FDA Warns Tootsie Foot Tanner Could Cause UV Radiation Overdose
Federal regulators are concerned that erroneous instructions on the Tootsie Tanner portable foot tanning device could lead consumers to suffer ultraviolet radiation overdose.
On Tuesday, the FDA issued a consumer warning on the Tootsie Tanner by IPCH in Sugarland, Texas, indicating that even if consumers follow the instructions issued with the foot tanner, they could suffer radiation burns, eye and skin injuries. The FDA also issued a warning letter to the manufacturer, but has discovered the company is now out of business. So far, there have been no injuries or serious adverse events reported in connection to the Tootsie Tanner foot tanner.
IPCH sold about 3,000 devices nationwide before it went out of business, so there will be no manufacturer recall, refunds, or update to the labels, the FDA warns.
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The device, usually used by tanning salons, comes with instructions that say it can be used for up to 30 minutes, and has a timer that permits 30 minutes of ultraviolet exposure. However, FDA testing has revealed that it is only safe for 20 minutes of exposure. FDA regulators also say that the device does not include prominent warnings about protective eyewear.
The warning comes as FDA is weighing whether it needs to increase regulation on tanning devices following last year’s reclassification of tanning beds as known carcinogens by the World Health Organization (WHO). Since then, there have been several studies which have raised concerns over the safety of tanning beds, particularly regarding use by teens and young adults.
One of the studies was by WHO itself in July 2009, which indicated that use of tanning beds before the age of 30 increases the risk of skin cancer by 75%. As a result of the study, WHO reclassified ultraviolet radiation from tanning beds and other sources as a definite carcinogen. Previously, they were considered “probable” carcinogens.
Some studies have shown that the use of tanning beds by young adults results in eight times the risk of developing melanoma, a deadly form of skin cancer once found mainly in the elderly, but which has increasingly become a problem for younger adults. The American Cancer Society says that melanoma, the most dangerous form of skin cancer, is diagnosed in about 69,000 Americans each year and causes about 8,650 deaths annually. Less dangerous, but more common, basal and squamous cell carcinomas affect more than one million Americans each year and cause about 2,000 deaths annually.
Currently, the FDA barely regulates indoor tanning facilities, classifying the ultraviolet radiation emitting beds as Class 1 medical devices; the same category as bandages and tongue depressors.
In March, an FDA advisory committee recommended that the agency either ban the use of tanning beds for people under the age of 18 or require parental consent.
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