Radiation-Emitting Products
Sunlamps and Sunlamp Products (Tanning Beds/Booths)
- Description
- Risks/Benefits
- Information for the Public
- Laws, Regulations & Standards
- Industry Guidance
- Other Resources
The FDA wants consumers to know that UV radiation in tanning devices poses serious health risks. A recent report by the International Agency for Research on Cancer, (IARC), part of the World Health Organization, concludes that tanning devices are more dangerous than previously thought. Exposure to UV radiation, whether from the sun or indoor tanning beds, can cause:
- Skin cancer
- Skin burns
- Premature skin aging
- Eye damage (both short- and long-term)
Description
Sunlamp products are electronic products designed to use one or more ultraviolet lamp(s) and are intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. Sunlamp products include portable home units, table top models, tanning beds and tanning booths.
The ultraviolet lamps, subject to the performance standard, produce radiation within a prescribed range of wavelengths and are intended for use in sunlamp products.
Risks/Benefits
Sunlamp products 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 1,800 hospital emergency room cases a year. This number is based on the average yearly estimate of injuries for 2009 and 2010 (the most recent years for which data are available). It is likely that the actual number of injuries may be higher because this estimate only includes cases that are initially treated in US hospital emergency departments. This estimate does not include cases that are treated in outpatient clinics, physicians' offices, or not medically treated at all.
(Source: National estimates for tanning bed/booth-related injuries, 2009-2010 are from the National Electronic Injury Surveillance System – All Injury Program operated by the US Consumer Product Safety Commission in collaboration with the National Center for Injury Prevention and Control (NCIPC), CDC. Estimates were computed by the Office of Statistics and Programming, NCIPC, CDC.)
Overexposure to sunlamps and/or sunlamp products can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of skin and skin cancer.
Information for the Public
The term "suntanning preparations" includes gels, creams, liquids, and other topical products that are intended to provide cosmetic effects on the skin while tanning through exposure to ultraviolet (UV) radiation (such as moisturizing or conditioning products) or to give the appearance of a tan by imparting color to the skin through the application of approved color additives, such as dihydroxyacetone, without the need for exposure to UV radiation.
Because such products include those sold for use at the beach or for use in tanning salons, consumers are strongly encouraged to read carefully the labeling of all tanning products to determine whether or not they provide protection against the harmful effects of UV radiation.
For more information, see Tanning.
Laws, Regulations & Standards
Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.
Manufacturers of sunlamps and sunlamp products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:
1003 - Notification of defects or failure to comply
1004 - Repurchase, repairs, or replacement of electronic products
1005 - Importation of electronic products
In addition, sunlamps and sunlamp products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040.20:
1010 - Performance standards for electronic products: general
1040.20 - Performance Standard for Sunlamp and Sunlamp Product.
Required Reports for the Sunlamps and Sunlamp Products Manufacturers or Industry
Industry Guidance - Other Documents of Interest
Policy on Warning Label Required on Sunlamp Products (PDF Only) (PDF - 71KB)Policy on Lamp Compatibility (sunlamps) (PDF Only) (PDF - 66KB)Medications that Increase Sensitivity to Light: A 1990 Listing (PDF - 583KB)Inspection and Field Testing of Radiation-Emitting Electronic Products Quality Control Guide for Sunlamp Products (FDA 88-8234) (PDF Only) (PDF - 4.2MB)Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products (PDF Only) (PDF - 182KB)Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
Other Resources
Indoor Tanning: The Risks of Ultraviolet Rays Does the Product Emit Radiation? Getting a Radiation Emitting Product to Market Records and Reporting (Radiation-Emitting Products) Importing and Exporting Electronic Products Tanning Date of Manufacture Label on Radiation-Emitting Consumer Electronics Report to Congress: Labeling Information on the Relationship Between the Use of Indoor Tanning Devices and Development of Skin Cancer or Other Skin Damage
