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FDA Misses BPA Deadline Again

Dec 30, 2009 | Parker Waichman LLP

For the third time this year, the U.S. Food and Drug Administration (FDA) will miss its own deadline on advising the public on the safety of products manufactured with the controversial chemical bisphenol A—BPA—reports the Milwaukee-Wisconsin Journal Sentinel (JSOnline). The estrogenic, industrial chemical is a polycarbonate plastic byproduct found in a large array of products.

According to Michael Herndon, agency spokesman, the FDA will not make any decision this year, breaking its prior promise of doing so by year-end, said JSOnline, noting that the year-end promise was made after the FDA missed its November 30th deadline.

"I'm extremely frustrated by the FDA delay, and I'm even more frustrated by their silence about the delay," said Janet Nudelman, policy director at the Breast Cancer Fund. "Each day it further delays taking action, more newborn babies, children, and pregnant women are left unprotected from this hormone-disrupting compound linked to breast cancer and birth defects," Nudelman added, quoted JSOnline.

Developed in the 1930s as an estrogenic mimicker, BPA appears to wreak havoc on the body’s endocrine system. In urine tests, BPA is found in the overwhelming majority of Americans, more than 93 percent. Of note, the chemical is found in 90 percent of all newborns; a significant concern given that BPA has been connected to increased risks of brain, reproductive, cardiac, and immune system diseases and disorders; problems with liver function testing; interruptions in chemotherapy treatment; and links with serious health problems. Studies have overwhelmingly found BPA to have negative effects at doses lower than current FDA standards; retention in the body longer than was previously believed; leeching into liquids being held in containers regardless of the containers’ temperature; and longer lasting damage, which some feel can be passed to future generations. Recent reports link high levels of exposure to BPA to erectile dysfunction and other sexual problems in males.

Environmental Working Group spokesman, Alex Formuzis, described BPA’s risks as "overwhelming." The group is a health advocacy organization known for conducting tests that looked at BPA exposure. "We believe it's time to act," said Formuzis, quoted JSOnline.

Industry argues that scientists and advocates exaggerate BPA’s adverse effects, continually citing two industry studies; however, at last count, over 900 peer-reviewed studies found links between BPA and such effects. The FDA has maintained BPA’s safety, declaring the chemical safe for all usage as of August 2008, said JSOnline; however, the agency’s science board recommended it had not looked at enough of the studies and began its review, setting the original November 30th deadline.

Previously, JSOnline reported that, based on emails it obtained, it seems the FDA’s prior ruling was crafted, in part, by “lobbyists for the BPA-makers.” The agency’s science board concluded that the apparently ignored studies pointing to BPA’s harm. Since, FDA director Margaret Hamburg, speaking to Congress, said the agency would take a "fresh look" at the issue, promising an early fall decision that was moved to November 30th, then year-end, said JSOnline. The agency has not issued another deadline and is not saying if consumers should consider the chemical harmful or safe, added JSOnline.

Earlier this fall, President Obama’s administration said it was slating $30 million to the National Institute of Environmental Health Sciences to look at BPA’s effects. Director Linda Birnbaum told JSOnline that people should find alternatives to BPA-containing products and pregnant women, infants, and children should not ingest BPA.

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