FDA Registration for Food: Why is it Mandatory and How Does it Work?

If you want to export food to the United States, registration with the Food and Drug Administration (FDA) is an essential requirement. Without this registration, your product will not be able to legally enter the country and may be held up in customs.

Although the registration process is relatively simple, it is mandatory to have a registered agent in the US , who acts as a liaison between your company and the FDA to ensure compliance with regulations.

In this article, we explain why FDA registration is essential and how to ensure that your product complies with all regulations to enter the US market without problems.

1. Why is FDA Registration Mandatory?

The FDA requires that all foreign companies that manufacture, process, package or store food for consumption in the U.S. be registered. This allows authorities to monitor products entering the country and ensure food safety for consumers.

If you do not meet this requirement, you are exposed to:

❌ Your products are held by US customs.
❌ Import blockage due to non-compliance with regulations.
❌ Fines or penalties for operating without registration.

Registration is a mandatory process that must be renewed every two years , ensuring that your business remains compliant with US market regulations.

2. The Importance of the Registered Agent for the FDA

If your business does not have a physical presence in the United States, the FDA requires you to designate a U.S. Registered Agent , who will be the official contact between your business and the agency.

💼 Registered Agent Duties:
✔ Receive official notifications from the FDA in case of inspections or audits.
✔ Represent your company before the FDA and provide regulatory assistance.
✔ Facilitate the compliance process to avoid delays or penalties.

Without a registered agent, your registration application will be automatically rejected , preventing your products from entering the country.

3. Regulatory Compliance: Ensure the Safety of Your Product

FDA registration is not just an administrative process, but a key step to demonstrate that your products comply with the food safety standards required in the US.

In addition to registration, it is advisable to ensure that labeling, packaging, and ingredients comply with FDA and other regulatory agencies such as the USDA. This will avoid rejections at customs and facilitate the distribution of your products in the country.

Conclusion: Register Your Company with the FDA and Expand Your Business

If you want to sell food in the US, registration with the FDA and having a Registered Agent is mandatory.

At Sell-U Latam , we manage your FDA registration and become your Official Registered Agent in the US , ensuring that your business operates smoothly.

📩 Contact us today and get your FDA registration quickly and safely