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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FDA StoriesAug 19, 2026

FDA Stories #027 — An Israeli Tahini Recall Exposed a Repeat Salmonella Risk in Sesame Paste

An eight-illness Salmonella outbreak tied to tahini led to an Israeli producer's recall and became part of a wider FDA review of recurring cases.

FDA StoriesAug 19, 2026

FDA Stories #028 — A Turkish Pistachio Filling Was Detained for Wheat Hidden Inside Kunefe

FDA listed Turkish pistachio fillings for detention because the label named kunefe but did not declare wheat contained within the compound ingredient.

FDA StoriesAug 19, 2026

FDA Stories #029 — An Azerbaijani Pomegranate Product Stayed on FDA's Illegal-Color Detention List

FDA's current import alert still lists pomegranate puree and juice from an Azerbaijani firm after an unidentified non-permitted red color finding.

FDA StoriesAug 19, 2026

FDA Stories #030 — A Chilean Swordfish Processor Reached FDA's Seafood HACCP Detention List

FDA listed frozen, vacuum-packed swordfish from a Chilean processor after finding gaps in hazard identification, critical limits, and monitoring.

FDA StoriesAug 19, 2026

FDA Stories #031 — Repeated Salmonella Findings Put Mexican Papayas Under a Countrywide FDA Import Alert

FDA found Salmonella in 15.6% of sampled Mexican papayas in 2011 and used outbreak and sampling evidence to establish a countrywide import alert.

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.

FDA StoriesAug 15, 2026

FDA Stories #024 — A Chinese Aloe Vera Gel Became an Unapproved Drug Because of Its Claims

FDA placed a China-made aloe vera gel on an unapproved-drug import alert after its label and website promoted sunburn, antiseptic, acne, and insect-bite uses.

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.

FDA StoriesAug 11, 2026

FDA Stories #023 — Pakistani Mercury Beauty Creams Landed on FDA's Detention List

FDA's current cosmetics import alert names multiple Pakistani skin-lightening creams for mercury, allowing detention without physical examination.

FDA StoriesAug 8, 2026

FDA Stories 032: The Skincare Brand That Didn't Report a Reaction

An illustrative composite scenario shows how one serious skincare reaction, lost in a reseller inbox, can expose an entire missing MoCRA adverse-event program.

FDA StoriesAug 7, 2026

FDA Stories #022 — One Indonesian Shrimp Detection Triggered Recalls and Import Certification

A cesium-137 detection linked to Indonesian shrimp led to recalls, an import alert, and FDA's first use of import certification authority for certain foods.

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.

FDA StoriesAug 3, 2026

FDA Stories #021 — Ecuador's Cinnamon Applesauce Recall Reached Nearly 3 Million Pouches

FDA traced extreme lead contamination in cinnamon applesauce made in Ecuador to a supplier-control failure, prompting a major recall and warning letter.

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.

FoodJul 28, 2026

Food-contact materials: FCN coverage, alternatives and supplier evidence

Assess the component, identified supplier and intended use: an FCN is one authorization route, not a requirement for every foreign packaging manufacturer.

FoodJul 27, 2026

Seafood HACCP: hazard analysis, conditional plans and importer verification

Covered processors conduct a hazard analysis; a written HACCP plan depends on reasonably likely hazards. Separate processor controls, importer verification and renewal.

FoodJul 26, 2026

FDA Allergen Labeling: Nine Major Allergens and Edition 5 Changes

Use FDA’s January 2025 Edition 5 to assess major-allergen sources, sesame timing, ingredient declarations and an exporter label-evidence worksheet.

FoodJul 25, 2026

Exporting Canned Food to the United States: FCE, SID, and Thermal Process Filing Requirements

Foreign canned food manufacturers must obtain FCE registration and file Scheduled Processes with the FDA before any thermally processed product can enter the US market.