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CMEC Meeting 14, 6 August 1999
Complementary Medicines Evaluation Committee
Extracted ratified minutes
Public recommendation summary
CMEC endorses the general direction of the Working Party, as presented in the first part of a two-part document (Guide to the level and kinds of evidence to support claims for nonprescription therapeutic goods). The second part of the document is to be forwarded from CMEC and may be developed as guidelines for industry by industry, or the Therapeutic Goods Advertising Code Council, in the future.
CMEC recommends revisions to the list of serious diseases for which Registration would normally be required (Table 4 of the first part of the above document). CMEC also recommends that the definition of a serious disease or disorder be one "for which there is a substantial body of medical opinion that the disease cannot or should not be diagnosed or treated except under medical advice".
CMEC endorses the principle of three levels of claims ["high", "medium" and "low"] and recommends that claims involving the prevention of any disease or disorder should be considered to be 'high' level claims rather than "medium" level claims as initially proposed in the document. CMEC also recommends that claims for treatment of vitamin/mineral deficiency diseases should be considered to be high level claims and that vitamin/mineral supplementation claims should be considered to be low level claims as nutritional support.
CMEC agrees that a list of symptoms about which claims are permitted is not a useful tool and should not be included in the draft document.
CMEC compliments ADEC on the quality of its conflict of interest guidelines and recommends that CMEC guidelines adhere to the same core principles.
CMEC recommends that Medicago sativa (alfalfa) is suitable for use as an active ingredient in therapeutic goods with no restriction on daily dose or dose size, provided that extraction processes do not increase the L-canavanine level above that of the original form of the dried herb.
CMEC recommends that all therapeutic goods containing Paullinia cupana (guarana) are required to carry label statements declaring that the product contains caffeine and stating the quantity of caffeine per dose unit, and that there be no minimum level of caffeine below which the statements are not required.
CMEC recommends that the requirement for label warning statements on therapeutic goods containing Piper methysticum (kava) be reviewed, and that the NDPSC be advised in advance that CMEC intends to do this.
CMEC recommends that label warnings about prolonged use of kava, and use in pregnancy and lactation, are not necessary for products containing less than 25 mg of kavalactones derived from kava.
CMEC recommends that Kunzea ambigua essential oil is suitable for use as an active ingredient in listable products other than in products intended for internal use, provided restrictive flow inserts are used and the following warning statements are included on the label:
- Keep out of reach of children.
- External use only.
- Do not apply undiluted to skin except on the advice of a health care practitioner.
CMEC recommends that freeze-dried, powdered Perna canaliculus (green lipped mussel) and lipid extracts of P. canaliculus prepared by supercritical fluid extraction are suitable for use as active ingredients in listable therapeutic goods, provided that the therapeutic goods containing them are labelled as containing shellfish products and that appropriate compositional specifications for these substances are put in place.
CMEC recommends that there is insufficient evidence of risk to alter the regulatory status of the oil derived from Oenothera biennis (evening primrose oil) and comments that evening primrose oil appears to be of sufficiently low risk as to continue to be suitable for use in listable therapeutic goods.
CMEC recommended a product for registration.
|CMEC 14 Extracted Ratified Minutes (pdf)||35KB|