Humana said it had dismissed four managers from product
development, quality control and its chemical laboratory
after tests showed the kosher Remedia Super Soya 1 product
contained less than one tenth the amount of vitamin B-1
advertised.
According to the most recent figures, two babies died and 14
were hospitalized as a result of the tragic problem. One
infant who was originally thought to have died from beriberi,
apparently died of other causes.
Remedia admitted that it knew that the manufacturer of the
German baby formula it marketed here had stopped adding
Vitamin B1 to the product, but it said that it did not know
that this resulted in the formula being deficient in B1,
because Humana had sent it a document asserting that the
soybeans on which the product was based contained enough
natural B1 to bring the quantity of the vitamin up to
accepted standards. Every shipment of the formula came with a
certificate from Humana asserting that it contained at least
385 micrograms of B1 per 100 grams, which is the accepted
international norm.
The product which Humana first shipped to Israel last spring
had been designed at Remedia's request, based on its
assessment of what would sell best in Israel and was not
marketed to other countries.
A legal advisor for Remedia said, the ministry did give
Remedia a permit to sell another new Humana product in recent
months, and that product, called Junior, a formula meant for
babies aged one year and above, was approved on the basis of
the same two documents that Humana provided in the case of
the formula for babies aged zero to 12 months: one stating
that no B1 had been added, since the product's natural
quantities of the vitamin were sufficient, and another
stating that the formula contained at least 385 micrograms of
B1 per 100 grams.
According to reports in the media, the Remedia soy-based
infant formula was never sold in the US. Its milk-based
formula, which is manufactured in England, was sold in the
US. Many soy-based products are sold in the US with
mehadrin kashrus, but Remedia's milk-based product is
more unique in this respect in the US.
As far as Remedia soy formula, in a statement the US Food and
Drug Administration said, "FDA has determined that no
commercial entries were distributed in the United States. It
is possible that noncommercial quantities of the product have
been brought in by travelers or through the mails."
Owners Reach Out
Parents whose children have been hospitalized apparently due
to the problem received a letter over the weekend from Moshe
and Naomi Miller, the Israeli owners of 49 percent of
Remedia, which included an offer of assistance. The Millers
also met personally with many of the parents to convey their
concern and offer their assistance.
In the letter they promised, "If the doctors taking care of
your babies believe that consultation with other medical
professionals from anywhere in the world is required, Remedia
will take it upon itself to cover the costs, including
flights for the parents and infant to such a destination."
Nursing the Best
According to a pamphlet published by the US Food and Drug
Administration (FDA) entitled, "Infant Formula: Second Best
but Good Enough," there is always a preference for mother's
milk. "A century ago, babies who couldn't be breast-fed
usually didn't survive. Today, although breast-feeding is
still the best nourishment for infants, infant formula is a
close enough second that babies not only survive but thrive.
. .
"While greater knowledge about human milk has helped
scientists improve infant formula, it has become
`increasingly apparent that infant formula can never
duplicate human milk,' write John D. Benson, Ph.D, and Mark
L. Masor, Ph.D., in the March 1994 issue of Endocrine
Regulations. `Human milk contains living cells, hormones,
active enzymes, immunoglobulins and compounds with unique
structures that cannot be replicated in infant formula.'
"Benson and Masor, both of whom are pediatric nutrition
researchers at infant formula manufacturer Abbott
Laboratories, believe creating formula that duplicates human
milk is impossible. `A better goal is to match the
performance of the breastfed infant,' they write. Performance
is measured by the infant's growth, absorption of nutrients,
gastrointestinal tolerance, and reactions in blood . . ."
As far as the choice of a milk formula or a soy formula, the
pamphlet is quite clear.
"The carbohydrates in most soy formulas are sucrose and corn
syrup, which are easily digested and absorbed by infants.
However, soy is not as good a protein source as cow's milk.
Also, babies don't absorb some minerals, such as calcium, as
efficiently from soy formulas. Therefore, according to the
American Academy of Pediatrics, `Healthy full-term infants
should be given soy formula only when medically necessary.'
"
