In Australia claims which may be made about therapeutic goods using evidence of traditional use are categorised into two levels-medium and general-according to the relative strength of the claim. Medium level claims are stronger claims but their wording is required to be qualified and more evidence is required to support them. This general approach is summarised in Table 4. Specific approaches have been developed for homeopathic and aromatherapy products. These approaches are summarised in Tables 5 and 6 respectively. A summary of the definitions of the types of claims is provided at Attachment 1 to these guidelines.
Table 4. Levels and types of claims and the evidence required to support them - based on evidence of traditional use
Level of claim |
Type of claim |
Wording of Claim2 |
Evidence required to support claim |
MEDIUM |
• Health enhancement1
• Reduction of risk of a disease/disorder.
• Reduction in frequency of a discrete event.
• Aids/assists in the management of a named symptom/disease/disorder.
• Relief of symptoms of a named disease or disorder.5,6
|
This (tradition) medicine has been used for (indication)5. This claim is based on traditional use3. |
Primary evidence:
Two of the following four sources that demonstrate adequate support for the indications claimed:
1. TGA-approved Pharmacopoeia.
2. TGA approved Monograph.
3. Three independent written histories of use in the classical or traditional medical literature4.
4. Availability through any country’s government public dispensaries for the indication claimed.
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Notes:
1 Health enhancement claims apply to enhancement of normal health. They do not relate to enhancement of health from a compromised state.
2 Or words to this effect
3 Where scientific evidence is available to support the entire claim, the words, “This claim is based on traditional use” is optional.
4 In cultures where an oral tradition is clearly documented, evidence of use from an oral tradition would be considered acceptable provided the history of use was authenticated. Modern texts that accurately report the classical or traditional literature may be used to support claims.
5 Terms must be in the original language of the traditional medical culture, for example “Shen” not “Kidney” in TCM.
6 All claims relating to symptoms must be accompanied by the advice “If symptoms persist consult your healthcare practitioner”.
Table 4. Levels and types of claims and the evidence required to support them - based on evidence of traditional use (cont’d)
Level of claim |
Type of claim |
Wording of Claim1 |
Evidence required to support claim |
GENERAL |
• Health maintenance, including for example claims relating to nutritional support.
• Relief of symptoms (not referring to a disease or disorder)2.
• Claims for traditional syndromes and actions 3.
|
This (tradition) medicine has been traditionally used for (indication)3. |
Primary evidence:
One of the following four sources that demonstrates adequate support for the indications claimed:
1. TGA-approved Pharmacopoeia.
2. TGA-approved Monograph.
3. Three independent written histories of use in the classical or traditional medical literature4.
4. Availability through any country’s government public dispensaries for the indication claimed.
|
Notes:
1 Or words to this effect.
2 All claims relating to symptoms must be accompanied by the advice “If symptoms persist consult your healthcare practitioner”.
3 Terms must be in the original language of the traditional medical culture, for example “Shen” not “Kidney” in TCM.
4 In cultures where an oral tradition is clearly documented, evidence of use from an oral tradition would be considered acceptable provided the history of use was authenticated. Modern texts that accurately report the classical or traditional literature may be used to support claims.
Table 4. Levels and types of claims and the evidence required to support them - based on evidence of traditional use (cont’d) - non-primary evidence
Supporting evidence |
Commonly referred to in appropriate prescribed teaching textbooks used in tertiary-level training of healthcare professionals.
This evidence does not stand alone and may only be used in conjunction with primary evidence.
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