|FDA OVERSIGHT HEARING ON CODEX BADLY NEEDED|
The Honorable Dan Burton
Dear Congressman Burton:
Prior to last September's meeting of the Codex Committee on Nutrition and Food for Special Dietary Use, you and four other members of Congress strongly requested in writing that the FDAs Dr. Yetley remove the second paragraph from the U.S. codex comments on agenda item #5 (vitamins and minerals), because it contradicted the first paragraph, and lent credence to the unscientific notion that "maximum upper potency limits" should be put on vitamins and minerals. Dr.Yetley not only ignored your written request, but John Hammell caught her doing so on videotape which has been put on the Life Extension Foundation's website in the political section, along with footage of John being forced to stop taping by the German Codex Chairman (http://www.lef.org). A complete account of what happened is available at http://www.iahf.com/ under "breaking news."
From a standpoint of safety, there is no justification for attempting to apply a "Risk Assessment" document which was designed for evaluating toxic pharmaceutical drugs, to dietary supplements, which have been well established through the National Association of Poison Control Centers, and numerous other sources to be extraordinarily safe, even when consumed in doses much higher than the RDA. Orthomolecular physicians such as Bonnie Camo, M.D. have seen doses as high as 3 grams per day of niacin used in complete safety, while the National Academy of Sciences and FDA are advocating a maximum upper potency limit of just 35 mg, just because a few highly sensitive individuals experience a tingling sensation known as the "niacin flush" when taking niacin in low doses. There is nothing unsafe about the niacin flush, which actually helps circulation and is considered pleasurable by some.
It is obvious to consumers around the world that the FDA is attempting to use the highly unscientific, and heavily prejudiced National Academy of Sciences document titled 'A Risk Assessment Model for Establishing Upper Limits for Nutrients" as a means of moving beyond the consumer generated impasse at the Codex Committee on Nutrition and Foods for Special Dietary Use. The FDA has announced its intention to harmonize its regulations to emerging Codex standards in an Advance Notice of Proposed Rulemaking that was published in the Federal Register on July 7, 1997, vol.62, #129 pp.36243-36248. You can view this at http://iahf.com/codx-fda.txt.
I urge you to call John Hammell, Bonnie Camo M.D., and other witnesses to a Hearing before your Committee, and I urge you to force the FDA to withdraw the second paragraph of its comments along with the NAS Risk Assessment document in keeping with current US Law. Congress has spoken clearly on this with the passage of DSHEA, and most recently again in October of 1997 when dietary supplements were specifically exempted from the harmonization language in the FDA Reform Bill.