The Federal Regulations To Change?

This fall, the Tanning Accountability and Notification (TAN) Act was signed into law. Under the terms of the new law, the Food and Drug Administration (FDA)—which already regulates the indoor tanning industry—is required to conduct consumer testing regarding the text and positioning requirements of the warning label used for tanning devices in effort to determine whether or not it provides sufficient information on the risks for “irreversible eye damage and skin damage, including skin cancer.” The FDA also is being asked to evaluate whether modifying or listing additional warnings would communicate the risk of skin cancer more effectively.

I suspect that anti-tanning advocates cannot believe there are folks who deliberately want to obtain a tan from an indoor tanning bed or booth. Guess what? There are! The millions of people who are aware that overexposure to UV light is not good actually choose to tan indoors where UV exposure is controlled, as opposed to tanning in the natural sunlight where UV exposure is uncontrolled. Guess they figure it’s because they aren’t reading the warning label. Newsflash: That label has been on all sunbeds in the United States for the past 20 years.

The current label reads: “DANGER—Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR:

FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product.”

So back to the TAN Act. What does it really mean? Well, one year after the date of the enactment of this Act, the FDA shall submit to the Congress a report that provides the determinations. In addition, the FDA shall include in the report the measures being implemented to reduce the risks associated with indoor tanning devices. The report must include: a) whether the labeling requirements for indoor tanning devices, including the positioning requirements, provide sufficient information to consumers regarding the risks that the use of such devices poses for the development of irreversible damage to the eyes and skin, including skin cancer; and b) whether modifying the warning label required on tanning beds to read “Ultraviolet radiation can cause skin cancer” or any other additional warning would communicate the risks of indoor tanning more effectively; or c) whether there is no warning that would be capable of adequately communicating such risks.

According to Executive Order 12291, should the FDA seek to make changes to the current regulations, it must first conduct an economic impact study. The purpose of the order is to reduce the burdens of existing and future regulations, increase agency accountability for regulatory actions, provide for presidential oversight of the regulatory process, minimize duplication and conflict of regulations, and ensure well-reasoned regulations. Some of the general requirements of this Order are as follows:

Section 2—In promulgating new regulations, reviewing existing regulations and developing legislative proposals concerning regulation, all agencies, to the extent permitted by law, shall adhere to the following requirements:

a) Administrative decisions shall be based on adequate information concerning the need for and consequences of proposed government action;

b) Regulatory action shall not be undertaken unless the potential benefits to society for the regulation outweigh the potential costs to society;

c) Regulatory objectives shall be chosen to maximize the net benefits to society;

d) Among alternative approaches to any given regulatory objective, the alternative involving the least net cost to society shall be chosen; and e) Agencies shall set regulatory priorities with the aim of maximizing the aggregate net benefits to society, taking into account the condition of the particular industries affected by regulations, the condition of the national economy and other regulatory actions contemplated for the future.

Section 3—In order to implement Section 2 of this Order, each agency shall, in connection with every major rule, prepare, and to the extent permitted by law consider, a Regulatory Impact Analysis.

So, at the end of the day, if the FDA looks to make any changes to the label, they apparently have to provide details on the economic impact of such a change. Would it/could it have a negative economic effect on the thousands of women and minority owners in the indoor tanning industry? You bet. They could push for (b), but would still have to address (e).

As I have stated before, these anti-tanning zealots don’t go after youth sports or beach resorts. Just us. What they want us to believe is that we need to virtually stay out of the sun and avoid all forms of UV, but millions of people weigh the risk and benefit of UV exposure and still choose the controlled and responsible manner of tanning indoors where exposures are regulated by a timer and by skin type.

For more information on LightSources tanning products, visit www.lsitanning.com. If you have a question that you would like answered in this forum, e-mail joe_lsi@bellsouth.net.