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12.2.02
10-S46 FDA.fm
i 37 Am Engl, A31008-H4600-A2-1-19
U.S. FDA
99
In summary, we do not have enough information at this point to assure the
public that there are, or are not, 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 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. population 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
increasing 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 compare the
usage of mobile phones among people with brain cancer with the use of
mobile phones among appropriately matched people without brain cancer.
This is called a case-control study. The current case-control study of brain
cancers 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
consumer 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 manufacturers 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.
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