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: NUTRITIONAL_LABELINGFD&C Act Section 403(q)Severity Weight: 4/10
✓ Form FDA 766 Relabeling Eligible

Misbranded: Fails to bear required Nutrition Facts or Supplement Facts panel format

Statutory & CFR Citation: 21 U.S.C. § 343(q) • 21 CFR § 101.9 (Nutrition Facts) & § 101.36 (Supplement Facts) • Associated Import Alert 99-20 / Import Alert 99-39
Plain-English Importer Translation:

The product label uses foreign nutrition tables (e.g., EU/CN per-100g format) instead of mandatory US FDA per-serving Nutrition/Supplement Facts formatting.

Typical Port Detention Window
10–18 calendar days
Estimated Defense / Lab Cost
$1,800 – $3,900 (Form 766 filing + compliant label artwork)
Primary Import Alert Trigger
Import Alert 99-20 / Import Alert 99-39

Form FDA 766 Relabeling / Reconditioning Playbook

HIGHEST APPROVAL RATE (92%+): Purely technical misbranding under Section 403(q) (foreign per-100g panel, missing % Daily Value, wrong font weight/hairline rules, or non-English allergens) is the textbook use case for Form FDA 766 bonded sticker relabeling.

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

  1. 1Generate a 100% 21 CFR 101.9 or 101.36 compliant US Nutrition/Supplement Facts panel with mandatory calorie bolding, added sugars indentation, and 4-micronutrient declarations (Vitamin D, Calcium, Iron, Potassium).
  2. 2File Form FDA 766 (Application for Authorization to Relabel or Perform Other Action) within 10 business days of the Notice of Detention.
  3. 3Once FDA Division Compliance issues conditional approval, print tamper-evident pressure-sensitive over-stickers and apply them over the foreign panel in a CFS/bonded warehouse.
  4. 4Notify FDA via ITACS to schedule a visual verification inspection and receive the Notice of Release.

Private Lab Packet (PLAP) & Importer Checklist

Required Analytical / Regulatory Protocol:

AOAC proximate & micronutrient panel verification only if declared nutrient quantities are disputed.

Pre-Shipment & Post-Detention Verification Checklist:
  • Submit Form FDA 766 proposing custom sticker relabeling under bond before customs liquidation.
  • Update dielines to 21 CFR 101.9 (Nutrition Facts) font size and declaration standards.
Historical OASIS Enforcement Precedents

Overseas Suppliers Cited for NUTRITIONAL_LABELING (4)

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Charge Code NUTRITIONAL_LABELING FAQ

What does FDA Charge Code NUTRITIONAL_LABELING (FD&C Act Section 403(q)) mean on a Notice of FDA Action?

Misbranded: Fails to bear required Nutrition Facts or Supplement Facts panel format. In plain English: The product label uses foreign nutrition tables (e.g., EU/CN per-100g format) instead of mandatory US FDA per-serving Nutrition/Supplement Facts formatting.

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

HIGHEST APPROVAL RATE (92%+): Purely technical misbranding under Section 403(q) (foreign per-100g panel, missing % Daily Value, wrong font weight/hairline rules, or non-English allergens) is the textbook use case for Form FDA 766 bonded sticker relabeling. Final authorization always rests with the reviewing FDA District Import Compliance Office.