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2.In a study of 209 brain tumor cases and 425 matched con- trols, there was no increased risk of brain tumors associated with mobile phone use. When tumors did exist in certain loca- tions, however, they were more likely to be on the side of the head where the mobile phone was used. Because this oc-

curred in only a small number of cases, the increased likeli- hood was too small to be statistically significant.4

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 agen- cies 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 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 cancer. This is called a case-control study. The current case-control study of brain cancers by the Na- tional Cancer Institute, as well as the follow-up research to be sponsored by industry, will begin to generate this type of infor- mation.

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. How- ever, 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 re- pair, replace or recall the phones so that the hazard no longer exists.

Although the existing scientific data do not justify FDA regula- tory actions at this time, FDA has urged the mobile phone industry to take a number of steps to assure public safety. The agency has recommended that the industry:

■support needed research into possible biological effects of RF of the type emitted by mobile phones;

■design mobile phones in a way that minimizes any RF ex- posure to the user that is not necessary for device function; and

■cooperate in providing mobile phone users with the best possible information on what is known about possible ef- fects of mobile phone use on human health.

4Hardell, L, Nasman, A, Pahlson, A, Hallquist, A and Mild, KH. Use of cellular telephones and the risk for brain tumors: a case-control study. Int. J. Oncol., 15: 113-116, 1999.