FDA Holds & Detentions

The U.S. Food and Drug Administration (FDA) has federal statutory authority over foods, drugs, cosmetics, medical devices, and cosmetics, among other things, offered for import into the United States.. Among its import surveillance activities, FDA exercises this authority by issuing ‘holds’ and ‘detentions’ on goods for which FDA would like additional information: viz., holds, requesting a review of product labeling or to conduct product sampling; or, when FDA alleges that a product actually violates the law: viz., detentions, if FDA believes there are quality issues (i.e., adulteration), labeling errors (i.e., misbranding) , or lack proper documentation.

At MyFDALawyers.com, PC, our FDA-focused lawyers have the knowledge, skills, and experience to handle the full range of FDA issues, including FDA Holds and FDA Detentions. We are committed to helping our clients find the best solution for their specific situations. If you have any questions or concerns navigating an inspection, warning, hold, detention, professional guidance and support are just a phone call away. Contact us today for a fully confidential, no-obligation initial consultation with a top-rated FDA attorney.

Navigating FDA Holds

An FDA hold can disrupt your operations, delay your timelines, result in costly storage or spoilage, and create problems with customers. FDA Holds can be especially problematic to deal with when every imported entry is time-sensitive. A hold may be imposed after an inspection, during a review of documentation, or if the FDA suspects that a product violates U.S. regulations. To be clear, it does not mean the product will be detained. But, it puts an importer on notice that FDA is watching and applying scrutiny to its entries. An FDA Detention often follows.

We help clients respond strategically to FDA Holds. Among other things, that includes assessing the reason for the hold, gathering appropriate evidence, and communicating with the right people within agency to resolve the concern efficiently. If an FDA Hold is followed by an FDA Detention, our FDA lawyers are already ready to act quickly to prepare and submit documentation to prove compliance, to argue that the detention is unlawful, and to secure the release of your products.

What You Need To Know About FDA Detentions

FDA Detentions occur because the FDA believes the goods offered for entry violate the Federal Food Drug and Cosmetic Act. Convincing FDA otherwise often takes time and can cause missed deadlines, so finding an advocate to help you identify the appropriate actions and responses can get your violations resolved quickly and efficiently can save your business money and headaches.

A proactive approach is a must. You should act quickly once FDA detains your entry , as delays can lead to additional storage fees or spoilage. Remember, importers have the right to submit evidence to challenge the detention and demonstrate that the product complies with FDA regulations. If the issue is not resolved, the product may be refused entry and will subject to destruction or export from the country. An FDA detention lawyer can help you build a strategy to resolve existing FDA detentions and prevent them from occuring in the future.

FDA Holds & FDA Detentions

If you have a product detained by the FDA, you, as the Importer of Record, or your Customs Broker, should receive a Notice of Detention.  You will be given a date before which you must provide testimony to overcome the alleged violation. Typically, you’ll have 10-20 days to deliver an effective response; otherwise, you can be issued an FDA Refusal of admission. The Notice of Action will outline the specific reasons for the detention, such as labeling issues, contamination, or insufficient documentation. It is critical to review the notice carefully and respond with clear, credible evidence that addresses each cited violation. Supporting documents can include lab results, revised labels, supplier certifications, or written explanations. If your response is accepted, the FDA may release the shipment for entry into the United States.

Often when people receive an FDA Detention, they assume the FDA is correct. We never take the FDA’s decision for granted and utilize our years of experience to help you get your goods released. In many cases, the detention is based on incomplete or inaccurate information, or a misunderstanding of the relevant law or regulations. Just because a product is detained does not mean it actually violates the law. We thoroughly analyze the Notice of Action and gather the strongest possible arguments and relevant documentation to challenge the detention. Our goal is to demonstrate compliance and resolve the matter without unnecessary delays or costs.

Terms to Familiarize Yourself With

Learning these terms will help you understand the process for resolving your FDA Detention.

Testimony – This is any information that we can provide to overcome the violation. We’ll work with you to understand, gather, and submit all evidence.

• Notice of Action – A Notice of Action is the FDA’s official communication to the importer regarding the status of an imported product. It may indicate that a shipment is held, detained, released, refused, or released with comment. This document outlines any applicable charges (violations), deadlines for response, and instructions for corrective action. It serves as the formal record of FDA’s decision at each stage of the import process. Importers are legally obligated to respond to any adverse findings in the Notice of Action by the stated deadline, or risk refusal and possible enforcement consequences.
• FDA Hold – An FDA hold is an initial action that temporarily stops a product from entering U.S. commerce while the FDA reviews documentation or conducts further evaluation. Products under hold remain at the port or designated storage location pending a decision to either release or detain the shipment.
• FDA Entry Review – The initial evaluation of a shipment by FDA’s import operations. During this stage, FDA may request documentation or place a hold to determine whether further action is needed.
• Sample Analysis – When the FDA takes a physical sample for laboratory testing. These tests may evaluate microbiological contamination, pesticide residue, label compliance, or drug constituents, depending on the product type.
• Private Lab Report – An independent laboratory report submitted by the importer to rebut FDA findings. Labs must be FDA-compliant and follow chain-of-custody and sampling protocols to be valid for consideration.
• FDA Detention – A detention is a formal action taken when the FDA has examined or reviewed documentation and finds that a product appears to violate FDA regulations. A Notice of FDA Action will be issued indicating “Detained,” and the importer must respond with evidence to overcome the stated charges. If unresolved, the product will be refused entry.
• Charges – Specific alleged violations listed in the detention notice. These may include mislabeling, adulteration, unauthorized ingredients, unapproved drug claims, or other regulatory infractions.
• Respond by Date – The deadline by which the importer must respond to a Notice of FDA Action. Failure to respond by this date will likely result in a Refusal of Admission.
• Hearing – A process by which the importer may respond to the FDA’s detention notice. This often involves written submissions, including legal and scientific evidence, to overcome the stated violations. It is typically handled via email and must be submitted before the “Respond by Date.”
• Refusal of Admission – A formal action indicating that the FDA will not allow the product into U.S. commerce due to unresolved violations. The product must be either exported or destroyed under supervision.
• FDA Release – This occurs when the FDA determines that a product complies with applicable regulations. A Notice of FDA Action will be issued showing “May Proceed” or “Released.” This allows the shipment to enter U.S. commerce. However, a release does not necessarily mean the FDA has reviewed the entire product—only that it is not objected to at the time of entry.
• Release with Comment – A release where FDA permits entry of the product but includes a comment noting a minor issue or potential concern. Importers should treat this as a warning for future compliance improvements.
• Entry Refused / Redelivery Requested – If a product is released and later found to be violative, FDA may issue a redelivery request. If redelivery is not possible, CBP may assess liquidated damages.
• Liquidated Damages – Penalties imposed by U.S. Customs and Border Protection (CBP) when an importer fails to comply with FDA redelivery orders or violates conditions of entry. These can amount to tens or hundreds of thousands of dollars.
• Detention Without Physical Examination (DWPE) – This is a type of automatic detention issued under an Import Alert. The FDA may detain a product without inspecting each shipment if the manufacturer, product, or country is listed on an alert. The burden shifts to the importer to prove compliance.
• Import Alert – A public notice by the FDA listing products, firms, or countries subject to DWPE. Products listed under an import alert are detained automatically upon entry unless an exemption or successful removal petition is granted.
• Importer of Record – The party legally responsible for ensuring that the product meets all U.S. requirements. This party communicates with FDA and Customs, submits responses, and coordinates testing and documentation.

Know the Most Common Reasons for FDA Detentions

The attempt to import a product that is subject to FDA regulation could be delayed/denied for a wide range of different reasons. If your product has been subject to an FDA detention, it is imperative that you have access to all relevant information. We’ll first evaluate why the FDA has detained your shipment and determine whether we agree with the agency’s findings. The most common reasons for product detentions by the FDA include:

• Labeling Violation – When the product appears to be misbranded due to inadequate, misleading, or noncompliant labeling. This can include false or misleading claims, missing required warnings, or improper format of the label.
• Adulteration – Unsanitary or Unsafe Conditions – The FDA refuses entry when a product appears contaminated, unsafe, or manufactured under conditions that fail to meet sanitary or safety requirements, such current Good Manufacturing Practices (cGMP) violations like pest contamination or improper temperature control.
• New Drug Without Approved Application – Products that qualify as “new drugs” must have an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
• Color Additive Violation – Products that contain color additives not approved by the FDA for their specific use (e.g., in food, cosmetics, or drugs) are illegal. This includes non-permitted dyes or lack of batch certification.
• Unsafe Food Additive – If a food product contains an unauthorized food additive that is not Generally Recognized As Safe (GRAS) or approved by regulation, the product will be detained.

How an FDA Lawyer Can Help With FDA Detentions & Holds

U.S. Federal food and drug regulations are complicated. It is normal to have a lot of questions about your rights and your responsibilities. At MyFDALawyers.com, PC, we help clients understand and address detentions. Bill Senior and Rick D. Quinn have decades of experience handling these matters. We handle FDA Holds and FDA Detentions. Our team is prepared to address the issues that your company is facing head-on. Notably, the laws and regulations that appear to have been violated will be outlined in your Notice of Detention or other documentation you received from the agency. We work to resolve problems quickly to minimize their impact on your business. While this process can be frustrating and confusing, the best thing you can do is to consult with a qualified attorney to help you create a plan to:

• Gather all documentation and facts about why your shipment has been detained.
• Review the Notice of Detention with an attorney skilled in FDA matters so to help you understand the violation and answer any questions that you may have.
• Pay close attention to the Respond By date. If you miss this date, the FDA will usually refuse admission and you’ll have 90 days to export or destroy your shipment.
• Provide a detailed explanation showing why your product has not violated FDA requirements or how you have resolved all issues.

It’s important not to respond until you fully understand the charges and have gathered all your evidence. It is our job to help you objectively view the situation and navigate the FDA’s requirements. Not responding properly can lead to making matters worse, further delaying your shipment and costing more money in the long run. The best strategy for responding to an FDA detention will always depend on the specific circumstances of the case. At MyFDALawyers.com, PC, we dedicate our time and resources to help you achieve the best course of action.