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CMEC Meeting 25, 2 February 2001
Complementary Medicines Evaluation Committee
Extracted ratified minutes
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.
CMEC confirms that the draft Minutes of its previous meeting (CMEC 24, 1 December 2000), as amended, are a true and accurate record of that previous meeting.
Item 3 Guidelines on levels and kinds of evidence to support claims for therapeutic goods ('Guidelines')
CMEC recommended the adoption of a number of minor amendments to the Guidelines (November 2000 version). CMEC also looks forward to receiving a draft, simplified version of the Guidelines, being developed by the Complementary Healthcare Council of Australia for industry, to facilitate future consideration of this matter.
CMEC noted that no substantial issues had been raised during stakeholder comment on the proposed label warning statement ("Do not use if pregnant or likely to become pregnant") for products containing more than 500 mg L-phenylalanine per daily dose. Members noted that the Therapeutic Goods Regulations will be amended to require the use of this warning statement on listed medicines.
CMEC recommends to the TGA that conjugated linoleic acid 60% is not suitable for use as an active or excipient ingredient in listable therapeutic goods as there is insufficient evidence to support its long-term safety for human use, particularly that associated with the trans-10, cis-12 form of linoleic acid.
CMEC recommends to the TGA that 'sugar cane wax alcohols' is suitable for use as an active ingredient in listable therapeutic goods, provided that the recommended daily dose of the substance does not exceed 12 mg, and that goods containing the substance carry the following label advisory statement:
"Not recommended for use by pregnant and lactating women" (or words to that effect).
CMEC recommends to the TGA that 'thiamine phosphoric acid ester chloride' is suitable for use as an active ingredient in listable therapeutic goods, without any substance-specific restrictions on its use.
CMEC recommends to the TGA that (S)-S-adenosyl-L-methionine is suitable for use as an active ingredient in listable therapeutic goods, provided that the following conditions are met:
- only the p-toluene sulfonate and sulfate salts (or a mixture thereof) are used;
- these substances are only produced by fermentative processes; and
- picrolonic acid is not used in the manufacturing process.
CMEC recommends to the TGA that lycopene is suitable for use as an active ingredient in listable therapeutic goods, provided that it is stabilised to minimise degradation.
CMEC recommends to the TGA that the current 50 mg daily dose limit (for products containing pyridoxine/pyridoxal/pyridoxamine) for the application of a label warning is scientifically justified. CMEC considers that pyridoxine-induced peripheral neuropathy remains a concern with high doses of pyridoxine, but notes that, under the current Australian regulatory requirements for pyridoxine, no significant safety problems appear to have arisen.
|CMEC 25 Extracted Ratified Minutes (pdf)||71KB|