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CMEC Meeting 18, 18 February 2000
Complementary Medicines Evaluation Committee
Extracted ratified minutes
Public recommendation summary
CMEC endorses the amended document Guidelines for levels and kinds of evidence to support claims for therapeutic goods.
CMEC commends the Working Party on its progress and endorses the direction it is taking in considering the remaining issues. CMEC endorses the following recommendations of the Working Party:
- That plant ingredients manufactured using specialised industrial chemical transformation techniques or procedures, such as enzymatic processes, acid/base hydrolysis, saponification of lipids, fermentation and oxidation/reduction reactions, should not automatically be assumed to be safe, and may be subject to pre-market evaluation by the TGA.
- That the TGA consult with appropriate stakeholders on the use of specialised industrial chemical transformation techniques in the manufacture of herbal ingredients; the availability of information required to determine the status of a herbal ingredient; and on the definition of "standardisation" in relation to herbal extracts.
- That herbal ingredients be expressed in product labels as the dried weight equivalent of the plant material used, other than for products sold in the form of the fresh juice.
- That CMEC support a safety review process for herbs that takes into account factors including the following:
- adverse events attributable to use of a particular herb, in Australia and overseas
- frequency of adverse events in relation to the number of doses taken
- severity of the adverse events reported.
- That the TGA be asked to document criteria based upon the above factors which could be followed when reports of adverse reactions or concerns implicating a particular herb are received.
CMEC recommends to the TGA that R,S-alpha lipoic acid and R-alpha lipoic acid are suitable for use as active ingredients in listable therapeutic goods, and that no substancespecific conditions of use are required at this time.
CMEC recommends to the TGA that the following substances are suitable for use as active ingredients in listable therapeutic goods and that no substance-specific conditions of use are required at this time:
- Acetyllevocarnitine hydrochloride
- Propionyllevocarnitine hydrochloride
- Levocarnitine hydrochloride
- Levocarnitine tartrate
- Levocarnitine fumarate
- Levocarnitine magnesium citrate.
CMEC recommends to the TGA that bromelain, whether derived from the fruit or the stem of the pineapple (Ananas comosus), is suitable for use as an active ingredient in listable therapeutic goods. CMEC suggests to the TGA that it explore mechanisms by which information on the source of bromelain (ie the stem or the fruit) used in therapeutic goods can be recorded and retained for future reference.
CMEC recommends to the TGA that soy phosphatidylserine-enriched soy lecithin is suitable for use as an active ingredient in listable therapeutic goods, and that no substance-specific conditions of use are required at this time.
|CMEC 18 Extracted Ratified Minutes (pdf)||30KB|