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1995S-0316
RPT 299
Volumes 234-237

Cover Letter

Letter from CFSAN to Natural ASA

Letter from Natural ASA to CFSAN

New Dietary Ingredient Notification for Omega-3 Phospholipids

References

CFR. 2005a. Title 21 - Food and Drugs. Part 184 - Direct food substances affirmed as generally recognized as safe. Subpart B - Listing of specific substances affirmed as GRAS. Section S 184.1400 - Lecithin. In: CFR. Code of Federal Regulations, 2001. U.S. Government Printing Office; Washington DC, p. 532.

CFR. 2005b. Title 21 - Food and Drugs. Part 582 - Substances generally recognized as safe. Subpart B - General purpose food additives. Section S 542.1400 - Lecithin. In: CFR. Code of Federal Regulations, 2001. U.S. Government Printing Office; Washington, DC, p. 534.

FAO-WHO. 1994. Report of a Joint Expert Consultation. Fats and Oils in Human Nutrition. Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO); Geneva, Switz., FOA Food and Nutrition Paper No. 57, pp. 49-55. Cited In: Sala-Vila et al., 2004.

FASEB. 1979. Evaluation of the Health Aspects of Lecithin as a Food Ingredient. Report of Select Committee on GRAS Substances. Produced by: Federation of American Societies for Experimental Biology (FASEB), Life Scienes Research Office (LSRO); Bethesda, Maryland for Food and Drug Administration, U.S. (FDA), Bureau of Foods; Washington, DC. [FDA/BF-80/14; PB-301 405/7/XAB; SCOGS-106]. Cited In: CIR, 2001.

FDA. 1997a. Premarket notification for a new dietary ingredient; Final rule [21 CFR Part 190 - Docket No. 96N-0232]. Fed Regist (US) 62(184): 49886-49892.

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

FDA. 2000a. Agency Response Letter GRAS Notice No. GRN 000043 [Lipase Enzyme Preparation, Sep. 22, 2000]. Food and Drug Administration, U.S. (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Premarket Approval; Washington, DC. Available from: http://www.cfsan.fda.gov/~rdb/opa-g043.html

FDA. 2000b. 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. Available from: http://vm.cfsan.fda.gov/~dms/ds-ltr11.html

FDA. 2004. Substances affirmed as generally recognized as safe: Menhaden oil; Tentative final rule [21 CFR, Part 184, Docket No. 1999P-5332]. Fed Regsit (US) 69(10): 2313-2317.

FDRL. 1973a. Approximate LD50 of FDA 71-88 (Lecithin) in Mice. Submitted by FDA in response to a Freedom of Information (FOI) request dated 11/27/95 Re: Food and Drug Research Laboratories Inc. (FDRL). DHEW Contract No. 71-260; Lab No. 1762]. Cited In: CIR, 2001.

FDRL. 1973b. Approximate LD50 of FDA 71-88 (Lecithin) in Rats. Submitted by FDA in response to a FOI request dated 11/27/95 Re: Food and Drug Research Laboratories Inc. (FDRL). [DHEW Contract No. FDA 71-260; Lab No. 1763]. Cited In: CIR, 2001.

FDRL. 1973c. Approximate LD50 of FDA 71-88 (Lecithin) in Rabbits. Submitted by FDA in response to a FOI request dated 11/27/95 Re: Food and Drug Research Laboratories Inc. (FDRL). [DHEW Contract No. FDA 71-260; Lab No. 1764]. Cited In: CIR, 2001.

FDRL. 1973d. Approximate LD50 of FDA 71-88 (Lecithin) in Mice. Submitted by FDA in response to a FOI request dated 11/27/95 Re: Food and Drug Research Laboratories Inc. (FDRL). [DHEW Contract No. FDA 71-260; Lab No. 1765]. Cited In: CIR, 2001.

FDRL. 1973e. Approximate LD50 of FDA 71-88 (Lecithin) in Rats. Submitted by FDA in response to a FOI request dated 11/27/95 Re: Food and Drug Research Laboratories Inc. (FDRL). [DHEW Contract No. FDA 71-260; Lab No. 1766]. Cited In: CIR, 2001.

FDRL. 1974. Approximate LD50 of FDA 71-88 (Lecithin) in Rabbits. Submitted by FDA in response to a FOI request dated 11/27/95 Re: Food and Drug Research Laboratories Inc. (FDRL). [DHEW Contract No. FDA 71-260; Lab No. 1767]. Cited In: CIR, 2001.

Litton Bionetics, Inc. 1975. Mutagenic Evaluation of Compound FDA 71-88, Lecithin. Produced by: Litton Bionetics, Inc.; Kensington, Maryland [LBI-2468-323] for the Food and Drug Administration, U.S. (FDA); Washington, DC [FDABF-GRAS-323]. [PB-245 478/3/XAB]. Cited In: CIR, 2001.

National Marine Fisheries Service. UN Fod and Agriculture Organization. 1996. Cited In: Abril and Barclay, 1998.

U.S. EPA. 2002. Child-Specific Exposure Factors Handbook (Interim Report). U.S. Environmental Protection Agency (U.S. EPA), Office of Research and Development, National Center for Environmental Assessment; Washington, DC. [EPA-600-P-00-002B]. Available from : http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?PrintVersion=True&deid=55145

USDA. 2004. Composition of Food: Raw, Processed, Prepared. In: USDA National Nutrient Database for Standard Reference, Release 17. U.S. Department of Agriculture (USDA), Agriculture Research Service (ARS), Beltsville Human Nutrition Research Center Nutient Data Laboratory; Beltsville, Maryland. Available from: http://www.nal.usda.gov/fnic/foodcomp/Data/SR17/sr17.html

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