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a scientific determination of safety, and thus the information required to overcome this assumption is not required to be absolute proof or evidence that a harm or adverse effect has occurred or will inevitably occur. Instead, the information required is something less. Rather than a quantitative, probabilistic assessment of risk, which is preferable and often possible when data about a chemical are substantial or at least include standard toxicology tests, it may be prudent or necessary to make a qualitative determination by using judgment and scientific inference to consider the limited data. In summary, to evaluate dietary supplements under DSHEA, it is necessary to determine only if an “unreasonable or significant risk” exists, not to have complete evidence that a dietary supplement causes a serious adverse event. That is, the standard of “unreasonable or significant risk” put forward by DSHEA is a lower standard than conclusive scientific proof, a fact that is likely to facilitate the ability to take action.


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