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Bisphenol A Safe, Says FDA

FDA Issues Draft Report on Bisphenol A Noting "Adequate Margin of Safety" in Typical Exposure From Food
By
WebMD Health News
Reviewed by Louise Chang, MD

Aug. 15, 2008 -- Bisphenol A, the controversial plastic chemical, is safe at typical exposure levels from food and drink, according to an FDA draft report.

Bisphenol A, also called BPA, is found in polycarbonate plastic, including some water bottles and baby bottles, and in epoxy resins, which are used to line metal products including canned foods.

Bisphenol A Timeline

The controversy over chemical bisphenol A erupted this year, when a government report noted some concern about possible health risks from the chemical.

Here's an overview of important dates in this ongoing story:

April 15: An NTP draft report notes "some" concern for bisphenol A's effects on the mammary gland, prostate gland, and accelerated female puberty, mainly based on lab tests on rodents.

April 17: The American Chemistry Council, an industry group, asks the FDA to update its bisphenol A safety review in light of "confusing and frightening" media reports.

April 18: Canadian health officials propose banning bisphenol A in polycarbonate baby bottles "to be prudent," although they see no proof of harm.

Reusable water bottle maker Nalgene says it's ditching bisphenol A in its consumer bottles.

April 21: Wal-Mart, Toys "R" Us, and Babies "R" Us say they will phase out baby bottles containing bisphenol A.

April 28: The FDA says it's reviewing bisphenol A safety but notes that a large body of evidence supports the chemical's safety.

June 11: An NTP advisory panel recommends changing "some concern" to "minimal concern" for bisphenol A's mammary and puberty effects in the NTP's draft report.

July 23, 2008: The European Food Safety Authority (EFSA) sees no bisphenol risk to human fetuses or newborns because bisphenol A exits the human body too quickly to pose a threat.

The draft report states that based on lab tests in rodents, infants and adults are exposed to bisphenol A levels that are below toxic levels. "Safe or safety means that there is reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use," but "complete certainty of absolute harmlessness is scientifically impossible to establish," the draft report states.

Bisphenol A safety became a hot topic in April, when U.S. government scientists at the National Toxicology Program (NTP) expressed "some" concern about bisphenol A's possible effects on the mammary gland, prostate gland, and accelerated female puberty.

Since then, there's been a storm of bisphenol A publicity, with major retailers including Wal-Mart backing away from baby bottles containing bisphenol A, the FDA probing bisphenol A safety, and consumers wondering how concerned they should be.

"It's become a bit of a media spectacle," says Sarah Vogel, PhD, MPH, whose Columbia University dissertation traces the politics, economics, and scientific history of bisphenol A.

That spectacle hasn't let up. Today's FDA draft report, which doesn't recommend banning bisphenol A, is the latest development. But California lawmakers are debating a bill that would limit bisphenol A to trace amounts in products for kids age 3 and younger, and the NTP's final report is expected this summer. An FDA subcommittee will meet on Sept. 16 to discuss the FDA's draft report on bisphenol A.

But will those reports settle the bisphenol A safety debate? Or have the questions lodged in the public consciousness, with opinion outpacing official guidance? And when all is said and done, will you ever look at your water bottles, baby bottles, and canned foods the same way?

It depends whom you ask, with three very different viewpoints vying for your favor.

View No.1: No Need to Worry

This is the stance that the European Food Safety Authority (EFSA) took in late July -- and it's in line with today's FDA draft report.

An EFSA panel reviewed bisphenol A research -- mostly done on rodents -- and concluded that bisphenol A passes through the human body much faster than in rodents, with little chance for harm to human fetuses or newborns.

That finding "supports FDA's position that data we have reviewed up until this time support the safety of the currently permitted uses of BPA in food contact material," FDA spokesman Sebastian Cianci told WebMD by email last week, before the draft report was issued. Like the European report, the FDA's draft report argues that studying bisphenol A's effects in rodents may "overestimate" bisphenol A's effects in humans.

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