Steril Aire – FDA Warning Letter

The FDA issued a Warning Letter to Steril-Aire, specifically to Dr. Robert Scheir, President and Chairman, regarding the unapproved marketing of their Steril-Zone Room Air Purifier with a UVC emitter in the U.S. The FDA's Center for Devices and Radiological Health (CDRH) identified this violation on July 1, 2010, by reviewing the company's website.

The Steril-Zone Room Air Purifier is deemed a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) due to claims suggesting its effectiveness against "mold, bacteria and viruses," including specific statements about eliminating infectious organisms, reducing allergy/asthma symptoms, and preventing the spread of diseases like flu, TB, and SARS. These claims indicate the device is intended for the cure, mitigation, treatment, or prevention of disease.

Consequently, the device is adulterated under Section 501(f)(1)(B) of the Act because Steril-Aire lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). It is also misbranded under Section 502(o) of the Act for failure to notify the FDA of intent to introduce the device into commercial distribution, as required by Section 510(k).

This is the second enforcement letter to Steril-Aire, following a previous Warning Letter in April