Articles for exporters dealing with FDA paperwork

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 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.

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 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.

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 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 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