FDA Import Detentions for EU Cosmetics: How Import Alerts Work and How to Protect Your Shipments

Most European cosmetics brands discover how US import detentions work the same way: with a terse email from their freight forwarder, a hold notice on a pallet sitting somewhere in New Jersey, and a 15-working-day response clock already ticking. By that point, the product is stuck, the launch timeline is in jeopardy, and nobody back at the factory quite understands what went wrong — because the formulation was EU-compliant.

EU compliance and FDA compliance are not the same thing. That distinction is obvious in theory. In practice, it catches even experienced European brands off guard when they first ship to the US market.

Here’s how FDA import screening actually works, which product types carry the highest detention risk, what MoCRA added to FDA’s import authority, and what you can do before your first shipment to reduce that risk substantially.

How the FDA Screens Cosmetics at the US Border

Every commercial shipment entering the United States is processed through the Automated Commercial Environment (ACE), the US government’s central trade management system. FDA plugs into ACE to screen all food, drug, device, and cosmetic import entries. For cosmetics, that means PREDICT — the FDA’s Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting system — runs a risk score on your entry before a human being looks at it.

PREDICT assigns risk based on several factors: the manufacturer’s compliance history, the country of origin, the product category, and whether the company appears on any active Import Alerts. Shipments that score above a threshold are routed to an FDA import examiner, who decides between three outcomes: routine admission, physical examination with sample collection, or Detention Without Physical Examination (DWPE).

DWPE is the one that creates real commercial damage. Under a DWPE order — which FDA issues through its Import Alert system — inspectors can refuse your shipment at the port without opening a single box. The burden of proof shifts entirely to the importer: you have 15 working days from the Notice of FDA Action (FDA Form 2766) to file testimony and supporting evidence demonstrating compliance. That might mean submitting ISO 17025-accredited laboratory results, Safety Data Sheets, formulation documentation, or Certificates of Analysis — often documents your US importer isn’t holding and your European team hasn’t prepared in FDA-compatible format.

If the evidence doesn’t satisfy the reviewing officer, FDA issues a Refusal of Admission. Products refused must be either re-exported or destroyed within 90 days. The landed cost, storage fees, and freight charges for refused goods fall entirely on the importer.

The Product Categories That Put EU Brands Directly in the FDA’s Crosshairs

Not all cosmetics carry equal import risk. Some product categories almost guarantee scrutiny — particularly those where EU and US regulatory frameworks diverge most sharply.

Skin-lightening and brightening products are arguably the highest-risk category for European exporters. The EU allows up to 2% hydroquinone in OTC cosmetics under Annex III of Regulation 1223/2009. In the US, FDA never finalized an OTC monograph for hydroquinone skin-bleaching products, and a 2019 Proposed Rule effectively moved hydroquinone outside the OTC drug category for new formulations. Any cosmetic containing hydroquinone is now treated by FDA as an unapproved new drug — not a cosmetic — and will be refused entry as misbranded. Products found to contain mercury above 1 ppm (a persistent adulterant in products sourced through certain third-party supply chains) are also refused under 21 USC 361 as adulterated cosmetics.

Kohl, kajal, and surma eyeliners are another category where EU-certified products regularly fail FDA screening. Traditional formulations use lead-based compounds — often galena, a lead sulfide mineral — at levels FDA considers unsafe for products applied near the eye. Even EU-reformulated versions carrying CPNP notifications have faced detention when testing reveals lead content above FDA’s informal guidance threshold.

Color additives represent a systemic compliance gap that most European brands don’t see coming. The US operates a closed-list system: only colorants specifically listed in 21 CFR Parts 73, 74, and 82 may be used in cosmetics sold in the US. Many EU-approved colorants under Annex IV of Regulation 1223/2009 simply don’t appear on FDA’s permitted list. A pigment fully legal in a French cosmetic may be an adulterating substance the moment that product clears a US port.

Sunscreen-containing cosmetics deserve their own category entirely. In the US, any product with SPF claims is regulated as an OTC drug, requiring a Drug Facts panel, a National Drug Code (NDC) number, and formulation within FDA’s approved active ingredient framework. EU-style SPF cosmetics carrying EU-compliant labeling will be detained as misbranded drugs at US customs. And before anyone asks: no, the EU’s rigorous clinical data requirements for SPF claims don’t satisfy FDA’s OTC drug approval pathway. They’re different regulatory animals.

What MoCRA Changed About FDA’s Import Toolbox

The Modernization of Cosmetics Regulation Act (MoCRA), signed December 29, 2022 as part of the Consolidated Appropriations Act, gave FDA more authority over cosmetics than it had held at any point since the original Food, Drug, and Cosmetic Act of 1938. For import compliance specifically, three provisions directly raised the stakes for European exporters.

Facility registration is now mandatory. Any facility manufacturing or processing cosmetics for distribution in the US must register with FDA via the FURLS (FDA Unified Registration and Listing System) portal. The original deadline for existing facilities was December 29, 2023. Small businesses — those with under $1 million in annual US cosmetics sales — received an extended deadline of July 1, 2024. Brands that haven’t registered carry a visible compliance gap that PREDICT can flag, and in some cases unregistered foreign facilities are being added directly to Import Alert lists.

FDA can now request records access during an import examination. Under section 608 of the FDCA as amended by MoCRA, the agency can require manufacturers to provide safety substantiation data and associated records within a reasonable timeframe when a product is under examination. Vague or incomplete documentation that might have passed a quick field examination before 2023 carries substantially less weight today.

Mandatory recall authority is new territory for cosmetics. FDA can now compel recalls — authority it previously lacked entirely for this product category. While this primarily affects products already in the US market, it reflects the broader regulatory posture shift. Import screening intensity has followed. The agency that once treated cosmetics as a lower priority than drugs and devices now has enforcement tools to match.

Six Steps to Take Before Your First US Cosmetics Shipment

Prevention is almost always cheaper than remediation. A single refused shipment — accounting for freight, storage fees, re-export logistics, and lost revenue — can easily exceed €50,000. A mandatory recall triggered by a compliance deficiency that slipped through on first entry can run into the millions. Neither outcome is hypothetical; we’ve worked with European brands managing exactly these situations.

Here’s what well-prepared brands lock down before the first container leaves port:

1. Register your manufacturing facility with FDA via the FURLS portal under the MoCRA framework. This is a legal requirement, not optional documentation. If your contract manufacturer handles production, confirm they are registered — the obligation follows the facility, not just the brand owner.

2. Audit your colorant list against 21 CFR Parts 73, 74, and 82. Build a cross-reference table for every formulation you intend to export. Don’t assume EU approval implies US approval. Many European formulators are surprised to find that a colorant they’ve used for years has no US equivalent on FDA’s permitted list.

3. Screen every formulation for OTC drug triggers. Any active ingredient regulated as a drug in the US — sunscreen actives (avobenzone, octocrylene, zinc oxide above certain concentrations), hydroquinone, fluoride, antibacterials like triclosan — means the product requires OTC drug compliance, not cosmetics compliance. The labeling, testing, and registration requirements are entirely different.

4. Commission third-party testing from an ISO 17025-accredited laboratory. Test for heavy metals (lead, mercury, cadmium, arsenic), microbial contamination per USP <61>/<62> or equivalent, and identity verification for botanical or plant-derived ingredients. FDA import examiners give significant weight to ISO 17025-accredited test results when evaluating detention response submissions — far more than internal CoAs or supplier documentation.

5. Ensure US-compliant labeling under 21 CFR Part 701. This means English-language labeling, net quantity declared in US customary units (fluid ounces, not millilitres), and INCI ingredient declarations in descending order of predominance as recognized in the US system. These are subtle differences from EU labeling under Regulation 1223/2009, but they’re differences that customs examiners look for.

6. Appoint a US Importer of Record or Regulatory Agent who understands FDA cosmetics requirements and is physically present to receive FDA communications. Your EU-based Responsible Person under Regulation 1223/2009 holds no legal standing under US law. FDA needs a US-based contact who can act — and respond to detention notices — within business-day timeframes.

None of these steps is complicated individually. The challenge is executing them systematically across an entire product range, with documentation formatted to FDA standards rather than the standards of your national competent authority.

The brands that ship through US customs without detentions tend to share one characteristic: they treated FDA compliance as a separate project from EU compliance, well before their first container shipped. The ones that assume regulatory harmonisation exists are the ones getting freight-forwarder emails about pallets sitting in warehouse bays in New Jersey — and scrambling to pull together ISO 17025 lab reports within a 15-working-day window they didn’t know was coming.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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Related from our network

• ISO 17025-Accredited Cosmetics and Supplement Testing for the US Market — Qalitex Laboratories provides FDA-recognised testing for heavy metals, microbial contamination, and colorant verification for European brands entering the US market.
• Health Canada Compliance for European Brands Entering Canada — Androxa helps European manufacturers navigate Canada’s cosmetics and NHP classification requirements before their first shipment crosses the border.