Reviews for High Level Claims
High level health claims are based on the evidence for a diet-disease/biomarker relationship. FSANZ has developed a framework for assessing the evidence, which is referred to as the ‘Substantiation Framework’. A number of diet-disease/biomarker relationships that have been reviewed by external experts will form the basis of pre-approved high level health claims. Those that are assessed as ‘convincing’ will be included in Standard 1.2.7 at gazettal.
Diet-disease/biomarker relationships initially considered in the pre-approval process were identified through a consultative process which drew on targeted workshops held mid-2004, public consultation on the P293 Initial Assessment Report, and feedback from the Health Claims Standards Development Advisory Committee (SDAC). Seven diet-disease/biomarker relationships selected for review reference information contained in the Australian and New Zealand Dietary Guidelines. External experts were then engaged by FSANZ to review each of the diet-disease/biomarker relationships.
Five of the diet-disease/biomarker relationships (#1 – 5 in the table below) were assessed as reaching a convincing level of evidence by the Scientific Advisory Group for the Development of the Substantiation Framework for Nutrition, Health and Related Claims . Two diet-disease relationships (#6 and 7 below) were assessed as not reaching a convincing level of evidence.
DIET - DISEASE RELATIONSHIPS REVIEWED |
1. Sodium (with or without potassium) AND hypertension |
2. Fruit & vegetables AND coronary heart disease |
3. Saturated fat and/or trans fat AND elevated serum cholesterol or heart disease |
4. Calcium (with or without Vitamin D) AND osteoporosis |
5. Folic acid AND neural tube defects |
6. Wholegrains AND coronary heart disease |
7. Omega-3 fatty acids AND cardiovascular disease |
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| [ pdf 383 kb] [ pdf ] FSANZ consideration of review |
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