Detention Without Physical Examination: What It Means for Products Held at Customs

Your cosmetic shipment has been stopped at the U.S. border, but unlike previous holds, this one is different. The notice from the U.S. Food and Drug Administration (FDA) says your product is subject to “Detention Without Physical Examination,” or DWPE.

Your goods are being detained automatically, without the FDA even looking at them. For a cosmetic importer, this can be a frustrating and costly experience, leaving you with little clarity on why your products are being held or how to get them released.

DWPE is one of the FDA’s most powerful enforcement tools, and it is essential for importers to understand what it is, why it happens, and how to respond.

This guide explains the mechanics of DWPE, its connection to FDA Import Alerts, and the steps you can take to resolve a DWPE-related detention and get your products off the automatic detention list.

(Readers are encouraged to explore the Bustos Law Group solution for the product held at custom. We provide trusted solutions for compliance and release for the cosmetic, food, & medical devices industry.)

What Is Detention Without Physical Examination (DWPE)?

Detention Without Physical Examination (DWPE) is an authority that allows the FDA to detain a product at the border without physically inspecting it. This action is taken when the agency has evidence that the product, manufacturer, or shipper has a history of non-compliance. In essence, the product is considered guilty until proven innocent.

Under normal circumstances, the FDA must have evidence that a specific shipment appears to violate the law before it can be detained. With DWPE, the history of violations is enough. The FDA can automatically detain future shipments based on past problems, shifting the burden of proof entirely onto the importer to demonstrate that the current shipment is compliant.

How DWPE Fits into the FDA Import Process

DWPE is not a random action. It is a direct consequence of being listed on an FDA Import Alert. An Import Alert is a public notice that the FDA has found a pattern of violations from a specific company, country, or product type. When a manufacturer or product is placed on an Import Alert, it is often subject to DWPE.

Here is how it works:

1. A Pattern of Violations: The FDA identifies a history of non-compliant products from a specific manufacturer (e.g., misbranded labels, unapproved ingredients).

2. Issuance of an Import Alert: The FDA issues an Import Alert that names the manufacturer and product. This alert authorizes FDA field staff to detain future shipments without physical examination.

3. Automatic Detention: When a new shipment from the listed manufacturer arrives at a U.S. port, the FDA’s screening system flags it. The shipment is automatically detained under DWPE authority.

Why Cosmetic Products Are Commonly Subject to DWPE

Cosmetic products are frequently subject to DWPE due to the high incidence of labeling and ingredient violations. Common triggers include:

• Labeling and Claims Issues: Making claims that the product can treat a condition or alter the body’s structure or function. For example, marketing a cream as “anti-aging” or a lotion as a “sunscreen” without being an approved drug.

• Ingredient and Safety Concerns: Using color additives that are not approved for use in cosmetics sold in the U.S. or containing ingredients that are prohibited.

• Facility Registration and Compliance Gaps: Failure to register a cosmetic manufacturing facility or list products with the FDA as required by the Modernization of Cosmetics Regulation Act (MoCRA).

What Happens When a Product Is Detained Under DWPE?

When your product is detained under DWPE, you will receive a “Notice of Detention and Hearing.” You now have a limited window of time (usually 10-20 days) to provide evidence that your product is compliant. This is not a simple process. You must provide clear and convincing proof, which may include:

• A third-party laboratory analysis of the specific shipment to demonstrate its safety and compliance.

• Revised labeling that corrects any misbranding violations.

• Documentation proving that the product is not subject to the Import Alert.

If you fail to provide sufficient evidence, the detention will be followed by a “Notice of Refusal,” and the product must be exported or destroyed.

How to Respond to Detention Without Physical Examination

Responding to a DWPE detention requires a strategic and evidence-based approach.

4. Identify the Import Alert Trigger: The first step is to determine which Import Alert is causing the detention. The Notice of Detention should specify the alert number.

5. Prepare Evidence of Compliance: You must prove that your specific shipment is compliant, even if past shipments were not. This usually requires hiring an independent laboratory to test the product and issue a certificate of analysis.

6. Submit a Response to the FDA: File a formal response with the FDA that includes the laboratory results and any other evidence demonstrating compliance. Your goal is to secure the release of the current shipment.

How to Seek Removal from DWPE

Getting a single shipment released is only half the battle. To prevent future automatic detentions, you must petition the FDA to be removed from the Import Alert’s Red List. This typically requires:

• Submitting a formal petition to the FDA’s Division of Import Operations.

• Providing evidence that you have corrected the underlying cause of the violations.

• Demonstrating a pattern of compliance, which often involves submitting evidence from five to fifteen consecutive compliant shipments that have been successfully imported into the U.S.

When Regulatory or Legal Support Becomes Important

Successfully navigating a DWPE detention and securing removal from an Import Alert is a complex regulatory challenge. The rules of evidence are strict, and the process is unforgiving of mistakes. An experienced FDA attorney can be a critical asset.

Bustos Law Group helps cosmetic importers resolve DWPE issues by:

• Developing a Strategy: We analyze the Import Alert and the specific reasons for your detention to create a clear roadmap for response.

• Managing Evidence Submission: We work with you and third-party labs to gather the necessary evidence and present it to the FDA in a persuasive format.

• Petitioning for Removal from Import Alerts: We prepare and file petitions to get your firm removed from the Red List, allowing your products to be imported without automatic detention.

If your cosmetic products are being held at customs under DWPE, contact Bustos Law Group today. We can help you resolve the immediate crisis and implement the compliance systems needed to protect your business in the long term.