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Company Says Baby Formula Lacked Vitamin

November 12, 2003

BERLIN (AP) _ The German maker of a kosher baby food linked to two infant deaths in Israel acknowledged a production error Tuesday, saying the formula contained too little of a vitamin that is vital for babies’ development.

Humana Milchunion, based in the western German town of Herford, said tests showed that the soy-based milk substitute contained only about one-tenth or less of the advertised quantity of Vitamin B1.

It said that was a result of an error when Humana and Remedia, the Israeli partner for which it made the product, developed the formula for Remedia Super Soya 1 in February. Remedia is partly owned by American food giant H.J. Heinz Co.

``We are talking here about a unique combination of unfortunate circumstances,″ Humana board member Albert Grosse Frie said in a statement. A delegation of Israeli government officials who traveled to Germany have been informed, he said.

The Health Ministry in Israel last Friday recalled the product, and said its own tests showed a lack of the vitamin. Hundreds of parents whose babies were fed the formula flooded Israeli hospitals and medical clinics over the weekend to have their children examined.

The recall also affected Orthodox Jewish communities in the United States, where the soy-based formula is sold. In Washington, Food and Drug Administration spokesman Brad Stone said Sunday that U.S. health authorities were unaware of any U.S. illnesses from the formula.

Vitamin B1, also known as thiamin, is vital for development of the nervous system in babies. Israeli Health Ministry officials say more than 20 infants suffered from a disorder caused by a deficiency in the vitamin after drinking the formula, and three have died.

The ministry initially said it resulted in three deaths, but on Wednesday revised that down to two. In one case, it said, further checks found that the baby nursed almost all of his life and was fed the formula only a few times.

Humana is in contact with judicial and other authorities and would ``draw the necessary organizational and personnel conclusions,″ Grosse Frie said. The statement did not elaborate.

Heinz, which owns a 51 percent stake in Remedia, offered to help with the investigation, said Debbie Foster, a spokeswoman for the Pittsburgh-based company.

``Heinz is a shareholder in Remedia and other companies around the world. It is not a Heinz brand. It is a Remedia product,″ she said. Nonetheless, she said, ``We are very sympathetic and concerned.″

In Israel, Remedia acknowledged that it had sought changes in the formula but blamed Humana for the mistake.

``The change in Vitamin B1 was made by Humana at its own decision without us being a part of it. Of course if we had known about it we would have prevented it,″ Moshe Miller, an owner of Remedia, said at a news conference.

Still, Dorit Nitzan-Klosky, an Israeli Health Ministry official, said only the distributor _ Remedia _ was responsible in Israel. The company should have informed the ministry of the change in the formula especially since it was ``not a minor change, it is a completely new formula,″ she said.

Earlier Tuesday, Israeli police began questioning Health Ministry officials, entering its Tel Aviv offices and gathering information. ``There is a suspicion of a crime,″ said Avi Mantzur, a police commander leading the investigation.

In Germany, Humana said tests on samples of the formula showed that it contained between 29 and 37 micrograms of Vitamin B1 for every 100 grams of prepared milk substitute. However, the product was advertised as containing 385 micrograms of the vitamin.

Humana said a content analysis of two previous versions of the product was misinterpreted in drawing up the new formula _ leading to the conclusion that no further Vitamin B1 needed to be added.

Insufficient tests were carried out on a sample of the new product’s first batch, taken on March 21, Humana said.

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