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Red-yeast product is no drug, court says
A federal court ruled that the Food and Drug Administration had unlawfully attempted to restrict distribution of an herbal supplement by designating it a drug.
References:
Pharmanex, Inc. v. Donna Shalala, 2: 97 CV 0262 K (1999).
Further Readings:
1998. FDA determines cholestin to be an unapproved drug. Available at http://www.fda.gov/bbs/topics/ANSWERS/ANS00871.html.
Dickinson, A. 1998. The regulation of dietary supplements before and after the Dietary Supplement Health and Education Act of 1994. Report by the Council for Responsible Nutrition. November.
Kurtzweil, P. 1998. An FDA guide to dietary supplements. FDA Consumer 32(September/October):28.
Raloff, J. 1998. Cholesterol-busting products provoke FDA. Science News 154(Nov. 14):311.
______. 1997. The rise of nutraceuticals. Science News Online (Feb. 15).
Sources:
Pharmanex
625 Cochran Street
Simi Valley, CA 93065-1939
U.S. Food and Drug Administration
Department of Health and Human Services
Public Health Service
5600 Fishers Lane
Rockville, MD 20857
From Science News, Vol. 155, No. 9, February 27, 1999, p. 132. Copyright © 1999, Science Service.