Settlement Reached for Health Claim Relating B Vitamins and Vascular Disease

Back to Qualified Health Claims: Letters of Enforcement Discretion

Judge Paul L. Friedman of the United States 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 this agreement, FDA stated its intention to exercise enforcement discretion to permit the plaintiffs to place the following statement on labels and in labeling of their 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.*

*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.

The parties further agreed that the second sentence of the claim (i.e., the disclaimer) must be immediately adjacent to and directly beneath the first sentence (i.e., the claim itself) with no intervening material that separates the claim from the disclaimer, and the second sentence must be in the same size, type face and contrast as the first sentence.

This document was issued on May 15, 2001.
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