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FDA CONSUMER UPDATE
SAFETY INFORMATION
FDA belongs to an interagency working group of the federal agencies
that have responsibility for different aspects of RF safety to ensure
coordinated efforts at the federal level. The following agencies belong
to this working group:
that have responsibility for different aspects of RF safety to ensure
coordinated efforts at the federal level. The following agencies belong
to this working group:
•
National Institute for Occupational Safety and Health
•
Environmental Protection Agency
•
Federal Communications Commission
•
Occupational Safety and Health Administration
•
National Telecommunications and Information Administration
The National Institutes of Health participates in some interagency work-
ing group activities, as well. FDA shares regulatory responsibilities for
wireless phones with the Federal Communications Commission (FCC). All
phones that are sold in the United States must comply with FCC safety
guidelines that limit RF exposure. FCC relies on FDA and other health
agencies for safety questions about wireless phones. FCC also regulates
the base stations that the wireless phone networks rely upon. While
these base stations operate at higher power than do the wireless phones
themselves, the RF exposures that people get from these base stations
are typically thousands of times lower than those they can get from
wireless phones. Base stations are thus not the subject of the safety ques-
tions discussed in this document.
ing group activities, as well. FDA shares regulatory responsibilities for
wireless phones with the Federal Communications Commission (FCC). All
phones that are sold in the United States must comply with FCC safety
guidelines that limit RF exposure. FCC relies on FDA and other health
agencies for safety questions about wireless phones. FCC also regulates
the base stations that the wireless phone networks rely upon. While
these base stations operate at higher power than do the wireless phones
themselves, the RF exposures that people get from these base stations
are typically thousands of times lower than those they can get from
wireless phones. Base stations are thus not the subject of the safety ques-
tions discussed in this document.
3. What kinds of phones are the subject of this update?
The term “wireless phone” refers here to handheld wireless phones
with built-in antennas, often called “cell,” “mobile,” or “PCS” phones.
These types of wireless phones can expose the user to measurable
radiofrequency energy (RF) because of the short distance between the
phone and the user’s head. These RF exposures are limited by Federal
Communications Commission safety guidelines that were developed with
the advice of FDA and other federal health and safety agencies. When
the phone is located at greater distances from the user, the exposure
to RF is drastically lower because a person’s RF exposure decreases
rapidly with increasing distance from the source. The so-called “cordless
phones,” which have a base unit connected to the telephone wiring in a
house, typically operate at far lower power levels, and thus produce RF
exposures far below the FCC safety limits.
with built-in antennas, often called “cell,” “mobile,” or “PCS” phones.
These types of wireless phones can expose the user to measurable
radiofrequency energy (RF) because of the short distance between the
phone and the user’s head. These RF exposures are limited by Federal
Communications Commission safety guidelines that were developed with
the advice of FDA and other federal health and safety agencies. When
the phone is located at greater distances from the user, the exposure
to RF is drastically lower because a person’s RF exposure decreases
rapidly with increasing distance from the source. The so-called “cordless
phones,” which have a base unit connected to the telephone wiring in a
house, typically operate at far lower power levels, and thus produce RF
exposures far below the FCC safety limits.
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SAFETY INFORMATION
FDA CONSUMER UPDATE
1. Do wireless phones pose a health hazard?
The available scientific evidence does not show that any health problems
are associated with using wireless phones. There is no proof, however,
that wireless phones are absolutely safe. Wireless phones emit low levels
of radiofrequency energy (RF) in the microwave range while being used.
They also emit very low levels of RF when in the standby mode. Whereas
high levels of RF can produce health effects (by heating tissue), exposure
to low level RF that does not produce heating effects causes no known
adverse health effects. Many studies of low level RF exposures have not
found any biological effects. Some studies have suggested that some
biological effects may occur, but such findings have not been confirmed
by additional research. In some cases, other researchers have had dif-
ficulty in reproducing those studies, or in determining the reasons for
inconsistent results.
are associated with using wireless phones. There is no proof, however,
that wireless phones are absolutely safe. Wireless phones emit low levels
of radiofrequency energy (RF) in the microwave range while being used.
They also emit very low levels of RF when in the standby mode. Whereas
high levels of RF can produce health effects (by heating tissue), exposure
to low level RF that does not produce heating effects causes no known
adverse health effects. Many studies of low level RF exposures have not
found any biological effects. Some studies have suggested that some
biological effects may occur, but such findings have not been confirmed
by additional research. In some cases, other researchers have had dif-
ficulty in reproducing those studies, or in determining the reasons for
inconsistent results.
2. What is FDA’s role concerning the safety of wireless phones?
Under the law, FDA does not review the safety of radiation-emitting
consumer products such as wireless phones before they can be sold, as
it does with new drugs or medical devices. However, the agency has
authority to take action if wireless phones are shown to emit radiofre-
quency energy (RF) at a level that is hazardous to the user. In such a case,
FDA could require the manufacturers of wireless 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, FDA has urged the wireless phone indus-
try to take a number of steps, including the following:
consumer products such as wireless phones before they can be sold, as
it does with new drugs or medical devices. However, the agency has
authority to take action if wireless phones are shown to emit radiofre-
quency energy (RF) at a level that is hazardous to the user. In such a case,
FDA could require the manufacturers of wireless 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, FDA has urged the wireless phone indus-
try to take a number of steps, including the following:
•
Support needed research into possible biological effects of RF of the
type emitted by wireless phones;
type emitted by wireless phones;
•
Design wireless phones in a way that minimizes any RF expo sure to
the user that is not necessary for device function; and
the user that is not necessary for device function; and
•
Cooperate in providing users of wireless phones with the best
possible information on possible effects of wireless phone use on
human health.
possible information on possible effects of wireless phone use on
human health.
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U.S. Food and Drug Administration -
Center for Devices and Radiological Health
Consumer Update on Mobile Phones
Center for Devices and Radiological Health
Consumer Update on Mobile Phones
070320_CDM-8955_EN_M_Centennial.indd 158-159
2007.3.23 8:13:22 PM