FDA Proposes Tougher Warnings for Tanning Beds
By Steve Reinberg
MONDAY, May 6 (HealthDay News) -- Despite a prior recommendation from its own expert advisory panel, the U.S. Food and Drug Administration on Monday announced that it does not plan to implement a ban on the use of indoor tanning devices by children.
Instead, the agency is proposing bumping up "sunlamp products" from a low-risk, class I device to a moderate risk, class II device, and mandating that tanning devices have labeling warning against their use by young people.
Numerous studies have supported strong links between use of UV ray-emitting indoor tanning devices and a raised risk for skin cancer.
According to a statement released by the FDA, "the proposed order does not prohibit the use of sunlamp products by those under the age of 18, but it provides a warning on the consequences," the agency said in a news release. "The labeling would have to include a warning that frequent users of sunlamp products should be regularly screened for skin cancer."
Moving tanning beds from a class I to class II device designation also means manufacturers will face tougher pre-market review from the FDA, something these devices are exempted from at the present time. The proposal is subject to a 90-day period of public comment.
Responding to Monday's announcement, Dr. Michele Green, a dermatologist at Lenox Hill Hospital in New York City, said: "It is about time that these sunlamps were reclassified and held to a higher standard. I applaud this move, especially since the rise in skin cancer, especially in young people, has been documented. I hope that this legislation keeps more sunlamps off the shelves and away from consumers."
Dr. Jennifer Stein, assistant professor of dermatology at NYU Langone Medical Center in New York City, said: "The important message from this statement is that the FDA has finally decided to reclassify tanning beds from low-risk to moderate-risk devices. This is an important step in making the public aware of the dangers of tanning beds. Indoor tanning damages the skin and is associated with skin cancers, including melanoma -- a potentially fatal form of skin cancer. Fortunately many states have passed bans on tanning bed use in minors. We have seen an increase in skin cancers among young women who have used tanning beds."
The FDA's reluctance to impose an outright ban on access to tanning beds for minors runs counter to a decision from an advisory panel the FDA commissioned to look at the issue in 2011. That ruling advocated barring minors from using tanning beds, or at least requiring parental consent.
In the same year, the American Academy of Pediatrics also came out in favor of a ban on tanning bed use by people under the age of 18. "Pediatricians should support and advocate for legislation to ban access to tanning parlors for children younger than 18 years," the AAP said in its policy statement.
The AAP also noted that other organizations, including the World Health Organization, the American Medical Association and the American Academy of Dermatology, already support such a ban.
Speaking at the time of the AAP recommendations, one expert said the link between indoor tanning and skin cancer is clear.
Dr. Doris Day, a dermatologist at Lenox Hill Hospital in New York City, applauded the AAP's move to support the tanning bed ban for minors.
"A review of seven studies found a statistically significant increase in the risk of melanoma in those who had been exposed to UV radiation from indoor tanning before the age of 35," said Day. "Studies have demonstrated that exposure to UV radiation during indoor tanning damages the DNA in the skin cells."
Day also said that "on an average day in the United States, more than 1 million people tan in tanning salons. Of the customers, nearly 70 percent are girls and women, primarily 16 to 29 years old."
Find out more about the indoor tanning-skin cancer link at the U.S. Centers for Disease Control and Prevention.
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