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FDA Raises Indoor Tanning Devices Classification to Class II Level
Posted: June 5, 2014
The American Academy of Dermatology Association (AADA) is extremely pleased that the U.S. Food and Drug Administration (FDA) has finalized stricter regulations of indoor tanning devices, including a strong recommendation against the use of tanning beds by minors under the age of 18.
In recognition of the dangers associated with tanning devices, the FDA announced that it is raising the classification for sunlamps and tanning beds to a Class II level which institutes stricter regulations to protect public health. Previously, indoor tanning devices were Class I—the category for items that have minimal potential to cause harm to individuals, such as adhesive bandages and tongue depressors.
Statistics show that 2.3 million teens tan indoors annually and the risk of developing melanoma increases by 59% for individuals who have been exposed to UV radiation from indoor tanning. This risk increases with each use of tanning devices.
“Restricting teens’ access to indoor tanning is critical to preventing skin cancer. As medical doctors who diagnose and treat skin cancer, dermatologists are committed to reducing its incidence and saving lives,” said board-certified dermatologist Brett M. Coldiron, MD, FAAD, president of the AADA. “Therefore, we will continue to communicate to the FDA the need for stricter regulations on the use and sale of indoor tanning devices for minors under the age of 18.”
In 2010, the FDA convened an Advisory Panel hearing to examine the current classification and regulations of tanning beds. Representatives from the AADA, leading dermatologists, researchers and patients testified before the panel highlighting the risks associated with indoor tanning and the need to protect the public from these dangers. Following the hearing, the AADA has been working closely with the FDA, and both state and federal legislatures to protect minors from the dangers of indoor tanning.
“The AADA has been working aggressively with the FDA, congressional leaders and policy makers to help make today’s reclassification of indoor tanning devices and the placement of additional restrictions on indoor tanning possible. We applaud the FDA for taking this important first step,” said Coldiron. “However, we recognize that there is still more work to be done to protect the public from these dangerous devices.”
With a reclassification, tanning bed and lamp manufacturers will be required to show that their products have met certain performance testing requirements. In addition, tanning bed and lamp manufacturers will be required to label the devices so that they:
- Clearly inform consumers about the risks of using tanning beds;
- Warn frequent users of sunlamps to be regularly screened for skin cancer; and,
- Alert users that tanning lamps are not recommended for people under 18 years old.
Under the final changes, manufacturers will be required to provide updated labeling for all products on the market within 450 days of June 2, 2014.
For more information, contact the Academy at 1-888-462-DERM (3376) or www.aad.org.