2004Q-0072
PDN 1
Volume 5

Petition Denial

References Cited

Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements. Rockville (MD): U.S. Food and Drug Administration; 2003 July 10. Available from: http://www.cfsan.fda.gov/~dms/nuttf-e.html

FDA Consumer Health Information for Better Nutrition Task Force Final Report. Rockville (MD): U.S. Food and Drug Administration; 2003 July 10. Available from: http://www.cfsan.fda.gov/~dms/nuttftoc.html

Interim Evidence-based Ranking System for Scientific Data. Rockville (MD): U.S. Food and Drug Administration; 2003 July. Available from: http://www.cfsan.fda.gov/~dms/hclmgui4.html

Institute of Medicine of the National Academies. Dietary Supplements: A Framework for Evaluating Safety. Chapter 7, Categories of Scientific Evidence - In Vitro Data. Washington (DC): The National Academies Press; 2004. Published Material

Spilker, B. Guide to Clinical Trials. New York: Raven Press; 1991. pages 59 - 64 and 498. Published Material

Kaye DH, Freedman DA. Reference Guide on Statistics. In Federal Judicial Center. Reference Manual on Scientific Evidence. 2d ed. 2000. Available from: http://www.fjc.gov Published Material

Jones PJH, Papamandjaris AA. Lipids: Cellular Metabolism. In: Bowman BA, Russell RM, editors. Present Knowledge in Nutrition 8th Edition. Washington (DC): ILSI Press; 2001. Published Material

Emken E. Alpha-linolenic acid conversion to n-3 LC-PUFAs. PUFA Newsletter [on the Internet] 2003 Sep. Available from: http://www.fatsoflife.com/articlePrint.asp?id=l30 Published Material

Wang C, et al. (Tuft-New England Medical Center Evidence-based Practice Center). Effects of Omega-3 Fatty Acids on Cardiovascular Disease, Evidence Report/Technology Assessment No. 94. Rockville (MD): Agency for Healthcare Research and Quality; 2004 March. AHRQ Publication No. 04-E009-2. Contract No,: 290-02-0022. Published Material

Institute of Medicine of the National Academies. Dietary Fats: Total Fat and Fatty Acids. In Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and,Arnino Acids. Washington (DC): The National Academies Press; 2002. p. 8-1 - 8-99. Published Material

National Heart, Blood and Lung Institute (NHLBI); National Institutes of Health. Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III); NIH Publication No. 01-3670; 2001. Available from: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3xsum.pdf

National Heart, Blood and Lung Institute (NHLBI); National Institutes of Health. Coronary Heart Disease Explained. Available from: http://nhlbisupport.com/chd1/chdexp.htm Published Material

USDA Nutrient Data Laboratory. USDA National Nutrient Database for Standard Reference, Release 17. 2004. Available from: http://www.nal.usda.gov/fnic/foodcomp

Institute of Medicine of the National Academies. "Cholesterol" and "Macronutrients and Healthful Diets." In: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: National Academies Press; 2002. p. 9-1 - 9-32 and 11-1 - 11-95. Published Material

U.S. Food and Drug Administration. Qualified health claim enforcement discretion letter: Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease (Docket No. 2003Q-0401). 2004 Sep 8. Available from: http://www.cfsan.fda.gov/~dms/ds-ltr38.html