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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FoodNov 4, 2026

FDA Proposes Mandatory GRAS Notification: What Foreign Ingredient Suppliers Should Do Before December 9, 2026

FDA's August 2026 proposed rule would end self-affirmed GRAS for human and animal food. Here is what it would require, the proposed timeline, and how foreign ingredient makers and food exporters can prepare now.

FoodNov 4, 2026

FD&C Red No. 3 Ends in US Food on January 15, 2027: A Reformulation Checklist for Foreign Exporters

FDA revoked the authorization for Red No. 3 (erythrosine) in food and ingested drugs. Foods sold in the US must be free of it from January 15, 2027. Here is how foreign exporters can check products, labels and stock in time.

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.

GeneralNov 4, 2026

FY 2027 FDA Medical Device Fees: The $13,785 Establishment Registration Fee and What Foreign Manufacturers Must Do by December 31

FDA's device user fees for October 1, 2026 to September 30, 2027 are set. The annual establishment registration fee is $13,785. Here is who pays it, how annual registration works, and the other FY 2027 fees.

FoodNov 4, 2026

Prior Notice for Food Sent by International Mail: Tracking Number Rule Enforcement Delayed to May 1, 2027

Since October 1, 2026 FDA's rules require the mail service name and tracking number in Prior Notice for food sent by international mail, but FDA will not enforce that part until May 1, 2027. Here is what changed and what senders should do now.

FoodNov 4, 2026

Renewing Your FDA Food Facility Registration and Changing Your US Agent at the Same Time

The 2026 renewal window closes on December 31. If you are unhappy with your current US Agent, renewal is the natural moment to change. Here is how renewal and an Agent transfer fit together, and why one does not complete the other.

FoodNov 4, 2026

Locked Out of Your FDA Account Before the 2026 Renewal? Lost PIN, Former Consultant or Unknown Login

Many foreign facilities discover in renewal season that they cannot sign in to the FDA account that holds their registration. Here is how to regain control legitimately, and what not to do, before December 31, 2026.

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.

FDA StoriesNov 4, 2026

FDA Stories #033 — The Food Exporter Whose Renewal Sat in Someone Else's Account

An educational composite: a food manufacturer assumed its old consultant had renewed its FDA registration. The registration expired on December 31, and a January container was held at the border.

FDA StoriesNov 4, 2026

FDA Stories #034 — The Cosmetic Brand Whose Reformulated Serum Outran Its Records

An educational composite: a skincare brand changed a best-selling serum's formula but not its product listing, label review or safety file. One consumer complaint exposed all three gaps at once.

GeneralNov 4, 2026

Switching Your FDA US Agent to FDABridge: Why Exporters Switch and How the Transfer Works

Your US Agent is FDA's link to your facility. If yours is unreachable, expensive or silent, you can change it. Here is why exporters move to FDABridge, and the step-by-step process for food, cosmetic, drug and device facilities.

FoodNov 4, 2026

U.S. Agent Confirmation and the 2026 FDA Food Facility Renewal: What Foreign Facilities Must Line Up

If a foreign food facility names a new U.S. agent in its 2026 renewal, FDA will not confirm the renewal until the agent confirms it has agreed to serve. How the check works, the 30-day limit and what to line up first.

FoodNov 4, 2026

What a 2026 FDA Food Facility Renewal Must Contain: A Section-by-Section Check for Foreign Facilities

A 2026 food facility renewal must contain every element of 21 CFR 1.232. How to check identity and UFI, product categories and activity types, contacts and the inspection assurance, and when the abbreviated renewal applies.

FDA StoriesNov 4, 2026

FDA Stories #035 — Backdated Process Records Put a Chinese Pickled Mustard Stem Maker on FDA's Detention List

An FDA investigator watched staff at a Chinese acidified mustard stem factory create and backdate pH and process records. The pouches went on Import Alert 99-38, followed by a warning letter.

FDA StoriesNov 4, 2026

FDA Stories #036 — An Unanswered FDA Records Request Put a Chinese Sunscreen Maker on a Drug Import Alert

A Chinese sunscreen manufacturer never answered FDA's section 704(a)(4) records requests, so all its drugs went on Import Alert 66-79. Its drug listing also showed a color additive FDA cancelled in 1966.

GeneralNov 4, 2026

Why Foreign Exporters Choose FDABridge for FDA Registration: Six Reasons You Can Verify Before You Order

Six reasons food, cosmetic and drug exporters choose FDABridge for FDA registration and U.S. Agent work, each one something you can check on FDABridge's own pages before you order.

GeneralNov 4, 2026

Comparing FDA Registration Offers: What to Check Before You Pay, and How FDABridge Answers

Headline prices are hard to compare. These are the terms to check in any FDA registration offer, why each matters under FDA's rules, and where FDABridge publishes its own answer.

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.