How to Export Food to the US

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Exporting food to the US can seem challenging. Essentially, the process requires your company to be registered with the FDA (Food and Drug Administration), appoint a US agent, and comply with safety and labeling standards, such as those defined by the FSMA law.

The American market is, without a doubt, one of the most coveted in the world. It is diverse and has great purchasing power. Getting your food on a supermarket shelf in New York or Miami is a seal of quality and a gateway to global growth.

The United States takes food safety very seriously. The agency that governs this area, the FDA, does not make life easy for exporters.

This article was designed for you, the business owner, who sees this potential but doesn't know where to start deciphering the acronyms FDA, FSMA, FSVP, PCQI... 

Understanding the FDA and FSMA

If you want to export food to the US, the first name you need to remember is FDA (Food and Drug Administration).

The FDA regulates practically everything consumed in the United States, from processed foods, beverages, supplements, to animal feed. (Meats, poultry, and processed eggs have specific USDA rules, but the FDA still oversees labeling and other aspects) .

For decades, the FDA operated on a reactive model. That is, they waited for a problem to happen (like a contamination outbreak) before acting.

In 2011, everything changed with the signing of FSMA (Food Safety Modernization Act).

FSMA is, perhaps, the most radical change in US food safety legislation in over 70 years.

What does this mean in practice? The FDA now requires that you, the producer, prove that you have total control over the risks in your production process. The responsibility for ensuring safety was transferred from the inspection at the port of arrival to the origin, back at your factory.

If you cannot prove your process is safe, your product does not enter the country.

Bureaucratic Step-by-Step: FDA Registration

Before thinking about sending your first sample, there is one unavoidable administrative step: FDA Registration.

What is Food Facility Registration? 

Any facility that manufactures, processes, packs, or holds food intended for human or animal consumption in the US must register with the FDA. This includes your factory.

This registration is free and done online, but don't be fooled by the apparent simplicity. Filling in incorrect or incomplete information can lead to the suspension of your registration and, consequently, the refusal of your goods at the border.

The registration generates a number (the FFR Number), which will be required on practically all export documents.

The FDA U.S. Agent 

Since your company is not physically in the US, the FDA requires you to designate a U.S. Agent.

This agent is not a salesperson or a distributor. They are your official point of contact for communications with the FDA. If there is an emergency, an inspection, or any regulatory notification, your U.S. Agent is who the FDA will contact. They need to be physically located in the US and available 24/7 to respond to the FDA.

Many specialized consulting firms offer this service, such as B2B TradeCenter.

Renewal: Don't forget the biennial! 

FDA registration is not for life. It must be renewed mandatory every two years, always in even-numbered years, between October 1st and December 31st.

If you miss this renewal window, your registration is considered expired, and your products will be barred.

The Food Safety Plan

Many companies already work with the HACCP system, which is great.

However, FSMA goes further.

It introduces the concept of HARPC (Hazard Analysis and Risk-Based Preventive Controls).

The difference is subtle but fundamental. HARPC requires you to identify not only traditional risks (microbiological, chemical, physical) but also "new" risks, such as intentional adulteration (food defense), radiological risks, and hazards introduced by suppliers.

Who needs a PCQI? 

Your food safety plan must be prepared (or at least supervised) by a "Preventive Controls Qualified Individual," or PCQI.

This is not a title you give yourself. The PCQI is a professional who has completed a specific standardized training by the FDA (taught by the FSPCA).

Having a PCQI on the team, or hiring a consultancy that has one, is mandatory. They will be responsible for validating your plan, reviewing your records, and ensuring everything is working as it should.

Food Labeling for the US

Your product passed the bureaucracy, your safety plan is impeccable. Now, let's talk about the "face" of your product: the label.

Food labeling in the US is one of the main reasons products are detained at the border.

Thinking that just translating your current label from your language to English is enough is a mistake. The American regulations are completely different from yours.

The "Nutrition Facts Panel" 

The American nutrition facts panel (Nutrition Facts Panel) has undergone major changes recently. Forget the format you use.

The FDA dictates:

• Serving Sizes: They are defined by law, based on what the American actually consumes (RACC - Reference Amounts Customarily Consumed), not on arbitrary portions.
• Added Sugars: It is mandatory to separately declare the sugars that were added during the process, not just the total sugar.
• Daily Values (%DV): The reference percentages for vitamins and minerals are different from those used in Brazil.
• Design: The font size for calories, the bolding, the order of nutrients... everything is standardized.

Allergen Declaration 

The US requires the clear declaration of the "Big 9" Allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and, most recently, sesame.

The way of declaring (e.g., "Contains: Wheat, Milk.") is specific.

"Claims": Be careful what you promise 

Want to say your product is "Light," "Healthy," "Gluten-Free," "Natural," or "Organic"? 

Each of these words is a "claim" regulated by the FDA.

Saying "Low Fat" is only allowed if the product meets a specific limit of fat grams per serving. Using the term "Natural" is extremely risky and complex. "Gluten-Free" requires tests and guarantees.

Labeling is one of the most complex areas and causes the most refusals. Avoid rework, reprinting costs, and the detention of your product; consider the support of specialized regulatory consulting from B2B TradeCenter to ensure 100% compliance from the start.

Logistics: From Your Factory to the American Port

You're almost there. Your product is registered, safe, and correctly labeled. Now, how does it get there? 

Prior Notice of Importation (Prior Notice - PN) 

This is another important administrative requirement. For every shipment of food you send to the US, you must electronically submit a "Prior Notice" to the FDA.

This notice informs the FDA and CBP (Customs and Border Protection) exactly what is arriving, from whom, for whom, and when.

The PN must be submitted within a specific time window (not too early, not too late) before the cargo's arrival.

Without a confirmed PN, the cargo cannot even be unloaded.

Customs Clearance in the US (Customs) 

When your product arrives at the US port or airport, it is under the control of CBP, which works together with the FDA.

Your US Customs Broker will submit the entry.

At that moment, the FDA reviews your documents (including FDA registration, PN, and product information) and decides the status of your cargo.

They can:

• Release (May Proceed): Great! Your product moves on to the distributor.
• Hold for Exam: The FDA may decide to physically inspect the cargo or collect samples for lab analysis.
• Detention: If something is wrong (incorrect label, expired registration, suspected contamination), your product is detained.

If a product is detained, you have a short period to prove it is in compliance. If you cannot, the cargo will be refused, and you will have to destroy it or return it, bearing all costs.

Is It Worth the Effort?

Yes, exporting food to the US is a complex process.

The FDA requirements are strict. The FSMA law demands a high level of process control, and food labeling in the US allows no room for amateurism.

However, it is a 100% manageable process. Success does not depend on luck, but on preparation.

Regulatory compliance should not be seen as a barrier, but as a competitive advantage.

By being compliant with the FDA, you signal to the market that your product has a global quality standard.

Don't let bureaucracy stop your expansion. The US food market moves trillions of dollars and is waiting for your product.

If you need a partner to navigate these FDA requirements, our regulatory consulting team is ready to help turn this challenge into a success story!