News Update: National Toxicology Program reviews soy-based infant formula

January 1, 2010

An expert committee convened by the federal National Toxicology Program carefully chose its wording at a recent meeting to say that there is "minimal concern" about adverse developmental effects in infants fed soy infant formula.

An expert committee convened by the federal National Toxicology Program carefully chose its wording at a recent meeting to say that there is "minimal concern" about adverse developmental effects in infants fed soy infant formula.

However, the pediatrician who chaired the panel, which met last month, said that recent scientific findings support the American Academy of Pediatrics (AAP) statement that there are few indications for soy protein-based formulas to be used in the place of cow's milk-based formulas for term infants and that the formulas are not designed or recommended for preterm infants.

New research underscores the idea that pediatricians should discuss the AAP guidelines with parents and talk about some of the risks, said Gail McCarver, MD, professor of pediatrics and pharmacology/toxicology at the Medical College of Wisconsin and panel chair.

An AAP statement from 2008 said that soy formulas might account for nearly 25% of the formula market. However, the Department of Health and Human Services said, based on 2009 market data, that sales of soy formula in this country are about half of what they were 10 years ago.

"We have strong evidence that there's a large, large number of people who simply ignore AAP recommendations. And so, we still know that soy is used rather widely by people without any indication for it," said Ruth Etzel, MD, PhD, of the George Washington University Department of Environmental and Occupational Health, another member of the panel.

A statement from the 14-member panel said, "A number of studies in experimental animals and one study in humans reported effects related to the reproductive system, and this elevates the concern from 'negligible' to 'minimal.'"

McCarver said the regulatory bodies will take the panel's statement, perhaps use it to drive dialogue, and try to decide the appropriate response. Approaches might include taking steps to educate more physicians and pharmacists about soy formula or "some other mechanism that says the public should be better informed."

The federal National Toxicology Program is to review the panel's findings, solicit public comment, and issue a final report by early summer.

Information and links to information on the issue are at: http://www.hhs.gov/children/soyformula.html.