The U.S. Food and Drug Administration (U.S. FDA) may detain without physical examination, certain products from specific manufacturers.
Some companies became clients when their DHL, UPS or FedEx international shipments were detained because they did not file Prior Notices (PN). Fortunately, ITB HOLDINGS LLC offers same day PN filing upon request.
Also, we can help create a food or OTC drug label as soon as possible, when needed.
Since most customs clearances are processed by FedEx, UPS, DHL or one of the 14,454 active licensed Customs Brokers in the United States, they will be the first to know.
When a shipment reaches the United States, the importer of record (owner, purchaser, or licensed customs broker designated by the owner, purchaser, or consignee) will file entry documents for the goods with the port director at the goods’ port of entry.
Therefore, do not ignore their emails messages.
It is the Importer of Record (IOR)’s responsibility to arrange for examination and release of the goods, because imported products regulated by the FDA are subject to inspection at the time of entry.
An electronic product for which there is a radiation performance standard (laser products, diagnostic x-ray equipment), may only be imported if a declaration is filed with each importer’s entry. Form FDA 2877 is available from the Food and Drug Administration, Center for Devices and Radiological Health.
Moreover, some imported foods regulated by the FDA, such as confectionery, dairy products, poultry, eggs and egg products, meats, fruits, nuts and vegetables, are also subject to the United States Department of Agriculture (USDA)’ requirements.
But, there are many other reasons for U.S. Customs and Border Protection ( CBP) and or U.S. Food and Drug Administration (U.S. FDA) detention, as indicated below.
Common Violations
Your product may be detained because it appears to be:
adulterated
the product is contaminated, is not safe, or does not otherwise meet applicable standards.
misbranded
the labels contain false or misleading information.
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.
Failure to Register
Foods, Drugs, Cosmetics, Medical Devices: the facility or establishment of the manufacturer, exporter, importer or distributor is required. So is the listing of medical devices and drug products. Finally, manufacturers and shippers must also file a Prior Notice (PN) with the FDA for any food shipment.
Otherwise, the shipment could be:
• Held at the port of arrival.
• Moved to secured storage pending compliance with PN requirements.
• Exported.
• Destroyed.
FDA Inspections
The refusal to permit inspection of a foreign facility or reasonable access to FDA’s inspectors, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.
Therefore, the products manufactured or exported by that facility, will be subject to refusal of admission into the United States.
When products in your shipment violate or appear to violate FDA laws and regulations, FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.”
Notice of Detention and Hearing is issued by the FDA.
Your options include submitting:
▪ evidence (testimony) to overcome the appearance of a violation.
▪ a request to recondition the products to correct the violation.
If you are unable to overcome the appearance of a violation, your products will be refused admission and you can work with U.S. Customs and Border Protection (CBP) and FDA to destroy the products or export them from the U.S within 90 days of the refusal.
LIMITED
OFFER
$350.00
Make sure to send us a copy of the email you received from the U.S. Customs, the FDA, or your Customs Broker (FedEx, UPS, DHL).
If your products are deemed misbranded for failure to register your facility or establishment, act as soon as possible to avoid additional Warehouse Storage Fees. Per diem charges are applicable when cargo or containers are held beyond the applicable free time: $20.00 + $.04 per lb. per day. While the container or cargo is on hold, numerous fees will begin to pile up, such as row fees, demurrage fees (per day), shifting fees, and admin fees.
Speeding shipments through customs and quickly addressing issues, can mean the difference between fulfilling a distribution contract and losing an important customer.