The Dermatology Nurses' Association
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FDA Takes A Stand

FDA Takes A Stand In The Fight Against Skin Cancer

FDA Takes A Stand

On May 29th of 2014, the FDA issued a press release announcing their final decision to reclassify tanning beds. The Dermatology Nurses’ Association (DNA) and our members were a part of this important regulatory process!

The full press release can be accessed by clicking the link below: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm399222.htm

In May of 2013 the FDA held a teleconference to introduce a new plan to address tanning bed regulation. This began with the introduction of a "proposed new order" and a call for public comment. DNA HPAC and many other skin cancer prevention advocates from various organizations, participated in this important call.

The tanning lamps classification momentum began in 1977 with two expert panels which included the General and Plastic Surgery Device Classification and the Physical Medicine Device Classification. The subsequent recommendation was "devices that provide UV radiation intended primarily for the treatment of dermatologic disorders or for tanning, be classified into class II." In June of 1988, the FDA separated UV lamps for tanning and dermatologic use and in 1990, the final rule classified "UV lamps for the purpose of tanning" as class I.

A class I devise is one that, when used as intended, presents “little to no risk to the user”.

  • Tongue depressors
  • Adhesive bandages

Subsequently, the General and Plastic Surgery Device Classification reconvened and debated this classification issue again in 2010. These experts concluded that tanning beds were not appropriately classified, but were divided on whether to recommend class II with special controls or class III (an example would be an implantable defibrillator).

Some class II devices “that require special controls to ensure reasonable safety for the user”

  • Surgical mesh
  • Tissue adhesive- topical
  • Surgical lamp
  • Low level laser system for aesthetic use
  • Ultraviolet lamp for dermatologic disorders

The full final order from the FDA can be found in the Federal Register here http://www.gpo.gov/fdsys/pkg/FR-2014-06-02/pdf/2014-12546.pdf

Summarizing the important points in the new order:

  • Sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices
  • Sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years
  • Certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications.
  • Manufacturers will now have to submit a premarket notification, 510 (k), to the FDA and obtain clearance before marketing. These products were previously exempt from this part of the approval process.

This action by the FDA, intended to “to increase consumer awareness of tanning bed risks” certainly supports our legislative efforts at the state level to prohibit minors from using tanning beds. It does not ban children from tanning beds. We hear from our colleagues at the American Cancer Society Cancer Action Network, that difference is simple; the regulation says "should not" rather than "shall not."

Dermatology nurses need to continue to speak out as advocates so that the public, parents and lawmakers alike are aware that that tanning bed use is not safe!

To find out what's going on in your state, see http://www.ncsl.org/research/health/indoor-tanning-restrictions.aspx