Legal Question in Product Liability in Pennsylvania

Re: FDA Approval

Air ionizers have been used for a long time in North America, Europe, and elsewhere. They were sold as health-promoting devices in the U.S. before 1960, but manufacturers could not support the health claims. For this reason, the Food and Drug Administration (FDA) forced the ionizers off the U.S. market. Currently they are sold in the United States as air cleaning devices. It appears that the British Allergy Foundation may have given its endorsement to certain air ionizers. Last I checked, however, there were no official standards in North America or Europe that specifically address the use of such ionizers. However, ionziers can produce ozone. In the United States any device that produces ozone is limited to maximum room concentrations of 50 ppbv ozone during appliance operation; that threshold has been promulgated by FDA regulation.