FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Back


1995S-0316
RPT 304
Volume 241

Cover Page

Letter from CFSAN to Shannon Minerals Inc

Letter from Shannon Minerals Inc to CFSAN

Coolwater Trim 75 Day Pre-Market Notification
Executive Summary
Table of Contents
Section 1 - Name and Address of Distributor and Current Manufacturer
Section 2 - Name and Identity of New Dietary Ingredient
Section 3 - Description of the Products Containing Extract of Garcinia Cambogia, (-)-HCA
Section 4 - History of Use/Safety Evidence
Section 5 - Designated Signatory

Appendix A - Background and History of Use

Lewis, Y. S. and S. Neelakantan. Research Paper (-)-Hydroxycitric Acid - The Principal Acid in the Fruits of Garcinia Cambogia Desr. Central Food Technological Resarch Institute, Mysore, India Received 15 March 1964. Available online 2 April 2001.

Clouatre, Dallas PhD. The Diet and Health Benefits of HCA. Published Material

Appendix B - Safety

Soni, M. G., et al. Safety assessment of (-)-hydroxycitric acid and Super CitriMax, a novel calcium/potassium salt. Food and Chemical Toxicology 42 (2004) 1513-1529. Published Material

Ohia, S. E., et al. Safety and mechanism of appetite suppression by a novel Hydroxycitric Acid extract (HCA-SX). Department of Pharmacy Sciences, Creighton University School of Pharmacy and Allied health Professions, Omaha, NE, USA.

Shara, M., et al. Physico-chemical properties of a novel (-)-hydroxycitric acid extract and its effect on body weight, selected organ weights, hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, and histopathological changes over a period of 90 days. Department of Pharmacy Sciences, School of Pharmacy and Health Professions, Creighton University Medical Center, Omaha, NE; IDEXX Veterinary Services, Inc., West Sacramento, CA, USA.

Shara, M., et al. 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

Appendix C - Mechanisms of Action

Lowenstein, J. M. Experiments with (-)-Hydroxycitrate. Graduate Department of Biochemistry, Brandeis University, Waltham, MA.

Watson, J. A., M. Fang, and J. M. Lowenstein. Tricarballylate and Hydroxycitrate: Substrate and Inhibitor of ATP: Citrate Oxaloacetate Lyase. Graduate Department of Biochemistry, Brandeis University, Waltham, MA.

Pruess, H. G. Effects of a natural extract of (-)-hydroxycitric acid (HCA-SX) and a combination of HCA-SX plus niacin-bound chromium and Gymnema sylvestre extract on weight loss.


Top | Back

Page last updated February 17, 2006 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management