Proposed Changes To The Performance Standards For Sunlamp Products: Part I
by Donald L. Smith
This article summarizes the regulatory changes to the performance standards for sunlamp products (21 CFR 1040.20) regarding a) warning labels, b) the definition of a manufacturer and c) eyewear that the FDA proposed to TEPRSSC (and TEPRSSC approved) on Oct. 1, 2003. It also covers the modifications/changes that I suggested during my testimony at that meeting on behalf of the Non-Ionizing Radiation Research Institute (NIRRI).
Keep in mind as you read this and next month’s article that these regulatory changes have been in play since the FDA published its advance notice of proposed rule making in 1999 and that, sooner or later, it will result in changes to the performance standards for sunlamp products that regulate the indoor tanning industry. Since I believe that it is better to be proactive than reactive, and the combined voice of the industry has the power to prevent onerous regulations being adopted, each of you reading this article must let the FDA know how you feel about these proposed regulatory changes.
Listed below is the FDA’s version of the warning label to be placed on all products covered under the performance standards for sunlamp products and the counterproposal I made at the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) meeting.
Our version adds specific warnings aimed at people with skin cancer and diseases such as systemic lupus erythematosis and rosacea, and enhances the warning regarding medications and cosmetics that may increase photosensitivity. Most important, it adds the scientifically correct word overexposure to the primary warning statement. There is no credible scientific data to support the premise that “Ultraviolet radiation may cause: injury to the eyes and skin; skin aging; and skin cancer” but there is scientific evidence to support the premise that “Overexposure to ultraviolet radiation” (especially intermittent overexposure) may contribute to causing those conditions.
Definition Of A Manufacturer
This amendment sets forth the conditions under which a salon owner may inadvertently become the “manufacturer of record” for a tanning device (appliance) because of changes and/or repairs that he or she have made including, but not limited to, using a sunlamp that may be compatible from a regulatory standpoint but not listed on the sunbed manufacturer’s list of compatible sunlamps.
The Catch 22 is that this amendment depends upon being able to determine the performance of a tanning device (appliance), but since there is no standard protocol for determining the performance of a tanning device (appliance), the indoor tanning industry would be in the position of trying to implement a regulation without the FDA making available the standard protocol that is required. (This would be like a state trying to enforce speed limits without having signs stating the allowable speeds posted on our highways.) I recommended to TEPRSSC that the FDA “hold in abeyance” the “definition of a manufacturer” amendment until after a standard protocol for determining the performance of a tanning device is made available to the indoor tanning industry.
The FDA believes that a special warning should be placed on eyewear used in HID/high-pressure tanning systems because of the higher level of energy in the visible wavelengths (400 nm - 700 nm). The FDA proposed to TEPRSSC that the unproven and untested Luminous Action Spectrum be adopted and used to verify that there is no more than 5 percent of the total irradiance in any 5 nm wavelength band between 400 nm and 550 nm.
I testified that while all of the eyewear currently being marketed to the indoor tanning industry met or exceeded the UVR transmission provisions of the current requirements—i.e., no more than a value of 0.001 W/cm2/nm transmission between 200 nm and 320 nm and no more than a value of 0.01 W/cm2/nm transmission between 320 nm and 400 nm—none of the eyewear we have tested met the new standards because of the mercury peaks found at 436-440 nm and 540-550 nm. Therefore, if the Luminous Action Spectrum provision proposed to TEPRSSC by the FDA is adopted, none of the existing eyewear currently being utilized will be acceptable for use by the indoor tanning industry.
I recommended that more testing of the available eyewear products be conducted, and that allowances be made to compensate for the emission in the mercury peak wavelength areas mentioned above before the proposed new eyewear requirements are adopted.
In next month’s LOOKING FIT® magazine I will, for the first time, publicly unveil the comprehensive proposal I submitted to the FDA to modify and improve the section of the performance standards for sunlamp products that deals with the way that we determine compatibility between original and replacement sunlamps and calculate exposure schedules, and compare our proposal to the X/Y Ratio system that the FDA proposed to TEPRSSC at the aforementioned meeting.