FDA INDUSTRY CODE 54 (Vitamins, Minerals & Unconventional Diets)5-Yr Detention Rate: 18.4%

Dietary Supplements, Nutraceuticals & Botanicals — FDA Port Detention & Violation Breakdown

Softgel, gummy, capsule, and functional powder manufacturers facing 21 CFR Part 111 cGMP audits, Supplement Facts panel misbranding holds, and disease-claim detentions.

2026 CBP ACE & FDA Division Compliance Enforcement Priority:Strict 21 CFR 101.36 Supplement Facts formatting checks and Foreign Supplier Verification Program (FSVP) audit requests for contract gummy and liposomal supplement factories.

5-Yr Refusals Tracked

1,890

Avg Container Hold

23 Days

Primary Entry Ports

Los Angeles, Newark, Miami

Audited Dossiers

2 Factories

Active DWPE Import Alerts in Dietary Supplements

Import Alert 54-16 (Dietary Supplements with Disease Claims)
Import Alert 99-41 (FSVP Foreign Supplier Verification Non-Compliance)
Import Alert 54-15 (Undeclared Active Pharmaceutical Ingredients)

Export Full Dietary Supplements Supplier Audit Sheet ($39)

Download the normalized 5-year Excel dataset with FEI/DUNS mappings and FSVP checklists.

Buy Cleaned 5-Yr Excel ($39 • Gumroad Instant Checkout)

Top Cited Statutory Charge Codes & Form FDA 766 Eligibility

NUTRITIONAL_LABELING • FD&C Act Section 403(q)Form FDA 766 Eligible

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

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.

Avg Defense Cost: $1,800 – $3,900 (Form 766 filing + compliant label artwork)Read NUTRITIONAL_LABELING Remediation Playbook →

UNAPPROVED_NEW_DRUG • FD&C Act Section 505(a)Form FDA 766 Eligible

Unapproved New Drug: Cosmetic or Supplement making therapeutic disease claims

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.

Avg Defense Cost: $3,200 – $7,800 (Form 766 application + website claim scrub)Read UNAPPROVED_NEW_DRUG Remediation Playbook →

INSANITARY_CONDITIONS • FD&C Act Section 402(a)(4) / 501(a)(2)(A)Lab Packet / Export Only

Adulterated: Prepared, packed, or held under insanitary conditions whereby it may have become contaminated

An FDA foreign inspection (Form FDA 483) or cGMP audit found systemic facility sanitation failures, non-sterile ophthalmic/OTC water systems, or pest harborage.

Avg Defense Cost: $8,500 – $22,000 (cGMP CAPA remediation & Import Alert petition)Read INSANITARY_CONDITIONS Remediation Playbook →

Audited Overseas Suppliers in Dietary Supplements, Nutraceuticals & Botanicals (2)

Xiamen, Fujian, ChinaFEI: 3017610293

Xiamen NutriGummy Biosciences Co., Ltd.

76/100

Major pectin functional gummy OEM (apple cider vinegar, ashwagandha, sea moss, and sleep gummies) supplying TikTok Shop and Amazon FBA brands. High detention frequency for 21 CFR 101.36 Supplement Facts panel formatting errors and disease claims on private-label jars.

3 Refusals1 Warning Letters0 RecallsLos Angeles

Red List — Import Alert 54-16 & 99-20 (Supplement Facts & Claims)Open Supplier Dossier

Milan, Lombardy, ItalyFEI: 3020192844

Milano Nutraceutica Liposomal S.r.l.

24/100

Premium European liquid liposomal glutathione and NAD+ sachet manufacturer. High cGMP manufacturing quality, but shipments arriving at Newark frequently get detained for retaining EU Directive 2002/46/EC 'NRV per 100mL' nutrition tables instead of US 21 CFR 101.36 Supplement Facts panels.

2 Refusals0 Warning Letters0 RecallsNewark

Yellow List — EU-to-US Nutrition Panel SurveillanceOpen Supplier Dossier

Dietary Supplements FDA Detention FAQ

What is the average FDA port detention rate and hold duration for Dietary Supplements?

Across 5-year CBP/FDA OASIS records, Dietary Supplements, Nutraceuticals & Botanicals (FDA Industry Code 54 (Vitamins, Minerals & Unconventional Diets)) experiences a 18.4% detention rate among flagged overseas shippers with an average port hold of 23 calendar days across Los Angeles, Newark, Miami.

What are the top FDA Charge Codes in Dietary Supplements?

The primary statutory charge codes for Dietary Supplements are NUTRITIONAL_LABELING, UNAPPROVED_NEW_DRUG, INSANITARY_CONDITIONS. Key active Import Alerts include Import Alert 54-16 (Dietary Supplements with Disease Claims); Import Alert 99-41 (FSVP Foreign Supplier Verification Non-Compliance); Import Alert 54-15 (Undeclared Active Pharmaceutical Ingredients). Historical refusal logs do not certify future admissibility.