Vitamin B Claim Gets Disclaimer

Vitamin B Claim Gets Disclaimer

WASHINGTON--Last November, the Food and Drug Administration (FDA) (www.fda.gov)stated that it would allow a qualified health claim for vitamins B6, B12 andfolic acid and their possible ability to reduce heart disease. However, FDAasked that a disclaimer be used in conjunction with the claim. The qualifiedlanguage should note that the scientific evidence for the association issuggestive rather than conclusive; that elevated levels of homocysteine may ormay not cause vascular disease; and that studies that link loweringcardiovascular risk with B vitamins are incomplete.

As of April 2, 2001, U.S. District Judge Paul Friedman of the District ofColumbia dismissed the complaint following an agreement reached between FDA andthe plaintiffs. FDA stated that it will exercise "enforcementdiscretion" to permit plaintiffs to place the following statement ondietary supplement labels: "As part of a well-balanced diet that is low insaturated fat and cholesterol, folic acid, vitamin B6 and vitamin B12 may reducethe risk of vascular disease."

FDA and the plaintiffs, counseled by Emord and Associates (www.emord.com),agreed that the disclaimer must be immediately adjacent to and directly beneaththe above sentence. The second sentence must also be in the same size, font andcontrast as the first sentence.