The team at FDAImports.com has once again obtained removal of a client from FDA Import Alert. Import Alert #53-06, “Detention Without Physical Examination of Cosmetics Containing Illegal Colors,” instructs FDA to automatically detain all entries of eye make-up and make-up kits containing eye make-up from Taiwan, as well as shipments of identified products from the firms listed on the Alert’s Red List.
In 2008 FDA placed one of FDAImports.com’s clients, a Chinese cosmetics manufacturer, on Import Alert after sampling and testing a shipment of a cosmetic product. According to the FDA test, the cosmetic contained Tartrazine (certifiable as FD&C Yellow No. 5), which was not declared on the product’s label. FDA placed the Chinese cosmetics company on Import Alert #53-06 because of this one shipment of one specific product. The company remained on Import Alert despite the fact that the company had ceased manufacturing the product, and had not attempted to make any more shipments of the product after the Import Alert listing. The Import Alert listing caused disruptions to the company’s import operations for other cosmetics not subject to the import alert.
The company’s failure to declare Tartrazine in its product was due to a simple labeling mistake (Yellow No. 5 was misdeclared as Yellow No.6 on the cosmetic’s ingredient list). There was obviously no attempt by the company to conceal the presence of a color additive because Yellow No. 6 was declared. The Chinese cosmetics company sought the assistance of FDAImports.com who petitioned FDA to remove them from Import Alert #53-06.
FDAImports.com was able to convince FDA to remove the company from Import Alert because the mislabeling issue was no longer of concern. Not only had the company ceased to make the product that was placed on Import Alert, but the company also implemented significant procedural changes to ensure that similar declaration errors on labels on future products would be detected and corrected prior to shipment. As a result of these procedural changes, the company has not had any mislabeling issues and has since successfully shipped various cosmetic products into the U.S. As a result of FDAImports.com’s successes, the company is able to negotiate transactions with U.S. buyers without the reputational damage caused by the Import Alert and without the concern that future shipments might be automatically detained by FDA.
