You are here
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
CMEC Meeting 13, 11 June 1999
Complementary Medicines Evaluation Committee
Extracted ratified minutes
Public recommendation summary
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 5.1 Hydroxycitric acid
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.
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 6.1 Paullinia cupana (Guarana)
- 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.
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.
CMEC did not recommend a variation to a currently registered product as sought by the sponsor.
|CMEC 13 Extracted Ratified Minutes (pdf)||40KB|