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1995S-0316
RPT 354
Volume 272-274

Cover Page, Letter from CFSAN to Natural ASA

New Dietary Ingredient Notification for Omega-3 Phospholipids

Appendix A - Redacted

Appendix B - Redacted

Appendix C - Redacted

Appendix D - List of References

CFR. 2005a. Part 184 - Direct food substances affirmed as generally recognized as safe. Subpart B - Listing of specific subtances affirmed as GRAS. Sections § 184.1065, 184.1259, 184.1400, 184.1472, 184.1555 - [Linoleic acid, Cocoa butter substitute, Lecithin, Menhaden oil, Rapeseed oil]. In: Code of Federal Regulations Title 21 - Food and Drugs. U.S. Government Printing Office; Washington, DC, pp. 489, 510-511, 532, 541-544 & 548-550. Available from: http://www.access,gpo.gov/nara/cfr/waisidx_05/21cfr184_05.html.

CFR. 2005b. Part 582 - Substances generally recognized as safe. Subpart B - General purpose food additives. Section § 542.1400 - Lecithin. In: Code of Federal Regulations Title 21 - Food and Drugs. U.S. Government Printing Office; Washington, DC, p. 534. Available from: http://a257.g.akamaitech.net/7/257/2422/01apr20051500/edocket.access.gpo.gov/cfr_2005/aprqtr/pdf/21cfr582.1400.pdf

CFR. 2005c. Part 182 - Substances generally recognized as safe. Sections § 182.10, 184.20 - [Spices and other natural seasonings and flavorings, Essential oils, oleoresins (solvent-free), and natural extractives (including distillates)]. In: Code of Federal Regulations Title 21 - Food and Drugs. U.S. Government Printing Office; Washington, DC, pp. 467-471. Available from: http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr182_05.html.

CFR. 2005d. Part 172 - Food additives permitted for direct addition to food for human consumption. Sections §172.210, 172.510, 172.615, 172.860 - [Coatings on fresh citrus fruit, Natural flavoring substances and natural substances used in conjunction with flavors, Chewing gum base, Fatty acids]. In: Code of Federal Regulations Title 21 - Food and Drugs. U.S. Government Printing Office; Washington, DC, pp. 39-40, 57-57, 67-68 & 98-99. Available from: http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr172_05.html.

CFR. 2005f. Part 101 - Food labeling. Section § 101.12 - Reference amounts customarily consumed per eating occasion. In: Code of Federal Regulations Title 21 - Food and Drugs. U.S. Government Printing Office; Washington, DC, pp. 52-61. Available from: http://a257.g.akamaitech.net/7/257/2422/01apr20051500/edocket.access.gpo.gov/cfr_2005/aprqtr/pdf/21cfr101.12.pdf

FDA. 1985. Direct food substances recognized as safe: Low erucic acid rapeseed oil (Final rule - 21 CFR Part 184) [Docket No. 82G-0207]. Fed Regist (US) 50(18): 3745-3755.

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. 2001 . Agency Response Letter GRAS Notice No. GRN 000080 [ARASCO (Arachidonic Acid-Rich Single-Cell Oil)]. U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety; College Park, Maryland. Available from: http://www.cfsan.fda.gov/~rdb/opa-g080.html.

FDA. 2002a. Agency Response Letter GRAS Notice No. GRN 000109 [Tuna Oil]. U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety; College Park, Maryland. Available from: http://www.cfsan.fda.gov/~rdb/opa-g109.html.

FDA. 2002b. Agency Response Letter GRAS Notice No. GRN 000105 [Fish Oil Concentrate]. U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety; College Park, Maryland. Available from: http://www.cfsan.fda.gov/~rdb/opa-g105.html.

FDA. 2002c. Agency Response Letter GRAS Notice No. GRN 000102 [Small Planktivorous Pelagic Fish Body Oil]. U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety; College Park, Maryland. Available from http://www.cfsan.fda.gov/~rdb/opa-g102.html.

FDA. 2004a. Agency Response; Letter GRAS Notice No. GRN 000138 [Fish Oil]. U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety; College Park, Maryland. Available from: http://www.cfsan.fda.gov/~rdb/opa-g138.html.

FDA. 2004b. Agency Response Letter GRAS Notice No. GRN 000146 [Salmon Oil]. U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety; College Park, Maryland. Available from: http://www.cfsan.fda.gov/~rdb/opa-g146.html

FDA. 2004c. Agency Response Letter GRAS Notice No. GRN 000137 [Algal oil (Schizochytrium sp.)]. U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety; College Park, Maryland. Available from: http://www.cfsan.fda.gov/~rdb/opa-g137.html.

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

All other References Published Material

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