24 Real FDA Import Mistakes — Case Studies

Real cases of shipments detained or refused at U.S. import — what went wrong, how long it took, what it cost, and how to prevent it.

• Kimchi — the Acidity Trap — Mistaking an FCE/SID Requirement
  Cause: FCE/SID not registered 3 weeks
• Instant Ramen — a Missed Allergen — Wheat Hidden Inside Soy Sauce Powder
  Cause: Allergen missed inside a compound ingredient 8 days
• Seaweed Snack — a Label Error — Sesame Oil, Sesame, and a Health Claim
  Cause: Missed allergen + Health Claim violation 11 days
• Black Garlic Concentrate — a Health Claim Violation — 'Immunity,' 'Antioxidant,' 'Relieves Fatigue'
  Cause: Unauthorized health claims Refusal of admission (12 days)
• Frozen Dumplings — No FSVP — Five Years of Trading Undone Within 24 Hours
  Cause: No FSVP documentation Recall + Import Alert
• Missing a Food Facility Registration Renewal — Every Even-Numbered Year, October–December
  Cause: FFR renewal missed All U.S.-bound cargo blocked
• Getting the U.S. Agent Wrong — It's Not Just a Name on a Form
  Cause: U.S. Agent poorly assigned / left unmanaged Ongoing Increased Scrutiny
• The Prior Notice Timing Trap — The Standard Is 'Confirm,' Not 'Submit'
  Cause: Prior Notice timing miscalculated 5–7 days detained
• An English Labeling Error — Compliance, Not Translation
  Cause: Failed to meet the 5 core labeling elements A week-long wait
• FSVP: the Rule Small Importers Don't Know Can Kill Them — Responsibility Sits With the Importer
  Cause: 4 common FSVP misconceptions Import Alert listing
• Not Checking the DWPE List — Import Alerts Are Public Information
  Cause: Import Alert not checked Automatic detention (5+ days)
• The Wrong First 24 Hours After an Import Alert Listing — The Wrong Response Is What Actually Ends It
  Cause: Mishandled the response after listing 6 months to permanent
• Red Ginseng Concentrate — a Structure/Function Claim Violation — Missing Disclaimer + Prohibited Wording
  Cause: Prohibited wording + missing disclaimer 3 months to re-export
• Probiotics — No NDI Notification — Mistaking a New Strain for an Old One
  Cause: NDI notification missed About 5 months to relaunch
• Collagen Drink — Classified as a Drug — The 'Skin Regeneration' Claim
  Cause: Drug-claim wording Refusal of admission + warning letter
• Omega-3 Capsules — a Supplement Facts Formatting Error — How EPA/DHA Content Should Be Displayed
  Cause: Supplement Facts format error 12 days
• Multivitamin — Missing SAE Contact on the Label — There Was No U.S. Contact
  Cause: U.S. contact missing from the label 7 days
• BB Cream — Classified as a Drug — One 'Skin Regeneration' Claim Was the Problem
  Cause: Drug-claim wording Refusal of admission
• SPF 50 Sunscreen — Failed the Drug/Cosmetic Dual Regulation — No Drug Facts Box
  Cause: OTC Monograph not followed 3 weeks
• Hair Treatment — No Facility Registration — Exported Without Knowing the MoCRA Obligation
  Cause: Facility registration missing 2 weeks
• Skincare Set — Delayed SAE Reporting — Missed the 15-Business-Day Window
  Cause: SAE reporting delayed Warning letter
• Lipstick — a Prohibited Ingredient — Lead Content Over the Limit
  Cause: Prohibited ingredient (heavy metal) present Forced recall
• Dietary Supplement Ingredient — Mistaking §1.511 for §1.502 — Applying Standard Food FSVP to a Supplement — a Structural Error
  Cause: §1.511 requirement missed FSVP remediation demanded
• Canned Tuna — Building FSVP for a Product That Didn't Need It — Missed the §1.501 Exemption — Wasted Time, Wrong Direction
  Cause: Exemption rule not checked 3 months (redo)