The encyclopedia · R&D & Science · Strategic decision · 1989–1990
L-tryptophan from Showa Denko killed 37 and disabled 1,500 — a contaminated supplement
Showa Denko's L-tryptophan contained a contaminant that caused a deadly syndrome. 37 died, 1,500 were disabled, and the supplement was banned for 15 years.
Showa Denko · 1989-11
What happened
In 1989, L-tryptophan was a widely sold dietary supplement used for insomnia, depression, and premenstrual syndrome. It was produced by several manufacturers, including the Japanese chemical company Showa Denko, which used a genetically engineered strain of Bacillus amyloliquefaciens to produce the amino acid in open fermentation vats. In an effort to cut costs, Showa Denko had reduced the amount of activated charcoal used in purification and, in some batches, bypassed the reverse-osmosis filtration step entirely.
These manufacturing changes introduced trace contaminants into the L-tryptophan. By November 1989, the US Centers for Disease Control had received the first reports of a mysterious new syndrome — eosinophilia-myalgia syndrome (EMS) — characterised by severe muscle pain, skin hardening, nerve damage, and respiratory failure. More than 1,500 cases were reported to the CDC, and at least 37 people died. The contaminated batches were traced to a single manufacturer: Showa Denko.
The FDA recalled L-tryptophan supplements in 1989 and banned most public sales in 1990. The ban remained in place for over a decade, with restrictions loosening only in 2001 and fully lifting in 2005. The case was one of the first major public health disasters linked to a genetically engineered product and a stark demonstration of how cost-cutting in manufacturing can produce deadly contaminants. Showa Denko faced multiple lawsuits, and the disaster permanently changed the regulation of dietary supplements.
Why it happened
- Showa Denko cut costs by reducing the activated charcoal used in purification and skipping reverse-osmosis filtration — these changes introduced trace contaminants that caused a deadly syndrome.
- The contaminated L-tryptophan was never tested for safety after the manufacturing changes — Showa Denko changed the production process without any toxicological testing of the resulting product.
- The FDA had no authority to require safety testing of dietary supplements before 1989 — L-tryptophan was sold as a supplement, not a drug, and escaped pre-market safety requirements.
The lesson
A manufacturing change that reduces purification is not a cost saving — it is a gamble with every patient's life, and a regulator who does not check is the one who lifts the ban 15 years later.
Sources
- Wikipedia — Eosinophilia-myalgia syndrome
- CDC MMWR — Eosinophilia-Myalgia Syndrome and L-Tryptophan-Containing Products (Nov 1989)
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