FDA Notices To Manufacturers
In addition to the code published in the Federal Register, the FDA periodically distributes notices to all manufacturers, importers and potential manufacturers of sunlamp products, clarifying general policy guidelines. These notices may serve the purpose of rectifying widespread instances of noncompliance by ensuring that the standard is understood, or of informing all interested parties that changes in the standard itself are imminent.
In the months before the amended version of 21 CFR 1040 took effect in 1986, two notices were sent to inform all manufacturers, importers and potential manufacturers of sunlamp products of the impending changes in timer intervals and lamp compatibility. In June 1985, the FDA had sent a notice to encourage manufacturers and importers to be sure their product labeling was in compliance with the standard.
Although these notices are written principally for manufacturers and importers, salon operators also may find them useful as a “plain-English” description of certain aspects of the code with which their equipment must comply. The notices are as follows:
Date:
June 25, 1985
To:
All Manufacturers, Importers and Potential Manufacturers of
Sunlamp Products.
Subject:
Policy on Warning Label Required on Sunlamp Products.
Background:
The Center for Devices and Radiological Health has found
numerous imported and domestic sunlamp products labeled in such a way as to
render the label illegible and/or inaccessible to view by the consumer under
normal conditions of purchase and use.
Sunlamp products are electronic products as defined by Section 355(2) [42 U.S.C. 263c(2)] of the Radiation Control for Health and Safety Act of 1968 (RCHSA) and medical devices as defined by Section 201(h)(3) of the Federal Food, Drug and Cosmetic Act (FD&C) [21 U.S.C. 321(h)(3)]. The performance standard for sunlamp products (21 CFR 1040.20), promulgated under authority of Section 358 of the RCHSA, requires that labels containing specific information be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use. The general labeling provisions for medical devices under 21 CFR 801.5 require adequate directions for use be provided to the user and 21 CFR 801.15 defines the prominence of the required label statements for devices.
Policy:
The intended purpose of the warning label required on sunlamp
products is to provide that information necessary for the consumer to make an
informed decision regarding the risks of using sunlamp products and to provide
adequate directions for skin tanning. Therefore, the label must be legible and
conspicuously placed on the product so as to render it likely to be read by the
user under normal conditions of purchase and use. The Agency will consider sunlamp products to be non-compliant
with the performance standard under Section 358(a)(1) of the RCHSA and
misbranded under Section 502(c) of the FD&C Act if the required product
label is not legible and accessible to view for the following reasons:
1) The label required under 21 CFR 1040.20(d)(1) does not appear on a prominent part or panel which is presented or displayed under normal conditions of purchase and/or use.
2) Adequate space is not provided for the required label or the label is not prominently displayed on the device.
3) The normal individual cannot read the label from a distance of 1 meter because of inadequate lettering size and background contrast. Lettering of 10 millimeters (height) for the word “DANGER” and 5 millimeters for the rest of the label information is recommended to meet the visibility requirements.
Date:
Aug. 21, 1986
To:
All Manufacturers, Importers and Potential Manufacturers of
Sunlamp Products.
Subject:
Policy on Maximum Timer Interval and Exposure Schedule for
Sunlamp Products.
Background:
The amended performance standard for sunlamp products (21 CFR
1040.20) was published in the Sept. 6, 1985, issue of the Federal Register and
became effective Sept. 8, 1986. Any sunlamp product manufactured on or after that
date must comply with the amended standard.
The 10-minute maximum timer interval requirement was removed from the original performance standard since there are newer sunlamp products on the market for which 10 minutes is not appropriate. The maximum timer interval now depends on the intensity and spectral distribution of ultraviolet (UV) radiation emission of each individual model of sunlamp product and must not exceed the maximum recommended exposure time provided on the required product warning label. Therefore, sunlamp product manufacturers must develop an exposure schedule and establish the maximum recommended exposure time (and therefore the maximum timer interval) based on the characteristics of their particular products.
The intended purposes of a sunlamp product timer are to provide for reliable control of exposures and to limit acute (and delayed) damage from unintentionally long exposures. However, the maximum timer setting also should allow for selection of exposure times needed to build up and maintain a tan. The maximum timer interval is in no way to be considered a safe limit; all ultraviolet radiation is potentially hazardous.
The standard requires the manufacturer to provide an exposure schedule in the product warning label. The purpose of the exposure schedule is to allow a person to build up skin pigmentation gradually and to maintain a tan while controlling the risk of acute injury and delayed adverse effects. Since the UV radiation dose that causes a barely discernible pink coloration (minimum erythemal dose or MED) is not the same for different skin types, the exposure schedule for first-time users will depend on the skin type of the user. Furthermore, suberythemogenic doses of UV radiation received at 24-hour intervals initially lead to lowering of the erythema and tanning thresholds. Therefore, the exposure schedule and maximum recommended exposure time should be constrained by the potential for erythema as well as the quantity of radiation necessary to achieve and maintain a tan.
Policy:
The Center for Devices and Radiological Health (CDRH) will use
the following criteria to evaluate the adequacy of the exposure schedule and the
recommended maximum exposure time (and therefore the maximum timer interval):
1). The maximum recommended exposure time (and maximum timer interval) must not exceed a value which will result in an exposure of four times the minimum erythema dose (MED) for untanned Type II skin (always burns, then tans slightly). This is based on the CDRH Erythema Action Spectrum [proposed action spectrum of the Commission Internationale de L’Eclairage (CIE) modified by CDRH].
2). The recommended maximum exposure time must not exceed a value which will result in an exposure of four times the minimal melanogenic dose (MMD) for untanned Type II skin. This is based on the melanogenic action spectrum developed by Parrish et al (1982).
3). The recommended exposure schedule should provide for exposures of no more than 0.75 MED three times the first week, gradually increasing the exposure time the following weeks until maximum tanning has occurred (approximately four weeks total) and then provide for maintenance of a tan by biweekly or weekly exposures of up to four MEDs or four MMDs, whichever is less.
CDRH believes that the above criteria balances the need to limit acute (and delayed) damages from unintentionally long exposure and the need to provide for single exposure durations adequate to achieve and maintain a tan.
Date:
Sept. 2, 1986
To:
All Manufacturers, Importers and Potential Manufacturers of
Sunlamps.
Subject:
Policy on Lamp Compatibility
Background:
The amended performance standard for sunlamp products (21 CFR
1040.20) was published in the Sept. 6, 1985, issue of the Federal Register and
became effective Sept. 8, 1986. Any ultraviolet lamp (intended to be used in
sunlamp products) and sunlamp products manufactured on or after that date must
comply with the amended standard.
The amended standard requires the user instructions of an ultraviolet lamp not accompanying a sunlamp product to contain a clear identification by brand name and model designation of all lamp models for which the replacement lamps are promoted, if applicable [21 CFR 1040.20(f)(2)(iii)]. As stated in the preamble of the amendment to the standard (Federal Register issue of Sept. 6, 1985), the promotion of incompatible lamps will be considered as marketing a falsely certified product.
The Center for Devices and Radiological Health (CDRH) has been asked what criteria will be used to evaluate lamp compatibility.
Policy:
A replacement lamp will be considered compatible with (or
equivalent to) another (original) lamp if:
1). The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail to comply with the standard or to become defective as defined by 21 CFR 1003.2 and;
2). The lamp is as effective, within + or - 10 percent, as the original lamp, in causing erythema and melanogenesis. It should be noted that the above criteria apply to the sunlamp product exposure and maximum timer interval which must appear on the product’s labeling. The manufacturer should use the following procedure to establish conformance with criterion number 2 above:
1). Calculate the recommended maximum exposure time for a single original lamp (Y) using the CDRH Aug. 21, 1986, guidance (Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products).
2). Calculate the recommended maximum exposure time for a single replacement lamp (X) using the same method.
3). Compare the values. If the value for the replacement lamp (X) is within plus or minus 10 percent of the value of the original lamp (Y), the lamp would be considered compatible [X+Y±10%].
The distance(s) used for this comparison should represent the typical use-distance range in products using the original (Y) lamp.
The CDRH welcomes comments on this policy.
