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)

More information - Indoor Tanning: The Risks of Ultraviolet Rays

 

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 3,000 hospital emergency room cases a year. Overexposure to sunlamp and/or sunlamp product 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:

1000 - General

1002 - Records and Reports

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.