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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.

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Articles in foreign languages / Yabancı dilde makaleler / 外国語の記事 / Artículos en otros idiomas →

🇹🇷 Türkçe — Gıda ve Kozmetik İhracatı

FDA gıda tesisi kaydı, US Agent, DUNS numarası ve MoCRA kozmetik kaydı hakkında Türk ihracatçılara yönelik kapsamlı bilgiler.

🇩🇪 Deutsch — FDA-Registrierung für deutsche Exporteure

FDA Lebensmittelregistrierung, US Agent Pflicht, DUNS-Nummer und MoCRA-Kosmetikregistrierung für deutsche Exporteure.

🇫🇷 Français — Enregistrement FDA pour les exportateurs français

Enregistrement d'établissement alimentaire FDA, agent américain, numéro DUNS et enregistrement cosmétiques MoCRA pour les entreprises françaises exportant vers les États-Unis.

🇮🇹 Italiano — Registrazione FDA per esportatori italiani

Registrazione stabilimento alimentare FDA, US Agent, numero DUNS e registrazione cosmetici MoCRA per aziende italiane che esportano negli Stati Uniti.

🇷🇴 Română — Înregistrare FDA pentru exportatorii români

Înregistrare unitate alimentară FDA, Agent SUA, număr DUNS și înregistrare cosmetice MoCRA pentru companiile românești care exportă în Statele Unite.

🇵🇱 Polski — Rejestracja FDA dla polskich eksporterów

Rejestracja zakładu spożywczego FDA, US Agent, numer DUNS i rejestracja kosmetyków MoCRA dla polskich firm eksportujących do Stanów Zjednoczonych.

🇬🇷 Ελληνικά — Εγγραφή FDA για Έλληνες εξαγωγείς

Εγγραφή μονάδας τροφίμων FDA, US Agent, αριθμός DUNS και εγγραφή καλλυντικών MoCRA για ελληνικές εταιρείες που εξάγουν στις Ηνωμένες Πολιτείες.

🇨🇳 中文 — FDA注册服务

中国食品出口FDA注册、FDA化妆品注册(MoCRA)、DUNS编号申请、美国代理人服务。帮助中国制造商顺利进入美国市场。

🇯🇵 日本語 — FDA登録サービス

FDA食品施設登録、USエージェント指定、DUNS番号取得、化粧品MoCRA登録。日本からアメリカへの輸出をサポート。

🇰🇷 한국어 — 한국 수출업체를 위한 FDA 등록

FDA 식품 시설 등록, 미국 대리인(US Agent), DUNS 번호 취득, MoCRA 화장품 등록. 서울, 부산, 인천의 제조업체 지원.

🇻🇳 Tiếng Việt — Đăng ký FDA cho nhà xuất khẩu Việt Nam

Đăng ký cơ sở thực phẩm FDA, US Agent, số DUNS và đăng ký mỹ phẩm MoCRA dành cho nhà xuất khẩu Việt Nam.

🇹🇭 ภาษาไทย — FDA สำหรับผู้ส่งออกไทย

การลงทะเบียนสถานประกอบการอาหาร FDA, ตัวแทนสหรัฐ, หมายเลข DUNS และการลงทะเบียนเครื่องสำอาง MoCRA สำหรับผู้ผลิตไทย

🇲🇾 Bahasa Melayu — Pendaftaran FDA untuk pengeksport Malaysia

Pendaftaran kemudahan makanan FDA, Ejen AS, nombor DUNS dan pendaftaran kosmetik MoCRA untuk syarikat Malaysia yang mengeksport ke Amerika Syarikat.

🇮🇳 हिन्दी — भारतीय निर्यातकों के लिए FDA पंजीकरण

FDA खाद्य सुविधा पंजीकरण, US एजेंट, DUNS नंबर और MoCRA सौंदर्य प्रसाधन पंजीकरण। मुंबई, दिल्ली और बेंगलुरु के निर्माताओं के लिए सहायता।

🇮🇩 Bahasa Indonesia — Pendaftaran FDA untuk eksportir Indonesia

Pendaftaran fasilitas makanan FDA, Agen AS, nomor DUNS, dan pendaftaran kosmetik MoCRA untuk perusahaan Indonesia yang mengekspor ke Amerika Serikat.

🇧🇩 বাংলা — বাংলাদেশি রপ্তানিকারকদের জন্য FDA নিবন্ধন

FDA খাদ্য সুবিধা নিবন্ধন, US Agent, DUNS নম্বর এবং MoCRA কসমেটিক্স নিবন্ধন। ঢাকা, চট্টগ্রাম ও সিলেটের উৎপাদনকারীদের সহায়তা।

🇺🇿 O'zbekcha — O'zbek eksportchilar uchun FDA ro'yxatga olish

FDA oziq-ovqat korxonasini ro'yxatga olish, AQSh agenti, DUNS raqami va MoCRA kosmetika ro'yxatga olish. Toshkent va Samarqand ishlab chiqaruvchilariga yordam.

🇰🇪 Kiswahili — Usajili wa FDA kwa wasafirishaji wa Kenya

Usajili wa kiwanda cha chakula FDA, Wakala wa Marekani, nambari ya DUNS na usajili wa MoCRA. Kusaidia wazalishaji kutoka Nairobi na Mombasa.

🇪🇹 አማርኛ — ለኢትዮጵያ ወጪ ላኪዎች FDA ምዝገባ

FDA የምግብ ተቋም ምዝገባ፣ የአሜሪካ ወኪል፣ DUNS ቁጥር እና MoCRA ምዝገባ። ከአዲስ አበባ እና ድሬዳዋ ላሉ አምራቾች ድጋፍ።

🇸🇦🇦🇪🇪🇬🇲🇦 العربية — تسجيل FDA للمصدِّرين العرب

تسجيل منشأة الأغذية FDA، تعيين وكيل أمريكي، رقم DUNS، وتسجيل مستحضرات التجميل وفق قانون MoCRA للشركات العربية المصدِّرة إلى الولايات المتحدة.

🇵🇰 اردو — پاکستانی برآمد کنندگان کے لیے FDA رجسٹریشن

FDA فوڈ فیسیلیٹی رجسٹریشن، امریکی ایجنٹ، DUNS نمبر اور MoCRA کاسمیٹکس رجسٹریشن۔ کراچی، لاہور اور فیصل آباد کے مینوفیکچررز کی مدد۔

🇵🇭 Filipino — FDA registration para sa mga exporters ng Pilipinas

FDA food facility registration, US Agent, DUNS number at MoCRA cosmetics registration. Tulong sa mga tagagawa mula Maynila, Cebu at Davao.

🇲🇽🇨🇴🇦🇷🇵🇪 Español — Registro FDA para exportadores latinoamericanos

Registro de instalaciones alimentarias FDA, número DUNS, agente estadounidense y registro de cosméticos MoCRA. Servicio completo desde $449 USD.

🇧🇷 Português — Registro FDA para exportadores brasileiros

Registro de estabelecimento alimentar na FDA, US Agent, número DUNS e Registro de cosméticos MoCRA para empresas brasileiras exportando para os EUA.

🇿🇦🇳🇬🇬🇭 English (Africa) — FDA Registration for African Exporters

FDA food facility registration, US Agent, DUNS number and MoCRA cosmetics registration for African companies exporting to the United States.