■ FDA may consider the failure to provide adequate Prior Notice as a factor in determining whether and where to examine an article of food.
■ Some detentions are the result of the FDA’s Import Alert List of imported products manufactured by or exported by companies with detected patterns of noncompliance.
■ FDA places the responsibility back on the buyer or ultimate consignee, to ensure that the products being imported into the United States are in compliance.
Products subject to DWPE will be detained by the FDA until it can be shown that they are safe and meet pre-approved standards.
Companies exporting or importing products are strongly encouraged to familiarize themselves with the FDA Import Alert List.
Reviewing this list allows you to make an informed decision, and to determine what types of product testing or evaluations to require from the seller prior to shipment. This can prevent the headache associated with a detained shipment, saving you time and money.
A product may be detained because it appears to be:
- adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards
- misbranded, meaning the labels contain false or misleading information
- an unapproved new drug
- manufactured, processed, or packed under insanitary conditions
- forbidden or restricted for sale in the country in which it was produced or from which it was exported
If you are unable to overcome the appearance of a violation, your product will be refused admission and you can work with U.S. Customs and Border Protection (CBP) and FDA to destroy the product or export it from the U.S within 90 days of the refusal.