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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All Food Cosmetics Drug EU General FDA Stories

GeneralJul 2, 2026

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

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.

CosmeticsJul 2, 2026

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

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.

FoodJul 1, 2026

Missed Food Facility Renewal: Check Status and Arrange Recovery

If a food registration was not renewed by the deadline, confirm its status with FDA and address registration and shipment obligations before resuming imports.

CosmeticsJul 1, 2026

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

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.

FoodJun 30, 2026

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

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.

CosmeticsJun 30, 2026

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

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

FDA StoriesJun 30, 2026

FDA Stories #013 — A Botanical Supplement: NDI Evidence, Notification and Import Review

An illustrative Chinese botanical-supplement scenario separates NDI status, qualifying notification, ingredient legality and the actual import-response process.

GeneralJun 29, 2026

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

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.

CosmeticsJun 29, 2026

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

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.

FoodJun 28, 2026

Why a Single FDA Compliance Partner Outperforms Fragmented Vendor Relationships

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.

DrugJun 28, 2026

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

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.

DrugJun 27, 2026

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

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.

GeneralJun 26, 2026

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

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.

DrugJun 26, 2026

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

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.

DrugJun 25, 2026

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

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 StoriesJun 25, 2026

FDA Stories #012 — Argan Oil: Assessing Food and Cosmetic Uses

An illustrative Moroccan argan-oil scenario explains intended use, current allergen scope and conditional food and MoCRA obligations.

DrugJun 24, 2026

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

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.

DrugJun 23, 2026

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

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.