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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CosmeticsNov 4, 2026

FDA's Final Guidance on Mandatory Cosmetic Recalls: What Foreign Brands Must Prepare For

MoCRA gave FDA the power to order cosmetic recalls. FDA's final question-and-answer guidance, issued in October 2026, explains when it can use that power, the steps it follows, and what a responsible person must do.

CosmeticsNov 4, 2026

MoCRA at the End of 2026: What Is Already in Force and What FDA Has Not Issued Yet

Three years after MoCRA's main duties took effect, several of its promised rules are still missing. Here is a clear status check for foreign cosmetic brands: what you must already be doing, what changed in 2026, and what is still pending.

CosmeticsNov 4, 2026

MoCRA Section 608 Safety Substantiation: What Foreign Cosmetic Brands Must Keep on File

Section 608 of the FD&C Act requires the label-named responsible person to ensure, and keep records supporting, adequate substantiation of each cosmetic's safety. Here is what that means and how it links to other MoCRA duties.

CosmeticsNov 4, 2026

FDA Records Access and Mandatory Cosmetic Recalls Under MoCRA: What Foreign Brands Should Prepare

FDA finalized its mandatory cosmetic recall guidance in October 2026 and has a draft guidance on records access. Here is when FDA can see your records or order a recall, and what foreign cosmetic brands should have ready.

CosmeticsSep 8, 2026

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

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.

CosmeticsAug 18, 2026

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

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.

CosmeticsAug 12, 2026

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

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.

CosmeticsAug 5, 2026

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

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.

CosmeticsJul 30, 2026

What Is FDA Adverse Event Management Under MoCRA?

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.

CosmeticsJul 16, 2026

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

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.

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.

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.

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.

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.

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.