The Food and Drug Administration argues that a margarine substitute known as Benecol is not a cholesterol-lowering dietary supplement but a food subject to regulation.
References:
1998. FDA determines cholestin to be an unapproved drug. (Available at http://www.fda.gov/bbs/topics/ANSWERS/ANS00871.html).
Heber, D., et al. In press. A Chinese red yeast rice dietary supplement significantly reduces cholesterol levels. American Journal of Clinical Nutrition.
Nguyen, T. 1998. Effects of three different phytostanol ester enriched spreads on serum lipoproteins in a mildly hypercholesterolemic US population. Meeting of the American Dietetic Association. October. St. Louis.
Further Readings:
1998. Putting together the regulatory puzzle. Food Testing & Analysis 4(October/November):20.
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.
Fackelmann, K.A. 1996. Fake fat gets FDAs okay. Science News 149(Feb. 3):68.
Kurtzweil, P. 1998. An FDA guide to dietary supplements. FDA Consumer 32(September-October):28.
Miettinen, T.A., et al. 1995. Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population. New England Journal of Medicine 333(Nov. 16):1308.
Raloff, J. 1998. Soya-nara, heart disease. Science News 153(May 30):348.
______. 1997. The rise of nutraceuticals. Science News Online (Feb. 15).
Sources:
Pharmanex, Inc.
625 Cochran Street
Simi Valley, CA 93605-1939Ron Schmid
McNeil Consumer Healthcare Products Company
7050 Camp Hill Road
Fort Washington, PA 19304U.S. Food and Drug Administration
Department of Health and Human Services
Public Health Service
5600 Fishers Lane
Rockville, MD 20857Amy Weiseman
McNeil Consumer Healthcare Products Company
7050 Camp Hill Road
Fort Washington, PA 19304From Science News, Vol. 154, No. 20, November 14, 1998, p. 311. Copyright Ó 1998 by Science Service.
copyright 1998 ScienceService