On May 29, 2014, the FDA issued a consumer update regarding the risk of skin cancer, skin damage and eye injury from the use of tanning beds or tanning booths. The FDA cites the American Academy of Dermatology and the World Health Organization for the proposition that indoor tanning heightens a person’s risk of developing melanoma by 59%. The 59% increased risk of developing melanoma increases with each use of a tanning bed or booth.
The FDA is changing its regulations governing sunlamp products and UV lamps that are intended for use in sunlamp products. Among other changes to existing regulations, the FDA is requiring that sunlamp products have a black-box warning stating that they should not be used on persons under the age of 18. The FDA is also reclassifying sunlamp products from Class I (lower risk) to Class II (moderate risk).
Consequently, the FDA will be able to exert more control over sunlamp products, and sunlamp products will have to undergo a premarket review by the FDA, which will entail complying with various requirements including performance testing.
The FDA is now also requiring that instructions and promotional materials include certain warnings and contraindications. Specifically, the following warnings and contraindications must be included: (1) the product is contraindicated for use on persons under the age 18 years; (2) the product must not be used if skin lesions or open wounds are present; (3) the product should not be used on people who have had skin cancer or a family history or skin cancer; and (4) people repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.