2026 CBP ACE & FDA OASIS Enforcement Update: MoCRA Cosmetic FEI & QMSR Device 510(k) Affirmation of Compliance cross-checks are active at Los Angeles, Newark, Miami & Savannah ports.
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CHARGE CODE: UNSAFE_COLORFD&C Act Section 601(e) / 402(c)Severity Weight: 6/10
✕ Form FDA 766 Relabeling Ineligible

Adulterated: Bears or contains an unsafe or uncertified color additive

Statutory & CFR Citation: 21 U.S.C. § 361(e) / § 342(c) • 21 CFR Parts 73, 74, and 82 • Associated Import Alert 53-06 / Import Alert 45-02
Plain-English Importer Translation:

The cosmetic or food item contains a dye/pigment either banned in the US or lacking an FDA batch certification number (e.g., FD&C Red No. 40 without batch cert).

Typical Port Detention Window
15–25 calendar days
Estimated Defense / Lab Cost
$2,800 – $6,500
Primary Import Alert Trigger
Import Alert 53-06 / Import Alert 45-02

Form FDA 766 Relabeling / Reconditioning Playbook

NOT ELIGIBLE if the pigment itself is uncertified or prohibited in the US (e.g., non-batch-certified FD&C lakes or banned eye-area coal-tar dyes). Eligible for Form 766 ONLY if the product actually used an FDA batch-certified lot (with a valid Lot Number) and merely misstated the INCI name on the label.

Step-by-Step CBP & FDA ITACS Response Sequence:

  1. 1Verify whether the overseas factory used an FDA Batch-Certified color additive lot (obtain the 2-letter/4-digit FDA Color Certification Lot Number, e.g., 'AH1234').
  2. 2If a valid FDA Color Certification Lot exists and matches batch manufacturing records, submit those records as testimony to overcome the appearance of adulteration.
  3. 3If the factory used domestic Chinese/EU industrial dye without FDA batch certification, order an HPLC color additive identification lab packet or arrange immediate export.
  4. 4Replace uncertified synthetic lakes with 21 CFR Part 73 certification-exempt mineral pigments (iron oxides, mica, titanium dioxide) for future SKUs.

Private Lab Packet (PLAP) & Importer Checklist

Required Analytical / Regulatory Protocol:

FDA LIB 4326 / HPLC-DAD synthetic color additive identification and subsidiary dye purity profiling.

Pre-Shipment & Post-Detention Verification Checklist:
  • Request FDA Color Additive Lot Certification numbers from the raw pigment supplier.
  • Cross-check eye-area cosmetics against 21 CFR Part 73/74 restricted color lists.
Historical OASIS Enforcement Precedents

Overseas Suppliers Cited for UNSAFE_COLOR (2)

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  • 21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab
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Charge Code UNSAFE_COLOR FAQ

What does FDA Charge Code UNSAFE_COLOR (FD&C Act Section 601(e) / 402(c)) mean on a Notice of FDA Action?

Adulterated: Bears or contains an unsafe or uncertified color additive. In plain English: The cosmetic or food item contains a dye/pigment either banned in the US or lacking an FDA batch certification number (e.g., FD&C Red No. 40 without batch cert).

Can a shipment detained for UNSAFE_COLOR be released via Form FDA 766 relabeling?

NOT ELIGIBLE if the pigment itself is uncertified or prohibited in the US (e.g., non-batch-certified FD&C lakes or banned eye-area coal-tar dyes). Eligible for Form 766 ONLY if the product actually used an FDA batch-certified lot (with a valid Lot Number) and merely misstated the INCI name on the label. Final authorization always rests with the reviewing FDA District Import Compliance Office.