Does FDA regulate compact fluorescent lamps?
Fluorescent lamps, including CFLs, are electronic products subject to Section 532 of the Food, Drug, and Cosmetic Act. Section 532 of the Act authorizes FDA to establish and carry out an electronic product radiation control program designed to protect the public health and safety from radiation that may be emitted from electronic products, such as the UV that may be emitted from CFLs. Although FDA regulates CFLs under the Code of Federal Regulations (CFR) 21 Part 1000, there are currently no specific standards or annual reporting requirements for CFLs. Manufacturers of CFLs are subject to CFR 21 part 1002.20, which requires CFL manufacturers to report accidental radiation incidents should any occur. In addition, CFR part 1003.10 requires manufacturers to notify FDA in the event of a product defect or failure which would result in an accidental exposure incident. The vast majority of products of concern to the FDA are capable of emitting significant levels of radiation, such as X-ray eq