A German baby formula that caused severe vitamin deficiency in 15 Israeli infants and killed 2 has led to a radical revamp of Israel's regulatory framework for infant formula, making the requirements more stringent than for pharmaceuticals.

Recipe for disaster: A series of errors led to rare cases of beriberi, a deficiency of thiamine. Credit: Reuters/Nir Elias NIR/RKR/CRB

In early November, several Israeli babies were hospitalized with the neurologic and cardiac symptoms of beriberi, a severe deficiency in thiamine, or vitamin B1. Thiamine has essential roles in converting carbohydrates to energy and in the synthesis of the neurotransmitter acetylcholine.

The infants had all been fed Remedia Super Soya 1, a kosher infant formula manufactured exclusively for Israel by the German company Humana. The affair prompted a police investigation in both Israel and Germany. Subsequent testing revealed that, contrary to product labels, the formula almost entirely lacked thiamine. The product has since been withdrawn from the market.

Humana, the oldest and one of the largest baby food companies in Germany, admitted to a series of blunders and fired four workers. According to a company spokesman, a Humana employee failed to add thiamine to the product because the vitamin naturally occurs in soybeans. The soy was treated with heat, however, which destroyed the thiamine.

Because follow-up quality testing didn't pick up on the deficiency, the scandal raised questions about the adequacy of the Israeli Health Ministry's supervision. In response, the Ministry changed its regulations for baby formulas. Previously, manufacturers had to submit laboratory test results for a formula's ingredients, after which the Ministry performed random testing of selected ingredients. Under the new regulations, the Ministry will test all batches of locally produced or imported formulas.

In effect, the Ministry will be duplicating the quality assurance process of the manufacturer—a practice unheard of anywhere else in the world, says Dorit Nitzan-Kaluski, director of the Ministry's Food and Nutrition Administration. “It's a catastrophe for the country because it's a huge expense and a huge mess, but there's no choice,” says Nitzan-Kaluski. “We've lost our credibility.”

In the US, manufacturers submit lab tests for each new infant formula to the Food and Drug Administration, but the agency doesn't retest the formulas before they go to market. It does, however, perform annual inspections of manufacturing plants and collect samples for nutrient analyses.

Beriberi is rare in the US and in Europe because most foods there are vitamin-enriched, and is seen primarily in chronic alcoholics or in people on dialysis. It is more common in parts of East Asia, where milled or polished rice is a dietary staple, but its incidence there has also dropped sharply as economic conditions have improved.