FDA is Sued for Failing to Regulate Bisphenol A
A top environmental group has sued the U.S. Food and Drug
Administration over its failure to regulate bisphenol A, a ubiquitous
chemical linked to reproductive harm, cancer and obesity in studies.
The Natural Resources Defense Council filed a lawsuit Tuesday in the
U.S. Court of Appeals for the D.C. Circuit arguing that millions of
Americans have been unnecessarily exposed to the substance - found in
everything from soda bottles and tuna cans to children's sippy cups -
in the two years since it first petitioned the agency to outlaw
Under the FDA's own rules, it was required to approve, deny or
otherwise respond to the October 2008 petition within 180 days, the
lawsuit said. After maintaining for decades that bisphenol A was safe,
the FDA reversed position in January, saying exposure to the chemical
was of "some concern" for infants and children. The FDA also said it
would further study bisphenol A over the next two years.
"More research is always welcome and interesting, but at some point
you have to say, 'We know enough,' and take action. We've reached that
point," said Sarah Janssen, senior scientist at the NRDC's Environment
and Public Health program in San Francisco.
The American Chemistry Council, the trade group representing makers
of bisphenol A, said in a statement that "the scientific process and
the public interest are both best served by allowing the U.S. Food and
Drug Administration to complete its ongoing review of the science
surrounding the safety profile of bisphenol A."
Doubts about chemical
Officials at the Food and Drug Administration said the agency does not comment on lawsuits.
First developed as a synthetic form of estrogen in the 1930s and
later transformed into a plastic used in food containers, bisphenol A
has come under increasing scrutiny not just for its connection to early
puberty and other reproductive harms, but also to suppressed immune
function, cancer, neurological delays and diabetes in studies of
Most bisphenol A exposure in humans occurs when the substance
leaches out of everyday plastics, such as the coatings on pizza boxes
or in reusable water bottles.
Urine, breast milk
In 2004, the Centers for Disease Control and Prevention found
bisphenol A in the urine of 93 percent of 2,500 test subjects, with the
highest levels in those 6 to 11 years old. The chemical has also been
detected in amniotic fluid, breast milk and umbilical cord blood.
A handful of governments around the world have moved to phase out
and otherwise curb bisphenol A. But efforts to ban the chemical in the
United States have had limited success.
In 2006, San Francisco became the first city in the country to
prohibit bisphenol A in children's products. But the city backpedaled
on the ordinance after legal pressure from retailers and chemical
A similar state bill sponsored by Sen. Fran Pavley, D-Agoura Hills
(Los Angeles County), passed the Senate but was defeated in the
Assembly on Monday.
According to some estimates, makers of bisphenol A have spent $5 million campaigning against the California measure.