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Thiamine-deficient infant formula: what happened and what have we learned?
1Institute of Gastroenterology, Nutrition, and Liver Diseases, Schneider Children's Medical Center, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. shamirraanan@gmail.com
Insights
A thiamine-deficient soy infant formula caused severe neurologic damage and deaths in Israeli infants in 2003. This highlights the critical need for stringent infant formula safety regulations and manufacturer accountability.
Area of Science:
- Nutritional Science
- Pediatric Neurology
- Public Health
Background:
- A thiamine-deficient soy infant formula was marketed in Israel in 2003.
- This led to infant encephalopathy admissions and diagnoses of thiamine deficiency.
Purpose of the Study:
- To summarize the events surrounding the thiamine-deficient formula incident.
- To analyze the neurologic outcomes and lessons learned.
Main Methods:
- Medline search for 'thiamine deficiency' and 'formula' or 'feeding'.
- Screening of Israeli newspapers from November 2003 to April 2011.
Main Results:
- 2-6% of Israeli infants consumed the deficient formula in November 2003.
- The formula was linked to 3 infant deaths and over 20 cases of neurologic damage.
Conclusions:
- Subtle deficiencies are hard to diagnose; safe use history is unreliable.
- Stringent criteria and full manufacturer responsibility are essential for infant formula production and import.
Introduction:
In 2003, a thiamine-deficient soy infant formula was produced in Germany and marketed exclusively in Israel. Between October and November 2003, infants with encephalopathy were admitted to several intensive care units in Israel and were later diagnosed as suffering from thiamine deficiency. The soy formula consumed by these children was found to be the cause of these admissions.
Methods:
A Medline search using the terms 'thiamine deficiency' and 'formula' or 'feeding' without year limit identified relevant published data on that event. Newspapers from Israel were screened from November 2003 until April 2011.
Results:
On November 2003, 2-6% of infants in Israel consumed this formula. The consumption of this thiamine-deficient formula was associated with the death of 3 infants and with more than 20 infants manifesting neurologic damage. In this report, we summarize the chain of events, the neurologic outcome, and discuss the lessons needed to be learned from this sad event.
Conclusions:
Based on difficulties in diagnosis of subtle deficiencies, we suggest that apparent history of safe use is not a reliable source for establishing adequate intake. Infant formulae can be produced or imported only under stringent criteria with the manufacturer/importer having total responsibility for the product.
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