The Food and Drug Administration has asked Carnation Co. to submit new data to substantiate the claims that its new infant formula is less likely to trigger allergies after the agency found flaws in the company's original research.
The questions surrounding the Carnation product, called Good Start, has led the FDA to request information from the makers of other formulas that also claim to reduce the chances of allergic reaction to cow's milk.
Pediatricians have also voiced their concern about the formulas labeled "hypo-allergenic." They say the products, which reduce, but do not eliminate the potential for causing allergies, may mislead many mothers into believing the formulas are allergy-free. The FDA has given Carnation 60 days to supply new information regarding the allergy reduction claims of its Good Start product. "We told Carnation, through their lawyer, that the studies to support the hypo-allergenic claims don't pass muster," said FDA spokesman Emil Corwin.
Corwin said the Carnation studies claimed Good Start could alleviate such symptoms as spitting up, runny noses and colic linked to milk allergy and intolerance. "But it was not supported by some of the data in the study," he said.
Carnation spokesman Dick Curd said: "We are now supplying greater detail on what we have already given them and supplying additional results."
Besides Carnation, the FDA requested more detailed information on similar products sold by Ross Laboratories, which makes Alimentum, and Bristol-Myers, maker of Nutramigen.
The controversy comes only three months after Los Angeles-based Carnation, a subsidiary of Nestle, launched Good Start--for infants allergic to milk and soybean-based formulas--in a drive to win a share of the $1.6 billion that Americans spend annually on infant nutrition products.
Good Start is made from whey, which is a component of milk. A sister product, Good Nature, is designed for infants who have begun to eat solid foods.
Carnation, which estimates 40,000 babies use Good Start, says it has received six medical reports so far of adverse reactions by infants who were fed Good Start. The company said that in each of the six cases, the infant had a severe milk allergy or other physical reaction.
Beginning in April, Good Start packages will point out that the product offers "reduced potential for allergic reaction. No formula, including ours, is nonallergenic." The company will also warn mothers not to use Good Start if their infants have suffered from anaphylactic shock or other severe reaction triggered by another formula.
Hypo-allergenic formulas are unsuitable for the 1% of infants who are allergic to cow's milk, say pediatricians. "Mothers should recognize that this is not allergy free," said Birt Harvey, president-elect of the American Academy of Pediatrics. "That's our concern. If the infant is truly allergic to cow milk, those severe allergic reactions could occur just the same with these hypo-allergenic formulas."
The academy has updated its members on the subject in the February issue of its newsletter. "There is no evidence to support the use of (hypo-allergenic) formulas for the treatment of colic, sleeplessness and irritability," the newsletter said.
Last year, pediatricians opposed Carnation efforts to market and advertise the product directly to mothers, a move the academy said would undermine breast feeding. Carnation later agreed to drop its name from such ads after meeting with academy officials.