FDA Export Certificate — Certificate of Free Sale

Many countries require an FDA Export Certificate or Certificate of Free Sale as proof that your cosmetic, food, drug, or device product is legally marketed in the United States. LMG assists with FDA export certificate applications.

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Export Certificate Services

FDA Certificates for food, dietary supplements, and cosmetics

Foreign businesses and governments often ask for FDA certificates for products exported from the U.S. The FDA is issuing a certificate of free sale, also known as an FDA export certificate, to US firms that manufacture food, dietary supplements, cosmetics, and food additives. The certificate indicates that the product is marketed in the U.S. or eligible for export and the manufacturer has no pending enforcement action before FDA.

The FDA Certificate to a Foreign Government is available for conventional foods, food additives, food contact substances, and infant formula that meet the applicable requirements of the FD&C Act for marketing in the United States. This certificate states, among other things, that a product (or products) may be marketed in and legally exported from the United States. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products issued in response to the same request, and $100 for each subsequent certificate for the same product issued in response to the same request.

The FDA Certificate of Exportability is available for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States but that meet the requirements of section 801(e) of the FD&C Act and may be legally exported. This certificate states that a product (or products) meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request.

The FDA Certificate of Free Sale is available only for dietary supplements, medical foods, and foods for special dietary use. FDA does not charge a fee for this certificate.

The FDA Certificate for Cosmetics is issued for products that meet the definition of a cosmetic under section 201(i) of the FD&C Act (21 U.S.C. 321(i)). The FDA does not issue cosmetic export certificates for raw or bulk materials and products marketed with drug claims, such as cleansers with acne treatment claims. There is no FDA fee for this certificate.

LMG assists manufacturers across all product categories with FDA export certificate applications — for cosmetics, food, drugs, and medical devices.

Export Certificate Application

Complete preparation and submission of your FDA export certificate application — the official document confirming your product is legally marketed in the United States.

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Cosmetic Export Certificate

Export certificates for cosmetic products under MoCRA — including Certificate of Free Sale documentation required by many import authorities.

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Food Export Certificate

FDA Certificate of Free Sale for food and dietary supplement products — required by food import authorities in many countries.

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Drug & Device Certificates

CPP certificates for pharmaceutical products and CFG certificates for medical devices — official FDA certificates for international market registration.

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How It Works

We manage the entire process from start to finish.

Product & Registration Check

We confirm your product registration status with FDA — a prerequisite for export certificate issuance.

Application Preparation

We prepare your complete export certificate application with all required product and establishment data.

FDA Submission & Fee

We submit your application to FDA and manage the review process. The FDA fee is $175. No Fees for cosmetics.

Certificate Delivery

Upon FDA approval, we deliver your certified export certificate for use in foreign market registration.

Frequently Asked Questions

Common questions about this FDA regulatory service.

What is an FDA export certificate?

An FDA export certificate (also called Certificate of Free Sale) is an official document issued by FDA confirming that a product is freely sold in the United States and meets applicable FDA requirements.

Which countries require an FDA export certificate?

Many countries in Asia, Latin America, Africa, and the Middle East require an FDA export certificate or Certificate of Free Sale as part of their product import registration process.

What is the government fee for an export certificate?

FDA charges a $175 government fee per export certificate application. There is no FDA fee for a cosmetic export certificate. LMG charges a separate professional service fee of $349 for preparation and submission assistance.

How long does it take to get an FDA export certificate?

FDA typically processes export certificate applications within 2–4 weeks of a complete submission. LMG monitors your application and follows up with FDA on your behalf.