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The
new rule will give the agency "special controls
(that) can provide reasonable assurance of the safety
and effectiveness of the product," Long said.
The
lawsuit settlement was reached on Monday with several
advocacy groups, including Moms Against Mercury, which
had sought to have mercury fillings removed from the
U.S. market.
While
the FDA previously said various studies showed no harm
from mercury fillings, some consumer groups contend
the fillings can trigger a range of health problems
such as multiple sclerosis and Alzheimer's disease.
In 2006, an FDA advisory panel of outside experts said
most people would not be harmed by them, but said the
agency needed more information.
Mercury
has been linked to brain and kidney damage at certain
levels. Amalgams contain half mercury and half a combination
of other metals.
Charles
Brown, a lawyer for one of the groups called Consumers
for Dental Choice, said the agency's move represented
an about-face. "Gone, gone, gone are all of FDA's
claims that no science exists that amalgam is unsafe,"
he said in a statement.
J.P.
Morgan Securities Inc. analyst Ipsita Smolinski said
the FDA is not likely to outright ban the fillings next
year but will probably call for restrictions.
"We
do believe that the agency will ask for the label to
indicate that mercury is an ingredient in the filling,
and that special populations should be exempt from such
fillings, such as: nursing women, pregnant women, young
children, and immunocompromised individuals," Smolinski
wrote in a research note on Wednesday.
Fewer
patients have been opting for mercury fillings in recent
years, instead choosing lighter options such as tooth-colored
resin composites.
Only
30 percent of fillings given to patients were mercury-filled
ones as of 2003, according to the American Dental Association
(ADA). Other options include glass cement and porcelain
as well as other metals such as gold, but they cost
more and are less durable, the group has said.
(Reporting
by Susan Heavey; editing by Carol Bishopric) |
