Atlanta, GA, December 19, 2002 - A new federal report, the 10th Report On Carcinogens (Roc) released to the public last week by the Department of Health and Human Services' National Toxicology Program (NTP) contains misleading information about the effects of Ultraviolet light associated with the use of indoor tanning equipment, according to experts. The listing is being challenged by independent scientists, tanning industry trade associations, and Wolff System Technology

The RoC listed for the first time, broad-spectrum ultraviolet radiation (UVR), whether generated by the sun or by artificial sources, as a "known" cause of cancer in humans. At a recent industry conference last week, Dr. Howard Cyr, acting Branch Chief of the Centers for Devices and Radiologic Health, (CDRH), a branch of the FDA, commented that his Working Group on Sunlamps at CDRH had investigated the relationship between sunlamps and melanoma and concluded that the scientific data was suggestive of a linkage, but that the linkage was not definitely proven. His conclusions were consistent with a classification of sunlamps as a probable cause of cancer, and differed from the classification of the NTP's ROC as a known cause of cancer. In his comments at the recent industry meeting, Cyr stated that the NTP's classification as a known human carcinogen was premature. The FDA has not taken a position on NTP's classification, but Dr. Cyr has spoken with NTP recently and expressed his concerns about the classification category. Dr. Cyr also pointed out that some of the studies cited to support NTP's conclusions lack statistical "power", because they were studies on small numbers of people and limited exposure times, and suffered from recall bias. Some of the researchers of the cited papers have since published reports contradicting their earlier findings.

Industry experts cite most of the "science" is with genetically selected fish, rats or mice that are either pre-disposed to cancer or contain no melanin, which is a natural sunscreen produced by humans to protect against further damage from UV. Dr. Cyr and others scientists note that drawing conclusions about humans based on fish/mice studies is difficult if not impossible, primarily because humans have repair mechanisms that are not present in "sensitive" lab animals. Cyr pointed out that the studies on using "sensitive" animals are important in understanding the mechanism of damage and repair, but are often not as useful in determining the extent of cancer risks in humans.

A new European case-controlled study has shown that use of indoor tanning equipment is not associated with melanoma skin cancer. The researchers stated, "No evidence was found for an association between sunbed use and melanoma." Previously the authors of the study, as quoted in the RoC, had supported such a link but the updated information was not published in this week's report.

Dr. Michael F. Holick, professor of Medicine, Physiology and Biophysics at Boston University Medical Center, advocates responsible UV exposure owing to its beneficial aspects far outweighing the risk. "Exposure to ultraviolet radiation from a fluorescent tanning bed with UVB results in the photosynthesis of vitamin D in human skin. This helps maintain the vitamin D requirement of the body. When vitamin D levels are adequate, calcium metabolism is preserved and this reduces the risk of development of bone disease, including osteoporosis," he said. In addition Dr. Holick cited studies whereby Vitamin D can alleviate symptoms caused by osteomalacia.

Ronni Sandroff, editor of Consumer Reports on Health, said in a recent report on CBS' Early Show, "as the days get shorter and winter approaches, most Americans will be soaking in fewer sun rays. But that's not necessarily a good thing."

The body relies on the sun to get most of the vitamin D it needs to stay healthy. A recent study estimates that tens of thousands of Americans die each year of cancers possibly caused by too little sun exposure and too little vitamin D. Research studies have found that insufficient levels of vitamin D can also contribute to developing different types of cancer such as colon and prostate cancer, heart disease and Type 1 diabetes.

"The public is not well served by incomplete reports that still contain dated, inaccurate information," said Michael Stepp, president and CEO of Wolff System Technology, the leading supplier of lamps for indoor tanning beds. "Although well-intentioned, the report provides a "half-empty glass" scenario that fails to document independent, published scientific research that supports UV light exposure." "We encourage the media, physicians and consumers to obtain a copy of the report in order to read the findings, which will allow them to make educated decisions."

From its own listing crtiteria, the RoC does not present quantitative assessments of carcinogenic risk and does not establish that such substance presents a risk to persons in their daily lives, according to John Overstreet, executive director of the Indoor Tanning Association. "Listing in the report does not establish that such substance presents a risk to persons in their daily lives. Ultraviolet light has become the first item on that list that humans need in order to live and would die if they didn't receive. That is nothing less than confusing."

According to ITA, the federal government violated its own procedures in placing ultraviolet light from tanning lamps on the list. According to specific guidelines published by the National Toxicology Program, the tanning industry should have been invited to be involved in discussions on this listing in early stages of the process. In 1999, Smart Tan, an international trade association for tanning salon owners, pointed out this omission to the NTP, which ignored their request for a delay and pushed the listing.

The criteria to be on the list does not take into consideration the dosage required for a substance to be harmful. Overstreet cited the listing is similar to when saccharine, which was included on the list in the 1980s, but was removed last year because the dosage required to cause cancer in lab animals was later revealed to be unrealistic.

According to Wolff System Technology's Stepp, the public should be aware of the following:

• Epidemiologic studies linking exposures to skin cancer are limited because they lack information on the specific wavelengths of UVR to which the individuals were exposed. Tanning beds used in these studies involved the use of lamps used in the early 1970's, which produced significant amounts of UVB and are not being sold today. Originally, tanning beds used in the study were built with mercury arc lamps, which emitted large quantities of UVB and UVC. Today's lamps emit mostly UVA.
  
  
• According to the UVR Research Institute, unlike mice commonly used in research, humans' own natural skin color and acquired pigmentation - better known as a "tan" - work synergistically to protect human DNA from damage. Therefore, the "core" or baseline business of indoor tanning salons delivering UVR is that they help their clients develop protective pigmentation when possible and often will protect the skin from being sunburned.
  
  
• The industry contends that moderation is the answer to warnings issued by dermatologists and government agencies of potential skin damage from indoor tanning. The list does not mean that moderate tanning will cause skin cancer.
  
  
• The Department acknowledges it does not address or attempt to balance potential benefits of use of alleged carcinogen-causing products.
  
  
• An August New York Times article stated, "The possibility that (sunlight) may wield some kind of anticancer power no longer seems so far-fetched. " "It went on to report that in April 2002, researchers at the cancer institute reported that the chances of dying from breast, colon, ovarian and prostate cancer were reduced by about 10 to 27 percent for people in the sunniest areas... Some early experiments have also found that the vitamin D compounds convert tumor cells into normal cells."
  
  
• Anti-tanning lobbyists have intentionally confused the public to believe that any UV light exposure is dangerous. In fact, regular moderate sun exposure is not linked to melanoma, but intermittent sunburn - particularly among those who are predisposed to sunburn - is believed to be the risk factor.
  
  
• In addition, ultraviolet light therapy is also used to treat psoriasis, a chronic skin disease affecting millions of Americans, and other skin disorders. Exposure to UV can prevent osteoporosis as well.
  
  
• According to the UVR Research Institute, for every person who dies prematurely each year as a consequence of overexposure to UVR, there are 100 people who die prematurely each year as a consequence of underexposure to UVR. Research has shown that moderate UV exposure may be associated with a decrease in the risk of breast, prostate, colon and ovarian cancer, and has also been linked to reducing high blood pressure, and to reducing the risk of osteoporosis.
  
  
• Indoor tanning is a more healthy, cautious alternative to the risks of outdoor tanning because the amount of time and the intensity of the skin's exposure to ultra violet rays are controlled. Building a tan gradually and responsibly helps avoid damaging consequences of too much exposure to the sun.
  
  
• The RoC makes a distinction between "known" human carcinogens, where there is sufficient evidence from human studies, and "reasonably anticipated" human carcinogens, where there is either limited evidence of carcinogenicity from human studies and/or sufficient evidence of carcinogenicity from experimental animal studies. Ultraviolet light was listed as "Reasonably Anticipated To Be A Human Carcinogen." In the Departmebnt's own definition "There is limited evidence of carcinogenicity from studies in humans, and there is less than sufficient evidence of carcinogenicity in humans or laboratory animals." In addition the RoC says, "There may be substances for which there is evidence of carcinogenicity in laboratory animals but there are compelling data indicating that the agent acts through mechanisms which do not operate in humans and would therefore not reasonably be anticipated to cause cancer in humans."
  
  
• According to the Report, malignant melanoma of the eye also is associated with use of sunlamps. There is little support for an association between exposure to sunlamps or sun beds and non-melanocytic skin cancer.

Wolff System Technology is one of the industry's leaders in the promotion of responsible tanning practices and has always promoted responsible tanning in moderation to protect the skin from sunburn and skin damage.

Moderate indoor tanning - for individuals who can develop a tan - is the smartest way to maximize the potential benefits of sun exposure while minimizing the potential risks associated with either too much or too little sunlight.

Despite media reports to the contrary and dermatologists' warnings, record numbers of people like to tan in order to improve their appearance, general sense of well-being and receive available health benefits. "The responsible thing to do is to teach people that have chosen to tan how to do it responsibly and in moderation," said Stepp.

NOTE TO EDITORS:

Wolff System Technology is offering a copy of the full 13 page report on ultraviolet light as well as a backgrounder release, "How to Tan Responsibly" to the media and will facilitate all interview requests.

About Wolff System Technology

Wolff System was founded by Friedrich Wolff, "the father" of the indoor tanning industry. The company, with patents in 16 countries, is the exclusive licensor of Wolff System certified tanning beds in the United States and Canada. As the leading supplier of lamps for indoor tanning beds, Wolff has more than 500,000 systems in use worldwide. With licensed Wolff System tanning equipment, the amount and type of exposure to ultraviolet light is predictable and consistent, unlike outdoor tanning where variables include the time of day, season, cloud cover, and proximity to the equator. For more information, contact (800) 959-6533 email sales@wolffsys.com or visit www.wolffsystem.com.

Contact:
Wolff System
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(800) 959-6533