The Israel police have launched a criminal investigation into the deaths from beriberi of two infants and the hospitalisation of 13 more who since August were fed a German made, non-dairy, baby formula made for sale only in Israel.
The special line of soya based formula—found by Israel's health ministry to "totally lack" the vital vitamin B-1 (thiamine)—was produced by the Humana company in Herford, Germany, one of the largest baby food manufacturers in Europe with an annual turnover of €3bn (£2.1bn;$1.2bn).
After two days of insistent denials of any error or wrongdoing, Humana finally took "technical and scientific responsibility" for the failure.
The company's chairman, Albert Grossa Fray, said at a press conference on Tuesday that the company believed the amount of thiamine found naturally in the soya beans was sufficient and that no synthetic vitamin needed to be added.
But Humana claimed that Remedia, the Israeli importer of the baby formula, had asked for this change. Senior Remedia officials denied this, saying they had been "misled" by the German company and had only asked for a "minor change of the fat components" of the non-dairy formula, but were unaware that the manufacturer had made a major change and eliminated the B-1 vitamin enrichment.
Fray said the formula sent to Israel contained "10 times less" the amount of thiamine as stated on the formula's container; the amount of vitamin B-1 in the formula amounted to 29 to 37 micrograms per 100 g, while the label said it had only 385 micrograms per 100 g.
The company called the lack of the optimum level of vitamin a "terrible mistake" but emphasised that this one-time error did not affect any of the company's other products.
The Israeli health ministry's director general, Dr Boaz Lev, charged that not only Humana was responsible, but also Remedia (51% of which is owned by the US based company H J Heinz) for having not informed the ministry of changes in the composition of the formula.
"Even a minor change required that we be informed and that Remedia apply for a new licence for the formula, as it is considered a new product."
But Remedia said that it had "no clue" that Humana removed the vitamin, and claimed that the change in fats—apparently to expand the market to older babies—was only a minor one that didn't require reapplication.
Dr Lev said that the lack of thiamine in the packaged formula constituted "fraud" as this vital component was listed on the label.
The problem started when doctors at Schneider Medical Centre for Israel in Petah Tikva (the largest children's hospital in the Middle East) noted that three infants had been admitted with encephalopathy within a week.
Ministry epidemiologists examined more than a dozen recent infant encephalopathy cases and found a common denominator: All had been exclusively or mainly fed the non-dairy Remedia formula.
Although beriberi is unknown in the Western world, a doctor at a Tel Aviv hospital identified it in a 9 month old baby admitted with encephalopathy and informed the ministry of the connection. Nine of the 10 babies still hospitalised have substantially improved after getting vitamin B-1 injections.
But Professor Tommy Scheinfeld, head of Schneider's intensive care unit, said there are no data in the medical literature on the long term effects of severe thiamine deficiency in Western babies; infants in the developing world develop beriberi and die quickly due to malnutrition and poor environmental conditions.