FDA Authorizes Qualified Health Claim for Vitamin B/Vascular Disease

FDA Authorizes Qualified Health Claim for VitaminB/Vascular Disease

WASHINGTON--The Food and Drug Administration (FDA) is making some progress onseveral health claims being reconsidered under the Pearson v. Shalalasuit. On Nov. 28, FDA gave notice that it will allow a qualified health claimassociating 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 theclaim. However, it also required extensive qualifications be used in conjunctionwith the claim. These include noting that the scientific evidence for theassociation is suggestive rather than conclusive, that elevated levels ofhomocysteine may or may not cause vascular disease, and that studies that linklowering levels of homocysteine with reduced risk of vascular disease are notcomplete.

Emord noted that the plaintiffs in the health claim case plan to develop ashort version of the qualifications and do not plan to contest the matterfurther in federal litigation and have taken the B-vitamin issue out of pendingfederal litigation. In fact, the clearance on the vitamin B claim came only daysafter the Department of Justice and Emord & Assoc. jointly asked aWashington, D.C., federal court to extend a litigation stay until Jan. 12 toallow time to resolve disputes on this claim and one concerning vitamin E andvascular disease. As of Nov. 30, FDA had not yet issued a ruling on the proposedhealth claim for antioxidant vitamins and cancer; the agency had previouslystated it would rule on that claim by Nov. 30. For more information, visit www.fda.gov.