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CMEC Meeting 04, 8 April 1998

Complementary Medicines Evaluation Committee

8 April 1998

Extracted ratified minutes

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CMEC Meeting 4 extracted ratified minutes (pdf,24kb)

Public recommendation summary

Item 3.1.2 Royal jelly safety review (label warning) - item 3.1.4 of CMEC3 refers

Recommendation to TGA:

that, in relation to the royal jelly label warning, a short warning attracting the attention of those most needing the warning was necessary in conjunction with a longer warning giving the same information as the current warning ie:

  • Not to be taken by asthma and allergy sufferers*' in 3 mm type
  • *Royal jelly may cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers in 1.5 mm type.

Item 3.1.4 Piper methysticum, kava - item 5.1 of CMEC3 refers

Recommendation to TGA:

that it was not necessary to impose label warnings regarding the consumption of alcohol or barbiturates on therapeutic goods containing kava, Piper methysticum, listed in the ARTG for supply in Australia.

Item 3.1.5 Harmala alkaloids - item 5.2 of CMEC 3 refers

Recommendation to TGA:

that in the first instance the products in Table 2 to Attachment 1 of the agenda paper, be used as the basis for exemptions from Customs (Prohibited Imports) Regulations and the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); and

to further exclude from the SUSDP:

  • dried herbs containing harmala alkaloid; and
  • harmala alkaloid extracts with 10mg maximum per dose.

Item 4. Evaluation of new substances

Item 4.1 Shark cartilage

Recommendation to TGA:

to accept shark cartilage as a low risk substance suitable for use in listable products but require appropriate warning statements.

Item 4.2 Azadirachta indica - seed extract

Recommendation to TGA:

that an evaluation of neem seed extract would require additional data to those supplied.

Item 4.3 Colloidal silver

CMEC requested more time to consider the genuine use of colloidal silver as a complementary medicine.

Item 4.4 Safety evaluation of Pinus pinaster stem bark extract

Advice to TGA:

that, from the available information, Pinus pinaster stem bark extract is of low risk.

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