The Food and Drug Administration said Friday it is too early to blame the deaths of 27 Americans who took L-tryptophan directly on gene splicing.
"We are still not sure what caused the problem," said FDA spokesman Jeff Nesbit. The FDA will review a petition filed by biotechnology watchdog Jeremy Rifkin asking the agency to hold more approvals of genetically engineered products.Rifkin, president of the Foundation on Economic Trends, said the deaths are the first cases on record connecting a genetically engineered product with human deaths and injuries.
The 27 who died were among more than 1,500 Americans who developed a rare blood disorder called eosinophilia-myalgia syndrome, or EMS, after taking L-tryptophan.
Until the FDA ordered all L-tryptophan off the market in March because of its link to EMS, the dietary supplement was sold in health food stores as a remedy for insomnia, appetite control and depression.
An Aug. 9 article in the New England Journal of Medicine said a Japanese chemical firm made two changes in itsmanufacturing process that could have caused the problem.