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CMEC Meeting 13, 11 June 1999

Complementary Medicines Evaluation Committee

11 June 1999

Extracted ratified minutes

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CMEC Meeting 13 extracted ratified minutes (pdf,41kb)

Public recommendation summary

Item 4 Report of the Working Party on Substantiation of Claims

Recommendation 1

CMEC and its Expert Advisory Panel endorses the direction being taken by the Working Party on levels of evidence needed to support claims and commended the Working Party to continue working on it and to bring it to implementation stage.

Item 5 Evaluation of new substances

Item 5.1 Hydroxycitric acid

Recommendation 2

CMEC recommends that hydroxycitric acid and its sodium, potassium and calcium salts are suitable for use as active ingredients in listable therapeutic goods but that a standard be developed for it and its sodium, potassium and calcium salts in order for it to be placed in Schedule 4.

CMEC also noted that the evidence before it relates to hydroxycitric acid (and its sodium, potassium and calcium salts) was not sufficient to support claims for these substances for weight loss in humans.

Item 5.2 Medicago sativa (Alfalfa)

Recommendation 3

CMEC recommends that Medicago sativa (alfalfa) is a herbal substance suitable for use as an active ingredient in listable therapeutic goods without restricting daily doses or dose size subject to:

  • determining the L-canavanine content of all parts of the Medicago sativa plant;
  • determining the details of the Medicago sativa tablets that were the subject of the adverse reactions reported in the evaluation; and

Once these data are available, CMEC will further consider the possible need for a warning in regard to the potential of the product to cause, or exacerbate, systemic lupus erythematosus (SLE).

Item 6 Safety review

Item 6.1 Paullinia cupana (Guarana)

Recommendation 4

CMEC agrees

  • to maintain Paullinia cupana as a listable substance but require both a label statement alerting consumers to the fact that Paullinia cupana contains caffeine and a label statement of the amount of caffeine, in milligrams, per unit dose but that the OCM brings back to CMEC a recommendation for a threshold caffeine level of guarana-containing products below which consideration would be given to the latter statement not being required;
  • that no restrictions should be placed at this time on the combination of Paullinia cupana with other stimulant substances; and
  • no new warning statements were required on guarana containing products in relation to anticoagulant therapy.

Item 6.3 Cut off level for warnings for Piper methysticum (kava)

Resolution 1

CMEC defers a decision on the warnings on kava products because of:

  • lack of evidence on cut-off levels for requiring such warnings; and
  • the need for a more extensive discussion of this issue than was possible at the meeting.

Item 7 Variation to a registered product

Item 7.1

Recommendation 5

CMEC did not recommend a variation to a currently registered product as sought by the sponsor.

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