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FDA Consumer Update - cases

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e FDA less Consumer Update ase FDA Consumer Update e The U.S. Food and Drug Administration's Center for Devices and Radiological Health Consumer Update on Mobile Phones: 1Th. eUD.So. FwooirdealnedsDsrupghones pose a health hazard? o be TAhdmeianvisatrialatiobnle's Csecniteenr tfoifricDeevvicidesence does not show that any health problems are associated with using wireless not panhdoRnaedsio.lToghiecarleHiesalnthoCpornosuomf,ehrowever, that wireless phones are absolutely safe. Wireless phones emit low levels loss oUfpdRaatedoion FMroebqilueePnhocnye(sR: F) energy in the microwave range while being used. They also emit very low levels of RF when in idle mode. Whereas high levels of RF can produce health effects (by heating tissue), exposure to low level public R1.F Dthoatwdioreelsenssotpphroondeuscpeohseeaating effects causes no known adverse health effects. Many studies of low level RF exphoesaulrtehs hhaavzearndo?t found any biological effects. Some studies have suggested that some biological effects may b oThcecauvra,iblaubltessucicehntiffiinc devinidgenscheadvoeesnot been confirmed by additional research. In some cases, other researchers have hnoatdshdoiwfficthualttyaniynhreeapltrhopdruobclienmgsthose studies, or in determining the reasons for inconsistent results. r off 2ar.e aWssohciaateidswthitheuFsiDngA'wsirreolelses concerning the safety of wireless phones? Uphnodnesr.tThherelaiswn,othperoFofD, hAowdeoveesr, 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 Radio Frequency (RF) energy at a level that is hazardous to the user. In such a case, the 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 does not justify FDA regulatory actions, the FDA has urged the wireless phone 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 phones; • Design wireless phones 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 phones with the best possible information on possible effects of wireless phone use on human health. The 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 45

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45
FDA Consumer Update
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health Consumer Update on
Mobile Phones:
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 Radio Frequency (RF) energy in the microwave range while being used. They also emit very low levels of RF
when in idle 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 the FDA’s role concerning the safety of wireless phones?
Under the law, the 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 Radio Frequency (RF) energy at a level that is hazardous to
the user. In such a case, the 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 does not justify FDA regulatory actions, the FDA has urged the wireless phone
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 phones;
•
Design wireless phones 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 phones with the best possible information on possible effects of
wireless phone use on human health.
The 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