Inspections, Compliance, Enforcement, and Criminal Investigations
Steril Aire 7/2/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
July 2, 2010
VIA UNITED PARCEL SERVICE
Dr. Robert Scheir
President and Chairman
2840 N. Lima Street
Burbank, California 91504
Dear Dr. Scheir:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Steril-Zone Room Air Purifier with a UVC emitter in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Most recently on July 1, 2010, FDA's Center for Devices and Radiological Health (CDRH) viewed your company's website. The website makes numerous claims for the product, which is a device within the meaning of Section 201(h) of the Act.
Your web site contains statements that suggest that use of Steril-Zone Room Air Purifier with a UVC emitter in ventilation systems are effective against "mold, bacteria and viruses."
"Steril-Zone's germicidal UVC energy eliminates infectious organisms more successfully than air purifiers without UV lamps-even those with HEPA filters, which have only limited effectiveness against viruses, the tiniest of parasites. The compact but powerful unit also reduces or eliminates symptoms of allergies, asthma and other maladies triggered by biological contaminants and VOCs. It is ideal for apartments, condos and single family residences, offices, waiting rooms, schools, day care and senior facilities, and hotel rooms. Special features include:
1. A patented germicidal UVC Emitter effectively cleans the air of mold, bacteria and viruses."
The following claims also appear on the home page of your web site:
• "New UVC kit destroys microorganisms, including flu viruses, bacteria and mold."
• "Kills or, inactivates surface and airborne microorganisms that trigger allergy-asthma symptoms-including mold and mold spores, solvents and other VOCs."
• "Prevents the spread of infectious diseases caused by bacteria (including TB, Legionella, E. coli, and whooping cough) and viruses (including colds, flu, measles, German measles, chicken pox, small pox and SARS)"
These statements indicate that the Steril-Zone Room Air Purifier with UVC emitter is intended for use in the cure, mitigation, treatment or prevention of disease within the meaning of section 201(h) of the Act, 21 U.S.C. 321(h). As such the Steril-Zone Room Air Purifier with UVC emitter is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(t)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g).
The device is also misbranded under section 502(0) the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You should take prompt action to correct the violations addressed in this letter. This is the second enforcement letter addressing the violative claims purported by your firm. The first Warning Letter was issued to you on April 2006 for your claims to mitigate the affects of SARS. Failure to promptly correct these current violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies such as the General Services Administration (GSA) are advised of the issuance of all Warning Letters about violative devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: George Kroehling, Acting Director, Division of Enforcement-A, Office of Compliance, Center for Devices and Radiological Health. If you have any questions about the content of this letter please contact: CAPT Ana Marie Balingit-Wines at 301-796~5497 or (Fax) 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter pertain only to the issues of pre-market clearance or approval of your devices and do not necessarily address other obligations you have under the Act. You should investigate and determine other possible violative claims, and take prompt actions to correct those violations in order to bring your products into compliance.
Office of Compliance
Center for Devices and