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Example 4:

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The labeling states, in connection with the product’s claim, that the dietary supplement has been “studied for years” in a particular country or region and is the subject of clinical or “university” research. Here, the labeling conveys the impression that the product has been studied and also conveys the impression that there is a substantial body of competently conducted scientific research supporting the claim. We recommend that manufacturers possess evidence to substantiate both the express statements and their implied meaning….

We recommend that the studies being used as substantiation for dietary supplement claims identify a specific dietary supplement or ingredient and serving size and that the conditions of use in the studies are similar to the labeling conditions of the dietary supplement product. Factors that would tend to indicate a stronger relationship between a substance that is the subject of a study and the substance that is the subject of the dietary supplement claim includes similarities in formulation, serving size, route of administration, total length of exposure, and frequency of exposure. Manufacturers should be aware that other substances involved in the study or included in the dietary supplement product itself might also affect the dietary supplement’s performance or the study results.

Food Regulation

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