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Settlement For B Vitamins And Vascular Disease Reached

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By: Sean Moloughney

Editor, Nutraceuticals World

The U.S. District Court for the District of Columbia on April 2, 2001 dismissed the complaint in Whitaker v. Thompson, which involved a challenge to an FDA decision regarding a dietary supplement health claim relating intake of B vitamins and risk of vascular disease. The dismissal followed an agreement reached between FDA and the plaintiffs regarding the use of a disclaimer with the health claim at issue. As part of its agreement, FDA stated its intention to exercise enforcement discretion to permit the plaintiffs to place the following statement on labels in labeling of their dietary supplements containing folic acid, vitamin B6 and 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.”*

*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.

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