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FDA Update on mobile phone safety
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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 pro-
vide 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 diag-
nosed 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 can-
cer. This is called a case-control
study.
The current case-control study of
brain cancers by the National
Cancer Institute, as well as the fol-
low-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-emit-
ting consumer products such as
mobile phones before marketing,
as it does with new drugs or med-
ical devices.
However, the agency has authori-
ty 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.
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
Most cancer causing agents
increase risk with increased expo-
sure. An ongoing study of brain
cancers by the National Cancer
Institute is expected to bear on the
accuracy and repeatability of these
results. 1)
• Researchers conducted a large
battery of laboratory tests to
assess the effects of exposure to
mobile phone RF on genetic mate-
rial. These included tests for several
kinds of abnormalities, including
mutations, chromosomal aberra-
tions, DNA strand breaks, and
structural changes in the genetic
material of blood cells called lym-
phocytes.
None of the tests showed any
effect of the RF except for the
micronucleous assay, which
detects structural effects on the
genetic material. The cells in this
assay showed changes after expo-
sure to simulated cell phone radia-
tion, but only after 24 hours of
exposure. It is possible that expos-
ing the test cells to radiation for
this long resulted in heating.
Since this assay is known to be
sensitive to heating, heat alone
could have caused the abnormali-
ties to occur. The data already in
the literature on the response of
the micronucleus assay to RF are
conflicting. Thus follow-up research
is necessary. 2)
FDA is currently working with
government, industry, and academ-
ic groups to ensure the proper fol-
low-up to these industry-funded
research findings.
Collaboration with the Cellular
Telecommunications Industry
Association (CTIA) in particular is
expected to lead to FDA providing
research recommendations and sci-
entific oversight of new CTIA-fund-
ed research based on such recom-
mendations.
Two other studies of interest
have been reported recently in the
literature:
• Two groups of 18 people were
exposed to simulated mobile
phone signals under laboratory con-
ditions while they performed cogni-
tive function tests. There were no
changes in the subjects’ ability to
recall words, numbers, or pictures,
or in their spatial memory, but they
were able to make choices more
quickly in one visual test when
they were exposed to simulated
mobile phone signals. This was the
only change noted among more
than 20 variables compared. 3)
• In a study of 209 brain tumor
cases and 425 matched controls,
there was no increased risk of
brain tumors associated with
mobile phone use. When tumors
did exist in certain locations, how-
ever, 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 num-
ber of cases, the increased likeli-
hood was too small to be statisti-
cally significant. 4)
Further information
User guide S40 US 19/09/01 15:44 Side 88