On December 19, 2014, the U.S. Food and Drug Administration issued a final guidance document regarding children’s toys that contain laser beams. In the guidance, FDA defines children’s laser toys and offers suggestions for both the manufacturing and labeling of laser toys.
FDA proposed a rule in June 2013 to define children’s laser toys and to require them to be manufactured within the IEC Class I emission limit, but the rule is still in the process of being finalized. For now, the definition and suggestions in the guidance are solely FDA suggestion and are not supported by enforceable legal requirements.
FDA defines a “children’s toy laser product” as “a product primarily used as a toy that is manufactured, designed, intended or promoted for novelty or visual entertainment use by children under 14 years of age.” The agency excludes lasers that are used by children in a professional or academic setting from this definition.
FDA believes that lasers have a higher chance of being used in an unsafe manner when in the hands of children. The agency suggests that lasers used in children’s toys be kept within the FDA Class I or IEC Class I emission limits to minimize the risks they pose, such as retinal injury or skin burns, to those in range of the laser beam. IEC Class I laser beams are safe for eyes, even when viewed directly for a long period of time.
FDA recommends that laser toy labelers use IEC Class I designation labeling so that purchasers are aware of the minimal risk associated with the product.
While the previous suggestions for children’s laser toys are not enforced at this time, they may be in the near future. Companies that wish to learn more about FDA’s regulations for laser products or need assistance with labeling a children’s laser toy should contact Registrar Corp.
About the Author: David Lennarz is Vice President of Registrar Corp, an FDA compliance firm located in Hampton, Virginia, USA. Lennarz served as a Technical Expert for FDA’s Foreign Facility Registration Verification Program and has conducted seminars on U.S. FDA regulations in more than 30 countries around the world.