From Our 2010 Archives
FDA on BPA: 'Some Concern,' No Ban
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Take 'Reasonable Steps' to Avoid Plastics Chemical Bishpenol A, Agency Advises
Daniel J. DeNoon
Reviewed By Louise Chang, MD
Jan. 15, 2010 -- Americans should take "reasonable steps" to avoid the plastics chemical BPA, the FDA says.
BPA, or bisphenol A, is everywhere. Created more than 40 years ago, millions of tons are made each year and used in a wide variety of products including plastic bottles and food can liners. More than 90% of Americans have detectable BPA in their bodies.
In 2008, the FDA issued a "draft assessment" finding that BPA was safe. But a short time later, the National Toxicology Program disagreed, noting "some concern" that BPA exposure during pregnancy or infancy might be bad for a person's long-term health.
Now the FDA says it officially agrees there is concern over fetus/infant exposure to BPA. FDA Commissioner Margaret Hamburg, MD, announced the change of course -- and the start of a $30 million BPA research program -- at a news conference.
"At this time, we share the perspective of the NTP of some concern of health effects of BPA. This means we need to know more," Hamburg said. "In the interim, as a precaution, the FDA is taking reasonable steps to help reduce human exposure to BPA."
Exactly what are the "concerns" over BPA? Linda Birnbaum, PhD, director of the National Institute of Environmental Health Sciences, spelled it out.
"There are critical periods of development when exposure to BPA may lead to certain health effects, including behavioral effects, diabetes, reproductive disorders, development of certain kinds of cancers, asthma, cardiovascular disease, and effects that can go from one generation to the next," Birnbaum said at the news conference.
The findings come from two previous National Institutes of Health studies that focused on developmental and reproductive effects. What about the adult health concerns raised by more recent studies?
The National Institutes of Health studies "focused on developmental and reproductive effects," Birnbaum said. "That is what led to our concern. It never looked at effects in adults, which is a different issue."
That's why the National Institutes of Health officially has "negligible concern" over adult health problems from BPA.
Despite it's newly increased concern, the FDA has not banned BPA and does not consider BPA-containing products, such as plastic baby bottles or plastic-lined cans of baby formula, to be unsafe.
In fact, the FDA says the risk of BPA from canned formula is far less than the risk of feeding a baby less nourishing food.
Nevertheless, U.S. health agencies are advising Americans to take "reasonable steps" to avoid BPA. Their advice:
Sharfstein said the FDA is seeking greater regulatory powers to track and control industrial use of the chemical. Current 1960s-era regulations allow manufacturers to use BPA without telling the FDA they are doing so. But the FDA is checking to see whether more recent legislation gives it the power to force manufacturers to notify the FDA of BPA use -- and to allow the FDA to ban products if manufacturers don't perform safety studies.
The plastics industry group American Chemistry Council says it's "disappointed" that the new FDA recommendations are "unfounded."
"Plastics made with BPA contribute safety and convenience to our daily lives because of their durability, clarity, and shatter resistance," the group says in a news release. "Can liners and food-storage containers made with BPA are essential components to helping protect the safety of packaged foods and preserving products from spoilage and contamination."
The FDA says it will help industry seek alternatives to BPA. Some alternatives exist. Sharfstein noted that the six largest manufacturers of baby bottles -- representing more than 90% of the U.S. market -- are now making baby bottles without BPA.
SOURCES: FDA/Health and Human Services news conference, Jan. 15, 2010, with
William Corr, deputy secretary, Department of Health and Human Services;
Margaret Hamburg, MD, commissioner, FDA; Linda Birnbaum, PhD, director,
National Institute of Environmental Health Sciences, National Institutes of
Health; and Robin Ikeda, acting deputy director for non-communicable disease,
Environmental Health and Injury Prevention, CDC.