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Death by Infant Formula
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Death by Infant Formula
Israeli public health officials learned in mid November, 2003, of the unusual
occurrence of severe illness and death of several Israeli infants. The one common
denominator among all these infants was their consumption of Remedia Soy Formula,
also called Super Soya-1, a soy based infant formula sometimes fed to infants
whose families follow the Jewish kosher dietary rules or who are allergic to
milk. This particular infant formula was produced by Humana in Germany and
imported into Israel by Remedia. On November 6, the Israeli Ministry of
Health issued an alert to the public advising them to immediately cease using
this formula. All cans of Remedia Soy Formula were removed from the shelves
in Israeli stores and all sales of the product were stopped.
The working hypothesis of the Israeli health officials at that time was that the infants'
severe illness was due to beriberi, a condition caused by a deficiency of thiamine (vitamin B1). The
dietary requirement for thiamine in infants has been known for many years, and infant formulas
have routinely been fortified with the vitamin. Nevertheless, samples of Remedia Soy
Formula were taken to the Israeli Public Health laboratories and analyzed for thiamine. Other
possible causes were also investigated. On November 8, laboratory tests confirmed that
the infant formula contained so little thiamine (less than one tenth the amount claimed)
that it would cause beriberi. What could have caused such a fatal deficiency? Remedia
said that Humana had admitted stopping the addition of thiamine to the formula because
the soy beans from which the formula was made provided sufficient thiamine. (Other batches
of the infant formula manufactured in England and imported into the U.S. and other countries
were not affected.) By November 11, three infants had died and fourteen more had developed
serious neurological problems. In an effort to rescue any infants already affected by the
Remedia formula, the Israeli Ministry of Health advised parents of all infants who had been
fed this formula during the last two months to report to their pediatricians to receive a
prescription for two weeks of thiamine supplementation.
On November 11, Humana published a stunning statement of responsibility, apology, and corrective
action on its website. The firm traced the problem to three separate events, each caused by human
error. First, the manufacturer reformulated their Remedia infant formula at the request of
Remedia in the spring of 2003. Humana performed a chemical analysis of the reformulated product,
later found to be erroneous, showing an excessive amount of thiamine. A company official decided
to stop adding thiamine to the formula but did not inform upper management. Second, Humana did
not measure thiamine in the reformulated product. Such a measurement, although not required by
law, was mandated by Humana's own quality control procedures. The third mistake occurred in
September, 2003, when Humana workers noticed that there were no data on vitamin levels in the
product but did not follow up appropriately. In November, Humana expressed "deep and sincere
sympathy" with the families of the infants who became ill or died and started consulting with the
Israeli government on appropriate compensation to the victims' families. Humana moved to put its
own house in order by firing four managers within the company and instituting new procedural
safeguards, starting with special training of Humana employees.
The U.S. population was warned about any possible danger to American infants by the press and
the Food and Drug Administration (FDA) nationwide, by local
government in New York, and by rabbis, private ambulance service, and word of mouth in
New York City's Orthodox Jewish communities. The U.S. firm H.J. Heinz, which owns 51% of
Remedia, hired a New York public relations agency to contact leading Jewish organizations
and 200 media out
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