The FDA’s TAN Act Response: A Warning

In our November 2008 article (“The Unfair Persecution of Solaria Down Under: Could it Happen Here?”), we set forth four things that tanning professionals must watch out for in order to protect the future of the industry. Those included: the outcome of the election, finding an American Claire Oliver, the FDA’s response to the Tan Act and the adoption of the European maximum-irradiance standard. Here’s what has happened since that article:

The Election. By the time you read this, Barack Obama will have been inaugurated. He has named Tom Daschle as secretary of health and human services (HHS). Since the FDA falls under the jurisdiction of HHS, we can expect Obama to name an interim head of the FDA until he can nominate and confirm a permanent director. Under normal circumstances, we would likely see a much more active and aggressive stance taken by the FDA but, given the state of the economy, that may not be forthcoming in 2009. Time will tell.

An American Claire Oliver. At this point in time—as far as we know—the dermatologists have not found a “poster girl” to make a public claim that indoor tanning caused her melanoma. That does not, however, mean that they are not still looking for an American Claire Oliver; therefore, we must continue to keep an eye on their actions.

Response to the TAN Act. (Read the full report to Congress here.) Specifically, the proposed changes to the warning label are not significant and actually might help the segment of the American public that chooses to patronize an indoor tanning salon to better understand the warning label. Unfortunately, one inconvenient fact was overlooked by the FDA—regardless of positioning, type size, text highlights or language simplification, clients are not going to read the warning label on tanning equipment prior to tanning. In meetings held with the FDA several years ago (and in memos sent to the FDA), we have repeatedly pointed out that the front desk is the best place for warnings to be given clients about the minimal and manageable risks of indoor tanning.

The warning label, though, is not what really concerns us. The statement that, “The FDA is also considering amending the performance requirements for sunlamp products to harmonize them with the IEC International Standard,” is what should grab the attention of everyone in the indoor-tanning industry. Why? Because this statement indicates the FDA is willing to give a green light to establishing a maximum-irradiance standard.

Adoption of the European maximum-irradiance standard. Despite the fact that we met with senior FDA representatives this summer and were told that FDA had no intention of adopting the 0.3 W/m^2 standard, this statement indicates that they are, in fact, considering it. Granted, we were very skeptical of their response initially—but it was still disrespectful of them to mislead our industry. In addition, the FDA acknowledges that it will be guided by international experts when considering any proposed changes to the performance standard—evidently, they don’t value the opinion and experience of the U.S. indoor-tanning industry, even though the industry has cooperated fully with the FDA since the publication of the ANPRM (Advanced Notice of Proposed Rule Making) in 1999 and has an enviable safety record.

Please note that the FDA believes that the maximum allowable dose of 4.0 MED that has been used since 1986 is excessive and can be reduced to 1.3 or 1.0 MED without affecting the results that clients are paying for, i.e., the development of a tan. Why? Since 1999, the Center for Devices and Radiological Health has conducted clinical research on the effects of UV exposure, supported by the FDA’s office of science, office of women's health, the Center for Food Safety and Applied Nutrition and the National Cancer Institute (NCI). The results of these studies have been published in numerous scientific publications, and the data generated helped to define typical erythema (sunburn) doses. Those were used to calculate exposure schedules and select the maximum timer interval for tanning devices. They also showed that UV exposures typically provided by sunlamp products are excessive, and that comparable cosmetic effects can be produced with cumulative exposures that are only one-third or one-fourth the levels currently used.

The FDA intends to use the results from the research and the experience gained from working with international experts on the IEC standard when considering any proposed changes to the sunlamp performance standard. Now that we have been forewarned about what the FDA intends to do, what actions can we expect them to take? The proper course of action would be to schedule meetings with indoor-tanning professionals to discuss these proposed changes, and allow them to provide data supporting our position and look at the data the FDA will use to support its position. Unfortunately, we believe that the first notice we will receive is when they publish what they intend to do in the Federal Register—which means we will not have a chance to argue our case in person. Instead, we’ll be forced to send written responses after the fact. Needless to say, this will put us at a great disadvantage.

Next month, we will provide the history of what has transpired since the ANPRM was published in 1999, explain why the articles published by FDA personnel actually support our position, and show why the 0.3 W/m^2 maximum-irradiance standard has no scientific basis and will only have a negative impact on the indoor-tanning industry. In addition, we will set forth the actions that we believe are needed to protect the best interests of the hard-working members of the industry.

For now, we leave you with the words of Cervantes: “Forewarned is forearmed; to be prepared is half the battle.” We have been forewarned about the FDA’s intentions and, if we do not take steps to fight the adoption of the 0.3 W/m^2 maximum-irradiance standard, we will have no one to blame but ourselves.

Patricia E. Reykdal and Donald L. Smith operate the Non-Ionizing Radiation Research Institute in Tucson, Ariz. They have written many articles promoting the benefits of controlled ultraviolet radiation exposure (CURE). You can e-mail comments or questions to DermWatcher@msn.com.

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