In 2010, the U.S. Food & Drug Administration (FDA) has made nine additions to Import Alert #95-04, “Detention Without Physical Examination Of Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail To Comply With Applicable Performance Standards And Reporting Requirements” (IA 95-04) updated on June 3, 2010.

The FDA has regulatory jurisdiction over any and all electronic products capable of emitting radiation: both domestic and of foreign build. As reported by Benjamin L. England, of FDA Imports.com, LLC, “Enforcement on laser pointers was big in the mid 90′s when I worked at the FDA; it appears as though this isn’t something they are going to ‘lighten up on’”. Any shipment may be subject to detention upon first attempt of entry without proper certification that a Laser product has met the Performance Standards (21 CFR 1010.2, 1010.3, 1040.10 and 1040.11) and will be subject to all future entries as well.

More than 60 firms have been placed on the Import Alert #95-04 Red List for importing a range of laser products that do not comply with FDA labeling and safety data. Violations have included failure to provide the required certifications and warnings, submitting false entry documents, or not submitting the correct safety documentation to the FDA’s Center for Devices and Radiological Health (CDRH). Any firm placed on IA #95-04 will have their products Detained Without Physical Examination (DWPE) at Customs. “Recent enforcement activities indicate that a firm may be placed on [Import Alert] #95-04 for only one violation,” Mr. England states “…once a shipment is found to be in violation, the manufacturer has to act quickly. If they don’t promptly show that the product is certified or up to FDA standards, the shipment will most likely be rejected and they may end up on the automatic detention [Import Alert].”

According to Mr. England, not all of the charges the FDA has made related to imported electronic products are accurate. If the importer has failed to provide an FDA “Accession Number” when the product was imported, the FDA has refused or detained any number of shipments, including laser pointers, CD players and DVD readers. “That, however,” says Mr. England, “is not a violation of law. Federal statutes and regulations do not require importers to provide ‘FDA Accession Numbers’ to avoid detention. Rather the law requires manufacturers to submit product reports and to certify that their products comply with regulatory performance standards. But the FDA uses the lack of an ‘Accession Number’ as a surrogate for the actual violation. Most Importers do not know this, and they end up exporting large shipments of product that could have entered US commerce if they had contacted someone like us for help.” FDAImports.com, LLC is a consulting practice that specializes in representing foreign manufacturers and US importers of FDA regulated products, electronic radiation emitting products being among them. The FDA identified eight different companies in a surveillance program within one specific port of entry (San Francisco) according to Import Alert #95-04. All of these companies were placed on the list due to IA #95-04 violations. Mr. England warns, “Expect FDA to expand this surveillance”.

It is important that you seek professional and experienced consults, such as those at FDAImports.com, LLC to help you work through FDA compliance. If you have had any electronic product shipments subjected to DWPE on IA 95-04, or need assistance with any questions you might have about required certification and documentation, contact FDAImports.com. FDAImports.com, LLC is dedicated to helping importers and manufacturers comply with federal regulations and laws, and works to help firms quickly correct violations. Avoid Import Alerts by hiring the qualified, experienced staff at FDAImports.com, LLC. If your firm has experienced any of the import issues listed above or if you are interested in learning how to avoid experiencing such issues in the future, visit www.FDAImports.com today to get the solutions and advice you need.

FDAImports.com was founded by Benjamin L. England, Esq., a former FDA professional with 20 years of direct FDA experience, 17 years of which were obtained inside FDA. Mr. England is now a privately practicing FDA lawyer managing food, drug, medical device, cosmetic, and electronic product regulatory compliance, international trade and customs law. FDAImports.com specializes in making the complex understandable.