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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
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