Misdeclared Handheld Lasers Subject to FDA Regulations

Tuesday, September 17, 2013

Misdeclared Handheld Laser Products Subject to FDA Regulations


In a letter to U.S. Customs and Border Protection (CBP), dated August 12, 2013, the Food and Drug Administration (FDA) has asked for cooperation in stopping the release and distribution of shipments containing illegal handheld laser products
FDA is requesting that CBP notify it of all importations of visible and non-visible laser products, including laser pointers, laser gun sights, laser levels, laser light shows, laser pointer key chains, veterinary laser products, laser illuminators and similar products, including small shipments entered as “section 321” or informal entries.

FDA regulations limit the energy output of handheld laser pointers to less than five milliwatts and require them to be labeled as Class IIIa. However, the FDA has observed a number of laser product shipments entering the U.S. via courier hubs and international mail facilities, mostly in small, personal use-sized shipments that are often misdeclared or labeled as party lights, toys, flashlights, etc. The FDA suspects that these shipments contain laser pointers that exceed the 5 milliwatts limit and are designed to avoid regulatory requirements. Because of the potential health concern, it’s important these products undergo FDA admissibility review at the time of importation.

For more information you may view the letter in its entirety. FDA Letter to CBP