FDA Proposes Changes to Regulations on Sunlamp Products
The Food and Drug Administration is proposing changes to its regulations on sunlamp products in an effort to improve consumer safety and align U.S. requirements with international standards. In one proposed rule (here), FDA would adopt elements of the International Electrotechnical Commission’s International Standard 60335-2-27, bringing U.S. regulations in line with current science and allowing manufacturers to comply with a single set of standards. The proposed rule would also subject manufacturers of ultraviolet (UV) lamps intended for use in sunlamps to the same recordkeeping and reporting requirements as sunlamp manufacturers, and set new technical requirements for sunlamps.
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The proposed rule would slightly amend the definition of covered products as “any device designed to incorporate one or more ultraviolet lamps 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,” including tanning beds and tanning booths. UV lamps would continue to be defined as ”any lamp that produces ultraviolet radiation in the wavelength interval of 200 to 400 nanometers in air and that is intended for use in any sunlamp product.”
In a separate proposed rule (here), FDA would amend restrictions on the sale, distribution and use of sunlamp products. Though most of the changes would apply to tanning salons, the proposal would require that manufacturers include a user manual with all sunlamp products, and provide that manual upon request by consumers. The two proposals follow a rule issued by FDA in 2014 that reclassified sunlamps from class I to class II devices, and required a special “black box” warning (see 14052926).
(Federal Register 12/21/15)