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Science 17 September 1999: Vol. 285. no. 5435, pp. 1853 - 1855 DOI: 10.1126/science.285.5435.1853
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Policy Forum
HEALTH: Regulation of "Nutraceuticals"
Steven H. Zeisel
The U.S. Congress, in the Dietary Supplement Health and Education Act (DSHEA) established a framework for regulation of dietary supplements by the U.S. Food and Drug Administration. For dietary supplements, the FDA regulates labeling to limit health claims, but is not empowered to insist on rigorous studies establishing safety before marketing (as would be required for drugs or food additives). This creates a substantial potential risk to the health of the public, and serious adverse effects have been reported from some dietary supplements that are currently being marketed. The author recommends that a new category of dietary supplements, called "nutraceuticals," be established for supplements to be administered at doses that exceed normal human exposure to these agents in foods. Regulations should require that these nutraceuticals be judged safe before they are marketed.
The author is at the School of Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7400, USA. E-mail: steven_zeisel{at}unc.edu.
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