FDA Registration for Ghanaian Exporters
We handle all FDA filings for Ghanaian food, cosmetics, and consumer goods companies.
What do Ghanaian businesses need to do to enter the US market?
Ghana is one of West Africa's most dynamic export economies, known for cocoa, shea butter, processed foods, herbal products, and natural cosmetics. Companies from Accra, Kumasi, and Tamale are actively seeking to expand their exports to the United States.
To export food products to the United States, your production facility must be registered with the FDA, you must designate a US Agent, and you need a DUNS number. For cosmetics and personal care products, the 2023 MoCRA law requires facility registration and product listing.
We help businesses from Accra, Kumasi, Tamale, and throughout Ghana complete the entire process online — no need to travel to any office.
Services for Ghanaian exporters
FAQ for Ghanaian exporters
Is FDA registration required to export food from Ghana to the US?+
Yes. Any company exporting food products to the United States must register their facility with the FDA before the first shipment.
What is a US Agent and why is it required?+
A US Agent is your company's official representative in the United States. FDA requires one for all registered facilities outside the US.
How long does FDA registration take?+
Most registrations are completed within 3–5 business days after we receive your documents.
Do Ghanaian shea butter and cocoa exporters need FDA registration?+
Yes. Shea butter, cocoa products, and processed foods exported to the US must comply with FDA requirements, including food facility registration.
Articles for Ghanaian exporters
FDA Registration Guide for Food and Cocoa Manufacturers in Accra and Kumasi
Food and consumer goods producers from Accra, Kumasi, and Tamale are expanding exports to the United States. This guide covers the FDA Food Facility Registration process and documentation needed before your first shipment.
Exporting Ghanaian Shea Butter and Natural Cosmetics to the USA: MoCRA and FDA Registration
The MoCRA law requires all foreign cosmetics brands to register facilities and products with the FDA before selling in the US market. Here is what manufacturers in Accra and Kumasi need to know.
What Is a DUNS Number and Why Food Exporters Need One Before FDA Registration
The DUNS number is a 9-digit identifier required by FDA before food facility registration. A complete guide for Ghanaian exporters.
How a Foreign Company Can Export Food to the United States: FDA Requirements for Ghanaian Exporters
Complete guide for Ghanaian food manufacturers seeking entry to the US market: FDA facility registration, DUNS number, US Agent and Prior Notice.
What Is OMUFA and What It Means for Ghanaian OTC Drug Manufacturers
OMUFA imposes mandatory annual fees on foreign OTC drug manufacturers. Guide for Ghanaian companies selling OTC products in the United States.
FDA Drug Establishment Registration: What Ghanaian Manufacturers Must File
For Ghanaian companies exporting drugs to the US: FDA drug facility registration via DRLS, annual renewal and US Agent requirement.
What Is an NDC Number and How Ghanaian Drug Manufacturers Obtain One
The National Drug Code (NDC) is a mandatory identifier for every drug product sold in the US. Guide to Labeler Code and NDC for Ghanaian manufacturers.
FDA Drug Labeling Requirements: What Ghanaian Manufacturers Must Include
FDA regulations determine drug labeling requirements in the US. Key labeling requirements for Ghanaian manufacturers exporting to the United States.
Medical Device Labeling Symbols: What Ghanaian Manufacturers Must Know
US medical device labeling uses standard symbols. Guide to FDA symbol standards for Ghanaian medical device manufacturers.
FDA Registration Numbers Explained for Ghanaian Exporters: FEI and DUNS
For Ghanaian food and drug exporters: explanation of FEI and DUNS numbers encountered in the FDA registration process.
FDA Inspections of Registered Ghanaian Facilities
FDA has authority to inspect foreign food and drug facilities. What Ghanaian manufacturers need to know about FDA inspections.
US Cosmetic Labeling in 2026: MoCRA Requirements for Ghanaian Brands
MoCRA introduced new mandatory labeling elements for Ghanaian brands exporting cosmetics to the US. Guide to 2026 requirements.
FDA Food Facility Registration Step by Step: Ghanaian Exporters
All steps of FDA facility registration for Ghanaian food exporters: from obtaining DUNS to completing registration in FFRPS.
Why FDA Rejects Food Facility Registrations: Ghanaian Applicants
Common reasons for FDA food facility registration rejection and how Ghanaian companies can avoid them.
What Is a UFI Number and How It Affects Ghanaian FDA Registration
The EU UFI number requirement and what it means for Ghanaian manufacturers exporting to both the US and Europe.
Documents to Prepare Before FDA Food Registration: Ghanaian Manufacturers
List of essential documents Ghanaian food manufacturers should gather before starting FDA facility registration.
FDA Export Certificates: When Ghanaian Manufacturers Need Them
What FDA export certificates are, when Ghanaian manufacturers should request them, and how to obtain them from FDA.
Medical Device Registration for Ghanaian Manufacturers
Complete guide to FDA 510(k), PMA and De Novo pathways for Ghanaian medical device manufacturers exporting to the US.
FSMA Preventive Controls: What Ghanaian Food Manufacturers Need
How FDA's preventive controls rule under FSMA affects Ghanaian food exporters and the mandatory Food Safety Plan requirement.
REACH Compliance for Ghanaian Exporters to Europe
REACH are EU chemical regulations affecting Ghanaian manufacturers that export chemicals or cosmetics to the EU.
DUNS Number FAQ for Ghanaian Food Exporters
The most common questions Ghanaian food exporters have about the DUNS number and clear answers.
What Is an FEI Number and Why It Matters to Ghanaian Exporters
FDA Establishment Identifier (FEI) is the permanent code assigned after registration. Guide to using and tracking FEI for Ghanaian exporters.
FSMA Non-Compliance: Consequences and Recovery for Ghanaian Food Facilities
FSMA compliance is not a one-time event. Ghanaian facilities that let their registration lapse or fail to meet FSMA requirements face serious consequences.
Managing FDA Registrations Across Food, Cosmetics, and Drug Products for Ghanaian Companies
Ghanaian companies exporting multiple categories to the US face overlapping FDA registration obligations.
FDA Registration for Ghanaian Egg and Egg Product Manufacturers
The registration obligation extends beyond shell eggs to liquid, frozen, dried eggs and dozens of derivatives.
Why Every Ghanaian Company Exporting to the US Needs a DUNS Number
The DUNS number is a prerequisite for FDA food facility registration and is required in many US government processes.
FDA Food Facility Registration: First-Time Registrant Questions from Ghana
First-time registrants from Ghana have practical questions about who must register and what the process involves.
Exporting Food and Products to the US in 2025: A Guide for Ghanaian Exporters
The US is the world's largest single import market. What Ghanaian exporters need to know about the US import process in 2025.
CPNP: What the Acronym Means and What the EU Cosmetic Notification Process Involves
CPNP stands for Cosmetics Products Notification Portal — the EU's mandatory pre-market notification system for cosmetic products. What Ghanaian exporters need to know.
DUNS Number FAQ for Ghanaian Food and Cosmetics Exporters
Answers to the most common questions Ghanaian exporters ask about the DUNS number before starting their FDA registration.
How Ghanaian Businesses Obtain a DUNS Number for FDA Registration
Step-by-step process for Ghanaian cocoa, food, and cosmetics exporters to get a DUNS number before submitting FDA food facility registration.
How FDA's 2018 Guidance Clarified Food Facility Registration for Ghanaian Exporters
FDA issued guidance in 2018 that clarified which facilities must register and which farms are exempt. What this means for Ghanaian cocoa, food, and natural product exporters.
MoCRA Cosmetics Guide: What FDA Now Requires from Foreign Manufacturers
MoCRA made FDA facility registration and product listing mandatory for all cosmetics. Here is what exporters need to know about adverse events, safety substantiation, GMP, and enforcement.
FDA UFI/DUNS Enforcement: Why Your Registration Could Be Cancelled
FDA now actively verifies DUNS numbers and cancels registrations that do not match. Importers are checking too. Here is what you need to know.
FDA Food Facility Renewal 2026: Prepare Now to Avoid Export Disruption
All FDA food facility registrations must be renewed between October and December 2026. Early preparation prevents last-minute problems.
Why You Need a Unified FDA Compliance Partner Instead of Multiple Agencies
Splitting FDA compliance across multiple agencies creates gaps. A single compliance partner reduces risk and builds importer confidence.
FDA Registration Is Not Enough: What Else You Need for the US Market
Many exporters think FDA registration is all they need. In reality, it is only the first step in a multi-layered compliance process.
FDA Renewal Deadlines and Penalties: 47,635 Facilities Removed in 2019
In 2019, FDA cancelled 47,635 food facility registrations for missing the renewal deadline. Expired registration means blocked exports.
Import Alert 99-32 Explained: Detention Without Physical Examination
Import Alert 99-32 allows FDA to detain shipments without inspection. Understanding how it works can save your business.
Who Is FDABridge?
Learn about FDABridge — a US-based company in Miami helping exporters navigate FDA registration with local-language service and affordable pricing.
Why Thousands of Exporters Choose FDABridge
Everything under one roof, native-language phone support, transparent pricing, and a 100% registration success rate.
FDABridge vs Other FDA Registration Services
An honest comparison of pricing, service scope, and support quality between FDABridge and competitors.
The FDABridge Mission
FDABridge philosophy: every manufacturer deserves US market access. Regulatory barriers should not block good products.
FDA Prior Notice and Import Compliance: What Ghanaian Exporters Must Know
Every food shipment to the USA requires an FDA Prior Notice filing. Here is what Ghanaian exporters of cocoa, shea butter, and cashew nuts need to know.
FDA Biennial Registration Renewal: What Ghanaian Manufacturers Need to Know
FDA facility registrations must be renewed regularly. Missing it means your products cannot legally enter the United States.
FDA Food Contact Substance Notification: What Foreign Packaging Manufacturers Must Know: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering food contact substances, FCN under 21 CFR 170-199, packaging migration testing.
Seafood HACCP for Foreign Exporters: FDA Requirements Under 21 CFR Part 123: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering seafood HACCP, critical control points, monitoring records, histamine and parasites.
FDA Allergen Labeling: The Nine Major Allergens and What the FASTER Act Changed: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering allergen labeling, FALCPA, FASTER Act, sesame, Contains statement, cross-contact.
Exporting Canned Food to the United States: FCE, SID, and Thermal Process Filing Requirements: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering canned food, FCE number, SID filing, 21 CFR 113, 21 CFR 114, commercial sterility.
FDA Nutrition Facts Panel: Format Requirements Foreign Manufacturers Get Wrong: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering Nutrition Facts panel, 21 CFR 101.9, serving size, RACC, added sugars, format rules.
Food Safety Modernization Act Explained: How FSMA Changed US Food Imports Forever: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering FSMA, preventive controls, produce safety, FSVP, accredited third-party certification.
FDA Voluntary Qualified Importer Program: How VQIP Speeds Up US Customs Clearance: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering VQIP, expedited entry, third-party certification, FSMA Section 302.
Exporting Dairy Products to the United States: FDA Requirements and Common Pitfalls: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering dairy exports, PMO, Grade A, 60-day aging rule, 21 CFR Parts 131-135.
FDA Food Facility Registration for Contract Manufacturers: Who Registers When Multiple Parties Are Involved: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering contract manufacturers, facility registration, co-packers, FSVP implications.
Sanitary Transportation of Human Food: What the FSMA Rule Means for Foreign Exporters: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering sanitary transportation, 21 CFR Part 1 Subpart O, cold chain, records.
FDA Juice HACCP Requirements: What Foreign Juice Manufacturers Must File Before Exporting to the US: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering juice HACCP, 5-log reduction, pasteurization, 21 CFR 120.
Exporting Spices and Seasonings to the United States: FDA Requirements and Import Risks: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering spices, salmonella contamination, aflatoxin, import alerts, Defect Action Levels.
FDA Infant Formula Registration: Why Foreign Manufacturers Face the Strictest US Import Requirements: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering infant formula, premarket notification, 21 CFR 106, 21 CFR 107, nutrient levels.
What Is the Foreign Supplier Verification Program and How It Affects Your Exports to the US: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering FSVP, importer hazard analysis, on-site audits, supplier evaluation.
FDA Food Additive Petition Process: How Foreign Manufacturers Get New Ingredients Approved for the US Market: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering food additives, FAP, GRAS, 21 CFR 171, Threshold of Regulation.
Exporting Confectionery and Chocolate to the United States: FDA Standards of Identity and Labeling Rules: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering confectionery, chocolate standards, 21 CFR 163, vegetable fats, color additives.
FDA Third-Party Certification Program: How Accredited Audits Expedite US Food Imports: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering third-party certification, FSMA Section 808, accreditation bodies.
Exporting Tea and Coffee to the United States: FDA Requirements Foreign Producers Overlook: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering tea, coffee, pesticide residues, ochratoxin A, organic certification.
FDA Preventive Controls Qualified Individual: What Foreign Food Facilities Must Know About PCQI Training: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering PCQI, Preventive Controls Qualified Individual, FSPCA training, food safety plans.
Exporting Frozen and Refrigerated Foods to the United States: Cold Chain and FDA Compliance: Guide for Ghana Exporters
Food manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering frozen foods, cold chain, refrigerated foods, temperature monitoring, reefer containers.
MoCRA Adverse Event Reporting: What Foreign Cosmetic Brands Must Track and Report to the FDA: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering MoCRA adverse events, 15-day reporting, serious adverse events, 6-year records.
Cosmetic vs Drug: How the FDA Classifies Products and Why It Matters for Foreign Manufacturers: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering cosmetic vs drug, intended use, drug claims, OTC monograph, cosmeceutical.
FDA Cosmetic Ingredient Review: How the CIR Panel Evaluates Safety and What It Means for Your Products: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering CIR, Cosmetic Ingredient Review, ingredient safety, safety substantiation.
Exporting Skincare Products to the United States: MoCRA, Labeling, and Ingredient Restrictions: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering skincare export, MoCRA, labeling, ingredient restrictions, SPF as OTC drug.
Hair Care Product Compliance for the US Market: FDA Requirements Foreign Manufacturers Must Meet: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering hair care, anti-dandruff shampoo as drug, coal tar, keratin treatments.
Color Additives in Cosmetics: FDA Certification Requirements Foreign Manufacturers Must Understand: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering color additives, 21 CFR Parts 73-82, batch certification, D&C colors, FD&C colors.
Fragrance and Perfume Export to the United States: What the FDA Requires and What It Does Not: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering fragrance, perfume, MoCRA listing, IFRA, ingredient disclosure, allergen rules.
MoCRA Small Business Exemption: Who Qualifies, Who Does Not, and What the Exceptions Cover: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering MoCRA small business exemption, $1M threshold, eye products, mucous membrane.
Nail Products and the FDA: Registration, Listing, and Safety Requirements for Foreign Manufacturers: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering nail products, MMA, formaldehyde, drug claims, color additives in nail polish.
Organic and Natural Claims on Cosmetics in the US Market: What Foreign Brands Can and Cannot Say: Guide for Ghana Exporters
Cosmetics manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering organic claims, natural claims, USDA NOP, FTC Green Guides, clean beauty.
OTC Drug Registration for Foreign Manufacturers: What the FDA Requires Before You Can Sell in the US: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering OTC drug registration, monograph system, NDC, Drug Facts, 21 CFR 201.66.
FDA Drug Listing: How Foreign Manufacturers Submit Product Information Under 21 CFR Part 207: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering drug listing, 21 CFR 207, SPL format, eDRLS, NDC directory.
FDA Current Good Manufacturing Practice for Drugs: What 21 CFR Parts 210 and 211 Require: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering drug CGMP, 21 CFR 210, 21 CFR 211, quality control, batch records.
Exporting Homeopathic Products to the United States: FDA Registration and Compliance Requirements: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering homeopathic drugs, HPUS, CPG 400.400, Drug Facts panel, potency labeling.
FDA OTC Monograph Reform: What the CARES Act Changed for Foreign Drug Manufacturers: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering OTC monograph reform, CARES Act, OMSIRA, administrative orders, OMUFA.
Drug Master Files: What Foreign API Manufacturers Must Know About DMF Submissions to the FDA: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering Drug Master Files, Type II DMF, API manufacturers, eCTD format.
FDA Drug Establishment Inspection: What Foreign Manufacturers Should Expect During a GMP Audit: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering drug inspections, Form 483, PAI, surveillance, VAI, OAI, corrective actions.
Exporting Hand Sanitizers and Antiseptic Products to the US: Why They Are OTC Drugs, Not Cosmetics: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering hand sanitizers, OTC drug, ethanol, antiseptic monograph, Drug Facts.
Prescription Drug User Fee Act and Foreign Manufacturers: What PDUFA Fees Mean for Market Entry: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering PDUFA fees, GDUFA, establishment fees, application fees, user fees.
FDA Drug Labeling: OTC Drug Facts Panel vs Prescription Drug Labeling Requirements: Guide for Ghana Exporters
Drug manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering drug labeling, Drug Facts, PLR format, Highlights of Prescribing Information.
How US Customs and Border Protection Works With the FDA to Screen Imported Products: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering CBP, FDA, ACE system, PREDICT, import screening, risk scoring.
FDA Warning Letters to Foreign Facilities: What They Mean and How to Respond: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering Warning Letters, Form 483, 15-day response, import alerts, public database.
Understanding the FDA PREDICT Risk Screening System: How Import Decisions Are Made: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering PREDICT system, risk scoring, compliance history, examination triggers.
FDA Recall Process: What Foreign Manufacturers Must Know When a Product Must Be Removed from the US Market: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering recalls, Class I, Class II, Class III, voluntary, mandatory, FSMA Section 206.
Tariffs and FDA Compliance: How US Trade Policy Affects Foreign Manufacturers Exporting to America: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering tariffs, HTS codes, Section 301, FTAs, customs duties, country of origin.
FDA Registration Scams: How to Identify Fraudulent FDA Registration Services and Protect Your Business: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering scams, fake certificates, inflated fees, FDA approval claims, verification.
What Happens at a US Port When Your FDA-Regulated Product Arrives: The Import Process Explained: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering port process, entry filing, Prior Notice, examination, detention, release.
FDA Establishment Identifier: The Transition from DUNS to FEI and What It Means for Foreign Facilities: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering DUNS, FEI, UFI, facility identifiers, Dun & Bradstreet, registration.
How to Export Cosmetics, Food, and Drugs to the US Simultaneously: Multi-Category FDA Compliance: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering multi-category, food + cosmetics + drugs, separate registrations, labeling.
Country of Origin Labeling for FDA-Regulated Products: What Foreign Manufacturers Must Mark on Every Package: Guide for Ghana Exporters
Product manufacturers in Accra, Kumasi must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering country of origin, 19 CFR 134, substantial transformation, marking, CBP.
FDA Stories #001 — A Sicilian Olive Oil Label Was 8 Days from Being Refused at the US Border
The facility had been exporting shrimp to the US for six years. Then a container was detained in Los Angeles. The FDA registration had lapsed — and no one told them.
FDA Stories #002 — A Vietnamese Seafood Factory Lost Its Registration and Didn't Know for 14 Months
The SPF 15 claim on their bestselling moisturizer meant it was not a cosmetic in the United States. It was an over-the-counter drug. They had no drug registration.
FDA Stories #003 — A Turkish Cosmetics Brand Discovered Their Moisturizer Was an Unregistered Drug
The DUNS record said one name. The FDA registration said another. The export certificate said a third. Every shipment was a ticking clock.
FDA Stories #004 — A Brazilian Coffee Exporter's DUNS Number Had the Wrong Company Name for Two Years
The certificate looked official. It had an FDA logo, a registration number, and a gold seal. It was completely fake.
FDA Stories #005 — A Pakistani Rice Mill Paid $2,400 for an FDA Registration That Did Not Exist
The FDA called the US Agent number on file. No answer. No callback. The facility was flagged. The shipment was held. All because of a phone that no one picked up.
FDA Stories #006 — An Indian Spice Exporter Was Detained Because the US Agent Phone Went to Voicemail
The FDA food facility registration was done. The label was ready. Then we asked one question: is your hot sauce acidified? The answer changed everything.
FDA Stories #007 — A Mexican Hot Sauce Maker Needed an FCE Number They Had Never Heard Of
Twenty-two cosmetic products were registered under MoCRA without issue. The twenty-third contained a color additive that is legal in Korea but banned in the United States.
FDA Stories #008 — A Korean Beauty Brand Listed 22 Products With the FDA. Product #23 Almost Sank Them.
The drug establishment registration was active. The product was listed. Then the annual fee invoice went unpaid for 60 days. The FDA put a hold on everything.
FDA Stories #009 — A German Pharmaceutical Company Forgot to Pay Their GDUFA Fee. Registration Suspended.
The facility was registered. The labels were compliant. But nobody filed Prior Notice for any of the 12 shipments. All 12 could have been refused.
FDA Stories #010 — A Thai Coconut Milk Producer Shipped 12 Containers Without Prior Notice
The words 'FDA Approved' appeared on the company's English-language website. The FDA does not approve food products or facilities. Those two words almost cost them the US market.
FDA Stories #011 — A Colombian Coffee Brand Put 'FDA Approved' on Their Website. The FDA Noticed.
The same bottle of argan oil was being marketed as a cooking oil on one website and a hair treatment on another. The FDA sees those as two completely different products.
FDA Stories #012 — A Moroccan Argan Oil Exporter Had to Choose: Cosmetic or Food. They Were Selling Both.
The dietary supplement contained a botanical ingredient widely used in Traditional Chinese Medicine. In the United States, it was an unapproved New Dietary Ingredient. The entire shipment was refused.
FDA Stories #013 — A Chinese Supplement Factory's Ingredient Was Legal in China but Banned by the FDA
The pierogis contained wheat, eggs, and milk. The label listed the ingredients. But there was no allergen declaration. Not 'Contains.' Not parenthetical. Nothing.
FDA Stories #014 — A Polish Frozen Pierogi Manufacturer Had No Allergen Declaration. At All.
The product was manufactured in India, shipped to Dubai for repackaging, and exported to the US labeled 'Product of UAE.' That is not how country of origin works.
FDA Stories #015 — A UAE Re-Exporter Learned That 'Made in UAE' Was the Wrong Country of Origin
The Prior Notice listed an FDA registration number that belonged to a different facility in a different city. Every shipment filed with that number was technically invalid.
FDA Stories #016 — An Egyptian Dates Exporter's Prior Notice Had the Wrong FDA Registration Number
The product claimed to 'boost energy and support immune function.' Those are structure/function claims. The product needed a Supplement Facts panel, not a Nutrition Facts panel.
FDA Stories #017 — A Japanese Matcha Company Was Selling a Dietary Supplement With a Food Label
The processing facility was registered. The warehouse where finished product was stored before export was not. The warehouse needed its own registration.
FDA Stories #018 — A Nigerian Shea Butter Producer Had Two Facilities But Only One Registration
They launched in Saks and Nordstrom. Twelve fragrances. Zero FDA registrations. MoCRA had been in effect for over a year. Nobody in their compliance team knew.
FDA Stories #019 — A French Perfume House Discovered MoCRA Applied to Them — After Their US Launch
The wine labels were printed. 30,000 bottles. Then the importer told them: US wine labeling is regulated by the TTB, not the FDA — and their labels did not comply with either.
FDA Stories #020 — An Argentinian Winery Spent $11,000 on Labels Before Discovering the US Requires a Different Format Entirely
The wine labels were printed. 30,000 bottles. Then the importer told them: US wine labeling is regulated by the TTB, not the FDA — and their labels did not comply with either.
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