The U.S. market is an important export market for many Vietnamese businesses, especially in the food, pharmaceutical, and cosmetic sectors. However, to export products to this market, businesses need to comply with numerous strict regulations from the U.S. Food and Drug Administration (FDA).

FDA Import Holds and Detentions is one of the crucial regulations that businesses need to understand. This regulation allows the FDA to hold or detain imported shipments if there are suspicions that the shipment violates U.S. laws. Let’s explore this important regulation further with GOL in the article below.

What is a FDA detention?

FDA detention occurs when products entering the United States are refused entry, either by the US Food & Drug Administration (FDA) or the US Customs and Border Patrol, acting on behalf of the FDA. These detentions occur when the FDA has reasonable grounds to suspect that the products do not comply with US laws and regulations. Common reasons for FDA import detention include:

• Adulteration or contamination of products
• Mislabeling or misbranding of products
• Manufacturing, processing, or packing under unsanitary conditions
• Importing products that are prohibited for sale in the United States

Many of these detentions stem from the FDA’s Import Alert List, which is compiled based on surveillance of imported products and identification of patterns of noncompliance. Most listings on the Import Alert List take the form of a Red List Import Alert, indicating specific firms from a particular country that have demonstrated a pattern of noncompliance and are therefore subject to detention without physical examination (DWPE) upon importation. Products from listed firms will be detained by the FDA until they can demonstrate compliance with pre-approved safety and quality standards. Importantly, companies on the Import Alert List can be removed from the list if they have five consecutive shipments that meet all safety and quality standards, demonstrating a commitment to compliance.

Read more: Selling Online to the US – An E-commerce superpower

Detention Notices

When the FDA determines that any products may violate the law, they will detain those products and issue a corresponding Notice of FDA Action – Detention (detention notice) to the importer, owner, consignee, and customs broker. The FDA does not require substantial evidence to detain a shipment; mere evidence of a potential violation is sufficient. In fact, the FDA may detain a shipment without examining or testing the specific products if they have other evidence indicating a potential violation, such as findings from a previous shipment examination.

The FDA import detention notice specifies the alleged violation and references the relevant law. The owner or consignee of the imported product has the right to request an informal hearing, during which they or an authorized representative can present testimony to the FDA regarding the product’s admissibility.

The detention notice includes a “respond by” date, typically granting the responsible party approximately 20 calendar days to respond. If additional time is needed, an extension can be requested.

If the owner or consignee fails to provide evidence of compliance, submit a plan to rectify the non-compliance, or otherwise address the appearance of the violation, the FDA will issue a Notice of FDA Action – Refusal (refusal notice), denying admission of the product into the United States.

How to Respond to an FDA Notice

Step 1: Promptly Review the Notice

Upon receiving an FDA notice, carefully read and review it immediately to understand the situation fully.

Step 2: Familiarize Yourself with Terminology

• Hearing: This provides an opportunity to present evidence to address the alleged violation and demonstrate compliance. It can range from informal discussions to formal meetings.
• Testimony: Any information submitted to refute the violation or support product release. It should be directed to the FDA Compliance Officer.
• Charges: Reasons for the detention, such as adulteration or misbranding.
• Respond by Date: The deadline for providing testimony. Failure to respond may lead to refusal of admission.

Step 3: Develop a Plan

The Notice of FDA Action will outline the charges and regulations violated. You can submit evidence or request product reconditioning to rectify the violation. Testimony must be provided by the specified date, typically within 10 business days/20 calendar days.

In our scenario involving the tree nut shipment, testimony may involve product sampling and testing to ensure compliance with aflatoxin limits. Notify the laboratory promptly to initiate the clearance process.

Step 4: Conduct Product Testing

Partner with a laboratory experienced in FDA detention procedures to ensure compliance with sampling and testing standards. Safe Food Alliance offers comprehensive services, including quality assurance details and sampling plans.

Note: If the lab report cannot be completed by the initial response date, request an extension.

If the product fails testing, consider reconditioning to meet compliance standards. This may involve sorting out moldy or damaged nuts. If compliance cannot be achieved, options include exportation or destruction within 90 days.

Step 5: Submit Testimony

If the testimony confirms compliance (e.g., aflatoxin levels below 20 parts per billion), submit the data package for FDA review. Be prepared for a waiting period, as FDA may request additional information.

Navigating FDA procedures can be complex, but timely action and communication with the FDA Compliance Officer are essential. Ensure you understand the requirements and deadlines outlined in the notice to facilitate a smoother resolution process.

Read more: How do I get a food import license in the USA?

FAQs about FDA Import Holds and Detentions

What is the status of FDA import hold?

The FDA will maintain products in a hold status as they assess compliance with U.S. regulations. During this period, the FDA may review entry information, physically inspect shipments, or collect samples for testing in FDA laboratories.

Why was my product detained?

Your product may have been detained because it appears to exhibit one or more of the following characteristics:

• Adulteration: This implies contamination, lack of safety, or failure to meet relevant standards.
• Misbranding: This indicates that the labels contain false or misleading information.
• Unapproved new drug status.
• Manufacturing, processing, or packing under unsanitary conditions.
• Prohibition or restriction for sale in the country of origin or exportation.

What can I do if my product is detained?

If your product is detained by the FDA, you have several options:

• Submit evidence (testimony) to refute the appearance of a violation and demonstrate compliance.
• Submit a request to recondition the product to address the violation.

If you are unable to resolve the violation:

Your product will be refused admission, and you can collaborate with U.S. Customs and Border Protection (CBP) and the FDA to either destroy the product or export it from the U.S. within 90 days of refusal.

How am I notified that my product has been detained?

The FDA notifies responsible parties of an imported product’s violation of FDA laws and regulations by issuing a “Notice of Detention and Hearing.” This notice includes a “respond by” date, allowing the importer, owner, and/or consignee to provide FDA with evidence, also known as testimony, to refute the appearance of a violation. Additionally, the Notice of Detention and Hearing specifies the sections of the laws and regulations that appear to be violated, referred to as charges.

What is the “respond by” date on the Notice of Detention and Hearing?

The “respond by” date specifies the time frame for providing testimony. According to FDA’s Regulatory Procedures Manual, it allows 10 business days from the date of detention. However, to accommodate weekends, holidays, and mailing time, the Notice of FDA Action typically specifies a timeframe of 20 calendar days following the date of detention indicated on the notice. Failure to respond within this specified timeframe may lead the compliance officer to issue a refusal of admission.

What if I need more time to respond to the detention?

If you require additional time to respond to the detention, you can request an extension within the timeframe specified on the “Notice of Detention and Hearing.” Your extension request should include a reasonable basis for the extension. If the request is approved, a new timeframe will be provided, clearly stated on a new Notice of FDA Action. For clarification on the specific timeframes applicable to your entry, you should reach out to the compliance officer listed on the Notice of FDA Action.

Who is responsible for responding to the Notice of Detention and Hearing?

The owner or consignee has the responsibility to respond to the Notice of FDA Action. Additionally, FDA recognizes the importer of record as eligible to provide information regarding the shipment. The importer of record may be the broker, consignee, owner, or any entity that owns the bond covering the shipment. A designated representative of the consignee, owner, or importer of record may also respond on behalf of the consignee (importer), provided they are authorized in writing by the consignee, owner, or importer.

What happens if I don’t respond?

If the FDA does not receive a response by the “respond by” date specified on the Notice of FDA Action, the compliance officer can issue a refusal of admission. Typically, the “respond by” date is set for 10 business days, although it may extend up to 20 calendar days to account for weekends, holidays, and mailing time.

If my product is detained by the FDA, can it be moved?

Products detained by the FDA are not specifically mandated to remain in a particular location prior to the FDA making an admissibility decision. However, the FDA expects the entry process to occur within the declared Port of Entry area. Consequently, if the FDA decides to conduct a physical examination or collect a sample, and the product has been relocated from the Port of Entry area, the FDA may request Customs and Border Protection (CBP) to issue a demand for redelivery, requiring the products to be returned to the port of entry.

I am informed that I can submit a private laboratory report. What should I do?

For products subject to Detention Without Physical Examination (DWPE), private laboratories can sample and test the products to provide evidence to refute the appearance of a violation. If additional time is required for the completion of a private lab report, a request for an extension can be sent to the FDA compliance officer listed on the Notice of FDA Action.

The Notice of FDA Action I received states that my product may be destroyed. What does this mean?

If your product is a drug imported via international mail, valued at $2,500 or less, and you received a Notice of FDA Action indicating potential destruction, it implies that the FDA has concluded the drug product violates the law and is subject to refusal, with the possibility of destruction. For further details on the destruction of drugs, please refer to the provided information.

Compliance with FDA regulations can be a significant challenge for foreign businesses, especially those new to exporting to the U.S. market. The complex processes of product registration, quality testing, and labeling can consume a considerable amount of time and resources.

To save time, ensure accurate compliance with FDA regulations, and avoid being detained or having shipments held by the FDA, many businesses opt to use FDA registration services. GOL is a reputable FDA registration service provider with years of experience.

GOL offers:

• A team of experts well-versed in FDA regulations.
• Simple and efficient registration processes.
• Professional customer service.

With GOL’s FDA registration services, businesses can rest assured that their products will comply with all FDA regulations and minimize the risk of being detained or having shipments held by the FDA. Contact GOL today for a free consultation on FDA registration services!