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FISH OIL AS DIETARY SUPPLEMENT IS NOT GENERALLY RECOGNIZED AS SAFE

Executive Summary

FISH OIL AS DIETARY SUPPLEMENT IS NOT GENERALLY RECOGNIZED AS SAFE or approved as a food additive, FDA Associate Commissioner for Regulatory Affairs Ronald Chesemore maintained in June 20 letters to the Nonprescription Drug Manufacturers Association and the Council for Responsible Nutrition. "FDA has not listed omega-3 polyunsaturated fatty acids as approved food additives or as being generally recognized as safe," Chesemore said. "Thus addition of these substances to foods may render those foods adulterated." FDA argued that there is currently "inadequate scientific evidence to support health claims on fish oils or support claims that these ingredients will have an effect on" coronary heart disease. "Label claims that fish oil favorably affects either serum lipoproteins or the risk of [coronary heart disease] would not be acceptable," he said. The agency was responding to 1988 letters from the two organizations asking that FDA recognize scientific data supporting the value of fish oils containing omega-3 polyunsaturated fatty acids in helping reduce the risk of heart disease. FDA agreed "that there is evidence, much of it preliminary in nature, from some studies that support a hypothesis that the ingestion of omega-3 polyunsaturated fatty acids may reduce blood cholesterol levels, resulting in a reduced risk or coronary heart disease." Nonetheless, the letter states, "there are other data that raise questions about the long-term effects of ingestion of these substances on serum lipoproteins, e.g., the effects in individuals with elevated cholesterol and normal triglycerides." Additionally, FDA continued, "there is very little if any information from human studies on which to determine whether consumption of the levels of omega-3 fatty acids that appear to be necessary to produce changes in lipoprotein patterns will have adverse effects on blood coagulation." FDA believes that by issuing the letters all fish oil product manufacturers will be "on a level playing field and [it] will enhance our chances of prevailing in a troublesome" court case involving Exachol. In a June 15 memorandum to Acting Commissioner Benson, Chesemore noted that FDA Chief Counsel Margaret Porter was "particularly interested in seeing these letters issue because the judge in the Exachol case perceived an inequality of treatment between fish oils and the Exachol product." A New York federal court blocked FDA's attempt to seize the product last July.
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