea ambigua Essential Oil

Recommendation 8

CMEC recommends that CMS write to the sponsor, requesting efficacy and safety data to allow the evaluation of Kunzea ambigua essential oil for registration.

Item 5.2 Melaleuca oil

Recommendation 9

CMEC recommends that the product be approved for registration, providing that:

  1. It is labelled in accordance with the requirements of the SUSDP and Therapeutic Goods Order No. 48.
  2. The indications and directions proposed for use on the label and product carton not be amended or extended without prior approval.
  3. The sponsor provides further information on stability test data as outlined in the product evaluation, in order to confirm the tentative shelf life of 5 years.
  4. The sponsor to provide analytical data on the first batch to show that that the composition is within the Australian standard.

Item 8 Matters referred from within TGA

Item 8.1 Advice on proposed amendments to the Therapeutic Goods Advertising Code Council relating to the cholesterol-lowering effects of psyllium fibre

Recommendation 10

CMEC recommends that any amendments in regard to health claims for food-derived substances should be taken in conjunction with action by ANZFA. CMEC requests that industry be asked to provide information that could be used for substantiation of this amendment through TGACC.

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