The FDA import refusal numbers for the first half of 2026 tell a sharper story than they have in years. Seafood remains the largest single refusal category — 138 entry-line refusals in February, 90 in March, 94 in May, driven heavily by antibiotic-contaminated shrimp. The Foreign Supplier Verification Program (FSVP) is being enforced as a functional, not paper, requirement. The Modernization of Cosmetics Regulation Act (MoCRA) is hitting its first biennial renewal deadline. And devices — even those that appear to fall into newly exempted 510(k) categories — are still being refused at the border when listings haven’t caught up to product codes.
If you are an importer of food, cosmetics, or medical devices coming through any U.S. port — including Florida’s PortMiami, Port Everglades, and Miami International Airport — this is the 2026 refusal landscape you need to be planning around.
FSVP enforcement has shifted to functional verification
Through 2024 and most of 2025, FDA’s FSVP inspections of importers found wide variation: some had robust programs, many had paper-only frameworks built from templates. Q1 2026 marks a clear pivot. FDA is now treating FSVP as a functional verification obligation — actual evidence that the importer is doing the verification work in 21 CFR 1.502(a), not just storing forms.
The escalation tools are now being used:
- Import Alert 99-41 — Detention Without Physical Examination (DWPE) for importers found out of FSVP compliance — was activated against multiple importers in early 2026.
- Warning Letters were issued to multiple importers in February 2026 for failure to develop FSVP programs at all — an escalation past the educational-outreach phase the agency had largely been in.
- Lookback risk. An importer flagged under FSVP now faces scrutiny on every prior entry into the same product line.
What “functional” looks like in practice: documented hazard analyses by supplier; supplier verification activities with frequency tied to risk; corrective actions when verification fails; and records that demonstrate the importer is the one doing the work, not the broker, not the supplier, not a generic third party.
MoCRA’s first biennial renewal — July 1, 2026
The Modernization of Cosmetics Regulation Act required cosmetics manufacturers and processors to register their facilities by July 1, 2024. The first biennial renewal — using Form FDA 5066 — is due July 1, 2026. Failing to renew means the facility is no longer registered, and product manufactured at an unregistered facility is subject to detention and refusal at import.
For Florida cosmetic importers — and Miami is one of the largest cosmetics import gateways in the Western Hemisphere — the action items are:
- Confirm every foreign manufacturing facility you import from has filed the biennial renewal.
- Confirm product listings for every product imported are current.
- Confirm Responsible Person designation and contact information is accurate in FDA records.
- If your supplier hasn’t renewed by mid-June, raise it formally and document the communication — that record matters if FDA inquires.
The 510(k) exemption expansion — and the trap inside it
On June 5, 2026, FDA expanded 510(k) exemptions by adding five new product codes: LDK, MVV, MQZ, MIG, and LXQ. For devices that fall within these codes, the regulatory pathway just got materially easier.
The trap: devices that look like they fall into these codes but are not listed under one of them are still refused at the border. The exemption applies to the code, not to the device name on your packing list. An importer who reads a news release and assumes a category is “now exempt” without verifying the device’s actual product code listing will see DWPE at the next entry.
Also unchanged: device facility registration and listing under 21 CFR 807 is still required even when 510(k) is exempt. Exemption from premarket clearance is not exemption from registration.
The 2026 Import Alert revisions you should know
- IA 66-40 — Drug Good Manufacturing Practice (revised May 20, 2026). Continues to catch foreign drug manufacturers with GMP deficiencies, including a number of API and finished-dose facilities serving the U.S. market.
- IA 66-41 — Unapproved Drugs (revised May 19, 2026). Increasingly used against products that straddle the cosmetic/drug line — particularly skincare with active pharmaceutical claims.
- IA 68-20 — Animal Drugs, with the addition of xylazine and medetomidine (March 4, 2026). Directly relevant for veterinary, equine, and certain compounding-import flows through Florida.
How Florida ports compare on refusal rates
FDA’s import refusal dashboard allows filtering by division and district, and Florida ports of entry (PortMiami, Port Everglades, MIA, Port of Tampa Bay, JAXPORT) historically show refusal patterns that track the import mix — heavier seafood and cosmetics share than national average, lighter device share. The most useful posture for an importer is to check your own line, not the average: pull your refusal history and your supplier-level history, and let that drive risk-based verification frequency.
Practical 2026 playbook for Florida importers
- Run an FSVP functional audit before FDA does. Pull your last 12 months of imports, sample 10% by supplier, and verify the hazard analyses and verification activities are real. Missing documentation now is much cheaper than DWPE later.
- Calendar the MoCRA July 1, 2026 deadline. If you import cosmetics, this is the single highest-leverage compliance task you have between now and August.
- Verify every 510(k) status against current FDA listings — not against press coverage. The June 5, 2026 expansion was real, but applies narrowly.
- Watch the seafood entry-line refusal numbers. Antibiotic contamination is the dominant theme. If you import shrimp, scallops, or finfish, supplier-level testing and farm-level certification have never been more important.
- Treat your broker as a partner, not a button. A broker who flags a 99-41 risk before the entry files is worth more than one who simply transmits paperwork.
Go-Freight customs brokerage in the 2026 enforcement environment
Go-Freight’s licensed customs brokerage team handles entries through Florida ports for food, cosmetics, devices, and a wide range of consumer and industrial imports. We integrate FDA Prior Notice, FSVP documentation, MoCRA verification, and device listing checks into the entry process — so the regulatory exposure surfaces before the container ships, not at the port. Contact us to put a more enforcement-ready brokerage process around your 2026 imports.