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HATCH AND RICHARDSON PRESS FDA TO "IMMEDIATELY" APPROVE FOLIC ACID CLAIM

This article was originally published in The Tan Sheet

Executive Summary

HATCH AND RICHARDSON PRESS FDA TO "IMMEDIATELY" APPROVE FOLIC ACID CLAIM in an Oct. 1 letter to FDA Commissioner David Kessler. "We urge you to approve immediately a claim for folic acid so that the government, non-profit organizations working to prevent birth defects, and manufacturers and retailers of supplements may begin the process of consumer education that will save lives," Sen. Orrin Hatch (R-Utah) and Rep. Bill Richardson (D-N.M.) stated in the letter. Hatch and Richardson are sponsors of dietary supplement legislation, which they said "is aimed at speeding approval of health claims such as that for folic acid." In light of the overwhelming support for folic acid health claims, Hatch and Richardson argued: "If the FDA believes there is not significant scientific agreement on the use of folic acid as a supplement (not as a fortifier), we believe it is questionable FDA feels any supplement could ever meet that standard." "We know of no credible scientific disagreement that the claim for folic acid is effective in preventing birth defects," they maintained, citing the Public Health Service's October 1992 recommendation that all women of childbearing age consume 400 mcgs folic acid per day to reduce the risk of bearing a child with neural tube defects. "It has now been a full year since" that recommendation was made, the bill sponsors complained. Hatch and Richardson also pointed to studies published in medical journals, the American Academy of Pediatrics' recent endorsement of folic acid supplementation ("The Tan Sheet" Sept. 20, In Brief), and a statement by the March of Dimes Birth Defects Foundation that "the evidence supports a public health recommendation" that should "permit broad commercial and social marketing of products that could increase folic acid consumption." The two members of Congress added that "folic acid is an excellent example of how FDA has used its interpretation of the scientific agreement standard to work against the public health rather than for it." The agency's "intransigence in refusing to approve this claim is one reason why 59 members of the United States Senate and 136 members of the House of Representatives have cosponsored the Dietary Supplement Health and Education Act," Hatch and Richardson charged. They concluded their letter to Kessler by declaring that FDA's implementation of the health claims provision of the Nutrition Labeling & Education Act "is preventing many consumers from receiving the scientifically valid information that could help prevent disease, save millions of health care dollars, and even save their lives. Clearly the government can, and must, do a better job." FDAers have indicated that publication of proposals to allow folic acid health claims and fortification is "imminent." In addition, FDA's Food Advisory Committee and its Folic Acid Subcommittee are slated to discuss the folic acid proposals during an Oct. 14-15 meeting ("The Tan Sheet" Sept. 27, In Brief).

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