FDA Extends Comment Period For Performance Standard For Sunlamp Products Until July 9
WASHINGTON--The Food and Drug Administration (FDA) has announced that it is extending the comment period for the advance notice of its intent to propose amendments to the performance standard for sunlamp products until July 9.
The FDA says it is taking this action to address concerns about the adequacy of the warnings on sunlamp products, current recommended exposure schedule to minimize risks to customers who choose to produce and maintain a tan, current labeling for replacement lamps and current health warnings that do not reflect recent advances in photobiological research.
The Safe Medical Devices Act of 1990, enacted Nov. 28, 1990, transferred the provisions of the Radiation Control for Health Service Act to Chapter V, subchapter C of the Federal Food, Drug and Cosmetic Act. This authority provides for developing, amending and administering radiation safety performance standards for electronic products.
Sunlamp products are class I medical devices exempt from premarket modification requirements. These products are intended to provide ultraviolet radiation to tan the skin. As class I devices, sunlamp products are subject to general controls such as registration, listing and current good manufacturing practices. In addition, sunlamp products also are subject to the regulations for electronic product radiation control.
The sunlamp performance standard originally was published in the Federal Register on Nov. 9, 1979. On Sept. 6, 1985, the FDA amended Sec. 1040.20 and made it applicable to all sunlamp products manufactured on or after Sept. 8, 1986. On Aug. 21, 1986, the FDA issued a guidance entitled, "Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products." The guidance explained the criteria the FDA uses to evaluate the adequacy of the exposure schedule and the recommended maximum exposure time for sunlamp products. On Sept. 2, 1986, the FDA issued another guidance entitled, "Policy on Lamp Compatibility." The guidance listed the criteria the FDA uses to evaluate lamp compatibility for sunlamp products.
Before proposing any electronic product performance standards, the FDA is required to consult a statutory advisory committee, the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). At the Sept. 23-24, 1998 meeting of TEPRSSC, the FDA presented general concepts for amendments to the performance standard for sunlamp products. The committee recommended the FDA pursue development of the amendments and the FDA intends to present more specific proposals to amend the performance standard to TEPRSSC prior to the publication of the proposed rule in the Federal Register.
The FDA is concerned that inadequate attention is being paid to the recommended exposure schedule that was designed to minimize risks for those who choose to produce and maintain a tan. In addition, the FDA is further concerned that the warnings for sunlamp products are not reaching many users of sunlamp products and that the existing exposure schedule does not take into account the variations in individual human UV sensitivity. In order to update the current sunlamp products standards, the FDA is considering revising Sec. 1040.20.
Additionally, sunlamp technology continues to change. These changes can affect both the intensity and the spectral characteristics of UV from sunlamps. Because there is no uniform grading/rating system, choosing a replacement lamp can be confusing for tanning bed owners. Owners choosing replacement lamps must consider lamp compatibility as well as compliance with the FDA's performance standard in order to protect users from excessive exposure to UV.
The FDA also is aware of new research findings that suggest a stronger association between exposures to UV radiation and the increased incidence of skin cancer that has been observed in the U.S. population. Some of this increase has been linked to intense, intermittent exposures to solar radiation; however, other research suggests that chronic, less intense exposures to UV radiation contribute to skin cancer.
Research has identified the fundamental chemical damage that occurs in the genetic material of humans and has linked some skin cancers to changes in specific genes. These scientific findings had led many in the medical community to strongly suggest that consumers avoid intense, intermittent exposures (the type that could produce sunburns) to UV radiation, and also minimize other UV exposures as well.
Some research has linked skin cancer to exposures to sunlamp products, and some research has even suggested an association between the use of sunlamps and malignant melanoma. This association is not definitive. The FDA solicits comments and information as to whether a warning about possible melanoma induction should be part of sunlamp labels. In order to provide users with sufficient information for the safe use of these devices at tanning salons and for home sunlamp products, the FDA is seeking comments and information on suggested changes to the current sunlamp labels.
After considering the risks, some consumers may still choose to tan, either by exposure to the sun or by use of sunlamp products. Those consumers who use sunlamp products should obtain their tan with the least amount of risk from sunburn and eye damage. Therefore, the FDA seeks advice on a recommended exposure schedule that would minimize the risks of adverse effects while still producing and maintaining a tan.
Revisions Under Consideration
The FDA is considering revising and updating the current sunlamp product performance standard (Sec. 1040.20) and harmonizing it with the International Electrotechnical Committee Standard 335-2-27 for UV- and infrared-emitting appliances. After consulting with international standards organizations and evaluation of the current scientific knowledge, the FDA intends to develop a recommended exposure schedule which will become part of the directions for use of sunlamp products.
As part of the development process, the FDA intends to review the material on the effects of UVA and UVB on skin, the effects of UV exposure on melanoma induction and the use of photobiological action spectra as a basis for risk assessment in health protection and product safety discussed at the American Society for Photobiology and European Society for Photobiology Joint Workshop on UV and Melanoma held in Snowbird, Utah, July 11-15, 1998; the International Symposium and Workshop on Measurements of Optical Radiation Hazards, at the National Institute for Standards and Technology held in Gaithersburg, Md., Sept. 1-3, 1998; and, the Research Workshop on Risks and Benefits of Exposure to Ultraviolet Radiation and Tanning, at the National Institutes of Health in Bethesda, Md., Sept. 16-18, 1998. The proceedings of these meetings describe current research findings that show a stronger correlation between UV exposure and skin cancer, photoaging and photoimmunological effects.
The FDA also is considering revising and updating its Aug. 21, 1986 guidance on the determination of the maximum timer interval and recommended exposure schedule for sunlamp products entitled, "Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products." The FDA intends to update this guidance after reviewing and evaluating material presented at the meetings listed previously and other available information. In addition, the FDA is further considering incorporating the previous guidance into the sunlamp product performance standard because it believes such incorporation would result in a more comprehensive regulatory standard with all relevant information for compliance in the standard.
Additionally, the FDA is considering adding a provision clarifying that manufacturing includes the modification of a sunlamp product, previously certified under Sec. 1010.2, by any person engaged in the business of manufacturing, assembling or modifying a sunlamp product's performance, information or intended function for which Sec. 1040.20 has an applicable requirement. This addition would clarify that sunlamp products are being regulated like other products regulated under Sec. 1010.2. The FDA also is considering requiring the manufacturer who performs such modification to recertify and re-identify the product in accordance with the provisions of Secs. 1010.2 and 1010.3. This potential amendment is intended to clarify the responsibilities of firms and individuals who are in the business of installing UV lamps and new timers with different performance characteristics than the original lamps and timers in previously certified products.
The FDA is concerned that the current warning label is not read by many tanning salon patrons because it is too long and detailed. Therefore, the FDA is considering updating the warning statement required by Sec. 1040.20 (d) (1) (i) to simplify the wording and to highlight the risk of skin cancers. In order to update the warning statements, the FDA intends to review and evaluate epidemiological and mechanistic information on UV exposure-related skin cancers, including possibly fatal cutaneous melanoma.
The FDA also is considering requiring the reproduction of the text of the warning statement specified in Sec. 1040.20 (d) (1) (i) in catalogs, specification sheets and brochures pertaining to sunlamp products. The FDA is concerned that consumers who purchase sunlamp products through catalog mail order or through catalogs on electronic media may not receive information about the associated hazards and risks until the products are delivered to their homes and unpacked.
Finally, to simplify appropriate lamp replacement, the FDA is considering the development of a biological efficacy rating scale for UV lamps intended for use in sunlamp products. Lamp technology continues to evolve, affecting the levels of UV exposure, the spectral characteristics and, therefore, the biological efficacy of ultraviolet lamp radiation. Presently, a label that specifies the type of lamps suitable for replacement in the product is required on sunlamp products and in the user instructions. As new lamps and new lamp manufacturers enter the marketplace, it is increasingly cumbersome to keep track of individual lamp designations that are compatible with the product and compliant with the standard. In order to simplify the process, especially for industry and state regulators, the FDA is considering a uniform grading/rating system.
Interested persons may submit to the Dockets Management Branch written comments regarding this ANPRM before July 9. Written comments should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Please include docket number 98N-1170 on all comments. For more information contact W. Howard Cyr, Center for Devices and Radiological Health (HFZ-114), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 or call (301) 443-7179.
