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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Cosmetics

MoCRA Cosmetic Facility Registration Renewal: Your 2026 Deadline Is Facility-Specific

Cosmetics

MoCRA Cosmetic Facility Registration Renewal: Your 2026 Deadline Is Facility-Specific

Sep 8, 2026

Cosmetic facility registrations now renew every two years from the initial registration date. Learn how the Cosmetics Direct renewal date, FEI, US Agent, amendments, and annual product listings fit together.

Cosmetics

The US Label Contact Every Foreign Cosmetic Brand Must Have — and What Happens Without It

Cosmetics

The US Label Contact Every Foreign Cosmetic Brand Must Have — and What Happens Without It

Aug 18, 2026

MoCRA requires every cosmetic label to provide a channel for adverse-event reports. For foreign brands, that contact must connect to a real intake and reporting process.

Cosmetics

The 15-Business-Day Rule: How MoCRA Serious Adverse Event Reporting Works

Cosmetics

The 15-Business-Day Rule: How MoCRA Serious Adverse Event Reporting Works

Aug 12, 2026

The MoCRA reporting clock starts when a serious cosmetic adverse event reaches the Responsible Person. Here is how the deadline, Form 3500A, and follow-up year work.

Cosmetics

What Happens If You Don't Report Cosmetic Adverse Events to the FDA

Cosmetics

What Happens If You Don't Report Cosmetic Adverse Events to the FDA

Aug 5, 2026

An unreported cosmetic reaction can expose missing records, a defective label channel, and a wider compliance failure that follows foreign brands to the US border.

Cosmetics

What Is FDA Adverse Event Management Under MoCRA?

Cosmetics

What Is FDA Adverse Event Management Under MoCRA?

Jul 30, 2026

MoCRA made cosmetic adverse-event handling a legal duty. Learn what must be recorded, what must reach the FDA within 15 business days, and who is responsible.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

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

Cosmetics

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.

Cosmetics

What Foreign Cosmetic Brands Need to Know About MoCRA

Cosmetics

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.

Cosmetics

When cosmetic product listing and label review should be bundled together

Cosmetics

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.

Cosmetics

What foreign cosmetic facilities should prepare before registration

Cosmetics

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.

Cosmetics

MoCRA basics for cosmetic brands outside the United States

Cosmetics

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.

Cosmetics

What Foreign Cosmetic Brands Need to Know About MoCRA

Cosmetics

What Foreign Cosmetic Brands Need to Know About MoCRA

Mar 3, 2026

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