FDAImports.com recently obtained removal for a manufacturer from Import Alert 66-41 (automatic detention of unapproved new drugs promoted in the U.S.). Under this Import Alert FDA detains all products it deems “unapproved new drugs” – even if they’re merely cosmetics with poorly drafted structure-function claims. Claims that a product is intended to affect a structure or function of the body can cause FDA to deem a product an unapproved new drug.
Our client/manufacturer was placed on Import Alert 66-41 and its products were being automatically detained. FDAImports.com reviewed the product and FDA’s allegations and counseled the manufacturer about how to revise the labeling to remove questionable claims. Although many people think “five consecutive clean shipments” is all you need to get off an import alert, FDA requires much more. The FDAImports.com team prepared the arguments and evidence and obtained removal with only 2 shipments. Because FDAImports.com was managing the detention process also, the detentions only lasted a few days each – rather than weeks on end. Import Alert petitions often languish in FDA under the agency’s review for months. Our team’s perseverance resulted in the manufacturer being removed from Import Alert in three short weeks.
Companies should always be vigilant in ensuring that their labels and claims are compliant with FDA regulation. Once FDA finds the “appearance” that a product is in violation of a law or regulation, the agency will automatically detain all future entries of that product from that manufacturer. Import Alerts and the automatic detentions that they cause are costly even in the best cases. FDAImports.com regularly reviews product labels to ensure compliance – contact us today for more information!
