Toy Industry Association to Submit Comments to FDA about Children’s Toy Laser Products
August 8, 2013 | As a follow-up to the June release of a proposed rule about children’s toy laser products, on August 7th the U.S. Food and Drug Administration (FDA) issued “Minimizing Risk for Children’s Toy Laser Products,” a draft guidance document outlining the Administration’s proposed approach on the safety of these products. Both the rule and the guidance document were developed by the FDA’s Center for Devices and Radiological Health’s (CDRH).
According to Dan Hewett, health promotion officer at CDRH, recent concern regarding children’s exposure to lasers is due in large part to increases in “low-cost, compact laser pointers” that are not intended for children’s use. Although adults may use these laser pointers for work, kids will purchase them for amusement. These products are at particular risk of being used in an unsafe or uncontrolled manner that could lead to retinal injuries or skin burns caused by laser light.
Toys are subject to numerous safety standards, including FDA regulations related to the use of lasers. Most “laser-like” toys on the market employ harmless LED lights to simulate lasers; any toy that uses actual laser technology and falls under current FDA definitions for laser products must comply with FDA rules for low power lasers.
Although the FDA acknowledges that most children’s toy laser products fall under existing general definitions for lasers, the Administration’s regulations do not address toy laser products specifically manufactured, designed, intended or promoted for use by children under 14 years of age. The FDA has therefore issued a proposed rule that would specifically define children’s toy laser products and require them to be within internationally recognized International Electrotechnical Commission (IEC) Class 1 emission limits that would reduce potential risks to eyesight or skin burns under conditions of operation, maintenance, service, failure, or breakage (e.g., when play continues with a broken toy).
“We are not aware of toys that violate any federal requirement for lasers; however, we are concerned that children may be accessing products with real laser technology, mistaking these for playthings,” said Joan Lawrence, Toy Industry Association (TIA) vice president of standards and regulatory affairs. “Parents should take care with the use of laser products and ensure that those to which their children have access are intended for children’s use.”
TIA will submit comments on behalf of the toy industry regarding the draft guidance document, as well as the proposed rule. Though the guidance document is not legally enforceable, it delineates the FDA’s current thinking on the topic of lasers and will inform the Agency’s interpretations of a final approved rule.
Questions or comments can be submitted to email@example.com by September 23, 2013 for the proposed rule and by November 15, 2013 for the draft guidance document.