Understanding How FDA Processes Imported Products

All FDA regulated products that are imported into the U.S. must meet Bureau of Customs and Border Protection (Customs) requirements in addition to FDA's.

If it appears from the "examination of samples or otherwise" that the product may be adulterated, or misbranded, or unapproved, or not permitted entry into the U.S., then FDA may detain it upon entry. If the apparent violation is not overcome (with evidence) FDA will ordinarily refuse admission to the detained medical device. When FDA refuses admission to a medical device, the law requires that it be destroyed, unless it is exported within 90 days of the date of FDA’s refusal of admission.

FDAImports.com consultants and affiliate attorneys regularly assist foreign manufacturers, shippers, growers, coalitions, and associations, and U.S. importers in managing the import process and in developing Standard Operating Procedures and manuals to increase compliance with government import requirements. Ensuring compliance in advance of shipping reduces FDA, USDA, and Customs delays when the shipment arrives at a U.S. port of entry.

The Entry

The FDA import process begins with the importer or customs broker submitting the necessary entry information to the local Customs port office. Most entries are filed electronically. Customs forwards the electronic data to FDA for that agency to conduct its review.

For those entries not filed electronically, a paper entry consisting of the commercial invoice and various Customs forms, along with other documentation provided to the customs broker by the importer will be submitted by the customs broker to Customs and FDA.

Even for electronic entries, FDA may required the presentation of certain documents. FDA requests the documents from the customs broker. The customs broker or the importer may ask the foreign shipper or foreign manufacturer for information that FDA or Customs requires to review whether the product should be admitted into the U.S.

When the entry is transmitted to FDA (through Customs) certain information MUST be provided by law, and other information SHOULD be provided to speed up the entry process. The customs broker is ordinarily able to describe the information FDA will expect to see in the electronic entry or in paper documents.

Entry information should clearly identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. For instance, for medical devices, the entry should include the device name, the manufacturer, the correct device FDA product code, the foreign manufacturer's and importer's establishment registration numbers, the device listing number, and any approval identifier (pre-market notification or pre-market approval number). For canned foods, the entry should include the food name, the food canning establishment, the manufacturer's Food Canning Establishment registration number, and the canning process ID number previously submitted for FDA review. Imported foods are also subject to FDA's prior notice requirements under the Bioterrorism Act. In most cases the prior notice is submitted at the same time the entry is submitted, by the customs broker. Drugs (human and animal), cosmetics, other food products (human and animal), food contact services (e.g., ceramic ware), and electronic products all have their own compliance affrmation codes. If the codes are not submitted to FDA with the entry, FDA will often detain the entry based upon the appearance that the product or the manufacturer are not in compliance with FDA law. Sometimes, this kind of detention is lawful. In many circumstances, this kind of detention (if the only evidence FDA has is the importer's failure to provide affirmation of compliance codes) is unlawful.

Ordinarily, Customs will release the imported shipment to the importer’s custody while FDA is still deciding whether the product may be admitted entry.

Customs requires the importer of record to file an importation bond, which generally should be in an amount at least equal to three times the invoice value of the goods. This Customs release is called a “conditional release.” One of the terms of the importation bond is that the importer of record agrees to redeliver the conditionally released goods back into Customs’ custody if Customs issues a lawful and enforceable demand for redelivery. If CBP issues a valid and enforceable demand for redelivery of a shipment conditionally released by CBP, the importer of record usually has a specified amount of time to comply with the demand. If the importer fails to redeliver the CBP released merchandise, CBP can issue a civil claim for liquidated damages in an amount equal to three times the invoice value of the goods that were not redelivered, up to the limit of the value of the bond.

Click here to obtain more information about the Customs bond, demand for redelivery, and liquidated damages claims.

FDA Detentions

FDA's regulations authorize FDA to detain an imported product under FDA jurisdiction if it appears to be out of compliance with the law. If a product appears to be out of compliance, the FDA district office will issue a “Notice of FDA Action” to the importer of record, the owner, consignee and the customs broker. The Notice will specify the nature of the violation and cite the relevant statutory provision. Under the Food Drug and Cosmetic Act, the owner or consignee of an imported product is entitled by law to an informal hearing during which he may provide testimony to FDA regarding the admissibility of the product. If the owner:

* Fails to submit evidence that the product is in compliance, * Fails to submit a plan to bring the product into compliance, or * Fails to overcome the appearance of the violation,

FDA will issue another “Notice of FDA Action” refusing admission to the product.

During the detention stage, it is very important to solve the detention. Very often, if an article is refused admission by FDA, FDA will not release it into U.S. distribution -- even if the refusal is wrong.

To find out how FDAImports.com consultants and affiliated attorneys can help resolve an FDA Detention or FDA delay in releasing FDA imported products, go to our FDA Entry Resolutions page.

FDA Refusals of Admission

If an importer fails to overcome the appearance of a violation on an FDA detained entry, or fails to respond to FDA within the time frame, FDA will ordinarily refuse admission to the product and issue an FDA Refusal of Admission. If a product is refused by FDA, it must be exported or destroyed within 90 days of the date of the refusal.

When FDA issues a refusal of admission, Customs will ordinarily issue a demand for redelivery of the FDA refused goods within 30 days of the refusal date. Customs grants the importer of record a total of 90 days from the date that appeared on the refusal of admission to export or destroy the product under government supervision. The importer of record ordinarily can comply with the Customs demand for redelivery by exporting the FDA refused merchandise (under Customs' supervision) or destroying the refused merchandise (under FDA’s supervision). Failure either export or destroy the FDA refused goods within the time allotted by Customs will ordinarily result in Customs issuing a claim for liquidated damages.

Rescinding an FDA refusal is very difficult and very rare. FDAImports.com consultants and attorneys have had success in these actions, but every case is unique. Rescinding an FDA refusal depends upon the facts, how FDA handled the entry (including how and when FDA issued its notices to the importer), whether the importer or customs broker supplied information to FDA to try to resolve the detention, and whether FDA is correct in its application or interpretation of the law.

To find out how FDAImports.com consultants and affiliated attorneys can help try to obtain rescission of an FDA Refusal, go to our FDA Entry Resolutions page.

To find out how FDAImports.com consultants and affiliated attorneys can help you challenge a Customs demand for redelivery or petition for cancellation or mitigation of a Customs claim for liquidated damages based upon an FDA Refusal, go to our Customs Issues page.

FDA Examinations or Sampling for Analysis

Upon entry of an FDA regulated product, FDA may examine the product to assure it complies with all applicable requirements. When this occurs, FDA will issue a notice of examination or sampling to the importer of a record, again on a form titled “Notice of FDA Action.” Sampling may involve examining the product at the port of entry or physical collection of a statistical portion of the lot for analysis by an FDA laboratory. If the sample is found to be in violation of the Food Drug & Cosmetic Act, or if the sample is determined to be out of compliance with required specifications, FDA will detain the product and the importer of record will be issued a “Notice of FDA Action” indicating the detention. This detention will be based upon an FDA examination of samples. The importer then may attempt to supply evidence demonstrating why FDA is wrong, or attempt to correct the problem by relabeling the product or cooking it or remanufacturing it, or taking some other action. If the importer fails to correct the problem or convince FDA it is wrong, FDA will ordinarily issue a refusal of admission for the product.

To find out how FDAImports.com consultants and affiliated attorneys can help you overcome an FDA detention based upon an examination or sample analysis, go to our FDA Entry Resolutions page.

Reconditioning or Relabeling

Under certain conditions, the importer of record of an FDA-detained product is given an opportunity to submit an application for authorization to bring the product into compliance with the Food Drug & Cosmetic Act by reconditioning or relabeling it. If the local FDA office permits an importer of record to recondition or relabel the shipment, FDA may collect a second sample to verify the reconditioning process was successful. If FDA does not require a second sample, or if the second sample demonstrates the detained product now complies with the relevant provisions of the law, the imported product will be released into U.S. commerce.

To find out how FDAImports.com consultants and affiliated attorneys can help you design an acceptable reconditioning or relabeling application and plan to overcome an FDA detention, go to our FDA Entry Resolutions page.