FDA Authorizes Qualified Health Claim for Vitamin B/Vascular Disease
WASHINGTON--The Food and Drug Administration (FDA) is making some progress on several health claims being reconsidered under the Pearson v. Shalala suit. On Nov. 28, FDA gave notice that it will allow a qualified health claim associating vitamin B6, B12 and folic acid with a reduced risk of heart disease.
In a 41-page letter to Emord & Associates (the petitioner for the claim), FDA noted that the evidence in support of a claim outweighs evidence against the claim. However, it also required extensive qualifications be used in conjunction with the claim. These include noting that the scientific evidence for the association is suggestive rather than conclusive, that elevated levels of homocysteine may or may not cause vascular disease, and that studies that link lowering levels of homocysteine with reduced risk of vascular disease are not complete.
Emord noted that the plaintiffs in the health claim case plan to develop a short version of the qualifications and do not plan to contest the matter further in federal litigation and have taken the B-vitamin issue out of pending federal litigation. In fact, the clearance on the vitamin B claim came only days after the Department of Justice and Emord & Assoc. jointly asked a Washington, D.C., federal court to extend a litigation stay until Jan. 12 to allow time to resolve disputes on this claim and one concerning vitamin E and vascular disease. As of Nov. 30, FDA had not yet issued a ruling on the proposed health claim for antioxidant vitamins and cancer; the agency had previously stated it would rule on that claim by Nov. 30. For more information, visit www.fda.gov.