Executive Summary

Scientific evidence supports a substance/disease relationship linking corn oil consumption to a reduced risk of coronary heart disease, but FDA "believes that the scientific evidence represents a very low level of comfort among qualified scientists that the claimed relationship is scientifically valid," the agency says in a qualified health claim approval March 26. Therefore, enforcement discretion will be exercised for label statements that provide a non-misleading description of the strength of the scientific evidence, such as "very limited and preliminary scientific evidence suggests," FDA notes. The Wood Burditt Group submitted a petition in April 2006 seeking approval of claims such as "substituting corn oil for solid fats may reduce your risk of heart disease." The agency points out in its approval letter that among the intervention studies submitted to support the claim, three did not measure a validated surrogate endpoint of CHD, 17 did not include a control group consuming saturated fatty acids, six did not perform statistical analysis between the intervention and control groups and 17 had a duration of intervention that was too short (less than three weeks)...