FDBusiness.com

The United States Food and Drug Administration (FDA) recently published a list of every foreign manufacturer that has had a shipment refused entry to the US since October 2001. In the past, FDA listed Import Refusals monthly on its website. The ‘Import Refusals’ page of FDA’s site was ‘out of commission’ due to technical problems for several months – until recently.

Now that FDA’s Import Refusal Report is once again operating, Benjamin England, founder of FDA Imports.com, a food and drug regulatory consulting firm, says that “Many foreign manufacturers will soon be facing potential enforcement action from their domestic regulatory bodies, as well as public and competitor scrutiny, concerning their products.”

FDA’s new publication of its FDA Refusals data is functioning more efficiently than ever before. Now the Import Refusal Report publicises cumulative refusal data since October 2001. The purpose for publishing FDA Refusal of Admission data is to “provide the public with information on products that have been found to appear in violation of the Act,” according to FDA. “While these manufacturers’ initial concern may be the extent to which the FDA Refusal Report affects their consumers’ image of their company,” notes Benjamin England, “there is a far greater concern to address and that’s the foreign manufacturer’s local government.”

For example, the China Inspection and Quarantine (“CIQ”) agency, which regulates and reviews the safety of food imports and issues inspection certificates and export permits, has already started sending letters to several Chinese manufacturers recently listed on FDA’s Import Refusal website page. In these letters, CIQ has been asking for an explanation about FDA Refusals of Admission of their products. Documenting what occurred can take some time and definitely money.