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U.S. FDA
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they were more likely to be on the side
of the head where the mobile phone
was used. Because this occurred in only
a small number of cases, the increased
likelihood was too small to be statisti-
cally significant.
4
In summary, we do not have enough in-
formation at this point to assure the pub-
lic that there are, or are not, any low inci-
dent health problems associated with use
of mobile phones. FDA continues to work
with all parties, including other federal
agencies and industry, to assure that re-
search is undertaken to provide the nec-
essary answers to the outstanding ques-
tions 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 ex-
pected 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 be-
cause 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 an-
swer that question is to compare the us-
age 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 Na-
tional Cancer Institute, as well as the fol-
low-up research to be sponsored by in-
dustry, 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 manufactur-
ers 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 in-
dustry to take a number of steps to assure
public safety. The agency has recom-
mended that the industry:
• Support needed research into possible
biological effects of RF of the type emit-
ted by mobile phones;
• Design mobile phones in a way that
minimizes any RF exposure to the user
that is not necessary for device func-
tion; and
• Cooperate in providing mobile phone
users with the best possible informa-
tion on what is known about possible
effects of mobile phone use on human
health.
• At the same time, FDA belongs to an in-
teragency working group of the federal
agencies that have responsibility for
different aspects of mobile phone safe-
ty to ensure a coordinated effort at the
federal level. These agencies are:
• National Institute for Occupational
Safety and Health
• Environmental Protection Agency
• Federal Communications Commission
