GAITHERSBURG, Md. – A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.
At a meeting March 25, most members of the FDA’s General and Plastic Surgery Devices Panel supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning.
Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent. The FDA usually follows the recommendations of its advisory panels, which are not binding.
The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices.
The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.
Currently, UV lamps and beds used for tanning are regulated by the FDA as Class I devices, the lowest risk category. Band-Aids are also regulated as Class I devices. Panelists were divided between recommending reclassifying tanning devices as Class II devices, which require special controls, or as Class III, the highest risk category. Examples of Class II devices include medical lasers and UV lamps used to treat dermatologic disorders; Class III devices include breast implants and injectable cosmetic fillers.
The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.
Among those speaking during the public hearing portion of the meeting was AAD President Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices.
The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.
Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are between ages 16 and 29. A total of 24% of female adolescents ages 13-19 have used a tanning bed at least once in the previous year, according to the AAD.
FDA officials at the meeting said they believe there’s evidence of a potential raised risk for skin cancer associated with increased UV exposure acquired with UV tanning lamps.
Standards for indoor tanning devices in Europe are more restrictive than in the United States and include age restrictions and requirements for informed consent in some countries, according to the FDA.
Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion prior to the meeting.
Photo credit: Markette Smith
AAD President Dr. William James testifying before the FDA panel on the dangers of tanning bed use.