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FDA And The Ongoing Ban Of Tryptophan

Apparently the FDA in its vigilance to obtain "rock-bottom truth" has rejected the findings of the official governmental investigative scientific agency, the U.S. Center for Disease Control (CDC) when it comes to the tryptophan-EMS question.

The EMS illnesses were caused by a contaminant in a few batches of tryptophan (an amino acid nutrient which is essential for human life) which a single manufacturer (Showa Denko) produced using an untried and inadequately tested technique. In an article published in the New England Journal of Medicine last August, the CDC unambiguously stated that the eosinophilic-myalgia syndrome (EMS) outbreak was caused by a contaminant, not by the nutrient amino acid tryptophan.1

Yet in the July 18, 1991 FDA TALK PAPER, an official FDA Press Office "guide to FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest," the FDA states that "conclusive evidence on the cause of EMS from L-tryptophan use still eludes researchers."

Presented at the July 18 hearing of the Human Resources and Intergovernmental Relations Sub-committee of the House Committee on Governmental Operations, the FDA stated that its goal is to develop a long-term enforcement strategy for the regulation of amino acids and vitamin and mineral supplements. Commissioner Kessler has emphasized that the FDA will not tolerate unsubstantiated drug claims made for foods including vitamins, minerals and amino acids, and has urged doctors to stop recommending them to patients.

In 1976 the Congress of the U.S. passed a law known as the Proxmire Bill specifically preventing the FDA from regulating vitamin-mineral supplements as drugs. Perhaps it is not surprising that just as the newspapers are filled on a daily basis with reports from the scientific literature on the health benefits of nutrients the regulators are at it again. For more information on this threat, the most recent of several attempts dating back to the 1950s to ban or severely restrict access to dietary nutrients, contact: Clinton Ray Miller, legislative advocate for the health food industry, who attended the hearings and submitted written material, but was not allowed to testify; he has hearing transcripts: phone 703-754-0228 fax 703-754-4324.

1. Belongia, et al. An investigation of the cause of the eosinophilic-myalgia syndrome associated with tryptophan use. N Engl J Med 1990;323:357-365.

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