Product Liability

FDA to add black box warnings, increase oversight of tanning beds and booths

tanning bed FDA image e1530822034890 FDA to add black box warnings, increase oversight of tanning beds and boothsSunlamps in indoor tanning beds and booths can damage skin, cause skin cancer, and injure the eyes, and can increase the risk of melanoma by 59 percent, warns the Food and Drug Administration (FDA) and other health organizations.

This isn’t the first time consumers have been told of the dangers of indoor tanning products, yet the warnings seems to fall on deaf ears. Nearly 13,000 people die each year from skin cancers, 9,700 of which are melanoma.

With each indoor tanning session, a person’s risk for developing melanoma increases. The American Cancer Society predicts that by the end of 2014, melanoma will account for 76,100 cases of skin cancer.

UV radiation adds up over time, raising concerns about skin and eye problems in children and teenagers who are exposed to indoor tanning products. The UV radiation emitted by high-pressure sunlamp products can be up to 10 to 15 times greater than the midday sun.

UV-A radiation penetrates into the deeper layers of the skin and can cause allergic reactions and rashes. The World Health Organization has classified all UV radiation, including that which comes from the sun outdoors, as carcinogenic, or cancer-causing.

As a result, the FDA is changing how it regulates sunlamps products and UV lamps intended for use in tanning beds and booths. The devices will fall under stronger federal oversight requiring them to comply with the same regulations as medical devices and radiation-emitting products.

The devices will now carry a visible, black-box warning stating that they should not be used by people younger than age 18, should not be used if skin lesions or open wounds are present, and should not be used by people who have skin cancer or a family history of skin cancer. The agency also recommends those who are repeatedly exposed to UV radiation be regularly evaluated for skin cancer.

Source: FDA