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- W2009446265 abstract "Information on labels of functional foods pertaining to the healthy attributes of these products is likely to be subject to Food and Drug Administration (FDA) food label claim regulations. Three primary claim categories that the FDA enforces are health, structure–function, and nutrient content. Health claims describe the relation of a food, food component, or dietary supplement in reducing the risk for a disease or health-related condition. Health claims must be evaluated and approved by the FDA before use in food labeling. There are three ways by which the FDA exercises oversight in determining which health claims may be used in food labeling. One is the issuance of authorizing regulations based on the FDA's conclusion that there is significant scientific agreement that available scientific evidence supports the relation. A second is through notifications submitted to the FDA of a health claim based on a deliberative review of scientific evidence on the substance–disease relation by a US government scientific body other than the FDA or by the National Academy of Sciences. The third way provides for FDA approval of qualified health claims in which the quality and strength of the scientific evidence fall below those required for the FDA to issue an authorizing regulation. Structure–function claims are food label statements that describe the role of a nutrient or dietary supplement ingredient to affect normal structure or function in humans. Structure–function claims have historically appeared on the labels of conventional foods and dietary supplements. However, the Dietary Supplement Health and Education Act of 1994 established special regulatory procedures for the use of such statements on dietary supplement labels. Nutrient content claims are statements that characterize the level of a nutrient in a food. Nutrient content claims on food labels must be used in accordance with FDA authorizing regulations." @default.
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- W2009446265 date "2001-05-01" @default.
- W2009446265 modified "2023-10-11" @default.
- W2009446265 title "Drug discoverers – you need us! – Reply" @default.
- W2009446265 doi "https://doi.org/10.1016/s1359-6446(01)01788-3" @default.
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