Posted : 03/01/2002

Posted : 03/01/2002

by Joe Schuster

"Joe, I have been hearing a lot about the FDA and its involvement with the indoor tanning industry. How does the FDA regulate our business?"
--Kathy Stroud, Planet Tan, N.C.

Kathy, while it is true that the FDA and our industry seem to be in the news a lot recently, the FDA has regulated indoor tanning since 1980. However, you might have read that these regulations currently are under review and there may be some changes in the near future.

The FDA's regulations for indoor tanning are found in the performance standard 21CFR1040.20. They are aimed mainly at the manufacturers and importers of equipment and involve four main areas--timers, lamps, eye protection and labeling.

Lamps

Lamps to be used in indoor tanning equipment shall only be those listed on the lamps as the original or a compatible replacement. The original lamp is the product with which the exposure schedule testing was performed.

The replacement can only be + or - 10% in producing erythema and melanogenesis as the original lamp and cannot significantly alter the exposure schedule. The lamp manufacturer must file the appropriate paperwork with the FDA for its replacement products and a letter noting the FDA compatibility should be available to a future purchaser of such lamps.

Timers

Each sunlamp product shall incorporate a timer system with multiple timer settings adequate to the recommended exposure intervals. The maximum time must not exceed the manufacturer's recommended maximum exposure time indicated on the label. The timer cannot have an interval greater than 10% of the maximum exposure time. The timer cannot automatically reset and must have a control to terminate the exposure.

Eye Protection

Each sunlamp product shall be accompanied with protective eyewear which blocks 99% UVA and 99.9% UVB, but allow the user to see clearly enough to terminate the exposure.

Labeling

• Each sunlamp product must have a warning label that contains the following:

DANGER--Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, overexposure can cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product.

The following also must be indicated:

• The recommended position.
• Directions warning that use of other positions may result in overexposure.
• The recommended exposure schedule which includes the duration and spacing of sequential exposures and maximum time in minutes.
• A statement on the time it may take before the expected results appear.
• Designation of the UV lamp type to be used in the product.

Labeling For Lamps

• Sunlamp product must have the warning prescribed for sunlamp products permanently affixed or inscribed on the exterior surface of the lamp and must be legible by the person being exposed.
• The sunlamp must indicate the name of the manufacturer and the month and year of production.
• The label may contain additional information as long as it is not false or misleading.

A more complete review of 21 CFR 1040.20 may be found at www.fda.gov/cdrh/radhlth/index.html.

For further information on Light Sources lamps visit www.light-sources.com or e-mail Joe a question at joe_lsi@bellsouth.net.