1995S-0316
RPT 270
Volume 202

Cover Letter

Letter to Olsson, Frank, & Weeda, P.C. from CFSAN

Letter to CFSAN from Olsson, Frank, & Weeda, P.C.

Premarket Notification - Synthetically Produced Hydroxycitric Acid

Appendix A - Research paper - (-)- Hydroxycitric Acid -The Principal Acid in the fruits of Garcinia Cambogia Desr. Y.S. Lewis and S. Neelakantan, Central Food Technological Research Institute, Mysore, India, March 1964 Published Material

Appendix B - Toxicology

Sullivan, A.C. and J. Triscari. Novel pharmacological approaches to the treatment of obesity, Recent Advances in Obesity Research (Westport, CT, Technomic Publishing Company, Inc. 1977) 442-452. Published Material

Appendix C - Detailed Research on HCA

Soni, M.G., G.A. Burdock, H.G. Preuss, S.J. Stohs, S. E. Ohia, D. Bagchi: Safety assessment of (-)- hydroxycitric acid and Super CitriMax, a novel calcium/potassium salt. Food and Chemical Toxicology 42 (2004) 1513-1529. Published Material

Watson, John A., Marie Fang, and John M. Lowenstein (1969). Tricarballylate and hydroxycitrate: Substrate and inhibitor of ATP: citrate oxaloacetate lyase. Archives of Biochemistry and Biophysics 135, 1 (1969) 209-217. Published Material

Watson, John A. and John M. Lowenstein (1970). Citrate and conversion of carbohydrate into fat. The Journal of Biological Chemistry 245, 22 (1970) 5993-6002. Published Material

Lowenstein, John M. (1970) Experiments with (-)-hydroxycitrate. In W. Bartley, H.L. Kornberg and J.R. Quayle, eds., Essays in Cell Metabolism (New York: Wiley Interscience, 1970) 153-166. Published Material

Sullivan, Ann C., Manoranjan Singh, Paul A. Srere, and Jenny P. Glusker (1977c). Reactivity and inhibitor potential of hydroxycitrate isomers with citrate synthase, citrate lyase, and ATP citrate lyase. The Journal of Biological Chemistry 252, 21 (November 10, 1977) 7583-7590. Published Material

Section 2 - Inhibition of Lipogenesis

Preuss, Harry G., Debasis Bagchi, Manashi Bagchi, C.V. Sanyasi Rao, S. Satyanarayana, Dipak K. Dey 2003. Efficacy of a novel, natural extract of (-)-hydroxycitric acid (HCA-SX) and a combination of HCA-SX, niacin bound chromium and Gymnema sylvestre extract in weight management in human volunteers: A pilot study. Nutritron Research 24 (2004) 45-58. Published Material

Sullivan, Ann C., Joseph Triscari, James G Hamilton, O. Neal Miller, and Victor R. Wheatley (1974a). Effect of (-)-hydroxycitrate upon the accumulation of lipid in the rat: I Lipogenesis. Lipids 9, 2 (1974) 121-128. Published Material

Sullivan Ann C. and Joseph Tristari (1977a). Metabolic regulation as a control for lipid disorders. I. Influence of (-)-hydroxycitrate on experimentally induced obesity in the rodent. The American Journal of Clinical Nutrition 30, 5 (May 1977) 767-776. Published Material

Sullivan Ann C., Joseph Triscari, and H.E. Spiegel (1977b). Metabolic regulation as a control for lipid disorders. II. Influence of (-)-hydroxycitrate on genetically and experimentally induced hypertriglyceridemia in the rat. The American Journal of Clinical Nutrition 30, 5 (1977) 777-784. Published Material

Brunengraber, Henri, Mirelle Boutry, and John M. Lowenstein (1978). Fatty acid, 3-B-hydroxysterol, and ketone synthtesis in the perfused rat liver: Effects of (-)-hydroxycitrate and oleate. Eur. J. Biochem., #2, (1978) 373-384. Published Material

Greenwood, M.R.C., M.P. Cleary, R. Gruen, D Blase, J.S. Stem, J. Tristan, and A.C. Sullivan (1981). Effect of (-)-hydroxycitrate on development of obesity in the Zucker obese rat. American Journal of Physiology 240, 1 (1981) E72-E78. Published Material

Section 3 - Appetite Suppression

Michael Shara, Sunny E. Ohia, Taharat Yasmin, Andrea Zardetto-Srmth, Anthony Kincald, Manashi Bagchi, Archana Chatterjee, Debasis Bagchi and Sidney J. Stohs: Dose- and time- dependent effects of a novel (-)- hydroxycitric acid extract on body weight, hepatic and testicular lipid peroxidation, DNA fragmentation and histopathological data over a period of 90 days. Molecular and Cellular Biochemistry 254: 339-346, 2003. Published Material

Sullivan Ann C. and Joseph Triscari (1976). Possible interrelationship between metabolite flux and appetite. In D. Novin, W. Wyriwicka and G Bray, eds., Hunger: Basic Mechanisms and Clinical Implications (New York: Raven Press, 1976) 115-125. Published Material

Conte, Anthony A. (1993). A non-prescription alternative in weight reduction therapy. The Bariatrician (Summer 1993) 17-19. Published Material

Sullivan, Ann C., Joseph Triscari, and Karen Comai, Pharmacological moderation of lipid metabolism for the treatment of obesity. Department of Pharmacology, Hoffmann LaRoche, Inc., Nutley, NJ 07110, USA. Published Material

Ohia, Sunny E., Catherine A. Opere, Angela M. LeDay, Manashi Bagchi, Debasis Bagchi, and SidneyJ. Stohs, Safety and mechanism of appetite suppression by a novel hydroxycitric acid extract (HCA-SX). Molecular and Cellular Biochemistry 238: 89-103, 2002. Published Material

Appendix D - Quality Control / Product Selection

Cheema-Dhadli, Surinder, Mitchell L. Halperin and Clifford C. Ieznoff (1973). Inhibition of enzymes which interact with citrate by (-)-hydroxycitrate and 1,2,3,-tricarboxybenzine. European Journal of Biochemistry 38 (1973) 98-102. Published Material

Lowenstein, John M. and henri Brunengraber (1981). Hydroxycitrate. In John M. Lowenstein, ed., volume 72 in Methods in Enzymology, Lipids (New York: Academic Press, 1981) 486-497. Published Material

Glusker, Jenny P. (1992). Structural aspects of Citrate Biochemistry. In Earl R. Stadtman and P. Boon Chock, eds., Current Topics in Cellular Regulation, volume 33, From Metabolite, to metabolism, to Metabolon (New York: Academic Press Inc., 1992) 169-184. Published Material

Branchaud, Bruce, Associate Professor of Chemistry, University of Oregon, Letter to Interhealth (February 23, 1994).

Additional Material Published Material