User's Guide

50 Certification and safety information for the United States and countries using FCC standards
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 radiofrequency 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 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.
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 interagency working 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 primary
subject of the safety questions discussed in this document.
What is FDA doing to find out more about the possible health effects of wireless phone RF?
FDA is working with the U.S. National Toxicology Program and with groups of investigators around the world to ensure that
high priority animal studies are conducted to address important questions about the effects of exposure to radiofrequency
energy (RF).
FDA has been a leading participant in the World Health Organization International Electromagnetic Fields (EMF) Project
since its inception in 1996. An influential result of this work has been the development of a detailed agenda of research
needs that has driven the establishment of new research programs around the world. The Project has also helped develop a
series of public information documents on EMF issues.