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FDA on vitamin health claims

FDA settled a lawsuit by reaching an agreement on a health claim for B vitamins and vascular disease. The agency will allow the following health claim on labels of dietary supplements containing folic acid, vitamin B6, and vitamin B12: “As part of a well-balanced diet that is low in saturated fat and cholesterol, folic acid, vitamin B6, and vitamin B12 may reduce the risk of vascular disease.*” But the claim must be immediately followed by the following sentence in the same size, type face, and contrast as the first sentence: “*FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.” FDA disallowed health claims relating antioxidant vitamins (vitamin C and vitamin E, alone or in combination) to reduced risk of certain kinds of cancer or of individual cancers (cancer of the bladder, breast, cervix, colon, rectum, oral cavity/pharynx, esophagus, lung, prostate, pancreas, skin, and stomach), finding that the scientific evidence against the relationship was greater than that for the relationship.

Any such claims would be misleading and could not be made nonmisleading with a disclaimer, FDA said.

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