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CMEC Meeting 12, 27-28 April 1999

Complementary Medicines Evaluation Committee

27 April 1999

Extracted ratified minutes

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CMEC Meeting 12 extracted ratified minutes (pdf,37kb)

Public recommendation summary

Item 2 Review of the Therapeutic Goods Advertising Code

Recommendation 1

That a Working Party be established, to deal with the levels, types and quality of evidence needed for substantiation of claims made in labelling and advertising of therapeutic goods, consisting of the Chairperson Professor Roberts, Ms Heather Yeatman, Dr Stephen Myers, Ms Val Johanson and Mr Graham Peachey.

Recommendation 2

That the Working Party holds three meetings to formulate a draft submission on behalf of CMEC to the review of the Advertising Code.

Recommendation 3

The draft submission should be considered at the next CMEC meeting.

Item 3.1 Report of the Working Party on Priorities for the Review of Herbs

Resolution 1

CMEC accepts the Report of the Working Party on Priorities for the Review of Herbs.

Resolution 2

CMEC requests TGA to prepare a paper, indicating future directions, for discussion at the next CMEC meeting.

Item 4 Herbal substances ARTG information requirements

Recommendation 4

That the decision on Herbal Substances ARTG Information Requirements be deferred pending further information on the proposed Electronic Lodgement Facility which is to be the subject of a presentation to the next CMEC meeting.

Item 5 Action arising from previous meetings

Item 5.1 Proposed consultancy regarding the regulation of probiotic organisms

Recommendation 5

That the Consultancy be arranged in the form drafted without amendment.

Item 6 Evaluation of new listable substances

Item 6.1 Squalene

Recommendation 6

That squalene is suitable for use as an active ingredient in listable therapeutic goods but that there be a warning related to the conflicting evidence of the effects on cholesterol in humans.

Recommendation 7

That TGA consults with stakeholders on a suitable form of wording for this warning and report back to next meeting of CMEC or as soon as possible thereafter.

Item 6.2 Bifidobacterium longum

Recommendation 8

That Bifidobacterium longum BB536 is suitable for use as an active ingredient in listable therapeutic goods.

Item 6.3 Ca-HMB

Recommendation 9

That Ca-HMB (calcium hydroxymethyl butyrate*) is suitable for use in listable therapeutic goods, without restrictions on daily doses or dose size.

Please note: While the CMEC review process established that CaHMB was of low risk, a corollary to that decision was CMEC's conclusion that current evidence does not support any therapeutic claims for CaHMB associated with lean muscle mass increase.

*AAN pending

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