subject: Many Firms Affected By Electronic Product Fda Labeling Violations [print this page] In 2010, the U.SIn 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]."
Mr. England says that it is also important to note that not every charge made by the FDA is correct in relation to imported electronic products. In many cases, the FDA has refused or detained laser pointer, DVD reader and CD player shipments simply because the importer did not provide the FDA "accession number" at the time of import. This however, is not a violation of the law. FDA accession numbers are not required by federal statutes and regulations in order to avoid being placed on detention. The law requires that manufacturers certify that their products are in compliance with regulatory performance standards and that they submit product reports to verify this. However, the FDA has recently started using the lack of an "accession number" as a way to put the importer on violation. Unfortunately, many importers are not aware of this fact and have ended up exporting large product shipments that could have been allowed into the US if only they'd had professional consultants like FDAImports.com, LLC working on their behalf. The FDA identified eight different companies in the San Francisco port of entry alone, according to the #95-04 Import Alert. Due to violations discovered in the FDA's surveillance program, all eight were placed on the Red List. Mr. England warns importers to expect the FDA to expand surveillance on this matter.
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.
