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CMEC Meeting 07, 3 August 1998

Complementary Medicines Evaluation Committee

3 August 1998

Extracted ratified minutes

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CMEC Meeting 7 extracted ratified minutes (pdf,59kb)

Public recommendation summary

Item 3.1.4 Kombucha tea

Recommendation to TGA:

Request that ANZFA consider preparing a media statement about the safety of kombucha tea, targeted to people who brew it at home.

Item 3.1.5 Probiotic Organisms

Recommendation to TGA:

That action is taken to amend the Therapeutic Goods Regulations to include Lactobacillus acidophilus DDS-1, Bifidobacterium bifidum Malyoth strain and Lactobacillus Delbrueckii subspecies Bulgaricus LB-51. If the NFAA could identify the strain for Lactobacillus casei it could also be included in the amendment but the amendment was not to be delayed pending receipt of this information.

Item 3.1.6 Fibre, including chitosan

Recommendation to TGA:

  1. Chitosan is suitable for use as an active ingredient in Listable products without limits.
  2. A warning should be required on the effect of chitosan on the absorption of other drugs (subject to advice from a chemist) and a statement advising that the product of seafood origin.
  3. Seek another round of public comment on the proposal that fibre in capsule, tablet or pill form be declared to be therapeutic goods, under Section 7 of the Act.

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Item 4.1 Oligofructosaccharides for use as dietary fibre supplements

Recommendation to TGA:

  • Inulin and oligofructose are suitable for use Listable products provided that the recommended dose is limited to 40g per day and that the claims that the substance to be a source of dietary fibre is not supported until the definition of 'dietary fibre' is resolved between TGA and ANZFA.

Item 5.1 Selenium

Recommendation to TGA:

  1. That NDPSC be requested to consider that selenium in the form of sodium selenite, selenomethionine or selenocysteine in therapeutic goods at or below 100 µg per daily dose be removed from the SUSDP.
  2. That if NDPSC endorses recommendation 1, selenium compounds be permitted in listable therapeutic goods in tablet or capsule (not powder) form with a maximum dosage unit of 50 µg.
  3. That if NDPSC endorses recommendation 1, therapeutic goods containing selenium at or below 100 µg per daily dose require warning statements as follows:
    • 'This product contains selenium, which is toxic in high doses.'
    • 'Do not exceed a daily dose of 100 µg selenium from dietary supplements.'
    • 'Selenium-containing products are not suitable for use by children under the age of 15 years.'
  4. That if NDPSC endorses recommendation 1, therapeutic goods containing selenium at or below 100 µg per daily dose require an information statement as follows:
    • 'Signs of toxicity include loss of hair and nails...'
  5. That an education program be developed on the safe use of supplements, particularly supplements containing trace metals.

Item 6.1 Eucalyptus oil

Recommendation to TGA:

  1. CMEC agreed that consideration of the item be deferred until a letter to the company is prepared, under section 31 of the Therapeutic Goods Act 1989 if necessary, requesting the following information:
    • data on the composition of the product; and
    • stability data including details on the test methods used.
  2. NDPSC (through the Working Party on Essential Oils) be requested to prepare a monograph for these two substances (eucalyptus and rosemary oil) as a priority. When the monographs are available CMEC may consider similar products on the ARTG that were grandfathered.

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