Group Hopes to Get FDA to Lift Ban on Tryptophan

A Costa Mesa-based association representing the health food industry went to Washington on Monday to lobby for the lifting of a federal ban on the sale of tryptophan, a food supplement used as a treatment for insomnia and premenstrual syndrome.

Health food products containing manufactured tryptophan were removed from the market in November at the request of the U.S. Food and Drug Administration because people using the products were coming down with a rare disease. The disease, called eosinophilia myalgia syndrome, affects the blood and muscular systems and has been linked to at least a dozen deaths.

But the National Nutritional Foods Assn. contends that the problems are not caused by tryptophan itself, but rather by contaminants in certain tryptophan products that were manufactured by Showa Denko, a Japanese firm.

“The faulty purification process (of Showa Denko) caused a contaminant to remain in the final tryptophan products,” said Patricia Heydlauff, executive director of the health food group.

Added Melissa Caresosa, an association spokeswoman: “With all of the problems associated with one manufacturer, it doesn’t seem fair to take all (tryptophan) off of the shelves.”

Caresosa said there are about five other manufacturers of tryptophan, which, before the marketing recall, represented a $300-million-a-year industry.

Heydlauff and other health food industry representatives were scheduled to present their arguments Monday to Ronald Chesemore, FDA associate commissioner for regulatory affairs. They said they would cite “strong evidence from the Centers for Disease Control” that tryptophan produced by manufacturers other than Showa Denko has not been linked with outbreaks of EMS.