Cover Image

HARDBACK
$59.95



View/Hide Left Panel

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.

REFERENCES

Feifer AH, Fleshner NE, Klotz L. 2002. Analytical accuracy and reliability of commonly used nutritional supplements in prostate disease. J Urol 168:150–154.

Fong HHS. 2002. Integration of herbal medicine into modern medical practices: Issues and prospects. Intergr Cancer Ther 1:287–293.


Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D. 2001. Current methods of the U.S. Preventive Services Task Force: A review of the process. Am J Prev Med 20:21S–35S.


IOM (Institute of Medicine). 1998. Dietary Reference Intakes: A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients. Washington, DC: National Academy Press.


NRC (National Research Council). 1992. Combining Information: Statistical Issues and Opportunities for Research. Washington, DC: National Academy Press.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement