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74
U.S. FDA
the public that there are, or are not,
any low incident health problems as-
sociated with use of mobile phones.
FDA continues to work with all par-
ties, including other federal agencies
and industry, to assure that research
is undertaken to provide the neces-
sary answers to the outstanding
questions about the safety of mobile
phones.
What is known about cases of human
cancer that have been reported in users
of hand-held mobile phones?
Some people who have used mobile
phones have been diagnosed with
brain cancer. But it is important to
understand that this type of cancer
also occurs among people who have
not used mobile phones. In fact,
brain cancer occurs in the U.S. popu-
lation at a rate of about 6 new cases
per 100,000 people each year. At
that rate, assuming 80 million users
of mobile phones (a number increas-
ing at a rate of about 1 million per
month), about 4800 cases of brain
cancer would be expected each year
among those 80 million people,
whether or not they used their
phones. Thus it is not possible to tell
whether any individual's cancer
arose because of the phone, or
whether it would have happened an-
yway. A key question is whether the
risk of getting a particular form of
cancer is greater among people who
use mobile phones than among the
rest of the population. One way to
answer that question is to compare
the usage of mobile phones among
people with brain cancer with the
use of mobile phones among appro-
priately matched people without
brain cancer. This is called a case-
control study. The current case-con-
trol study of brain cancers by the Na-
tional Cancer Institute, as well as the
follow-up research to be sponsored
by industry, will begin to generate
this type of information.
What is FDA's role concerning the safety
of mobile phones?
Under the law, FDA does not review
the safety of radiation emitting con-
sumer products such as mobile
phones before marketing, as it does
with new drugs or medical devices.
However, the agency has authority
to take action if mobile phones are
shown to emit radiation at a level
that is hazardous to the user. In such
a case, FDA could require the manu-
facturers of mobile phones to notify
users of the health hazard and to re-
pair, replace or recall the phones so
that the hazard no longer exists.
Although the existing scientific data
do not justify FDA regulatory actions
at this time, FDA has urged the mo-
bile phone industry to take a number
of steps to assure public safety. The
agency has recommended that the
industry:
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