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According to U.S. law, the company was allowed to sell the L-tryptophan produced in gene-spliced bacteria without any safety testing because it and other firms had been selling the supplement produced in non-genetically engineered bacteria for years without ill effects. The method of production was considered immaterial. What was important was that the new product was "substantially equivalent" to the L-tryptophan that had been sold for years.
In 1989, an outbreak of eosinophilia-myalgia syndrome (EMS) occurred among L-tryptophan users . A hitherto rare disorder, EMS is a debilitating disease characterized by severe muscle and joint pain, weakness, swelling of the arms and legs, fever, skin rash, and an increase of eosinophils (certain white blood cells) in the blood. Over the next year, more than 1,500 cases and twenty-eight deaths were reported to the U.S. Centers for Disease Control and Prevention . The actual toll probably was more than 5,000 people, many of whom suffered for years and are still disabled. Soke of the victims were children. When the link between EMS and L-tryptophan became apparent, the FDA quickly banned its sale [4,5].
1) On February 9, 1993, a US government patent (#5185157) was issued to use L-Tryptophan to treat and cure EMS, the very same deadly flu-like condition that prompted the FDA to take L- Tryptophan off the market in 1989.