Two Washington area mothers of children who became seriously ill after being fed deficient baby formulas yesterday accused the Food and Drug Administration of failing to crack down adequately on the makers of infant formulas.
The sons of Lyn Pilot and Carol Laskin were two of at least 118 babies who refused food and failed to grow properly while being fed Neo-Mull-Soy and CHO-free, two formulas recalled by the FDA last August when they were found to contain dangerously low levels of the nutrient chloride. In December, the agency approved the company's corrected versions of the formulas, and they are reappearing on supermarket shelves.
The parents and doctors of the affected babies worry that the children may have suffered permanent damage by being deprived of a nutrient during the months when brain growth is most rapid.
Pilot and Laskin, speaking yesterday at a consumer meeting at the Department of Health, Education and Welfare, urged the FDA to begin regulating infant formula as a drug to ensure that they meet strict standards.
FDA officials said that since the Neo-Mull-Soy recall their agency has demanded the recipes of infant formulas from manufacturers, moved to require tighter control of manufacturing and begun its own laboratory testing of most of the baby formulas on the market.
Pilot and Laskin said that isn't enough.
"What stick do you have to enforce this?" demanded Pilot, whose husband Larry spent 10 years as an FDA lawyer. "You have no statutory authority." l
The agency has no power to seize formula shipments or examine company records but is seeking that authority through legislation pending in Congress, said Bureau of Foods director Sanford Miller.
The mothers argued that changing the law will take years and urged FDA Commissioner Jere E. Goyan to start regulating the substances as a drug.
Goyan said defining formula as a drug would not prevent incidents similar to the Neo-Mull-Soy case in which removing salt fro the formula made its chloride content fall too low. He said such accidents could only be prevented by tighter FDA control over manufacturing. He also said that calling a formula drug would subject it to stringent pre-market testing and that cost might prevent companies from making specialized formulas that some babies need to survive. No such testing is now required.
Some doctors have expressed concern that the FDA has accepted lack of salt as the whole explanation for the babies' symptoms, including severe blood abnormalities, could not have been due to chloride lack alone, and suggest that the two formulas may have contained an ingredient that mimicked a hormone, prostaglandin.
Goyan said the agency has not ruled out that possibility and still is awaiting results of further tests being done on the formulas in Europe. He said all the evidence so far indicates that lack of chloride caused the illnesses, so the FDA cannot delay remarketing of Neo-Mull-Soy and CHO-free without proof.
"If we took every product off the market over which there has been a controversy, there would be no products," he said.