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1995S-0316
RPT 343
Volumes 268 and 269

Cover Page

Correspondence

Cover Letter for Premarket Notification

New Dietary Ingredient Notification for Omega-3 Phytosterol Esters

Appendix A - Redacted

Appendix B - Specifications of Dietary Supplement Product and Batch Analyses

Appendix C - Analyses of Pesticides, Heavy Metals, and Other Impurities

Appendix D - Redacted

Appendix E

Agency Response Letter GRAS Notice No. GRN 000137

Agency Response Letter GRAS Notice No. GRN 000138

References Cover Sheet for NDI Notification Body

FDA. 1997. Final rule Menhaden oil - Substances affirmed as generally recognized as safe. 62 FR 30751; June 5, 1997.

FDA Letter 2000. Dated October 31, 2000 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. at http://vm.cfsan.fda.gov/~dms/ds-ltr11.html

FDA Letter 2003. Dated February 14, 2003 Regarding Enforcement Discretion with Respect to Expanded Use of an Interim Health Claim Rule about Plant Sterol/Stanol Esters and Reduced Risk of Coronary Heart Disease to Cargill Health and Food Technologies at http://www.cfsan.fda.gov/~dms/ds-ltr30.html

FDA Letter 2004. Dated September 8, 2004 Letter Responding to Health Claim Petition Dated November 3, 2003 (Wellness): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease to Jonathan W. Emord, Emord & Associates, P.C. at http://www.cfsan.fda.gov/~dmslds-ltr38.html

Federal Register 2000. Interim Final Rule on Plant Sterol/Stanol Esters and Coronary Heart Disease Health Claim 65 FR 54685, September 8, 2000 at http://www.cfsan.fda.gov/~lrd/fr000908.html

Federal Register 2005. Final Rule on Menhaden Oil 70 FR 14530, March 23, 2005: Substances Affirmed as Generally Recognized as Safe at http://www.cfsan.fda.gov/-lrd/fr050323.html

GRAS Notice No. GRN 000039: (April 24 and November 2, 2000) FDA/CFSAN/OPA: Agency Response Letter to Novartis Consumer Health, Inc on tall oil phytosterols at http://www.cfsan.fda.gov/~rdb/opa-g039.html

GRAS Notice No. GRN 000048: (November 27, 2000) FDA/CFSAN/OPA: Agency Response Letter to Cargill Incorporated on vegetable oil phytosterol esters at http://www.cfsan.fda.gov/~rdb/opa-g048.html

GRAS Notice No. GRN 000053: (December 20, 2000): FDA/CFSAN/OPA: Agency Response Letter to Proctor and Gamble on phytosterol esters at http://www.cfsan.fda.gov/~rdb/opag053.html

GRAS Notice No . GRN 000061: Response from FDA dated April 18, 2001: FDA/CFSAN/OPA: Agency Response Letter to Archer Daniels Midland Company on plant sterols and plant sterol esters at: http://www.cfsan.fda.gov/~rdb/opa-g061.html

GRAS Notice No. GRN 000102 (September 3, 2002): FDA/CFSAN/OPA: Agency Response Letter to Jedwards International on small planktivorous pelagic fish body oil. http://www.cfsan.fda.gov/~rdb/opa-g102.html

GRAS Notice No. GRN 000105 (October 15, 2002): FDA/CFSAN/OPA: Agency Response Letter to Unilever United States, Inc. on Marinol omega-3 concentrate. http://www.cfsan.fda.gov/~rdb/opa-g105.html

GRAS Notice No. GRN 000109 (December 4, 2002): FDA/CFSAN/OPA: Agency Response Letter to Clover Corporation on tuna oil. http://www.cfsan.fda.gov/~rdb/opa-g109.html

GRAS Notice No. GRN 000112: (February 4, 2003): FDA/CFSAN/OPA: Agency Response Letter to Teriaka Ltd on phytosterols at http://www.cfsan.fda.gov/~rdb/opa-gras.html

GRAS Notice No. GRN 000146 (August 17, 2004): FDA/CFSAN/OPA: Agency Response Letter to Jedwards International on salmon oil. http://www.cfsan.fda.gov/~rdb/opa-g146.html

All other references Published Material


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