Comments on U.S. FDA Docket # 94N-0103 on the Statement:
"Omega-3 Fatty Acids Lower the Risk of Coronary Heart Disease"
Submission letter to the U.S. Food
and Drug Administration
Omega-3 PUFA in Clinical Trials/Studies with Coronary Heart Disease (CHD) Risk Factor-Relevant Endpoints Recommendations for Adequate Intakes (AI) of PUFA for Adults
The Hypotriglyceridemic Effect of Long-Chain Omega-3 Fatty Acids
Submission letter to the U.S. Food and Drug Administration
To:
The Center of Food Safety and Applied Nutrition
5630
Fishers Lane
Room 1061
Rockville, MD 20852
In Response to reference: United States Food and Drug Administration Docket # 91N-0103
"Omega-3 Fatty Acids Lower the Risk of Coronary Heart Disease."
Dear Sir or Madam:
As President of The Omega-3 Research Institute, Inc. I respectfully submit the following in strong support of the statement that "Omega-3 (n-3) fatty acids lower the risk of coronary heart disease (CHD)."
My professional background includes 15 years as extramural Director, Metabolic Diseases Research Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (1978-1992). One area of research covered by the program included fatty acid metabolism in inherited metabolic disorders. As Program Director I was responsible for about 350 grants at academic institutions nationwide. Since I left the NIH in early 1993, I worked as a consultant and focused on the role of omega-3 polyunsaturated fatty acids (PUFA) in health and disease . After a year as Visiting Researcher at the Center of Marine Biotechnology, University of Maryland Biotechnology Institute, Baltimore (1997-1998), I co-founded the Omega-3 Research Institute, Inc. (O3RI) where I built a program to provide research grade oils for basic and clinical researchers, and to co-organize workshops and conferences. One such workshop, initiated in collaboration with the Kennedy Krieger Institute, Baltimore, Maryland, is an International Workshop on Brain Uptake and Utilization of Fatty Acids: Application to Peroxisomal Biogenesis Disorders, March 2-4, 2000, Bethesda, Maryland.
Submission of the attached material is intended to exemplify the breadth and variety of approaches used in basic and clinical studies/trials that resulted in similar outcomes, i.e., "Omega-3 fatty acids lower the risk of coronary heart disease." This submission does not contain a rigorous scientific evaluation of both sides; rigorous scientific evaluation by itself is only one component of the equation used in reaching public health decisions. Health benefits to the public and potential risks and safety considerations are also important factors in reaching such decisions.
For example, according to the American Heart Association, about 500,000 Americans will suffer some kind of heart disease each year. Even a 10% reduction in that number would amount to 50,000 healthier and functional individuals whose deaths would be avoided and morbidity expenses saved.
Each one of the three clinical studies/trials discussed below reported at least a 10% reduction in the relative risks of recurring fatal myocardial infarcts (MI) non-fatal (N-F) myocardial infarcts and occurrence of other death and N-F strokes.
In addition we discuss the issues of the Recommendation for Adequate Intake (AI) of omega-6 and omega-3 fatty acids as supported by prior clinical trials and conclude with a summary description of the inverse relationship of omega-3 consumption and levels of triglycerides in plasma. These studies suggest an inverse association between omega-3 fatty acids and lowering the risk of coronary heart disease.
Sincerely,
Robert Katz
President