An indoor tanning sunbed re-lamped with red light lamps and marketed as a “red light therapy” unit needs to have proper U.S. Food and Drug Administration pre-market approval before being marketed for sale, the FDA said in a Dec. 21 letter to the Indoor Tanning Association.

“Unless and until such device receives 510(k) clearance or premarket approval from FDA, it would be an adulterated and misbranded device that may not be marketed for sale,” Steven D. Silverman, director of compliance for the FDA’s Center for Devices and Radiological Health, wrote in a letter to ITA.

The letter states:

The Food and Drug Administration (FDA) is aware that some tanning salon owners are removing the original ultraviolet (UV)-emitting tanning lamps from their tanning beds/booths and replacing them with lamps that emit red light. These salon owners are then selling sessions in the red-light units with a range of indications and promotional claims, including ones pertaining to:

• reversal of sun or UV damage to the skin,
• wound healing,
• increased blood flow/circulation
• reduced pain and/or inflammation
• treatment of acne
• reduction of appearance of wrinkles, pigmentation spots, stretch marks, and/or scarring,
• skin rejuvenation, restoration, oxygenation, and/or hydration,
• collagen/elastin production/reorganization, and
• skin structure, elasticity, and/or metabolism.

Ultraviolet tanning beds/boots/lamps meet FDA’s definition of “device” and “electronic product” at sections 201(h) and 531 of the Federal Food, Drug and Cosmetic Act (FD&C Act). Tanning lamps are subject to an electronic product performance standard, and are generally 510(k) exempt. See 21CFR 878.4635, part 1010 and 1040.20.

Replacing the original ultraviolet lamps with lamps that emit red light and are intended for uses such as those listed above creates a new type of product that is also a ‘device’ and an ‘electronic product’ under the FD&C Act. Exposure to red light had been scientifically shown and is understood by consumers to affect skin structure, for example by reducing wrinkles for months after treatment, which may be the result of new collagen formation or reorganization, or repair of elastin damage. Claims such as those listed above would cause the product to meet one or both of the ‘device’ definitions at sections 201(h)(2) and (3) of the FD&C Act.

Red lights intended for uses such as those listed above would not fall under 21CFR878.4635, and would not be 510(k)-exempt (they also would not fall under 21CFR 1040.20, but would be subject to the regulations generally applicable to electronic products at parts 1000-1005). Unless and until such device receives 510(k) clearance or premarket approval from FDA, it would be an adulterated and misbranded device that may not be marketed for sale. Red light therapy systems intended for uses such as those described above may fall under 21CFR 878.4810, 878.5400, or 890.5500, depending on the technology and the claims made. For devices that fall within one of these classification regulations, the proper application to file is the 510(k) or “Premarket Notification.”

FDA requests the Indoor Tanning Association’s assistance in getting this message out to its members. FDA is also communicating this message to state radiation control programs. Some states have expressed concern about this practice to FDA and have already taken action on their own.