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 a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration.

(c) A number of devices currently on the market generate ozone by design or as a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated and/or misbranded within the meaning of sections 501 and 502 of the act if it is used or intended for use under the following conditions:

FTC Seeks Civil Penalties Against Ozone-Generator Firm over Air Cleaning Claims in Violation of Prior Order

FTC Seeks Civil Penalties Against Ozone-Generator Firm over Air Cleaning Claims in Violation of Prior Order FTC News Release January 5, 1998 The Federal Trade Commission has filed suit in federal district court alleging that Alpine Industries, Inc., a company based in Tennessee and Minnesota, has violated a 1995 Commission order by continuing to claim, without adequate substantiation, that its ozone-generating indoor “air cleaner” devices remove numerous pollutants, do so better than other methods, and prevent or relieve medical or health related conditions. The FTC is seeking a court order against the firm and its president, William J. Converse, and civil penalties up to $11,000 per order violation. Alpine and Mr. Converse are bound by the 1995 order, which requires competent and reliable scientific evidence …

Alpine Industries, of Greeneville Tennessee, manufactures various consumer and commercial products and markets them through independent distributors. Its best known products are air-purification devices — ozone generators that circulate room air through an electrically charged plate. The plate converts the oxygen into ozone that is recirculated into the room by a fan in the unit [1]. The company states that its distributors have sold more than three million of its air-purification systems since 1987 [2]. In January 2000, a federal court ordered the company to stop making health claims for its ozone generators [3,4]. In April 2001, the judge assessed a civil penalty of $1.49 million plus costs and interest against Alpine Industries and its president William J. Converse. The court also entered an injunction …

Kenneth R. Thiefault and his wife, Mardel Barber, formerly of Jupiter, Florida, were sentenced in the U.S. District Court for the Southern District of Florida in March to prison terms that together total more than eight years and fines that add up to more than $100,000. They illegally distributed ozone generators, devices that turn oxygen into ozone, by claiming that the devices could cure a variety of diseases, including cancer and AIDS. FDA has never approved ozone generators or ozone gas for treating any medical conditions. . They continued to sell the unapproved medical devices, even after FDA informed them several times that FDA approval was necessary to market medical devices or medical gas in this country. This would require the submission of scientific data