RPT 249
Volume 181

Cover Page, Letter from CFSAN to W. Patrick Noonan, Letter from W. Patrick Noonan to CFSAN

Kreider, Richard B. Creatine supplementation: analysis of‘ergogenic value, medical safety, and concerns, Journal of Exercise Physiology Online, Apr 1998.

New Dietary Ingredient Notification: Creatine Ethyl Ester HCL

Table of Contents

Section 1 - Names and complete addresses of the distributor and manufacturer of the new dietary ingredient.

Section 2 - Name of the new dietary ingredient.

Section 3 - Description of the new dietary ingredient with attachments.
Attachment 1: Product Standard Specification Sheet - Redacted
Attachment 2: Material Safety Data Sheet

Section 4 - Level of the new dietary ingredient in the dietary supplement.
Attachment 4 - Jellin JM, Gregory P, Batz F, Hitchens, K et al. Pharmacist’s Letter/Prescriber’s Letter Natural Medicines Comprehensive Database. 3rd ed. Stockon Ca: Therapeutic Research Faculty; 2000: pp. 345-346
Attachment 5 - PDR for Nutritional Supplements 1st ed., Medical Economics, Creatine, pp. 114-117

Section 5 - The conditions of use recommended or suggested in the labeling of the dietary supplement.

Section 6 - History of use or other evidence of safety establishing that the dietary ingredient creatine ethyl ester HCL as recommended in the labeling of dietary supplement products will be reasonably expected to be safe

Attachment 6 - Vennerstom JL, Miller DW. Creatine Ester Pronutrient Compounds and Formulations. International publication number WO 02/221535A1. World Intellectual Property Organization, 21 March 2002.

Attachment 7 - Ferro Pfanstiehl. Computer printout of A History of Innovation.

Attachment 8 - “Creatine Fuel” and “Creatine 1000” trademark applications with filing dates.

Attachment 9 - Kreider RB. Creatine Supplementation: analysis of ergogenic value, medical safety and concerns. JEPonline 1:1, 1998.

Attachment 10 - Anonymous. Long term safety of oral creatine supplementation, Fact Sheet No. 4. Provided by Creapure manufacturer Degussa BioActives.

Attachment 11 - Poortmans Jr, Francaux M. Adverse effects of creatine supplementation: Fact or Fiction? Sports Med 30: 155-170.

Attachment 12 - Shilling, BK, Stone MH, et al. Creatine supplementation and health variables: A retrospective study. MedSci Sports Exerc 33: 183-188, 2001.

Attachment 13 - Dietary Supplements: Toxicology and Clinical Pharmacology edited by M.J. Cupp and TS. Tracy. Humana Press, Creatine Monohydrate pp. 91-120.

Attachment 14 - Persky, AM, Brazeau, G. Clinical Pharmacology of the Dietary Supplement Creatine Monohydrate. Pharmacological Reviews, May 10, 2001.

Attachment 15 - Kreider, RB. Effects of creatine supplementation on performance and training applications. Molecular and Cellular Biochemistry 244: 89-94, 2003.

Attachment 16 - Robinson TM, Sewell DA, et al. Dietary creatine supplementation does not affect some haematological indices, or indices of muscle damage and hepatic and renal function. Br J Sports Med 34:
284-288, 2000.

Attachment 17 - Poortmans JR, Francaux M. Long-term oral creatine supplementation does not impair renal function in health athletes. Med Sci Sports Exerc 31: 1108-1110, 1999.

Attachment 18 - Waldron JE, Pendlayi GW, et al. Concurrent creatine monohydrate supplementation and resistance training does not affect markers of hepatic function in trained weightlifters. JEPonline 5: 1, 2002.

Attachment 19 - Kreider RB, Melton C, ef al. Long-term creatine supplementation does not significantly affect clinical markers of health in athletes. Molecular and Cellular Biochemistry 244: 95-104, 2003.

Attachment 20 - Pritchard NR, Kalra PA. Renal dysfunction accompanying oral creatine supplements. Lancet 351: 1252-1253, 1998.

Attachment 21 - Koshy KM, Griswold E, Schneeberger EE. Interstitial nephritis in a patient taking creatine. NEJM 340: 814-815, 1999.

Attachment 22 - NCAA Banned-Drug Classes 2004-2005

Attachment 23 - The International Olympic Committee Anti-Doping Rules applicable to the Games of the XXVIII Olympiad in Athens in 2004.

Attachment 24 - ChemPharma Int’l. final report of the study entitled “Identification and Quantitation of Bioavailable [14C]Compounds Present it the Blood and Urine of Rats Following Oral Administration of a Single Dose of [14C]Creatine Ethyl Ester”

Attachment 25 - Background information on ChemPharma Int’l and the professional credentials of the author and other scientists involved with the ChemPharma Int’l. study.

Section 7 - Summary