Incorrect exposure information could lead to overdose of ultraviolet radiation

SILVER SPRING, Md., Aug. 24 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.

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Use of the tanning device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer. The labeled exposure schedule indicates that the device may be used for 30 minutes, and the timer control permits 30 minutes exposure. Based on FDA testing, the maximum exposure time for this device is 20 minutes.

The device fails to provide prominent warnings about the need for protective eyewear. Use of this product according to the labeling could result in an overdose of ultraviolet radiation, which may cause immediate and delayed serious eye and skin injuries.

The FDA has issued a warning letter to the device manufacturer and distributor, IPCH, located in Sugarland, Texas. Since issuing the warning letter, the FDA learned that IPCH is no longer in business. Thus, the device will not be replaced or updated with the correct labeling. Refunds will not be available for the estimated 3,000 devices sold.

The FDA recommends that users of this device, which include tanning salon owners and operators, stop using this device, remove the lamps and safely discard all components of the device according to local environmental protection standards.

Although the FDA has received no adverse event reports to date, the agency is concerned about the risk of eye and skin injuries from an overdose of ultraviolet radiation.

Consumers may report serious adverse events (side effects) with the device to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 800-FDA-0178
• Phone: 800-332-1088

For more information:

Radiation-Emitting Products

Radiation Safety

FDA Warning Letter to IPCH (Feb. 3, 2010)

Media Inquiries: Erica Jefferson, erica.jefferson@fda.hhs.gov; 301-796-4988

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

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