User's Manual

Washington, D.C.; and personal communication, unpublished results.
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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 the 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 case
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 weather any individual’s cancer arose because of the
phone, or whether it would have happened anyway. A key question in whether the risk of getting
a particular form of cancer is greater among people who use mobile phones than among the
population. One way to answer that question is to compare the usage of mobile pones 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 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 manufactures 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 phones industry to take a number of steps to assure public safety. The agency
has recommended that the industry:
■ support needed research into possible biological effects of RF of the type emitted by mobile
phones;
■ design mobile phones in a way that minimizes any RF exposure to the user that is not
necessary for
device function ; and
■ cooperate in providing mobile phone users with the best possible information on what is
know about
possible effects of mobile phone use on human health.
At the same time, FDA belongs to an interagency working group of the federal agencies working
group of the federal agencies that have responsibility for different aspects of mobile phone
safety to ensure a coordinated effort at the federal level. These agencies are: