Indoor Tanning Association

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.