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1995S-0316
RPT 272
Volumes 204-208

Cover Letter

Letter from CFSAN to Enzymotec Ltd.

Letter from Enzymotec Ltd. to CFSAN

New Dietary Ingredient Notification for carDiabeat

Appendix A - Product Specifications

Appendix B - Efficacy Study of carDiabeat in Animal Model

Appendix C - Safety and Efficacy Study of carDiabeat

Reference List

FDA. 1993. Appendix I. Table 14. Conversion table for test chemical treatment doses used in PAFA. In: Priority Based Assessment of Food Additives (PAFA) Database. Food and Drug Administration, U.S. (FDA), Center for Food Safety and Applied Nutrition (CFSAN); Washington, DC, p. 58.

FDA. 1997. Substances affirmed as generally recognized as safe: Menhaden oil - Final rule (21 CFR Part 184, Docket No. 86G-0289). Fed Reg U.S. 62 (108): 30751-30757.

FDA. 2000a. Letter Regarding Dietary Supplement Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease (Docket No. 91N-0103) [To Jonathan W. Emord, Emord & Associates, P.C. from Christine J. Lewis, Director]. Food and Drug Administration, U.S. (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Nutritional Products, Labeling, and Dietary Supplements. [http://vm.cfsan.fda.gov/~dms/ds-ltr11.html].

FDA. 2000b. Food labeling: Health claims; Plant sterol/stanol esters and coronary heart disease (Interim final rule - 21 CFR Part 101). Fed Reg U.S. 65 (175): 54685-54739.

FDA. 2004. Substances affirmed as generally recognized as safe: Menhaden oil (Tentative final rule - 21 CFR Part 184). Fed Reg U.S. 69(10): 2313-2317.

All other references Published Material


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