US FDA Takes Enforcement Actions Against Invalid Certification for Impact Resistant Lenses

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FDA Import Alert 86-07 consists of importers and foreign manufacturers who have been Red-Listed for violating ‘certified product’ quality standards for ‘impact-resistant lenses’. Sunglasses (with or without UV protection) and eyeglasses (prescription and nonprescription) are regulated by FDA as medical devices. Benjamin England, founder of FDAImports.com, notes that “The FDA is only recently beginning to demonstrate excessive concern relating to impact resistant lenses, likely due to their rising popularity in the US market.” This is demonstrated by the fact that Import Alert 86-07’s Red List consists of five firms which have been added only since July 15, 2010. Three of these five firms were added on August 26, 2010.

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Detention Without Physical Examination of and Guidance for ‘Impact-Resistant Lenses in Eyeglasses and Sunglasses’

The Food and Drug Administration (FDA) is proving its newly formed concern regarding the safety and validity of claimed ‘impact-resistant lenses’ in eyeglasses and sunglasses by initiating a new FDA Import Alert, last updated on August 26, 2010. Import Alert 86-07 “Detention Without Physical Examination of and Guidance for ‘Impact-Resistant Lenses in Eyeglasses and Sunglasses’” (IA 86-07) includes a Red List of five firms which have been added only since July 15, 2010. Three of these five firms were added on August 26, 2010. Benjamin L. England, founder of FDAImports.com and former FDA Attorney comments, “This is a new area for FDA to show such intense scrutiny and enforcement. Impact resistant lenses are a rising commodity in the United States and importers and foreign manufacturers should expect FDA to take aggressive enforcement action against any ‘certified product’ that does not meet mandatory quality standards.” Sunglasses (with or without UV protection) and eyeglasses (prescription and nonprescription) are regulated by FDA as medical devices.

Upon importation into United States Commerce, importers of sunglasses and eyeglasses must present to FDA a certificate validating that the lenses were tested for impact resistance and passed those tests. According to FDA Import Alert 86-07 the agency independently started testing imported sunglasses and eyeglasses and found as many as 70% of certified impact resistant lenses (in an extreme case) had invalid certificates. Benjamin England says “FDA isn’t fond of manufacturers certifying a product to comply with certain quality standards, and then testing it to find the certification is completely unsubstantiated.” Mr. England adds, “It won’t matter where the imported sunglasses or eyeglasses originated. With such a high percentage of falsified certificates as FDA reports, you can expect FDA to test every batch it can.”
If FDA finds that the number of failing lenses in a shipment exceeds minimum standards, FDA will refuse (or reject) the entire shipment and require the importer to deliver the shipment for destruction or exportation. The responsibility falls on the importer to ensure that their imported products meet the requirements of the Federal Food, Drug and Cosmetic Act (FDCA). Because the certification of impact resistant lenses is filed by the manufacturer, “It is imperative,” says Benjamin England, “that importers are able to trust the manufacturers with whom they do business. One way to be sure you can trust your manufacturer is to have the certificates and the underlying tests evaluated before relying on them.”

Once FDA starts finding a problem like impact resistant lenses breaking during the agency’s testing process, FDA will increase its surveillance and testing efforts to populate the Import Alert Red List. If you import or manufacture impact resistant lenses and need assistance getting through at the U.S. Port of Entry, call FDAImports, a Food and Drug Law consulting firm, and speak with Benjamin England. FDAImports can show you ‘the way through’ FDA enforcement actions, as well as assist you in avoiding IA 86-07’s Red List all together.

Rick Quinn FDAImports

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Rick Quinn
FDAImports
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