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A certificate of free sale is a must for U.S. businesses exporting specific products abroad. If you’re expanding into new markets, this document can help you navigate regulatory requirements, build trust with international buyers, and avoid shipment delays.
In this article, we’ll explain how to obtain a Certificate of Free Sale and introduce how Wise Business can support you in managing payments and operations as you grow internationally.
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A certificate of free sale, also known as a certificate for export or certificate to foreign governments, verifies that a product is legally sold and freely available in the U.S. market. It acts as evidence to foreign regulatory agencies that your goods meet domestic standards and are approved for sale in the United States.
The certificate is most commonly used for:
What is a certificate of free sale in practical terms? It's a regulatory passport that helps you gain access to international markets. Many countries require this certificate before allowing your goods into their borders, especially if your products fall under health and safety regulations.
Depending on the product category, different issuing authorities issue certificates of free sale. For example, an FDA certificate of free sale applies to food, cosmetic, and supplement products regulated by the U.S. Food and Drug Administration.
You typically need a free sale certificate for export when:
Here’s a practical example: if your U.S.-manufactured face serum is already sold domestically and you’re exporting it to Brazil, their health authorities may request a free sale certificate from the USA before they allow it through customs.
It’s worth checking the destination country’s import requirements in advance. While not all countries require a certificate of free sale, many do, especially for consumables, health-related items, or personal care goods.2
If you’re wondering how to obtain a certificate of free sale, the process depends on the type of product you sell and which agency regulates it. Below are the most common pathways.
If your product is regulated by the U.S. Food and Drug Administration, you’ll need to submit a request to the FDA.1
The types of products that fall under this include:
Product Category | Examples |
---|---|
Food and Beverages | Packaged snacks, bottled juice, canned goods |
Dietary Supplements | Multivitamins, herbal capsules, protein powders |
Cosmetics | Moisturizers, shampoos, lotions (excluding color additives requiring premarket approval) |
Medical Devices (Class I & II) | Thermometers, blood pressure monitors, bandages |
Once you’re ready to apply, follow these steps.
Step 1: Register for a CECATS Account
Create an account on the FDA’s CDRH Export Certification Application and Tracking System (CECATS) to start your application.3
Step 2: Complete Form FDA 3613
Submit Form FDA 3613 or its variations, depending on the product type you’re exporting.
Step 3: Submit Proof of U.S. Marketing
Include documentation, such as labels, invoices, or promotional materials, showing that the product is legally sold in the U.S.
Step 4: Pay Required Fees
Processing fees must be paid through the FDA’s designated portal. Ensure payment is completed to avoid delays.
Step 5: Await FDA Review and Issuance
The FDA will review your submission and, if everything is in order, issue the Certificate of Free Sale.
Note: Processing times can vary depending on the volume and completeness of your submission.
If you need faster documentation or have products not regulated by the FDA, many exporters turn to chambers of commerce or trade organizations. The American World Trade Chamber of Commerce (AWTCC) and various state-level entities (like Select Florida of the Florida Chamber of Commerce) offer these certificates.4,5
You’ll typically need to:
These certificates often come faster than federal ones, sometimes within a few business days.
If you export meat, dairy, or other agricultural products, you may need to request your certificate of free sale from the U.S. Department of Agriculture (USDA). The Foreign Agricultural Service (FAS) manages these certificates through a state contact point system.
You can visit the USDA’s Certificate of Free Sale Point of Contact list⁶ to find your regional contact and application process.
A certificate of free sale might just seem like a small piece of paper, but it’s a powerful tool for entering new markets. Whether you’re expanding into the EU, the Middle East, or Asia, understanding how to obtain a certificate of free sale ensures smoother logistics and regulatory compliance.
The steps can vary, from navigating the FDA certificate of free sale process to working with your local chamber of commerce, but the payoff is global growth. With tools like Wise Business, you can manage international payments just as efficiently as your domestic ones.
Wise Business can help you save big time on international payments.
Wise is not a bank, but a Money Services Business (MSB) provider and a smart alternative to banks. The Wise Business account is designed with international business in mind, and makes it easy to send, hold, and manage business funds in currencies.
Signing up to Wise Business allows access to BatchTransfer which you can use to pay up to 1000 invoices in one go. This is perfect for small businesses that are managing a global team, saving a ton of time and hassle when making payments.
Some key features of Wise Business include:
Mid-market rate: Get the mid-market exchange rate with no hidden fees on international transfers
Global Account: Send money to countries and hold balances in multiple currencies, all in one place. You can also get major currency account details for a one-off fee to receive overseas payments like a local
Access to BatchTransfer: Pay up to 1000 invoices in one click. Save time, money, and stress when you make 1000 payments in one click with BatchTransfer payments. Access to BatchTransfer is free with a Wise Business account
Auto-conversions: Don't like the current currency exchange rate? Set your desired rate, and Wise sends the transfer the moment the rate is met
Free invoicing tool: Generate and send professional invoices
No minimum balance requirements or monthly fees: US-based businesses can open an account for free. Learn more about fees here
Sources:
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This publication is provided for general information purposes and does not constitute legal, tax or other professional advice from Wise Payments Limited or its subsidiaries and its affiliates, and it is not intended as a substitute for obtaining advice from a financial advisor or any other professional.
We make no representations, warranties or guarantees, whether expressed or implied, that the content in the publication is accurate, complete or up to date.
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A Free Sale Certificate is essential for exporting many products to certain international markets and is often required before distribution and sales can start.