In a shift of position, the U.S. FDA is expressing concerns about possible health risks from bisphenol A, or BPA, a widely used component of plastic bottles and food packaging. The agency declared BPA safe in 2008.
But the FDA now has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.”
The action is another example of the drug agency becoming far more aggressive in taking hard looks at what it sees as threats to public health over the past year. In recent months, the agency has stepped up its oversight of food safety and has promised to tighten approval standards for medical devices.
Concerns about BPA are based on studies that have found harmful effects in animals, and on the recognition that the chemical seeps into food and baby formula. Nearly everyone is exposed to BPA, starting in the womb.
Dr. Sharfstein said the drug agency was also re-evaluating the way it regulates BPA.
The substance is now classified as a food additive, a category that requires a cumbersome and time-consuming process to make regulatory changes. Dr. Sharfstein said he hoped its status could be changed to “food contact substance
,” which would give the F.D.A. more regulatory power and let it act more quickly if it needed to do so.