1. Indoor Tanning Association Dan Humiston President

2. Indoor Tanning Association  The Indoor Tanning Association is a not-for-profit industry group that represents all companies in the indoor tanning industry.  Our membership, which includes manufactures, distributors and salon owners have unparalleled expertise in the design, use, and operation of tanning equipment.  ITA members are committed to ensuring that their products are used safely and effectively.  On behalf of the over 150,000 people employed in the US indoor tanning industry I appreciate the opportunity to talk to you today about our industry and modifications that you are considering making to the current regulations.

3. Current FDA Regulations   The indoor tanning industry was developed under the current FDA regulations.  These regulations that address performance standards, labeling requirements, and other controls were specifically tailored to communicate and minimize the risks of overexposure.  Under the current FDA regulations, UV devices are subject to the general regulatory controls applicable to all medical devices.

4. General Regulatory Controls  Sunlamp manufacturers must: –register their facilities –list their products –comply with good manufacturing practice requirements –use truthful labeling

5. Adequacy of Current Regulations  Multiple times over the past 20 years the FDA has assessed the adequacy of: –The performance standard –The policy use to calculate exposure schedules –The format, text and placement of the warning label

6. After every review the FDA always comes to the same conclusion; that the current regulations are adequate and that there isn’t a need for more significant action, such as device reclassification

7. There is no new evidence to support a change in this conclusion  FDA has known about the risks of UV exposure for years, and has discussed the literature in multiple forums. The literature hasn’t changed.  The so-called “recent information”, including the 2009 IARC report, does not add anything new to the discussion. It is simply repackages existing data. –In addition, the 2009 IARC Report is subject to numerous methodological and substantive flaws. Consequently, the literature does not provide an adequate basis for regulatory decision-making

8. Current FDA Standards are the Most Protective in the World  In comparison to international standards, FDA’s standard mandates lower overall exposure and a more effective maintenance schedule for UV emitting devices  FDA should not impose unnecessary changes to achieve harmonization with a less protective international standard   The Panel should account for the strength of the existing regulations and controls when making recommendations.

9. Conclusions  There is no evidence that supports modifying the performance standard, warning labels, exposure policy or warrant reclassification.  The ITA believes that the current standards and controls regulating UV devices provide adequate protection.