The Food and Drug Administration requested and was given the go-ahead to develop amendments to the U.S. performance standard for sunlamp products based on certain initiatives of international standards organizations concerning sunlamp products. This came after the FDA’s Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) heard a proposal Oct. 1, 2003, for rule changes associated with indoor tanning products. Several industry professionals spoke at the TEPRSSC hearing, including representatives from the Indoor Tanning Association, Ultraviolet Research Institute, National Tanning Training Institute, LOOKING FIT magazine and Suntanning Association for Education, as well as a Pennsylvania salon owner. During the sunlamps session of the meeting, the FDA’s Sharon Miller proposed several regulatory changes regarding indoor tanning on behalf of the FDA. The changes covered warning labels, eyewear, the definition of a manufacturer and more. Warning Label The proposed revised label must include the following text: "WARNING— Ultraviolet radiation may cause: Read instructions carefully.
Wear protective eyewear provided.
Certain medicines and cosmetics may increase sensitivity to ultraviolet radiation." It is recommended that the word "warning" have lettering at least 10 millimeters in height and the rest of the label information be 5 millimeters tall to meet the visibility requirements specified in 21 CFR 1010.3. Label Placement The label must be included in catalogs, specification sheets and descriptive brochures. The FDA proposes: " ... in all catalogs, specifications sheets, and descriptive brochures and any other purchasing information pertaining to each sunlamp product and ultraviolet lamp, a legible reproduction of the warning statement required by 21 CFR 1040.20 shall be affixed." This modification is designed to be used only in promotional material for home tanners.
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