NexoNutra

Manufacturing supplements in the United States to sell in Latin America

A brand in Latin America can have its supplement made in the United States and sell it at home. It is a common path, and it works best when you know from the start what U.S. manufacturing gives you and what it does not.

Updated October 2026

What you gain

• Every supplement manufacturer in the United States has to follow the FDA's good manufacturing practice rules, and the FDA can inspect the facility.
• A manufacturer with a GMP certificate has also been audited by an independent body.
• You get the production records and tests for each batch, which most authorities and distributors ask about.
• Your product is manufactured in the United States. What the label may say about origin depends on your ingredients and on the rules where you sell.

What does not change

Manufacturing in the United States does not register your product in your own country. The FDA does not approve supplements, so there is no “FDA approval” to present; our guide on FDA-registered versus FDA-approved explains the difference.

You still have to meet your country's requirements, with a label in Spanish that follows local rules. The ingredients and amounts allowed also differ from one country to another, so check your formula against your country's rules before you produce, not after.

Documents your country may ask for

• A certificate of free sale. The FDA issues one for dietary supplements made in the United States.
• The manufacturer's GMP certificate.
• A certificate of analysis for the batch.
• The formula, the product specifications and the label.

Ask the manufacturer early which of these it can provide, and ask your regulatory specialist which ones your country requires.

Shipping and importing

Your order leaves the United States and enters your country through customs. You will need an importer, which can be your own company, and duties and taxes depend on the country. Ask whether your quote can include shipping, and who prepares the export paperwork.

A sensible order of steps

• Check your country's requirements for your formula and your label.
• Ask for a quote, and ask which documents the manufacturer can provide.
• Start your registration or notification early. It can take longer than the production itself.
• Approve the formula, the label and a sample, and produce.
• Ship, import and plan your reorder.

How NexoNutra helps

We handle the conversation in Spanish or English, introduce you to the manufacturer's team in the United States and make sure you get your quote. We do not register products: for that you need a regulatory specialist in your country. If you are just starting, read how to start a supplement brand first, and what sets the cost of manufacturing before you budget.

This is general information to help you plan. It is not legal or regulatory advice.

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