FDA Policy on Ozone Devices
Part 801—Labeling Subpart H—Special Requirements for Specific Devices Sec. 801.415 Maximum acceptable level of ozone. (a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals. (b) Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs to result in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure; thus, symptomatic response is not …
Continue Reading >California Cleans Up Indoor Air Cleaners
Devices Emit Ozone, a Gas Known to Create and Exacerbate Respiratory Problems California Air Resources Board News Release, September 27, 2007 The California Air Resources Board (CARB) has adopted the nation’s first regulation to prohibit indoor air cleaners from emitting more than 0.050 parts per million of ozone. Some air cleaning devices, called ozone generators, have been shown to produce indoor ozone concentrations several times higher than the state’s outdoor air quality standard. CARB’s new regulation prohibits the sale of devices in California that produce enough ozone to harm human health. The standard of .050 parts per million will assure that concentrations remain below that level. Some devices exceeding these levels may be exempted but only for industrial use and where exposures are already regulated. There are …
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