FDABridge Blog

Articles for exporters dealing with FDA paperwork

Read practical guides about food registration, MoCRA, drug filings, and the paperwork that comes before your products enter the market.

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FoodJul 12, 2026

Food Facility Biennial Renewal: Submission and Recordkeeping Checklist

Prepare authorized account access, review the registration details and DUNS/UFI match, submit the renewal and retain the outcome.

FoodJul 12, 2026

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

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.

FoodJul 11, 2026

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

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.

FoodJul 11, 2026

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

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.

CosmeticsJul 10, 2026

Cosmetic Product Listing Under MoCRA: Responsible Person, Grouping and Updates

Who lists cosmetics with FDA, what Form 5067 requires, when certain variants may share a listing, and how initial and annual updates work.

FoodJul 10, 2026

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

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 StoriesJul 10, 2026

FDA Stories #015 — Dubai Repacking: Origin, Marking and Food Registration

An illustrative spice-repacking scenario separates origin analysis, classification-dependent marking exceptions and facility-specific FDA registration.

GeneralJul 9, 2026

FDA U.S. Agent: Food, Drug, Device and Cosmetic Roles

When a foreign establishment needs an FDA U.S. agent, what that contact does in each programme, the separate update clocks and a practical handover checklist.

FoodJul 9, 2026

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

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.

GeneralJul 8, 2026

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

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.

CosmeticsJul 8, 2026

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

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.

CosmeticsJul 7, 2026

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

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.

CosmeticsJul 6, 2026

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

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.

CosmeticsJul 5, 2026

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

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

FDA StoriesJul 5, 2026

FDA Stories #014 — Pierogi Ingredients and the Optional Contains Statement

An illustrative pierogi label already identifies wheat, egg and milk; absence of a separate Contains statement alone does not establish noncompliance.

CosmeticsJul 4, 2026

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

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

GeneralJul 3, 2026

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

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.

CosmeticsJul 3, 2026

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

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.