FDA Adds Firms to ‘Import Alert’ for Electronic Product Labeling Violations: Many Non-U.S. Firms Affected According to FDAImports.com, LLC

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In 2010, the U.S. Food & Drug Administration (FDA) has made five 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) published on April 1, 2010. FDA has regulatory jurisdiction over all electronic products that emit radiation; both foreign and domestic. According to Benjamin L. England, of FDAImports.com, LLC, “Enforcement on laser pointers was big in the mid 90’s when I worked at FDA; it appears as though this isn’t something they are going to ‘lighten up’ on.”

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Enforcement on laser pointers was big in the mid 90’s when I worked at FDA; it appears as though this isn’t something they are going to ‘lighten up’ on.

In 2010, the U.S. Food & Drug Administration (FDA) has made five 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) published on April 1, 2010. FDA has regulatory jurisdiction over all electronic products that emit radiation; both foreign and domestic. According to Benjamin L. England, of FDAImports.com, LLC, “Enforcement on laser pointers was big in the mid 90’s when I worked at FDA; it appears as though this isn’t something they are going to ‘lighten up’ on.” Upon a shipments’ first attempt of entry, without properly certifying that a Laser product meets the Performance Standards (21 CFR 1010.2, 1010.3, 1040.10 and 1040.11), it may be subject to detention – detention of any future entries as well.

Over 60 firms have been placed on Import Alert #95-04, for importing a variety of laser producing products without FDA compliant labeling and safety data. Violations included submitting false entry documents, failure to provide the required certifications and warnings, or not submitting the correct safety documentation to FDA’s Center for Devices and Radiological Health (“CDRH”). Firms placed on IA 95-04 will have their products Detained Without Physical Examination (“DWPE”) by Customs. “Recent enforcement activities indicate that a firm may be placed on [Import Alert] 95-04 for only one violation,” stated Mr. England, “…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 probably be rejected and they may end up on the automatic detention (Import Alert).”

According to England, not all of the charges FDA makes related to imported electronic products are correct. Many times, FDA detains or refuses shipments of laser pointers, DVD readers, and CD players because the importer failed to provide an FDA “Accession Number” when the product was imported. “That, however, is not a violation of law”, said England. “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 their products comply with regulatory performance standards. But 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 represents foreign manufacturers and US importers of FDA regulated products, such as electronic radiation emitting products. According to Import Alert 95-04, FDA identified eight companies in a surveillance program within only one port of entry (San Francisco). All eight of these companies were placed on IA 95-04 due to violations. “Expect FDA to expand this surveillance,” warned England.

If you have been placed on IA 95-04, presently have shipments of electronic products subject to DWPE, or are unsure if your firm has the required certification and documentation, let FDAImports.com, LLC show you ‘the way through.” FDAImports.com, LLC is a consulting firm that can help you comply with federal laws and regulations, as well provide expert guidance to help you correct violations that have caused you to be placed on Import Alert #95-04. Let FDAImports.com help you avoid Import Alerts. If you are experiencing issues like those mentioned above, or desire to avoid such costly business impediments, contact FDAImport.com, LLC immediately for advice and solutions.

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Rick Quinn
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