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.” This notice is considered the Notice of Detention and Hearing.
- Why was my product detained?
- What can I do if my product is detained?
- How am I notified that my product has been detained?
- What is a “hearing”?
- What is Testimony?
- What is the “respond by” date on the Notice of Detention and Hearing?
- What if I need more time to respond to the detention?
- Who is responsible for responding to the Notice of Detention and Hearing?
- What happens if I don’t respond?
- If my product is detained by FDA, can it be moved?
- I am told I can submit a private laboratory report. What do I do?
- The Notice of FDA Action I received indicates that my product may be destroyed. What does that mean?
The 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 FDA detains your product, your options include:
- Submitting evidence (also called testimony) to overcome the appearance of a violation.
- Submitting a request to recondition the product to correct the violation.
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.
FDA notifies the responsible parties that an imported product violates FDA laws and regulations by issuing a "Notice of Detention and Hearing.” The Notice of Detention and Hearing provides a “respond by” date for the importer, owner, and/or consignee to provide FDA with evidence, also called testimony, to overcome the appearance of a violation. The Notice of Detention and Hearing will provide the sections of the laws and regulations that appear to be violated; these are referred to as charges.
A hearing is your opportunity to present evidence, or testimony, to overcome the appearance of a violation and to give FDA confidence that the product is in compliance. The hearing will vary from a series of email or telephone conversations to a more formal meeting. The hearing officer is generally the FDA compliance officer listed on the Notice of Detention and Hearing.
You have the right to provide oral or written testimony, to the Food & Drug Administration, regarding the admissibility of the article(s) or the manner in which the article(s) can be brought into compliance. Testimony is any information you wish to submit to overcome the appearance of the violation, or to otherwise support the release of your product. Testimony should be provided to the contact that is listed on the Notice of FDA Action, usually a compliance officer.
You can provide entry documentation to FDA in these ways:
Upload the documents into Import Trade Auxiliary Communication System (ITACS). ITACS is the preferred method of submitting documents to FDA. This can be done by the importer, customs broker (entry filer) or other responsible party; OR
Use the find an import office contact page to determine your local import division email address, postal address, and/or FAX number to submit documents outside of ITACS.
When applicable, testimony may include the submission of an application to FDA requesting permission to re-label or recondition non-compliant articles using the Form FDA 766 (https://www.fda.gov/media/71537/download). Refer to the FDA’s Reconditioning page for more information.
The “respond by” date is the amount of time to provide testimony. FDA’s Regulatory Procedures Manual allows 10 business days from the date of detention. To allow for weekends, holidays, and mailing time the Notice of FDA Action generally specifies a timeframe of 20 calendar days following the date of detention shown on the notice. If the FDA does not receive a response to the detention within the specified timeframe, the compliance officer can issue a refusal of admission.
You may request an extension if it is made within the specified timeframe shown on the "Notice of Detention and Hearing," and a reasonable basis for extension is provided. If the request is granted, the new time frame should be clearly stated on a new Notice of FDA Action. If you have questions regarding the timeframes specific to your entry, you should contact the compliance officer listed on the Notice of FDA Action.
The owner or consignee may respond to the Notice of FDA Action. In addition to the consignee and the owner, FDA also recognizes the importer of record as eligible to provide information to FDA about the shipment. The importer of record may be the broker, consignee, owner, or whoever owns the bond covering the shipment. A designated representative of the consignee, owner, or importer of record may appear or respond on the consignee's (importer's) behalf; however this representative must be authorized in writing by the consignee, owner, or importer.
The compliance officer can issue a refusal of admission if FDA does not receive a response by the “respond by” date listed on the Notice of FDA Action. Typically the “respond by” date is 10 business days but can be up to 20 calendar days to allow for weekends, holidays, and mailing time.
Products are not specifically required to be held in a particular location prior to FDA making an admissibility decision. However, the FDA’s expectation is that the entry process is conducted within the declared Port of Entry area. Therefore, if FDA decides to conduct a physical examination or collect a sample and the product has been moved out of the Port of Entry area, the FDA may ask Customs and Border Protection (CBP) to issue a demand for redelivery for the products to be returned to the port of entry.
Depending on the nature of the violation, products that are subject to Detention Without Physical Examination (DWPE) may be sampled and tested by a private laboratory to provide evidence to overcome the appearance of a violation. If you need more time for a private lab report to be completed, you may send a request for extension to the FDA compliance officer listed on the Notice of FDA Action. Visit the Private Laboratory Testing page and CPG Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs) page for more information.
The Notice of FDA Action I received indicates that my product may be destroyed. What does that mean?
If your product is a drug that was imported through international mail, is valued at $2,500 or less, and you received a Notice of FDA Action indicating that the drug is potentially subject to destruction, then FDA made the determination that the drug product violates the law and is subject to refusal and possible destruction. For more information regarding destruction of drugs, please visit FDA’s Administrative Destruction Authority page.