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CMEC Meeting 31, 7 December 2001

Complementary Medicines Evaluation Committee

7 December 2001

Extracted ratified minutes

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CMEC Meeting 31 extracted ratified minutes (pdf,83kb)

Public recommendation summary

This summary has been posted immediately after the CMEC meeting to give quick advice of the recommendations made by CMEC to the TGA. This summary does not represent the decisions of TGA. Reasons underlying these recommendations will be available after Members ratify the Minutes at the next CMEC meeting.

Item 2 Minutes of CMEC's 30th meeting

Recommendation 31.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 30, 30 October 2001), as amended, are a true and accurate record of that previous meeting.

Item 5.1 Bovine colostrum extract

Recommendation 31.2

CMEC affirms its Recommendation 29.3 to the TGA in so far that bovine colostrum extract (BCE) is considered suitable for use as an active ingredient in listable therapeutic goods, subject to a label statement indicating that products containing bovine colostrum extract contain lactose and cow's milk proteins (or words to that effect).

CMEC amends that part of Recommendation 29.3 pertaining to use of BCE in children and recommends that labels of products containing BCE should included a warning that the product is not suitable for use in infants except on advice of a health professional.

Item 5.2 Activated charcoal

Recommendation 31.3

Further to Recommendation 30.6 (from CMEC 30) in which CMEC recommended that the TGA further investigate whether activated charcoal is suitable for use by children, CMEC recommends to the TGA that a warning statement be developed for the labels of products containing activated charcoal to the effect that:

  • activated charcoal should be used with caution in children since it may interfere with
  • absorption of nutrients; and
  • this substance may interact with other medicines; and
  • activated charcoal is not recommended for long-term use.

CMEC further recommends that none of these labelling requirements apply to homoeopathic medicines based on activated charcoal.

Item 6.1 Bovine colostrum powder

Recommendation 31.4

CMEC recommends to the TGA that bovine colostrum powder is suitable for use as an active ingredient in listable therapeutic goods, subject to the following conditions:

  1. a label statement indicating that products containing bovine colostrum powder contain lactose and cow's milk proteins (or words to that effect).
  2. a label statement indicating that products containing bovine colostrum powder are not suitable for infants except on advice of a health professional.

Item 10.1 Adverse reactions

Recommendation 31.5

CMEC recommends to the TGA that:

  • labelling of caffeine-containing herbal preparations should be reviewed with a view to indicating the presence of caffeine on labels; and
  • action be taken by the TGA in regard to the safety risk posed by illegal or potentially illegal products containing colloidal silver, including liaison with State and Territory jurisdictions and the National Drugs and Poisons Schedule Committee as and if required, and to contact complementary medicine practitioners to advise on safety concerns over colloidal silver.

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