The FDA Increases Regulation of Indoor Tanning
The U.S. Food and Drug Administration (FDA) recently announced increased regulatory control over ultraviolet lamps for tanning beds. Until now, as class I devices, sunlamps faced no more FDA oversight than products like elastic bandages and tongue depressors. But in May, the federal agency issued an order to reclassify sunlamps and other ultraviolet (UV) tanning devices as Class II devices (moderate to high risk), putting them in the same class as other radiation-emitting devices such as X-ray machines and CT scans. In addition, the FDA will require them to carry warning labels stating that they should not be used by children under age 18. “The change is due to concerns that
the effects of UV radiation add up over time, and children and teenagers who are exposed to indoor UV radiation are at greater risk for skin and eye damage,” according to an FDA release.
Attacking the Problem
Tanning bed use is linked to some 419,000 cases of skin cancer in the US each year, according to a January 2014 meta-analysis published in JAMA Dermatology. With the reclassification, sun lamp devices must meet greater safety standards before becoming available on the market; they also must display specific warnings in pamphlets and catalogues and on websites. New models of sun lamp products must comply with the labeling rules by September 2014. Older models have until August 2015 to comply with the requirements. The reclassification is the culmination of four years of advocacy work by health organizations including the Skin Cancer Foundation, whose physicians testified before the FDA about the rising rates of skin cancer. In 2010, when the FDA first issued a proposal to reclassify tanning beds from Class I to Class II, the Foundation led an online letter-writing campaign to support the change, resulting in some 1,400 letters to Senators and the FDA. In addition to weighing such public
testimony, the FDA said it based its decision on mounting scientific evidence that tanning increases skin cancer risks, noting that children and young adults are particularly vulnerable. “There is increasing epidemiological evidence that tanning in childhood to early adult life increases the rate of melanoma… FDA is also concerned
that youths and adolescents may fail to appreciate the long-term dangers…” the proposed order stated.
Youth Will Still Be Served
The new warning label does not prohibit tanning salons from serving minors under age 18, and despite its efforts to better regulate these devices and educate the public about their dangers, the agency has no current plans to recommend a federal under-18 ban. “We think that strengthening our regulation will help mitigate risks at this time,” said FDA spokesperson Susan Laine.
Published on August 13, 2014