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CMEC Meeting 11, 24 February 1999

Complementary Medicines Evaluation Committee

24 February 1999

Extracted ratified minutes

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CMEC Meeting 11 extracted ratified minutes (pdf,41kb)

Public recommendation summary

Item 3 Working Party on Priorities for the Review of Herbs

Item 3.1.1 CMEC10 refers (Dr Myers)

Recommendation 1

The present CMEC recommends that Dr Stephen Myers, on behalf of the Working Party, submits a final report for review by a future (reconstituted) CMEC.

Item 4.1 Coenzyme Q10

Recommendation 2

CMEC recommends that coenzyme Q10 is suitable for use in listable therapeutic goods with the following requirements:

  1. A maximum daily recommended dosage of 150 mg; and
  2. Coenzyme Q10 products to carry the warning statement "do not take while on warfarin therapy without medical advice".
  3. Dr Stephen Myers will prepare a Position Paper, for CMEC12, on the justification for the inclusion of warning statements that medical advice should be sought before taking any complementary medicine in conjunction with warfarin therapy for ADEC's consideration.

Item 5.1 Echinacea

Recommendation 3

CMEC recommends that Echinacea be maintained as a listable substance with no additional conditions.

Item 6.1 Bifidobacterium longum

Recommendation 4

CMEC recommends that the registration application be rejected due to insufficient product efficacy data to support product claims.

Item 6.2 Coenzyme Q10

Recommendation 5

CMEC recommends that the registration application be rejected due to insufficient efficacy data to support the product claims.

The Office of Complementary Medicines should inform the sponsor of the previous recommendation (1) that coenzyme Q10 be accepted for use in listable goods.

Item 8.1 Regulatory status of herbal component names

Recommendation 6

CMEC recommends that Industry and the TGA work together to produce a workable mechanism that addresses both Industry and TGA concerns.

Item 8.2 Identifying low risk herbal ingredients

Recommendation 7

CMEC recommends that the TGA coordinate a consultative forum with Industry and Stakeholders to discuss the issue of Low Risk Herbal Substances.

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