FDA Amendment 21 CFR Part 1040 Effective Sept. 1986

6. One comment urged that UVA lamps should be exempt from the provisions of 1040.20(d) that require the warning: "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." The comment argued that radiation at wavelengths in air longer than 320 nm cannot induce skin cancer and that only radiation at wavelengths in air shorter than 320 nm is responsible for premature skin aging. The comment argued further that UVA radiation that does not contain measurable UVB radiation (280 nm to 320 nm) has positive effects, for example, a UVA tan can protect a person against the harmful UVB radiation of the sun (photoprotection), and UVA radiation that does not contain UVB radiation can monomerize pyrimidine dimers in the deoxyribonucleic acid (DNA).

FDA disagrees that it has been proven that UVA does not cause skin cancer or premature skin aging, or that UVA radiation can protect humans against UVB radiation. Relatively few studies have been carried out on the long-term biological effects of UVA radiation in humans or in animals. Further studies are needed to establish clearly the long-term biological effects of UVA radiation. There are, however, reports that, under long-term continuous exposure, UVA radiation can induce skin cancer in test animals (Refs. 1 and 2). Also, there is evidence that the incidence of skin tumors induced in animals by irradiation with a combination of UVB and UVA radiation can be increased by
subsequent irradiation with UVA alone (Ref. 3).

There is evidence (Ref. 4) that UVA radiation can enhance the photoreactivation of pyrimidine dimers in the DNA of human leukocytes. However, this effect has not been shown to provide humans protection against UVB radiation (Ref. 5). The Task Force on photobiology of the American Academy of Dermatology has expressed concerns about potential risks of tanning with UVA radiation (Ref. 8).

Based on available evidence, FDA concludes that to exempt UVA lamps from the warning statement required by the standard would not promote the public health and safety.

7. One comment disagreed with the language of the warning statement set forth in 1040.20(d)(1) of the proposed amendments and argued that the statement, "If you do not tan in the sun, you are unlikely to tan from the use of this product," would be inappropriate because it may confuse the sunlamp user. The comment argued that the action of direct exposure to the sun cannot be compared to that of exposure to either UVA or UVB suntanning equipment: that the current warnings already clearly and accurately provide the same information in more detail; and that the quoted statement would be redundant to the statement "Consult a physician before using lamp if taking any medication or if you believe yourself sensitive to sunlight."

The agency disagrees with the comment. The scientific literature clearly demonstrates that some people do not tan or that they tan only with great difficulty using either the sun or sunlamps (Ref. 7). People who, when exposed to the sun, do not tan or tan only with great difficulty should be informed about the futility of exposures to potentially hazardous ultraviolet radiation.