FDA Told Tougher Tanning Bed Regulation Needed

A panel of experts yesterday recommended that minors be barred from using <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">tanning beds. At the very least, the group of experts convened by the Food & Drug Administration (FDA) said parent should be required to sign a consent form warning of tanning-bed dangers before a person under 18 could use one.

Tanning beds and tanning lamps are listed as FDA Class I devices — those least likely to cause harm. But the FDA is considering reclassifying them as class II or class III medical devices, which would subject them to stricter regulation. By increasing their classification to Class II, the FDA could limit the levels of radiation the devices emit and make other changes to their design.

According to the American Journal of Dermatology, more than 30 million people tan indoors every year, and nearly three quarters of them are women between the ages of 16 and 29. Using a tanning bed before the age of 35 increases the risk of melanoma by 75 percent. It is one of the most common cancers among young adults in the United States, and it is on the rise in all age groups.

Melanoma is the deadliest form of skin cancer. More than three-quarters of all skin cancer-related deaths are from melanoma. About one person dies of melanoma every hour in the United States.

At yesterday’s panel meeting, representatives from the Skin Cancer Foundation, American Cancer Society and American Academy of Dermatologists, along with melanoma survivors, urged the FDA to reclassify tanning beds.

Members of the panel agreed that the devices should be reclassified, and said that more restrictions are needed to protect teenagers from the cancer risks of tanning beds. “Given the absence of any demonstrated benefit, I think it’s an obligation for us to ban artificial tanning for those under 18,” said panelist Dr. Michael Olding.

Not all panel members were in agreement with the idea of a ban, however, calling it unrealistic. Instead, they pushed for a requirement for strong warnings and parental notification.

Concerns about the cancer risks associated with tanning beds have been growing in recent years. The International Agency for Research on Cancer, which is affiliated with the World Health Organization, just added tanning beds to its “Group One” list, which identifies the most harmful forms of radiation.

Earlier this year the Federal Trade Commission charged the Indoor Tanning Association with making false claims about the health benefits of their products. The group has entered a settlement agreement with the government and pulled the ads in question.

This entry was posted in Defective Medical Devices, Health Concerns. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.