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The FDA wants consumers to know that UV radiation in tanning devices poses serious health risks. A 2009 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)
Sunlamp products are medical devices and 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 and are subject to FDA medical device labeling requirements and special controls, as well as an electronic product performance standard (21 CFR 1040.20).
The ultraviolet lamps, also subject to the performance standard, produce radiation within a prescribed range of wavelengths and are intended for use in sunlamp products.
Sunlamp products for indoor UV tanning 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.
The FDA recognizes these products as hazardous and that they produce over 3,000 hospital emergency room cases a year. This number is based on the average yearly estimate of injuries for 2003 and 2012 (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 and reported to a central database. This estimate does not include cases that are treated in outpatient clinics, physicians' offices, not medically treated, or not reported.
(Source: National estimates for tanning bed/booth-related injuries, 2003 and 2012 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 the skin and skin cancer.
To ensure that consumers are appropriately educated about the risks associated with the use of sunlamp products and UV lamps, the FDA requires warnings on product labeling and in promotional materials. One of the warnings includes a recommendation stating, “Attention: This sunlamp product should not be used on persons under the age of 18 years."
However, because people under age 18 are especially at risk, the FDA is now proposing to restrict tanning facility operators from allowing use of the device by consumers under 18 years old. In addition to the age restriction, the FDA is proposing that tanning facility operators must obtain a signed, FDA-prescribed risk acknowledgement certification before use and then every 6 months thereafter. The risk acknowledgement certificate states that the user has been informed of the risks to health that may result from use of sunlamp products.
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.
Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FD&C Act), 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 of the Code of Federal Regulations, including but not limited to, Subchapter J (Radiological Health), Parts 1000 through 1005:
In addition, sunlamps and sunlamp products must comply with electronic product performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040.20:
Required Reports for the Sunlamps and Sunlamp Products Manufacturers or Industry
- Guide for Preparing Product Reports on Sunlamps and Sunlamp Products
- Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products
- FDA eSubmitter
Industry Guidance - Other Documents of Interest
- Sunlamp Products; Proposed Amendment to Performance Standard
- 510(k) Submission Process
- How to Prepare a Traditional 510(k)
- Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s
- CDRH LEARN video, âPre-market Notification, 510(k)"
- Policy on Warning Label Required on Sunlamp Products (PDF Only)
- Policy on Lamp Compatibility (sunlamps) (PDF Only)
- Medications that Increase Sensitivity to Light: A 1990 Listing
- Inspection and Field Testing of Radiation-Emitting Electronic Products
- Quality Control Guide for Sunlamp Products (FDA 88-8234) (PDF Only)
- Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products (PDF Only)
- Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
- 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
- Report to Congress: Sunlamp Products; Proposed Amendment to Performance Standard (Proposed Rule) Regulatory Impact Analysis