FDA tanning bed reclassification

The U.S. Food and Drug Administration (FDA) has issued a final order that strengthens regulations of tanning beds by:

  • A strong recommendation against the use of tanning beds by minors under 18;
  • The reclassification of indoor tanning devices from a Class I to a Class II medical device; and
  • Labeling that clearly communicates the risk of skin cancer to all users.

Prior to the FDA’s final order, indoor tanning devices were categorized as Class I — the category for items that have minimal potential to cause harm to individuals, such as adhesive bandages and tongue depressors. With a Class II 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.

AADA Advocacy

The AADA recognizes that there is still more work to be done to protect the public from these dangerous devices, and urges the FDA and state legislative and regulatory bodies to prohibit the use and sale of indoor tanning devices for minors.

On May 6, 2013, the FDA issued a proposed order to strengthen restrictions of tanning beds.

Advocates for skin cancer prevention and education in the U.S. House and Senate have sent letters to the FDA in support of the agency’s effort to reclassify tanning devices.


 

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