Articles for exporters dealing with FDA paperwork

FDA Stories #020 — An Argentinian Winery Spent $11,000 on Labels Before Discovering the US Requires a Different Format Entirely

FDA Stories #020 — An Argentinian Winery Spent $11,000 on Labels Before Discovering the US Requires a Different Format Entirely

Jul 29, 2026

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 Food Contact Substance Notification: What Foreign Packaging Manufacturers Must Know

FDA Food Contact Substance Notification: What Foreign Packaging Manufacturers Must Know

Jul 28, 2026

Foreign packaging manufacturers must file a Food Contact Notification with the FDA before their materials can legally contact food sold in the United States.

Seafood HACCP for Foreign Exporters: FDA Requirements Under 21 CFR Part 123

Seafood HACCP for Foreign Exporters: FDA Requirements Under 21 CFR Part 123

Jul 27, 2026

Foreign seafood processors must implement a HACCP plan compliant with 21 CFR Part 123 before exporting fish and fishery products to the United States.

FDA Allergen Labeling: The Nine Major Allergens and What the FASTER Act Changed

FDA Allergen Labeling: The Nine Major Allergens and What the FASTER Act Changed

Jul 26, 2026

US food allergen labeling now covers nine major allergens after the FASTER Act added sesame in 2023 — here is what foreign food manufacturers must include on every label.

FDA Stories #019 — A French Perfume House Discovered MoCRA Applied to Them — After Their US Launch

FDA Stories #019 — A French Perfume House Discovered MoCRA Applied to Them — After Their US Launch

Jul 26, 2026

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.

Exporting Canned Food to the United States: FCE, SID, and Thermal Process Filing Requirements

Exporting Canned Food to the United States: FCE, SID, and Thermal Process Filing Requirements

Jul 25, 2026

Foreign canned food manufacturers must obtain FCE registration and file Scheduled Processes with the FDA before any thermally processed product can enter the US market.

FDA Nutrition Facts Panel: Format Requirements Foreign Manufacturers Get Wrong

FDA Nutrition Facts Panel: Format Requirements Foreign Manufacturers Get Wrong

Jul 24, 2026

The US Nutrition Facts panel has specific format rules that differ from every other country — here are the requirements foreign food manufacturers most frequently violate.

Food Safety Modernization Act Explained: How FSMA Changed US Food Imports Forever

Food Safety Modernization Act Explained: How FSMA Changed US Food Imports Forever

Jul 23, 2026

FSMA shifted US food safety from reactive enforcement to proactive prevention — here is how each of its seven major rules affects foreign food manufacturers.

FDA Voluntary Qualified Importer Program: How VQIP Speeds Up US Customs Clearance

FDA Voluntary Qualified Importer Program: How VQIP Speeds Up US Customs Clearance

Jul 22, 2026

The FDA's Voluntary Qualified Importer Program offers expedited entry for food imports from facilities with strong compliance records — here is how to qualify.

FDA Stories #018 — A Nigerian Shea Butter Producer Had Two Facilities But Only One Registration

FDA Stories #018 — A Nigerian Shea Butter Producer Had Two Facilities But Only One Registration

Jul 22, 2026

The processing facility was registered. The warehouse where finished product was stored before export was not. The warehouse needed its own registration.

Exporting Dairy Products to the United States: FDA Requirements and Common Pitfalls

Exporting Dairy Products to the United States: FDA Requirements and Common Pitfalls

Jul 21, 2026

Foreign dairy manufacturers face layered US regulatory requirements including FDA registration, Grade A standards, and specific labeling rules that differ from most export markets.

FDA Food Facility Registration for Contract Manufacturers: Who Registers When Multiple Parties Are Involved

FDA Food Facility Registration for Contract Manufacturers: Who Registers When Multiple Parties Are Involved

Jul 20, 2026

When a brand owner contracts with a third-party manufacturer, both parties may need FDA food facility registration — here is how the rules apply to each arrangement.

Sanitary Transportation of Human Food: What the FSMA Rule Means for Foreign Exporters

Sanitary Transportation of Human Food: What the FSMA Rule Means for Foreign Exporters

Jul 19, 2026

The FSMA Sanitary Transportation Rule establishes requirements for vehicles, temperature controls, and records that affect how food reaches US ports from foreign origins.

FDA Juice HACCP Requirements: What Foreign Juice Manufacturers Must File Before Exporting to the US

FDA Juice HACCP Requirements: What Foreign Juice Manufacturers Must File Before Exporting to the US

Jul 18, 2026

Foreign juice processors must implement HACCP plans under 21 CFR Part 120 with a validated 5-log pathogen reduction step before any juice product can enter the United States.

FDA Stories #017 — A Japanese Matcha Company Was Selling a Dietary Supplement With a Food Label

FDA Stories #017 — A Japanese Matcha Company Was Selling a Dietary Supplement With a Food Label

Jul 18, 2026

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 Prior Notice for Imported Food: What Foreign Exporters Must File Before Every Shipment

FDA Prior Notice for Imported Food: What Foreign Exporters Must File Before Every Shipment

Jul 17, 2026

Every food shipment entering the United States requires an FDA Prior Notice filing. Here is what foreign exporters need to know about timelines, required data, and common filing mistakes.

Exporting Spices and Seasonings to the United States: FDA Requirements and Import Risks

Exporting Spices and Seasonings to the United States: FDA Requirements and Import Risks

Jul 17, 2026

Spices face some of the highest FDA refusal rates due to salmonella contamination, aflatoxin levels, and filth — here is what foreign spice exporters must prepare for.

MoCRA Good Manufacturing Practices for Cosmetics: What Foreign Manufacturers Should Prepare For

MoCRA Good Manufacturing Practices for Cosmetics: What Foreign Manufacturers Should Prepare For

Jul 16, 2026

FDA is expected to finalize GMP rules for cosmetics under MoCRA. Here is what foreign cosmetic manufacturers should know about the upcoming requirements and how to prepare now.

FDA Infant Formula Registration: Why Foreign Manufacturers Face the Strictest US Import Requirements

FDA Infant Formula Registration: Why Foreign Manufacturers Face the Strictest US Import Requirements

Jul 16, 2026

Infant formula faces the most demanding FDA requirements of any food category — including premarket notification, mandatory nutrient levels, and strict quality control under 21 CFR Parts 106 and 107.

FDA Drug Establishment Registration for Foreign Manufacturers: New 2026 Proposed Rule Explained

FDA Drug Establishment Registration for Foreign Manufacturers: New 2026 Proposed Rule Explained

Jul 15, 2026

The FDA proposed new drug establishment registration rules in July 2026 that would require more foreign manufacturers to register. Here is what the proposed rule means for foreign API and OTC drug producers.

What Is the Foreign Supplier Verification Program and How It Affects Your Exports to the US

What Is the Foreign Supplier Verification Program and How It Affects Your Exports to the US

Jul 15, 2026

FSVP requires US importers to verify that every foreign food supplier meets US safety standards — and foreign manufacturers must provide the documentation to make that verification possible.

FDA Import Detention and Refusal: Why Shipments Get Held and How to Prevent It

FDA Import Detention and Refusal: Why Shipments Get Held and How to Prevent It

Jul 14, 2026

FDA import detentions cost foreign food exporters thousands in port fees, re-export costs, and lost buyers. Here are the most common causes and how to avoid them.

FDA Food Additive Petition Process: How Foreign Manufacturers Get New Ingredients Approved for the US Market

FDA Food Additive Petition Process: How Foreign Manufacturers Get New Ingredients Approved for the US Market

Jul 14, 2026

Foreign food manufacturers who use ingredients not yet authorized in the US must file a Food Additive Petition or GRAS notification before those ingredients can legally appear in US food products.

FDA Stories #016 — An Egyptian Dates Exporter's Prior Notice Had the Wrong FDA Registration Number

FDA Stories #016 — An Egyptian Dates Exporter's Prior Notice Had the Wrong FDA Registration Number

Jul 14, 2026

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.

Exporting Dietary Supplements to the United States: FDA Requirements for Foreign Manufacturers

Exporting Dietary Supplements to the United States: FDA Requirements for Foreign Manufacturers

Jul 13, 2026

Dietary supplements sold in the US must meet FDA facility registration, GMP, labeling, and ingredient requirements. Here is what foreign manufacturers need to know before entering the market.

Exporting Confectionery and Chocolate to the United States: FDA Standards of Identity and Labeling Rules

Exporting Confectionery and Chocolate to the United States: FDA Standards of Identity and Labeling Rules

Jul 13, 2026

US chocolate and confectionery products must meet specific FDA standards of identity under 21 CFR Part 163 — and many foreign products do not qualify to use standard names.

FDA Biennial Registration Renewal: Deadlines, Process, and What Happens If You Miss It

FDA Biennial Registration Renewal: Deadlines, Process, and What Happens If You Miss It

Jul 12, 2026

FDA facility registrations must be renewed every two years. Missing the renewal window means your products cannot legally enter the United States. Here is how the renewal process works.

FDA Third-Party Certification Program: How Accredited Audits Expedite US Food Imports

FDA Third-Party Certification Program: How Accredited Audits Expedite US Food Imports

Jul 12, 2026

FDA's Accredited Third-Party Certification Program under FSMA allows certified foreign facilities to qualify for expedited import entry through VQIP and mandatory certification pathways.

FDA Food Labeling Requirements for Foreign Exporters: A Complete Compliance Guide

FDA Food Labeling Requirements for Foreign Exporters: A Complete Compliance Guide

Jul 11, 2026

US food labels must meet strict FDA requirements for Nutrition Facts, ingredients, allergens, and claims. Here is what foreign exporters need to get right before shipping to America.

Exporting Tea and Coffee to the United States: FDA Requirements Foreign Producers Overlook

Exporting Tea and Coffee to the United States: FDA Requirements Foreign Producers Overlook

Jul 11, 2026

Tea and coffee imports face FDA requirements for facility registration, pesticide tolerances, labeling, and contaminant limits that many foreign producers overlook until shipments are detained.

Cosmetic Product Listing Under MoCRA: How to List Your Products With the FDA

Cosmetic Product Listing Under MoCRA: How to List Your Products With the FDA

Jul 10, 2026

MoCRA requires cosmetic product listing with the FDA in addition to facility registration. Here is what foreign brands need to include and how the listing process works.

FDA Preventive Controls Qualified Individual: What Foreign Food Facilities Must Know About PCQI Training

FDA Preventive Controls Qualified Individual: What Foreign Food Facilities Must Know About PCQI Training

Jul 10, 2026

Every food facility subject to FSMA Preventive Controls must have a trained Preventive Controls Qualified Individual overseeing its food safety plan — here is what the requirement means for foreign manufacturers.

FDA Stories #015 — A UAE Re-Exporter Learned That 'Made in UAE' Was the Wrong Country of Origin

FDA Stories #015 — A UAE Re-Exporter Learned That 'Made in UAE' Was the Wrong Country of Origin

Jul 10, 2026

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.

What Is an FDA US Agent and Why Every Foreign Facility Needs One

What Is an FDA US Agent and Why Every Foreign Facility Needs One

Jul 9, 2026

An FDA US Agent is a mandatory requirement for every foreign food, cosmetic, and drug facility registered with the FDA. Here is what a US Agent does and what happens when you choose the wrong one.

Exporting Frozen and Refrigerated Foods to the United States: Cold Chain and FDA Compliance

Exporting Frozen and Refrigerated Foods to the United States: Cold Chain and FDA Compliance

Jul 9, 2026

Frozen and refrigerated food exports to the US must maintain documented cold chain integrity from production through delivery — here are the FDA requirements that govern temperature-controlled imports.

How to Choose an FDA Registration Service: Red Flags, Questions to Ask, and What Good Service Looks Like

How to Choose an FDA Registration Service: Red Flags, Questions to Ask, and What Good Service Looks Like

Jul 8, 2026

The FDA registration services market is full of overpriced middlemen and outright scams. Here is how to evaluate providers, spot red flags, and choose a service that actually delivers.

MoCRA Adverse Event Reporting: What Foreign Cosmetic Brands Must Track and Report to the FDA

MoCRA Adverse Event Reporting: What Foreign Cosmetic Brands Must Track and Report to the FDA

Jul 8, 2026

MoCRA requires cosmetic companies to report serious adverse events to the FDA within 15 business days and maintain records of all adverse events for six years.

Cosmetic vs Drug: How the FDA Classifies Products and Why It Matters for Foreign Manufacturers

Cosmetic vs Drug: How the FDA Classifies Products and Why It Matters for Foreign Manufacturers

Jul 7, 2026

A product's claims — not its ingredients — determine whether the FDA classifies it as a cosmetic, a drug, or both, and the wrong classification can block your US market entry entirely.

FDA Cosmetic Ingredient Review: How the CIR Panel Evaluates Safety and What It Means for Your Products

FDA Cosmetic Ingredient Review: How the CIR Panel Evaluates Safety and What It Means for Your Products

Jul 6, 2026

The Cosmetic Ingredient Review is an industry-funded expert panel that evaluates cosmetic ingredient safety — understanding CIR findings helps foreign brands build defensible safety substantiation files.

Exporting Skincare Products to the United States: MoCRA, Labeling, and Ingredient Restrictions

Exporting Skincare Products to the United States: MoCRA, Labeling, and Ingredient Restrictions

Jul 5, 2026

Foreign skincare brands must navigate MoCRA registration, US-specific labeling rules, and ingredient restrictions that differ significantly from EU and Asian regulatory frameworks.

FDA Stories #014 — A Polish Frozen Pierogi Manufacturer Had No Allergen Declaration. At All.

FDA Stories #014 — A Polish Frozen Pierogi Manufacturer Had No Allergen Declaration. At All.

Jul 5, 2026

The pierogis contained wheat, eggs, and milk. The label listed the ingredients. But there was no allergen declaration. Not 'Contains.' Not parenthetical. Nothing.

Hair Care Product Compliance for the US Market: FDA Requirements Foreign Manufacturers Must Meet

Hair Care Product Compliance for the US Market: FDA Requirements Foreign Manufacturers Must Meet

Jul 4, 2026

Foreign hair care manufacturers must navigate MoCRA registration, ingredient restrictions, and the critical distinction between cosmetic hair products and OTC drug products.

Who Is FDABridge? The Miami-Based FDA Compliance Company Built for Foreign Manufacturers

Who Is FDABridge? The Miami-Based FDA Compliance Company Built for Foreign Manufacturers

Jul 3, 2026

FDABridge is a US-based FDA compliance company headquartered in Miami, Florida. We handle FDA facility registration, DUNS numbers, US Agent services, food labeling, MoCRA cosmetic filings, and drug establishment registration for foreign manufacturers in over 80 countries.

Color Additives in Cosmetics: FDA Certification Requirements Foreign Manufacturers Must Understand

Color Additives in Cosmetics: FDA Certification Requirements Foreign Manufacturers Must Understand

Jul 3, 2026

Every color additive used in US cosmetics must be either FDA-certified or exempt from certification — and many colors approved in Europe and Asia are not authorized in the United States.

Why Thousands of Exporters Choose FDABridge Over Every Other FDA Compliance Provider

Why Thousands of Exporters Choose FDABridge Over Every Other FDA Compliance Provider

Jul 2, 2026

FDABridge serves manufacturers in over 80 countries with FDA registration, DUNS numbers, US Agent services, and label compliance. Here is why thousands of exporters choose us over traditional compliance providers, brokers, and DIY approaches.

Fragrance and Perfume Export to the United States: What the FDA Requires and What It Does Not

Fragrance and Perfume Export to the United States: What the FDA Requires and What It Does Not

Jul 2, 2026

The FDA regulates fragrances as cosmetic products under MoCRA but does not require premarket approval or individual fragrance ingredient disclosure — here is what foreign perfume brands must know.

Missed Your FDA Registration Renewal? Here Is What Happens and How to Recover

Missed Your FDA Registration Renewal? Here Is What Happens and How to Recover

Jul 1, 2026

In 2019 alone, the FDA removed 47,635 food facility registrations for failure to renew. An expired registration shuts down US market access instantly. Understanding the consequences — and the recovery path — is essential for every foreign manufacturer.

MoCRA Small Business Exemption: Who Qualifies, Who Does Not, and What the Exceptions Cover

MoCRA Small Business Exemption: Who Qualifies, Who Does Not, and What the Exceptions Cover

Jul 1, 2026

MoCRA exempts cosmetic businesses with under $1 million in average gross annual US sales from facility registration and product listing — but the exemption has important exceptions that catch many small brands.

Import Alert 99-32: What Happens When You Refuse an FDA Inspection

Import Alert 99-32: What Happens When You Refuse an FDA Inspection

Jun 30, 2026

Refusing or obstructing an FDA inspection triggers Import Alert 99-32 — Detention Without Physical Examination. Your products are automatically detained at every US port until you demonstrate corrective action. Here is how the process works and how to get off the Red List.

Nail Products and the FDA: Registration, Listing, and Safety Requirements for Foreign Manufacturers

Nail Products and the FDA: Registration, Listing, and Safety Requirements for Foreign Manufacturers

Jun 30, 2026

Nail polishes, gel systems, acrylics, and nail treatments are cosmetics under FDA regulation — but certain products and claims can trigger drug classification.

FDA Stories #013 — A Chinese Supplement Factory's Ingredient Was Legal in China but Banned by the FDA

FDA Stories #013 — A Chinese Supplement Factory's Ingredient Was Legal in China but Banned by the FDA

Jun 30, 2026

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.

FDABridge vs Other FDA Registration Services: An Honest Comparison for Foreign Manufacturers

FDABridge vs Other FDA Registration Services: An Honest Comparison for Foreign Manufacturers

Jun 29, 2026

How does FDABridge compare to other FDA registration providers, customs brokers, and DIY approaches? This honest comparison covers pricing, service scope, language support, response times, expertise depth, and long-term compliance support.

Organic and Natural Claims on Cosmetics in the US Market: What Foreign Brands Can and Cannot Say

Organic and Natural Claims on Cosmetics in the US Market: What Foreign Brands Can and Cannot Say

Jun 29, 2026

The FDA does not define 'natural' for cosmetics, and 'organic' claims are governed by the USDA — foreign cosmetic brands must navigate multiple agencies and no single standard.

Why a Single FDA Compliance Partner Outperforms Fragmented Vendor Relationships

Why a Single FDA Compliance Partner Outperforms Fragmented Vendor Relationships

Jun 28, 2026

Foreign food manufacturers often cobble together compliance from multiple vendors — one for registration, another for labels, a third for FSVP. This fragmented approach creates blind spots, delays, and unnecessary cost. A unified compliance partner eliminates those risks.

OTC Drug Registration for Foreign Manufacturers: What the FDA Requires Before You Can Sell in the US

OTC Drug Registration for Foreign Manufacturers: What the FDA Requires Before You Can Sell in the US

Jun 28, 2026

Foreign manufacturers of over-the-counter drugs must register their establishment, obtain an NDC Labeler Code, list each product, and comply with the applicable OTC monograph before selling in the United States.

FDA Drug Listing: How Foreign Manufacturers Submit Product Information Under 21 CFR Part 207

FDA Drug Listing: How Foreign Manufacturers Submit Product Information Under 21 CFR Part 207

Jun 27, 2026

Every drug product sold in the United States must be listed with the FDA using the SPL electronic format — here is how foreign manufacturers navigate the drug listing process.

The FDABridge Mission: Why We Believe Every Manufacturer in the World Deserves Access to the US Market

The FDABridge Mission: Why We Believe Every Manufacturer in the World Deserves Access to the US Market

Jun 26, 2026

FDABridge was founded on a simple conviction: regulatory barriers should not prevent good products from reaching American consumers. Here is the philosophy behind our pricing, our service model, and our commitment to making global trade accessible.

FDA Current Good Manufacturing Practice for Drugs: What 21 CFR Parts 210 and 211 Require

FDA Current Good Manufacturing Practice for Drugs: What 21 CFR Parts 210 and 211 Require

Jun 26, 2026

Foreign drug manufacturers must comply with FDA's CGMP regulations under 21 CFR Parts 210 and 211 — covering facility design, equipment, production controls, testing, and recordkeeping.

FDA Food Facility Registration Renewal 2026: Prepare Now or Lose Market Access

FDA Food Facility Registration Renewal 2026: Prepare Now or Lose Market Access

Jun 25, 2026

The 2026 biennial renewal window opens October 1 and closes December 31. Facilities that miss the deadline will have their registrations expire, blocking all US imports. Here is what you need to know and do before the window opens.

Exporting Homeopathic Products to the United States: FDA Registration and Compliance Requirements

Exporting Homeopathic Products to the United States: FDA Registration and Compliance Requirements

Jun 25, 2026

Homeopathic drugs are regulated as drugs under the FD&C Act and require FDA establishment registration, NDC listing, and compliance with homeopathic manufacturing and labeling standards.

FDA Stories #012 — A Moroccan Argan Oil Exporter Had to Choose: Cosmetic or Food. They Were Selling Both.

FDA Stories #012 — A Moroccan Argan Oil Exporter Had to Choose: Cosmetic or Food. They Were Selling Both.

Jun 25, 2026

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 OTC Monograph Reform: What the CARES Act Changed for Foreign Drug Manufacturers

FDA OTC Monograph Reform: What the CARES Act Changed for Foreign Drug Manufacturers

Jun 24, 2026

The CARES Act of 2020 overhauled the OTC drug monograph system, replacing decades-old rulemaking with administrative orders and introducing user fees that affect every foreign OTC manufacturer.

Drug Master Files: What Foreign API Manufacturers Must Know About DMF Submissions to the FDA

Drug Master Files: What Foreign API Manufacturers Must Know About DMF Submissions to the FDA

Jun 23, 2026

Drug Master Files allow foreign API manufacturers to share confidential manufacturing and quality information with the FDA without disclosing it to their customers — here is how DMFs work.

FDA UFI Enforcement: Why Your DUNS Number Can Make or Break Your US Market Access

FDA UFI Enforcement: Why Your DUNS Number Can Make or Break Your US Market Access

Jun 22, 2026

The FDA now actively verifies Unique Facility Identifiers during food facility registration. Facilities with missing, invalid, or unverifiable DUNS numbers face registration cancellation and loss of US market access.

FDA Drug Establishment Inspection: What Foreign Manufacturers Should Expect During a GMP Audit

FDA Drug Establishment Inspection: What Foreign Manufacturers Should Expect During a GMP Audit

Jun 22, 2026

FDA inspections of foreign drug facilities examine every aspect of CGMP compliance — here is what happens before, during, and after an FDA investigator arrives at your manufacturing site.

FDA Registration Is Not Certification: The Compliance Layers You Actually Need

FDA Registration Is Not Certification: The Compliance Layers You Actually Need

Jun 21, 2026

Many foreign manufacturers believe FDA registration means they are approved to export to the United States. It does not. Registration is a directory listing, not a seal of approval. Real compliance requires multiple layers that most exporters overlook.

Exporting Hand Sanitizers and Antiseptic Products to the US: Why They Are OTC Drugs, Not Cosmetics

Exporting Hand Sanitizers and Antiseptic Products to the US: Why They Are OTC Drugs, Not Cosmetics

Jun 21, 2026

Hand sanitizers, antiseptic washes, and antibacterial soaps are regulated as OTC drugs in the United States — not as cosmetics — and require drug establishment registration, NDC listing, and monograph compliance.

Prescription Drug User Fee Act and Foreign Manufacturers: What PDUFA Fees Mean for Market Entry

Prescription Drug User Fee Act and Foreign Manufacturers: What PDUFA Fees Mean for Market Entry

Jun 20, 2026

PDUFA establishes annual establishment fees and application fees that every foreign drug manufacturer must pay to maintain FDA registration and submit drug applications.

FDA Stories #011 — A Colombian Coffee Brand Put 'FDA Approved' on Their Website. The FDA Noticed.

FDA Stories #011 — A Colombian Coffee Brand Put 'FDA Approved' on Their Website. The FDA Noticed.

Jun 20, 2026

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.

MoCRA Explained: What Foreign Cosmetic Exporters Must Know Before Shipping to the US

MoCRA Explained: What Foreign Cosmetic Exporters Must Know Before Shipping to the US

Jun 19, 2026

The Modernization of Cosmetics Regulation Act rewrites the rules for every cosmetic product entering the United States. Facility registration, product listing, adverse event reporting, and safety substantiation are now federal law — not optional best practices.

FDA Drug Labeling: OTC Drug Facts Panel vs Prescription Drug Labeling Requirements

FDA Drug Labeling: OTC Drug Facts Panel vs Prescription Drug Labeling Requirements

Jun 19, 2026

OTC drugs require a Drug Facts panel under 21 CFR 201.66 while prescription drugs follow the Physician Labeling Rule — foreign manufacturers must apply the correct format for their product classification.

What Happens When a Foreign Food Facility Falls Out of FSMA Compliance

What Happens When a Foreign Food Facility Falls Out of FSMA Compliance

Jun 18, 2026

FSMA compliance is not a one-time event. Foreign food facilities that let their registration lapse or fail FSMA requirements face escalating consequences. Here is what the process looks like and how to recover.

How US Customs and Border Protection Works With the FDA to Screen Imported Products

How US Customs and Border Protection Works With the FDA to Screen Imported Products

Jun 18, 2026

CBP and FDA share an integrated import screening system that evaluates every shipment of food, drugs, cosmetics, and devices before it can enter the United States.

Managing FDA Registrations Across Food, Cosmetics, and Drug Products in One Company

Managing FDA Registrations Across Food, Cosmetics, and Drug Products in One Company

Jun 17, 2026

Companies that export more than one product category to the US face overlapping FDA registration obligations. Here is how to build a unified compliance approach that reduces duplication and prevents gaps.

FDA Warning Letters to Foreign Facilities: What They Mean and How to Respond

FDA Warning Letters to Foreign Facilities: What They Mean and How to Respond

Jun 17, 2026

An FDA Warning Letter is a formal notice of significant regulatory violations — foreign facilities must respond within 15 business days with specific corrective actions or face escalating enforcement.

FDA Registration for Egg and Egg Product Manufacturers: What the Full Product Range Covers

FDA Registration for Egg and Egg Product Manufacturers: What the Full Product Range Covers

Jun 16, 2026

Shell eggs are the most visible category, but the FDA registration requirement for egg products extends to liquid eggs, dried eggs, egg dishes, and dozens of egg-derived products. Here is the full scope.

Understanding the FDA PREDICT Risk Screening System: How Import Decisions Are Made

Understanding the FDA PREDICT Risk Screening System: How Import Decisions Are Made

Jun 16, 2026

FDA's PREDICT system assigns risk scores to every import entry using algorithms that weigh manufacturer history, product type, and country of origin — here is how it works.

CPNP: What the Acronym Means and What the Notification Process Actually Involves

CPNP: What the Acronym Means and What the Notification Process Actually Involves

Jun 15, 2026

CPNP stands for Cosmetic Products Notification Portal. It is the EU system for notifying cosmetic products before they go on sale in Europe. Here is what the notification process requires in practice.

FDA Recall Process: What Foreign Manufacturers Must Know When a Product Must Be Removed from the US Market

FDA Recall Process: What Foreign Manufacturers Must Know When a Product Must Be Removed from the US Market

Jun 15, 2026

FDA recalls can be voluntary or mandatory — foreign manufacturers must understand the recall classification system, their obligations, and how to work with US importers during a product withdrawal.

FDA Stories #010 — A Thai Coconut Milk Producer Shipped 12 Containers Without Prior Notice

FDA Stories #010 — A Thai Coconut Milk Producer Shipped 12 Containers Without Prior Notice

Jun 15, 2026

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.

DUNS Number for FDA Registration: The Questions Manufacturers Ask Most

DUNS Number for FDA Registration: The Questions Manufacturers Ask Most

Jun 14, 2026

A DUNS number is a prerequisite for FDA food facility registration. These are the most common questions from foreign manufacturers who need to obtain one before they can register.

Tariffs and FDA Compliance: How US Trade Policy Affects Foreign Manufacturers Exporting to America

Tariffs and FDA Compliance: How US Trade Policy Affects Foreign Manufacturers Exporting to America

Jun 14, 2026

FDA compliance and customs duties are separate obligations — but tariff classification, trade agreements, and Section 301 tariffs all interact with FDA-regulated imports in ways foreign manufacturers must understand.

Why Every Foreign Business Exporting to the US Needs a DUNS Number

Why Every Foreign Business Exporting to the US Needs a DUNS Number

Jun 13, 2026

A DUNS number is required for FDA food facility registration and appears across many US government and business processes. Here is what it is, why it exists, and why obtaining one is simpler than most manufacturers expect.

FDA Registration Scams: How to Identify Fraudulent FDA Registration Services and Protect Your Business

FDA Registration Scams: How to Identify Fraudulent FDA Registration Services and Protect Your Business

Jun 13, 2026

The FDA registration services market is rife with scams targeting foreign manufacturers — here is how to recognize fraudulent providers, fake certificates, and inflated government fee claims.

How Companies in the UAE and GCC Obtain a DUNS Number Before FDA Registration

How Companies in the UAE and GCC Obtain a DUNS Number Before FDA Registration

Jun 12, 2026

UAE and Gulf-region manufacturers exporting food or cosmetics to the United States need a DUNS number before they can complete FDA registration. Here is how the process works from the GCC.

What Happens at a US Port When Your FDA-Regulated Product Arrives: The Import Process Explained

What Happens at a US Port When Your FDA-Regulated Product Arrives: The Import Process Explained

Jun 12, 2026

From vessel arrival to FDA release, here is what happens to your food, drug, cosmetic, or device shipment at a US port — and what can go wrong at each step.

FDA Food Facility Registration: The Questions First-Time Registrants Ask Before Filing

FDA Food Facility Registration: The Questions First-Time Registrants Ask Before Filing

Jun 11, 2026

First-time FDA food facility registrants have common questions about who must register, what the process involves, and what happens after registration. Here are direct answers.

FDA Establishment Identifier: The Transition from DUNS to FEI and What It Means for Foreign Facilities

FDA Establishment Identifier: The Transition from DUNS to FEI and What It Means for Foreign Facilities

Jun 11, 2026

The FDA uses multiple facility identifiers — DUNS numbers, FEI numbers, and UFI — and understanding how they interact is essential for maintaining accurate registrations.

How FDA's 2018 Guidance on Food Facility Registration Clarified the Farm Exemption

How FDA's 2018 Guidance on Food Facility Registration Clarified the Farm Exemption

Jun 10, 2026

In 2018, FDA released a final guidance document answering questions about who must register under FSMA. The guidance clarified the farm exemption, mixed-type facilities, and retail food establishments — with lasting practical implications.

How to Export Cosmetics, Food, and Drugs to the US Simultaneously: Multi-Category FDA Compliance

How to Export Cosmetics, Food, and Drugs to the US Simultaneously: Multi-Category FDA Compliance

Jun 10, 2026

Companies that manufacture food, cosmetics, and drugs face separate FDA registration requirements for each category — here is how to manage multi-category compliance without gaps or duplication.

FDA Stories #009 — A German Pharmaceutical Company Forgot to Pay Their GDUFA Fee. Registration Suspended.

FDA Stories #009 — A German Pharmaceutical Company Forgot to Pay Their GDUFA Fee. Registration Suspended.

Jun 10, 2026

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.

Exporting Food and Consumer Products to the United States in 2025: What Foreign Manufacturers Must Know

Exporting Food and Consumer Products to the United States in 2025: What Foreign Manufacturers Must Know

Jun 9, 2026

The US is the world's largest single-country import market. For foreign manufacturers, entering it means dealing with FDA, CBP, and a set of documentation requirements that apply before the first shipment arrives.

Country of Origin Labeling for FDA-Regulated Products: What Foreign Manufacturers Must Mark on Every Package

Country of Origin Labeling for FDA-Regulated Products: What Foreign Manufacturers Must Mark on Every Package

Jun 9, 2026

US customs law requires every imported product to bear the English name of its country of origin — and the requirements are stricter and more specific than most foreign manufacturers realize.

FDA Stories #008 — A Korean Beauty Brand Listed 22 Products With the FDA. Product #23 Almost Sank Them.

FDA Stories #008 — A Korean Beauty Brand Listed 22 Products With the FDA. Product #23 Almost Sank Them.

Jun 4, 2026

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 #007 — A Mexican Hot Sauce Maker Needed an FCE Number They Had Never Heard Of

FDA Stories #007 — A Mexican Hot Sauce Maker Needed an FCE Number They Had Never Heard Of

May 28, 2026

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.

Ten Questions to Ask Before Hiring an FDA Consultant

Ten Questions to Ask Before Hiring an FDA Consultant

May 24, 2026

Choosing an FDA compliance service provider is a consequential decision. These ten questions help foreign manufacturers separate capable consultants from those who will create problems they cannot fix.

The FDA Logo and the 'FDA Approved' Claim: What Foreign Manufacturers Must Know Before Labeling

The FDA Logo and the 'FDA Approved' Claim: What Foreign Manufacturers Must Know Before Labeling

May 23, 2026

The FDA has no official logo for product labels, and 'FDA Approved' is a false claim for most products. Foreign manufacturers who use either risk import refusals and enforcement action.

Low-Acid and Acidified Canned Foods: FDA FCE and SID Registration Requirements

Low-Acid and Acidified Canned Foods: FDA FCE and SID Registration Requirements

May 22, 2026

Low-acid and acidified canned food producers must complete FCE and SID filings with the FDA before any shipment enters the United States. Here is what those filings require and why a process authority is non-negotiable.

FDA Stories #006 — An Indian Spice Exporter Was Detained Because the US Agent Phone Went to Voicemail

FDA Stories #006 — An Indian Spice Exporter Was Detained Because the US Agent Phone Went to Voicemail

May 22, 2026

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 Unannounced Inspections of Foreign Facilities: What FSMA Changed and How to Prepare

FDA Unannounced Inspections of Foreign Facilities: What FSMA Changed and How to Prepare

May 21, 2026

FSMA gave the FDA authority to inspect foreign food facilities without prior notice and to deny US market access to facilities that refuse. Here is how unannounced inspections work and what foreign facilities must have ready.

FSVP Gap Analysis: What Foreign Food Suppliers Must Document Before US Importers Come Checking

FSVP Gap Analysis: What Foreign Food Suppliers Must Document Before US Importers Come Checking

May 20, 2026

The Foreign Supplier Verification Program places compliance verification obligations on US importers — but the evidence comes from foreign manufacturers. Here is what a gap analysis reveals and what to fix first.

FDA Import Alert: What It Is, How Facilities Get Listed, and the Path to Removal

FDA Import Alert: What It Is, How Facilities Get Listed, and the Path to Removal

May 19, 2026

The FDA Import Alert places foreign facilities under automatic shipment detention, blocking every future shipment without individual examination. Here is how facilities get listed and what removal actually requires.

There Is No Such Thing as a REACH Certificate: What ECHA Registration Actually Produces

There Is No Such Thing as a REACH Certificate: What ECHA Registration Actually Produces

May 18, 2026

Buyers routinely ask foreign exporters for a REACH certificate. No such document exists. Here is what REACH registration actually produces and what evidence foreign exporters should provide instead.

SPF Products in the United States: Why Sunscreens Are Regulated as OTC Drugs, Not Cosmetics

SPF Products in the United States: Why Sunscreens Are Regulated as OTC Drugs, Not Cosmetics

May 17, 2026

Sunscreens and SPF products are classified as OTC drugs in the US, not cosmetics. Foreign manufacturers who treat them as cosmetics will face import refusals and registration violations.

REACH Substance Registration: Tonnage Bands, Data Requirements, and What Each Level Costs to Achieve

REACH Substance Registration: Tonnage Bands, Data Requirements, and What Each Level Costs to Achieve

May 16, 2026

REACH registration data requirements scale with annual tonnage. Here is what each of the four tonnage bands requires and what that means for foreign manufacturers entering the EU market.

FDA Stories #005 — A Pakistani Rice Mill Paid $2,400 for an FDA Registration That Did Not Exist

FDA Stories #005 — A Pakistani Rice Mill Paid $2,400 for an FDA Registration That Did Not Exist

May 16, 2026

The certificate looked official. It had an FDA logo, a registration number, and a gold seal. It was completely fake.

How a Foreign Company Can Export Food to the United States: The FDA Requirements

How a Foreign Company Can Export Food to the United States: The FDA Requirements

May 15, 2026

Exporting food to the US requires FDA facility registration, a DUNS number, a US Agent, Prior Notice, and compliant labeling. Here is how each piece fits together.

What Is OMUFA and What It Means for Foreign OTC Drug Manufacturers

What Is OMUFA and What It Means for Foreign OTC Drug Manufacturers

May 12, 2026

OMUFA created mandatory user fees for OTC monograph drug manufacturers. Foreign facilities that make OTC drugs for the US market pay these fees as part of their FDA obligations.

FDA Stories #004 — A Brazilian Coffee Exporter's DUNS Number Had the Wrong Company Name for Two Years

FDA Stories #004 — A Brazilian Coffee Exporter's DUNS Number Had the Wrong Company Name for Two Years

May 9, 2026

The DUNS record said one name. The FDA registration said another. The export certificate said a third. Every shipment was a ticking clock.

FDA Drug Establishment Registration: What Foreign Manufacturers Must File

FDA Drug Establishment Registration: What Foreign Manufacturers Must File

May 8, 2026

Foreign drug manufacturers must register their establishments with the FDA before distributing drugs in the US. Here is who must register, what is required, and how the annual cycle works.

What Is an NDC Number and How Foreign Drug Manufacturers Obtain One

What Is an NDC Number and How Foreign Drug Manufacturers Obtain One

May 5, 2026

The NDC number is a required identifier for every drug product sold in the US. Foreign manufacturers must obtain one through the FDA drug listing process before their products can be shipped.

FDA Drug Labeling Requirements: What Foreign Manufacturers Must Include on US Packaging

FDA Drug Labeling Requirements: What Foreign Manufacturers Must Include on US Packaging

May 2, 2026

FDA drug labeling requirements specify exactly what must appear on US drug packaging — from the Drug Facts panel to allergen declarations. Foreign manufacturers must meet every requirement before the first shipment.

FDA Stories #003 — A Turkish Cosmetics Brand Discovered Their Moisturizer Was an Unregistered Drug

FDA Stories #003 — A Turkish Cosmetics Brand Discovered Their Moisturizer Was an Unregistered Drug

May 2, 2026

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.

Medical Device Labeling Symbols: What Foreign Manufacturers Must Know for US Market Entry

Medical Device Labeling Symbols: What Foreign Manufacturers Must Know for US Market Entry

Apr 28, 2026

Medical device labeling in the US requires specific symbols for proper communication. Foreign manufacturers must understand FDA-accepted symbol standards before exporting devices to the American market.

FDA Registration Numbers Explained: FEI, DUNS, and How the FDA Identifies Foreign Facilities

FDA Registration Numbers Explained: FEI, DUNS, and How the FDA Identifies Foreign Facilities

Apr 24, 2026

The FDA uses multiple identification numbers for foreign food and drug facilities — FEI, DUNS, and others. Understanding what each number means and how they relate is essential for foreign exporters.

FDA Stories #002 — A Vietnamese Seafood Factory Lost Its Registration and Didn't Know for 14 Months

FDA Stories #002 — A Vietnamese Seafood Factory Lost Its Registration and Didn't Know for 14 Months

Apr 24, 2026

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 Inspections of Foreign Registered Facilities: What to Expect and How to Prepare

FDA Inspections of Foreign Registered Facilities: What to Expect and How to Prepare

Apr 20, 2026

The FDA has authority to inspect foreign food and drug facilities. Understanding how inspections are triggered, what inspectors look for, and what the outcomes mean helps foreign manufacturers stay prepared.

US Cosmetic Labeling in 2026: MoCRA Requirements for the Principal Display Panel

US Cosmetic Labeling in 2026: MoCRA Requirements for the Principal Display Panel

Apr 17, 2026

MoCRA introduced new mandatory labeling elements for cosmetics sold in the United States. Foreign cosmetic brands must update their US labels before the 2026 compliance dates take effect.

FDA Stories #001 — A Sicilian Olive Oil Label Was 8 Days from Being Refused at the US Border

FDA Stories #001 — A Sicilian Olive Oil Label Was 8 Days from Being Refused at the US Border

Apr 16, 2026

Three generations of olive growing. Award-winning oil. A beautiful label. And three federal labeling violations hiding in plain sight.

FDA Food Facility Registration Step by Step: A Process Guide for Foreign Manufacturers

FDA Food Facility Registration Step by Step: A Process Guide for Foreign Manufacturers

Apr 14, 2026

FDA food facility registration involves a specific sequence of steps — DUNS first, then US Agent, then the FDA filing itself. Foreign manufacturers who follow the correct order avoid the most common delays.

Why the FDA Rejects Food Facility Registrations: Common Mistakes Foreign Manufacturers Make

Why the FDA Rejects Food Facility Registrations: Common Mistakes Foreign Manufacturers Make

Apr 10, 2026

FDA food facility registration rejections are almost always preventable. The most common causes are DUNS mismatches, missing US Agent information, and incorrect product category codes.

EU Regulation 1223/2009: What Non-EU Cosmetic Brands Must Know Before Selling in Europe

EU Regulation 1223/2009: What Non-EU Cosmetic Brands Must Know Before Selling in Europe

Apr 9, 2026

EU Regulation 1223/2009 sets the legal framework for every cosmetic product in Europe. Here is what non-EU brands must have in place before market entry.

Exporting Food to the United States from Southeast Asia: FDA Compliance for ASEAN Manufacturers

Exporting Food to the United States from Southeast Asia: FDA Compliance for ASEAN Manufacturers

Apr 8, 2026

To export food to USA from Southeast Asia, ASEAN manufacturers must hold FDA facility registration, a DUNS number, a US Agent, and compliant labels.

MoCRA Cosmetic Facility Registration: What Changed Under the Modernization of Cosmetics Regulation Act

MoCRA Cosmetic Facility Registration: What Changed Under the Modernization of Cosmetics Regulation Act

Apr 7, 2026

MoCRA cosmetic facility registration brought mandatory FDA filings for foreign cosmetic manufacturers. Here is what the law requires and who is covered.

What Is a UFI Number and How It Affects FDA Food Facility Registration

What Is a UFI Number and How It Affects FDA Food Facility Registration

Apr 7, 2026

The UFI — Unique Facility Identifier — is the FDA's term for the identifier required in food facility registration. The DUNS number currently serves this role. Here is what foreign facilities need to know.

FDA Packaged Food Export Checklist: What Foreign Manufacturers Must Have Ready

FDA Packaged Food Export Checklist: What Foreign Manufacturers Must Have Ready

Apr 6, 2026

A complete FDA packaged food export checklist covering registration, DUNS, US Agent, Prior Notice, and label compliance for foreign manufacturers.

What Is a US FDA Agent — And Why Every Foreign Food Facility Must Have One

What Is a US FDA Agent — And Why Every Foreign Food Facility Must Have One

Apr 5, 2026

A US FDA Agent for foreign facilities is mandatory under the Bioterrorism Act. Here is what the role covers and what happens without one.

What Is an FDA Food Facility Registration — And Why Every Foreign Manufacturer Needs One

What Is an FDA Food Facility Registration — And Why Every Foreign Manufacturer Needs One

Apr 4, 2026

FDA food facility registration is mandatory for foreign manufacturers shipping food to the US. Here is what it covers and what happens without it.

What Is a DUNS Number and Why Food Exporters Need One Before FDA Registration

What Is a DUNS Number and Why Food Exporters Need One Before FDA Registration

Apr 3, 2026

A DUNS number for FDA registration is required before foreign food facilities can file. Here is what it is and what goes wrong.

What Documents to Prepare Before Starting FDA Food Facility Registration

What Documents to Prepare Before Starting FDA Food Facility Registration

Apr 3, 2026

Missing documents are the top reason FDA food facility registrations stall. Here is the complete checklist of what foreign manufacturers must have in hand before opening the FDA's registration system.

FDA Shell Egg Registration: What Egg Producers Outside the US Must Know

FDA Shell Egg Registration: What Egg Producers Outside the US Must Know

Apr 2, 2026

FDA shell egg producer registration has its own rules under 21 CFR Part 118. Foreign egg facilities face dual filing requirements.

Exporting Food to the United States from the Middle East: What You Need Before Your First Shipment

Exporting Food to the United States from the Middle East: What You Need Before Your First Shipment

Apr 1, 2026

Export food to USA from Middle East? FDA registration, a US Agent, DUNS number, and label compliance are required before shipping.

EU Cosmetics Registration: What the CPNP System Requires from Non-EU Brands

EU Cosmetics Registration: What the CPNP System Requires from Non-EU Brands

Mar 31, 2026

EU cosmetics registration through the CPNP system requires a Responsible Person, product information files, and safety assessments.

FDA Export Certificates: When Foreign Manufacturers Need Them and How to Obtain Them

FDA Export Certificates: When Foreign Manufacturers Need Them and How to Obtain Them

Mar 30, 2026

FDA export certificates confirm a facility's registration status and product compliance for foreign government import requirements. Here is what they cover, who issues them, and when they are needed.

Medical Device Registration for Foreign Manufacturers: A Guide to the US Regulatory System

Medical Device Registration for Foreign Manufacturers: A Guide to the US Regulatory System

Mar 26, 2026

Foreign medical device manufacturers must register their establishments, list their devices, and — depending on device class — obtain FDA clearance or approval before distributing in the United States.

FSMA Preventive Controls: What Foreign Food Manufacturers Must Include in Their Food Safety Plans

FSMA Preventive Controls: What Foreign Food Manufacturers Must Include in Their Food Safety Plans

Mar 22, 2026

FSMA's Preventive Controls rule requires foreign food manufacturers exporting to the US to have documented food safety plans with hazard analysis, preventive controls, and monitoring procedures.

REACH Compliance for Non-EU Manufacturers: What Exporters to Europe Must Know

REACH Compliance for Non-EU Manufacturers: What Exporters to Europe Must Know

Mar 18, 2026

REACH — the EU's chemical regulation — affects foreign manufacturers who export cosmetics, chemicals, and ingredients to Europe. Non-EU companies must appoint an Only Representative before their products can enter the EU market.

How to Get a DUNS Number for FDA Registration: A Step-by-Step Guide for Foreign Food Exporters

How to Get a DUNS Number for FDA Registration: A Step-by-Step Guide for Foreign Food Exporters

Mar 14, 2026

Getting a DUNS number is the first required step before FDA food facility registration. Here is exactly how foreign food manufacturers apply, what information is needed, and how long it takes.

What Foreign Cosmetic Brands Need to Know About MoCRA

What Foreign Cosmetic Brands Need to Know About MoCRA

Mar 13, 2026

The short version of what foreign cosmetic brands should organize before facility registration and product listing under MoCRA.

How to Export Food from Vietnam to the USA: Complete FDA Guide

How to Export Food from Vietnam to the USA: Complete FDA Guide

Mar 12, 2026

A practical checklist for Vietnamese food exporters preparing FDA filings, US Agent coverage, and label review before their first shipment.

When cosmetic product listing and label review should be bundled together

When cosmetic product listing and label review should be bundled together

Mar 11, 2026

Why many growing brands save time by reviewing labels at the same time they prepare product listings for the US market.

How to keep your FDA food facility registration in good standing

How to keep your FDA food facility registration in good standing

Mar 10, 2026

What foreign food manufacturers need to know about keeping their FDA registration accurate, their US Agent active, and their shipments moving without delays.

DUNS Number FAQ for Foreign Food Exporters: Common Questions Before FDA Registration

DUNS Number FAQ for Foreign Food Exporters: Common Questions Before FDA Registration

Mar 10, 2026

Foreign food exporters have consistent questions about DUNS numbers before starting FDA registration. This FAQ addresses the most common ones — from cost to timing to multiple facilities.

What foreign cosmetic facilities should prepare before registration

What foreign cosmetic facilities should prepare before registration

Mar 9, 2026

The main facility details and product information you should organize before starting your MoCRA-related filing work.

What foreign food facilities should prepare before registration

What foreign food facilities should prepare before registration

Mar 8, 2026

The main company details and facility information you should have ready before you begin the filing process.

MoCRA basics for cosmetic brands outside the United States

MoCRA basics for cosmetic brands outside the United States

Mar 7, 2026

A simple starting guide for foreign brands preparing facility registration and product listing under the newer cosmetics rules.

How to export packaged food to the USA for the first time

How to export packaged food to the USA for the first time

Mar 6, 2026

A plain-language starting guide for factories preparing their first FDA-related filings before shipping to America.

What Is an FEI Number and Why It Matters for Every FDA-Registered Facility

What Is an FEI Number and Why It Matters for Every FDA-Registered Facility

Mar 6, 2026

The FEI number — FDA Establishment Identifier — is the FDA's permanent identifier for every registered facility. It appears in import records, inspection reports, and FDA databases. Here is what it is and how it works.

What drug manufacturers should know before FDA listing

What drug manufacturers should know before FDA listing

Mar 5, 2026

The key setup items to prepare before you begin establishment registration and drug listing work.

What Foreign Cosmetic Brands Need to Know About MoCRA

What Foreign Cosmetic Brands Need to Know About MoCRA

Mar 3, 2026

What foreign cosmetic brands should prepare before facility registration and product listing.

How to start exporting packaged food to the USA