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: UNAPPROVED_NEW_DRUGFD&C Act Section 505(a)Severity Weight: 7/10
✓ Form FDA 766 Relabeling Eligible

Unapproved New Drug: Cosmetic or Supplement making therapeutic disease claims

Statutory & CFR Citation: 21 U.S.C. § 355(a) • 21 U.S.C. § 321(g)(1) (Intended Use Doctrine) • Associated Import Alert 66-41 / Import Alert 54-16
Plain-English Importer Translation:

The product (often a skincare serum, device, or dietary supplement) uses medical or disease-cure claims on its packaging or website without an approved NDA/ANDA.

Typical Port Detention Window
14–28 calendar days
Estimated Defense / Lab Cost
$3,200 – $7,800 (Form 766 application + website claim scrub)
Primary Import Alert Trigger
Import Alert 66-41 / Import Alert 54-16

Form FDA 766 Relabeling / Reconditioning Playbook

CONDITIONAL ELIGIBILITY: FDA Division Compliance may approve Form FDA 766 physical relabeling ONLY if the active ingredients are cosmetic/DSHEA-compliant and the importer simultaneously scrubs all disease claims from the brand's website and social media.

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

  1. 1Conduct a 100% digital & physical Intended Use audit: inspect outer cartons, inner leaflets, QR code landing pages, and Amazon/Shopify meta descriptions.
  2. 2Prepare revised structure/function or cosmetic appearance dielines removing disease endpoints ('treats eczema', 'reverses alopecia', 'lowers blood glucose').
  3. 3File Form FDA 766 within 10 business days of detention, attaching before/after packaging artwork, bonded warehouse address, and proof of website URL remediation.
  4. 4Schedule FDA Inspector supervision for destruction of removed violative cartons and submit Form FDA 766 completion certificate to release the customs bond.

Private Lab Packet (PLAP) & Importer Checklist

Required Analytical / Regulatory Protocol:

Not a laboratory test violation unless undeclared API (Import Alert 54-15) is suspected; requires regulatory legal brief & compliant artwork submission.

Pre-Shipment & Post-Detention Verification Checklist:
  • Audit all product box copy, package inserts, and linked Shopify/Amazon URLs for therapeutic verbs ('cures', 'treats inflammation', 'heals acne').
  • File an FDA Relabeling Application (Form FDA 766) if the violation is purely on physical packaging.
  • Verify active ingredients against OTC Monograph compliance requirements.
Historical OASIS Enforcement Precedents

Overseas Suppliers Cited for UNAPPROVED_NEW_DRUG (6)

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

What does FDA Charge Code UNAPPROVED_NEW_DRUG (FD&C Act Section 505(a)) mean on a Notice of FDA Action?

Unapproved New Drug: Cosmetic or Supplement making therapeutic disease claims. In plain English: The product (often a skincare serum, device, or dietary supplement) uses medical or disease-cure claims on its packaging or website without an approved NDA/ANDA.

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

CONDITIONAL ELIGIBILITY: FDA Division Compliance may approve Form FDA 766 physical relabeling ONLY if the active ingredients are cosmetic/DSHEA-compliant and the importer simultaneously scrubs all disease claims from the brand's website and social media. Final authorization always rests with the reviewing FDA District Import Compliance Office.