FDA Seeking Recall of Food Supplement

The Food and Drug Administration called late Friday for a nationwide recall of L-tryptophan, an over-the-counter dietary supplement linked to a mysterious blood and muscle ailment.

An FDA statement urged consumers to stop using dietary supplements containing L-tryptophan, an amino acid, which is widely available in health food stores, supermarkets and drugstores.

The federal action was taken two days after California Health Director Kenneth W. Kizer ordered retail merchants in the state to discontinue sales of the dietary supplement.

FDA field offices will be told on Monday to contact all manufacturers of the food supplement in their area, asking them to recall the products. Each manufacturer would be expected to contact places where the products are sold.

The action occurred after federal health officials warned consumers to stop taking L-tryptophan, saying they have received 287 reports in 37 states of a mysterious blood and muscle ailment called eosinophilia-myalgia syndrome, or EMS, that may be linked to the pills.

Thus far, 24 cases have been reported in California, officials said.

While the investigation continues, the FDA, the federal Centers for Disease Control in Atlanta and state health officials have concluded there is a “strong, virtually unequivocal link between consumption of L-tryptophan tablets or capsules and the syndrome,” the FDA statement said.

The disease is characterized by an elevated count of eosinophils, a white blood cell, severe muscle pain and an absence of infection or illness that can explain the symptoms.

Scientists have not determined a cause-and-effect relationship between L-tryptophan and the recent outbreak of EMS, whose other symptoms include weakness, joint pain, swelling of the arms and legs, fever, skin rashes and respiratory problems.

But most victims became ill after taking tablets or capsules containing a concentrated form of the amino acid, said Kizer, who noted that the link between L-tryptophan and the illness was “very strong and very compelling.”

Besides California, other states, including Massachusetts, New York and New Mexico, have acted to ban the sale of the food supplement after reports this week of health problems associated with L-tryptophan.

Because L-tryptophan, which is manufactured in Japan, is sold as a food supplement rather than a drug, it is not subject to the same stringent testing process as drugs.