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CMEC Meeting 05, 14 May 1998

Complementary Medicines Evaluation Committee

14 May 1998

Extracted ratified minutes

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CMEC Meeting 5 extracted ratified minutes (pdf,42kb)

Public recommendation summary

Item 3.1.1.2 Shark cartilage - item 4.1 of CMEC4 refers

Recommendation to TGA:

  • that a proposal that shark cartilage in forms such as powder (subject to evidence of use as a food), capsules, tablets, and pills, be declared to be therapeutic goods, under section 7 of the Act, be circulated for a second round of public comment (subject to evidence on the use of shark cartilage powder as a food).

Recommendation to TGA:

The following warning statement be included for discussion in the proposal:

Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice. (1.5 mm type with consideration of larger type for larger containers).

Recommendation to TGA:

A proposed monograph for shark cartilage be circulated for comment as follows:

Definition
Shark cartilage is the cartilaginous material derived from species of the class Chondrichthyces, sub-class Elasmobranchii. It has been cleaned of adhering flesh and blood and may or may not be dried and milled.

Contaminants
Shark cartilage shall not contain more than the maximum permitted concentrations of the following metals:

Metal Maximum permitted concentration
Lead 0.5 mg/kg
Copper 10.0 mg/kg
Mercury 1.0 mg/kg
Arsenic 1.0 mg/kg as inorganic arsenic
Antimony 1.5 mg/kg
Selenium 1.0 mg/kg
Zinc 150 mg/kg

Methods of analysis
As specified in the US Pharmacopoeia.

This monograph would be included for comment in the proposal for a section 7 declaration for shark cartilage when it is circulated for a second round of public comment.

Recommendation to TGA:

  • that TGA laboratories assay the heavy metal levels in shark cartilage products currently available on the market.

Item 3.1.3 Report from the Working Party on Priorities for the Review of Herbs - Item 3.1.1 of CMEC4 refers

Recommendation to TGA:

that Kerry Bone and Steven Clavey be co-opted as members of the Working Party on Priorities for the Review of Herbs for the meeting on 10 June 1998 in order to expedite the Working party's deliberations.

Item 3.2.2 Proposed Schedule 14 - item of CMEC2 and item 3.1.2 CMEC3

Recommendation to TGA:

  1. Schedule 14 be amended as follows:
    • bioflavonoids in item 2 of Schedule 14 could be deleted because they were covered by item 6 (plant and herbal materials etc);
    • item 6 of Schedule 14 be amended to include fungi after algae;
    • item 6 of Schedule 1, include a comma after the word 'chlorophyll'; and
    • item 8 of Schedule 14 -amend the entry to state 'microorganisms, whole or extracted, except vaccines'.
  2. That an explanatory memorandum on the purpose of the Schedule be included with the Schedule.

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Item 3.3 Kombucha tea - item 3.1.3 of CMEC3 refers

Recommendation to TGA:

  • that the safety concerns of kombucha tea be discussed at the next foods/drugs interface meeting with a view to discussing education of consumers to address the safety issues.

Item 4.1 Zinc ascorbate

Recommendation to TGA:

  • that zinc ascorbate is suitable for use in listable therapeutic goods
  • and that
  • Schedule 4 of the Regulations should be amended to permit this.

Item 4.2 New substances in fat storage reduction and muscle building products

Recommendation to TGA:

  1. In consultation with NFAA, TGA would establish a list of substances that could be reviewed as a package as potential ingredients in fat storage reduction and muscle building products that would be listable subject to review, for consideration at CMEC6; and
  2. CMEC would subsequently undertake safety evaluations of these substances, individually and when used in combination.

Item 5.1 Guarana

Recommendation to TGA:

  1. That the chemistry and pharmacology of guarana be researched; and
  2. depending on the information from TGA, CMEC would consider appropriate action on providing information to consumers about the caffeine content of these products.

Item 8.2 CMEC meetings

Recommendation to TGA:

  • that after the meeting on 10 June future meetings of CMEC would be held approximately every six weeks.

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