Each import alert is different, and presents unique complexities that need to be addressed comprehensively...
Glen Burnie, MD (PRWEB) May 30, 2012
FDAImports.com recently achieved another success, this time helping a client obtain removal from FDA Import Alert 53-17. This particular Import Alert, “Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination," affects over 50 International manufacturers and distributors of cosmetic products, especially products that come packaged in a kit or contain a variety of cosmetic products in one sellable unit. In this case, a Chinese manufacturer was placed on the Import Alert Red List due to a labeling error that failed to declare another company, the one with the actual safety issue.
Years ago a U.S. importer was importing a cosmetic kit from two separate Chinese manufacturers. Company A manufactured the entire kit except for a single item, which was produced by Company B. When the various products were shipped together to the United States, FDA flagged the entire shipment for microbiological contaminants in that single product produced by Company B and placed the manufacturer whose address was actually printed on the product on FDA Import Alert (Company A). The cosmetic product in question was not manufactured by the company placed on Import Alert but since the only address on the packaging was for the company producing most of the products, they were the ones placed on the Import Alert. The importer of record is the one who, by default, receives the Notice of Action from FDA, not the manufacturer, and since FDA doesn’t notify for Import Alerts, this Chinese manufacturer, who shipped completely safe products, was left in the dark.
Many months later, the importer sent another valuable shipment to the United States and suddenly discovered that they were on FDA Import Alert, unable to bring their product in to the country. The team at FDAImports.com examined the administrative files from FDA, demanded the evidence, analyzed it and convinced FDA that they accused the wrong company, finally obtaining removal from Import Alert for their client. Since there are no exact rules from FDA regarding removal from Import Alert, the team at FDAImports.com had the burden to prove up the legitimacy of the production story for the cosmetic kit, which is exactly what happened, thus allowing the company to successfully import their product to the United States.
“Sending clean shipments is not sufficient to remove a company from FDA Import Alert,” said Rick Quinn, Principal at FDAImports.com. “Each import alert is different, and presents unique complexities that need to be addressed comprehensively and in a manner that will cause FDA to exempt the subject firm, on the presentation of properly-presented facts and persuasive legal and regulatory arguments.” Mr. Quinn also stressed the value of having cosmetic labels and packaging reviewed for FDA compliance, as this Import Alert crisis was more about labeling than it was product safety.
FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact: Jon Barnes, (410) 220-2800 or pr(at)fdaimports.com.