FDA publishes import refusal data
Manufacturers face greater enforcement action
The United States Food and Drug Administration (FDA) has published a list of every foreign manufacturer that has had a shipment refused entry to the US since October 2001.
The FDA says that its Refusal of Admission data “provides the public with information on products that have been found to appear in violation of the Act”.
The announcement will put pressure on foreign manufacturers to understand and comply with all the FDA’s laws on product labelling in order for their products to be approved.
“Whatever the reason for the refusal, being published on the FDA Refusal of Admission report means greater enforcement action on several levels,” explains Benjamin England, founder of food and drug regulatory consulting firm, FDAImports.com. “First, once a product is refused admission and published on the refusal page, FDA may refuse admission to future importations of that product to the US. Now that the FDA Import Refusal Report page is being published again, with a 10 year history of import enforcement actions, regulatory overreaching by non-US governmental bodies is likely to increase.”