U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling, and Dietary Supplements
May 15, 2001
Settlement Reached for Health Claim Relating B Vitamins and Vascular Disease
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.
For more recent information on Dietary Supplements
See http://www.cfsan.fda.gov/~dms/supplmnt.html
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