| Who it’s for | Importers of record, foreign manufacturers and exporters, U.S. distributors, Amazon and e-commerce sellers, and customs brokers handling FDA-regulated goods |
| What’s covered | Pre-shipment compliance reviews, product classification, detention responses, reconditioning requests, refusals, and Import Alert removal petitions |
| Legal basis | FD&C Act § 801 (21 U.S.C. § 381); 21 CFR Part 1, Subpart E (import procedures), Subpart I (Prior Notice), and Subpart L (FSVP) |
| Key deadline | Detention responses are due by the date on the Notice of FDA Action, often about 10 working days |
| Products covered | Food, dietary supplements, cosmetics, medical devices, OTC drugs, and other FDA-regulated products |
How FDA Regulates Imports
Every FDA-regulated product entering the United States is screened by FDA when the entry is filed with U.S. Customs and Border Protection. FDA’s automated screening system reviews entry data and decides whether the shipment may proceed, needs document review, or should be held for examination or sampling.
Under section 801 of the FD&C Act, FDA can refuse admission to any product that appears to be adulterated, misbranded, or unapproved. That standard is lower than the one FDA must meet for domestic products. FDA does not need to prove a violation; it only needs an appearance of one, and the importer carries the burden of showing the product complies.
This is why import compliance catches so many companies off guard. A product legally sold in Europe, Canada or Asia can still fail U.S. rules on ingredients, labeling, claims, or registration.
Why FDA Import Problems Are Costly
An FDA hold at the port affects far more than one shipment. Common consequences include:
- Storage and demurrage fees that build every day a shipment sits at the port
- Refusal of admission, requiring export or destruction of the product
- Placement on an Import Alert, which allows FDA to detain future shipments without examination
- Missed retail and marketplace launches while inventory is held
- Liquidated damages claims from CBP when refused goods are not properly exported or destroyed
- Supplier and customer disputes over who carries the cost of the delay
Has FDA detained your shipment? The response clock is already running. Contact an FDA attorney today so your response is filed on time.
Schedule a ConsultationWhat FDA Checks, by Product Type
| Product Type | Key Requirements | Common Detention Reasons |
|---|---|---|
| Food and beverages | Food facility registration, Prior Notice, FSVP, 21 CFR Part 101 labeling, low-acid canned food filings | Missing or incorrect Prior Notice, labeling and allergen violations, contamination, unapproved colors or additives |
| Dietary supplements | Facility registration, Supplement Facts labeling, lawful dietary ingredients, 21 CFR Part 111 | Unapproved drug claims, undeclared or prohibited ingredients, labeling errors |
| Cosmetics | Facility registration and product listing under MoCRA, ingredient labeling, approved color additives | Drug claims, unapproved color additives, labeling violations, microbial contamination |
| Medical devices | Establishment registration, device listing, 510(k) or PMA status, labeling and UDI | Device not cleared or approved, missing registration or listing, labeling issues |
| OTC drugs | Drug establishment registration, drug listing, OTC monograph compliance, Drug Facts labeling | Unlisted products, non-monograph ingredients or claims, cGMP concerns |
What’s Included in Our FDA Import Services
- Pre-shipment compliance review of formulations, ingredients, labels and claims
- Product classification to confirm whether your product is regulated as a food, supplement, cosmetic, drug or device
- Registration and listing checks for facilities, products and U.S. agents
- Detention responses with testimony, documents and test results to support release
- Reconditioning requests on Form FDA 766 to relabel or bring detained goods into compliance
- Refusal guidance on export, destruction and CBP obligations
- Import Alert removal petitions and Green List strategies
- FSVP and Prior Notice support for food importers
- Direct communication and negotiation with FDA import compliance officers
Core Service Areas
Pre-Shipment Compliance Reviews
The fastest way to clear an FDA import problem is to avoid it. Before your first shipment, we review ingredients against U.S. rules, check labels for required English-language elements, confirm product classification, and verify that facility registrations, product listings and U.S. agent designations are in place. Learn more about ingredient reviews and label reviews.
Responding to FDA Detentions
When FDA detains a shipment, it issues a Notice of FDA Action stating the charge and giving the importer a chance to respond. The response can include testimony, documentation, and laboratory results showing the product complies. We analyze the charge, gather the right evidence from you and your supplier, and prepare a clear response that addresses each issue FDA raised.
Reconditioning Requests
If a detained product can be brought into compliance, FDA may allow it to be relabeled or reconditioned instead of refused. The request is submitted on Form FDA 766 and must explain exactly how the product will be corrected. The work is done under FDA supervision and requires a CBP bond. We prepare the request, propose a method FDA can accept, and coordinate with FDA through final release.
Refusals of Admission
If FDA refuses a product, it generally must be exported or destroyed under CBP supervision within 90 days. Mistakes at this stage can trigger liquidated damages claims. We help you understand your options, meet export and destruction requirements, and fix the underlying issue so future shipments are not refused.
Import Alert Removal
An Import Alert allows FDA to detain products without physical examination, often called DWPE. Once a firm or product is listed, every shipment can be held until the importer proves compliance. Removal requires a petition showing that the root cause has been corrected, supported by corrective actions, documentation, and a record of compliant shipments. We build the petition and track the evidence FDA needs under the specific Import Alert.
Food Import Requirements
Food importers face added requirements. Prior Notice must be submitted to FDA before the shipment arrives, and most importers must maintain a Foreign Supplier Verification Program showing their suppliers meet U.S. safety standards. Foreign food facilities must also be registered with FDA, with renewals due between October 1 and December 31, 2026. Learn more about our food services.
Our FDA Import Process
- Case intake: send us the Notice of FDA Action, entry details, product labels and supplier documents
- Charge analysis: we identify exactly why FDA held the product and what evidence will answer it
- Response strategy: we decide whether to seek release, request reconditioning, or plan for refusal
- Submission and negotiation: we file the response and work directly with FDA compliance officers
- Prevention: we correct the root cause so future shipments clear without delay
Detention matters move quickly. For shipments already at the port, contact us as soon as you receive the Notice of FDA Action.
Why Work With an FDA Attorney on Import Issues
Customs brokers handle the entry process, but they do not argue compliance with FDA. An FDA attorney fills that gap.
- Regulatory knowledge. We understand the product rules behind the detention, not just the entry paperwork.
- Direct advocacy. We present your case to FDA and negotiate reconditioning and release terms.
- Attorney-client privilege. Discussions about product problems and supplier failures are generally protected.
- Commercial support. We review supplier and distribution agreements that decide who pays when shipments are held.
Frequently Asked Questions
- What does an FDA consultant do?
- An FDA consultant helps companies bring products to market in compliance with FDA law. That includes classifying the product, reviewing ingredients and labels, handling registrations and filings, reviewing marketing claims, and responding to FDA enforcement. Our firm provides these services through a licensed FDA attorney.
- Why hire an FDA attorney instead of an FDA consultant?
- An attorney provides the same practical compliance work a consultant offers, plus legal advice, attorney-client privilege, and the ability to represent you if FDA, the FTC, a retailer or a plaintiff challenges your product.
- How does FDA decide how my product is regulated?
- FDA looks at a product’s ingredients and its intended use, which is shown by its labeling, marketing and claims. The same ingredient can be regulated as a food, dietary supplement, cosmetic or drug depending on how the product is sold and what it claims to do.
- Does FDA approve labels or products before they are sold?
- For most foods, dietary supplements and cosmetics, no. FDA does not pre-approve these products or their labels, and the company is responsible for compliance. Many medical devices need 510(k) clearance or Premarket Approval, and new drugs generally need FDA approval before sale.
- Which FDA registrations does my company need?
- It depends on the product and your role. Food and supplement facilities register with FDA and renew every two years, cosmetic facilities register and list products under MoCRA, device establishments register and list devices annually, and drug establishments register and list their products. Foreign firms usually need a U.S. agent.
- Can you help foreign companies selling into the U.S.?
- Yes. We help foreign manufacturers and exporters with product classification, U.S. labeling, registrations, U.S. agent questions, and FDA import detentions.
- How much do FDA consultant services cost?
- Cost depends on the product and scope of work. Many ingredient, label and website reviews are offered on a flat-fee basis so you know the cost before work begins.
- How quickly can you review my product?
- Most label and ingredient reviews are completed within five to seven business days. Rush timelines are available for launches and urgent FDA matters.
Shipment on hold at the port? Contact us today for a fast review of your Notice of FDA Action.
Toll-free: (866) 785-0873
Direct: (305) 507-9843
Email: contact@giannamore-law.com
Schedule a ConsultationThis page provides general information and is not legal advice. Reading it does not create an attorney-client relationship. FDA import procedures and deadlines may change; contact our office for advice about your specific shipment.