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U.S. FDA
112
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date: 040413
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of CF62 Leopard TMO FUG us, A31008-H6050-A50-1-4A19 (25.06.2004, 14:28)
any low incident health problems
associated with use of mobile
phones. FDA continues to work with
all parties, including other federal
agencies and industry, to assure that
research is undertaken to provide
the necessary answers to the out-
standing 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
anyway. 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 com-
pare the usage of mobile phones
among people with brain cancer
with the use of mobile phones
among appropriately matched peo-
ple without brain cancer. This is
called a case-control study. The cur-
rent case-control study of brain can-
cers by the National 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
repair, 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
mobile phone industry to take a
number of steps to assure public
safety. The agency has recom-
mended that the industry:
• Support needed research into pos-
sible biological effects of RF of the
type emitted by mobile phones;
