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food additives. Because of the limited and variable amount and type of data available, definitive statements judging safety may be difficult to completely substantiate scientifically. However, the standard for demonstrating that a significant or unreasonable risk exists with use of a dietary supplement ingredient does not require the same level of information as is needed to conclusively demonstrate or prove that a substance is unsafe for human consumption.

The principles used by the scientific community to determine the risk associated with consumption of various substances should also apply to dietary supplement ingredients, bearing in mind that dietary supplements, by virtue of DSHEA, have been assumed to be safe, but have not been required to be proven safe. Thus, the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe. Many of these scientific principles are outlined in Chapters 4 through 10, but several warrant additional mention here (see Box 13-1).

What Constitutes a Scientific Assessment of Unreasonable Risk?

It is important to consider the relevance and value of information presented by other organizations and regulatory bodies to the regulation of dietary supplement ingredients in the United States. Criteria for evaluating the relevance of other approaches are outlined in Chapter 2. These criteria include the importance of reliance on scientifically based data, consideration of all types of data (including animal data, in vitro data, data about chemical and taxonomical relatedness, and as data on human use), and some form of peer review.

To be of use in the safety Framework, conclusions of other regulatory bodies or similar organizations as to the safety of particular dietary supplements should be based on primary informational sources rather than reviews, and standardization and similarity of different preparations containing the active ingredient under study needs to be considered when assessing results. Further, if expert judgments play a significant role in the study conclusions, potential biases and conflicts of interest should be noted, and peer review should be part of the evaluative process.

Approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and, at times, efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients.

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