BACKGROUND

A sunlamp product is an electronic product designed to use one or more ultraviolet lamp(s) and is intended for irradiation of any part of the living human body by ultraviolet radiation within a specified range of wavelengths to induce skin tanning. The ultraviolet lamps, subject to the performance standard, produce radiation within a prescribed range of wavelengths and are intended for use in sunlamp products.

Sunlamp products include portable home units, table top models, tanning beds and tanning booths. These units may incorporate different types of fluorescent lamps, reflector spot (RS) or High Intensity Discharge (HID) with different levels of energy output and radiation at different wavelengths. These products are recognized as hazardous and produce an estimated 3,000 hospital emergency room cases a year.

Since sunlamp products are radiation emitting electronic products as defined by Section 531 of Subchapter C- Electronic Product Radiation Control (EPRC) formerly the Radiation Control for Health and Safety Act (RCHSA) and medical devices as defined by Section 201(h)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA), they are regulated under both laws.

Under authority of Section 534 of the (EPRC), a performance standard for sunlamp products and ultraviolet lamps intended for use in these products was promulgated effective May 7, 1980 (21 CFR 1040.20). The standard was intended to reduce sunlamp related injuries by reducing unnecessary exposure and overexposure to sunlamp radiation by: (1) limiting shorter wavelength emissions that are not necessary and pose unreasonable risk, (2) providing for adequate warning label and user instructions containing safety information, and (3) requiring special lamp bases, protective eyewear, timers, and controls to help users limit the duration and amount of exposure.

This performance standard was promulgated when the common sunlamp product was a table-top, home portable unit incorporating one or two RS lamps having a large part of their radiation output in the wavelength range of 260 to 320 nanometers (UVB). In 1979-80, a new-wave of sunlamp products came onto the market. These products, commonly referred to as Tanning Booths, usually measured 3'x3'x7' and contained one or two fluorescent ultraviolet lamps in each corner. These products also had relatively high UVB output.

Around early 1983, another product in the shape of a bed and/or canopy entered the market with fluorescent lamps that emit radiation mainly in the 320-400 nanometer range (UVA), with usually less than 5% in-the UVB range. This type of product requires longer exposure times to achieve its intended purpose and the risk of chronic sunburn is reduced relative to the older type of products. Most manufacturers requested variance under 21 CFR 1010.4 to equip the products with timers which would allow exposure in excess of ten minutes. Since the products usually required 30 minutes to achieve their intended result, the variances were granted with two conditions: (1) the maximum timer interval shall not exceed the maximum recommended exposure time specified in the required product label, and (2) the UVB to UVA ratio shall not exceed .05 (no more than 5% UVB). The manufacturers are required to specify the variance number and effective date on the product).

Some of these products incorporate High Intensity Discharge (HID) lamps. These lamps are usually used for facial tanning, although some whole body exposure systems use such lamps exclusively. In most cases, however, these lamps are used in conjunction with ultraviolet fluorescent lamps. The HID lamps are much smaller than fluorescent lamps, (usually about 1/2" in diameter by 3" in length) and they usually incorporate an outer, clear, glass envelope.

On September 6, 1985, amendments to the performance standard were published and became effective in September 8, 1986. The purpose of the amendments is to accommodate new products employing design concepts significantly different from those for which the original standard was developed. Also, FDA experience in applying the original standard indicated that some requirements were either inappropriate for or not applicable to some products. The amendments are intended to establish a standard that is appropriate for the present technology of suntanning and new sunlamp product designs.  This revised program offers guidance for testing products against the original standard or revised standard, as appropriate.

The District Offices have the authority (delegated under 21 CFR 5.37 and 5.89) to make declarations of noncompliance and/or defect. The field also has the authority to approve corrective action plans under 21 CFR 1004 and to grant exemptions (from notification and product repair) in accordance with 21 CFR 1003.31.

Source: Excerpted from Compliance Program Guidance Manual: Field Implementation of the Sunlamp and Sunlamp Product Performance Standard, as amended; Final Guidance for Industry and FDA, October 6, 2001