FDA Amendment 21 CFR Part 1040 Effective Sept. 1986

1. One comment agreed with the proposed amendments as they would apply to the use of sunlamp products for skin-tanning purposes but questioned whether the regulations also were intended to apply to sunlamp products used for medical purposes. The comment stated that most of the safety provisions of the proposed rule should be adhered to regardless of the purpose of the sunlamp use. The comment suggested, however, that the warning statement in 1040.20(d)(1)(i) not be required to be included on medical therapy units because the statement would establish a negative environment for the treatment regimen and would be counterproductive. In addition, the warning statement could cause patients to resist the use of an effective form of therapy for diseases such as psoriasis. Section 1840.20 applies only to sunlamp products as defined in 1040.20(b)(9): "Sunlamp product means any electronic product designed to incorporate one or more ultraviolet lamps intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths between 200 nm and 400 nm, to induce skin tanning" (emphasis added). Accordingly, the warning statement of 1040.20 (d)(1)(i) applies only to sunlamp products intended for skin tanning.

2. One comment suggested that the proposed amendments should be modeled after the draft German Industrial Standard DIN 50-50, "Non-Therapeutical UV Irradiation Apparatus for the Human Body." In this standard, a sunburn effect is defined
by the erythema-threshold time and by the tanning effect (pigmentation-threshold time). Each manufacturer is required to declare on its sunlamp product label the erythema and pigmentation threshold times for the product. In addition, the product is required to be classified and labeled according to the magnitude of the erythema-threshold time.

FDA believes that the current standard, which requires manufacturers to provide adequate directions for use, including recommended exposure schedules and exposure positions, achieves the same goals that the German standard achieves. FDA’s Evaluation indicates that little safety advantage is to be gained by rating sunlamp products according to an estimated erythema potential. To establish a system of erythema potential ratings that would be appropriate under all use conditions and for all product designs or configurations would be burdensome and excessively complicated. A sunlamp product may have almost any spectral distribution and irradiance depending upon varying factors; for example, product design, lamp design and lamp age. Also, human skin varies greatly from individual to individual in sensitivity to burning induced by sunlamp products. For all these reasons, FDA declines to adopt the suggestion.

3. One comment on 1040.20(c)(2)(ii) objected to FDA’s proposal to remove the current 10-minute limit on a sunlamp product timer. The comment also objected to the proposal to revise 1040.20(c)(4) to proscribe only automatic resumption of emission from a product. The comment argued that such changes inappropriately allow the manufacturer, seller, or user of the product to decide what conditions of sunlamp use are safe.

FDA believes that irradiation of the skin with ultraviolet radiation to induce skin tanning is hazardous. The performance standard for sunlamp products was established to protect the consumer from acute burns (as evidenced by erythema) and from exposure to hazardous radiation that is unnecessary for skin tanning (in this case, UV radiation of wavelengths in air of less than 280 nm and to warn the consumer of the known adverse effects to the body after exposure to ultraviolet radiation. FDA believes that the user of a sunlamp product can take appropriate action when informed of the possible adverse effects to the body from exposure to ultraviolet radiation, if the product is equipped with necessary safety performance features.