Siemens TDMA 800, TDMA 1900 manual 101, What is FDAs role concerning the safety of mobile phones?

31.5.02 10-S46 FDA.fm i 37 Am Engl, A31008-H4600-A2-1-19

U.S. FDA 101

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 provide 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 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 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 cancer. This is called a case-control study. The current case-control study of brain cancers by the National Cancer Institute, as well as the follow-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 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 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.