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FDA Seeks CBP Help in Cracking Down on Illegal Laser Product Imports

Thursday, August 22, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has asked U.S. Customs and Border Protection for its help in preventing the delivery and distribution of illegal handheld laser pointers by monitoring small packages that could contain them. Specifically, the 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 those entered as “section 321” or informal entries.

According to the letter, 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 pointer 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 mW limit and are designed to avoid regulatory requirements that the importer submit information on each shipment to CBP and the FDA and affirm that the products they are importing comply or do not comply with federal performance standards.

In light of the potential health concerns associated with laser pointers, the letter states, it is important that they undergo FDA admissibility review at the time of importation. If a given shipment meets all applicable requirements, the FDA will release it. If not, the products will be detained by the FDA and, unless the requirements are met, refused admission into the U.S. The letter notes that importations of this type do not meet the FDA's criteria for enforcement discretion for personal importation.

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