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FDA CONSUMER UPDATE
SAFETY AND WARRANTY
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:
• 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 inter-agency
working group activities, as well. FDA shares regulatory responsibilities
for wireless handsets with the Federal Communications Commission
(FCC). All handsets 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 handsets. FCC also
regulates the base stations that the wireless handset networks rely upon.
While these base stations operate at higher power than do the wireless
handsets themselves, the RF exposures that people get from these base
stations are typically thousands of times lower than those they can get
from wireless handsets. Base stations are thus not the subject of the safe-
ty questions discussed in this document.
3. What kinds of handsets are the subject of this update?
The term “wireless handset” refers here to hand-held wireless handsets
with built-in antennas, often called “cell,” “mobile,” or “PCS” handsets.
These types of wireless handsets can expose the user to measurable
radiofrequency energy (RF) because of the short distance between the
handset 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 handset 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 hand-
sets,” which have a base unit connected to the device wiring in a house,
typically operate at far lower power levels, and thus produce RF expo-
sures far below the FCC safety limits.
139
SAFETY AND WARRANTY
FDA CONSUMER UPDATE
U.S. Food and Drug Administration -
Center for Devices and Radiological Health
Consumer Update on Wireless Handsets
138
1. Do wireless handsets pose a health hazard?
The available scientific evidence does not show that any health problems
are associated with using wireless handsets. There is no proof, however,
that wireless handsets are absolutely safe. Wireless handsets 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 stand-by 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 difficulty in reproducing those studies, or in determining the reasons
for inconsistent results.
2. What is FDA’s role concerning the safety of wireless handsets?
Under the law, FDA does not review the safety of radiation-emitting
consumer products such as wireless handsets before they can be sold, as
it does with new drugs or medical devices. However, the agency has
authority to take action if wireless handsets are shown to emit
radiofrequency energy (RF) at a level that is hazardous to the user. In
such a case, FDA could require the manufacturers of wireless handsets to
notify users of the health hazard and to repair, replace or recall the
handsets so that the hazard no longer exists. Although the existing
scientific data do not justify FDA regulatory actions, FDA has urged the
wireless handset industry to take a number of steps, including the
following:
• Support needed research into possible biological effects of RF of the
type emitted by wireless handsets;
• Design wireless handsets in a way that minimizes any RF exposure to
the user that is not necessary for device function;
and
• Cooperate in providing users of wireless handsets with the best
possible information on possible effects of wireless handset use on
human health.