“FDA certification” for exporting to the USA: what does it really require?

Written by admin on September 30, 2026. Posted in GUIDE, news.

Category: Guide
Verification of sources: September 30, 2026

Do I need FDA certification to sell in the United States?” This is a reasonable question, but it contains a misunderstanding: there is no single FDA certification that authorizes any company to export any product to the USA.

For food and cosmetics, speaking generally about certification can confuse different requirements: plant registration, appointment of a US Agent, shipment communications, specific registrations, and label compliance. The path depends on the product, who produces it, and the structure of the import.

Registration and approval are different things

Registration places a facility on the FDA’s systems when required by law. It does not mean that FDA has approved the products, verified all labels, or certified the company’s quality.

The FDA clarifies that, in general, it does not pre-approve individual food importers, products, labels, or shipments. In cosmetics, registration and product listing do not equate to product approval. Instead, there are different processes for drugs, medical devices, and other categories: this guide focuses on food, beverages, and cosmetics.

A document issued by a private consultant does not therefore become an official certificate from the American authorities. Before purchasing a “certification”, it is necessary to understand what practice will actually be carried out.

Food and beverages: registration of the establishment

Facilities that produce, process, package, or hold food intended for consumption in the USA generally must register, subject to applicable exemptions. The requirement applies to the structure and activities of the facility: not every entity that markets a food must necessarily register.

The name, address, activity, food categories, and unique identifier of the establishment must be checked. FDA currently recognizes the DUNS number as an acceptable identifier for this registration. Inconsistent data may require further verification.

Food registration requires renewal every even number of years. The 2026 window runs from October 1st to December 31st. The FDA reminded on September 29 that an unregistered product will be considered expired. The FDA does not charge a registration or renewal fee; any professional fees and the US Agent service are separate costs.

US Agent: a precise reference, not all import roles

An overseas food facility subject to registration must designate a US Agent resident or with operations in the United States. Their role involves liaising with the FDA for the registered facility.

The US Agent does not automatically become an importer, distributor, customs broker, or FSVP responsible party. Before shipping, it is necessary to separately assign these responsibilities and verify who has actually accepted them.

When applicable, the Foreign Supplier Verification Program requires the FSVP importer to verify the foreign supplier and the risks of the food. The role is determined by the regulations and the situation at the time the goods enter; the mere appointment of a US Agent for registration does not absolve them.

Prior Notice: a compliance related to shipping

For imported foods subject to the regulations, FDA must receive the Prior Notice before arrival, following applicable procedures and timelines. There are exemptions that must be evaluated on a case-by-case basis.

The Prior Notice concerns shipment and does not replace registration of the establishment. A valid registration, in turn, does not replace communications regarding incoming goods. Exporters, importers, and logistics intermediaries must coordinate so that information and documents are consistent.

Some foods require additional practices

Not all foods follow the same path. Certain acidified foods and low-acid foods stored in airtight containers require specific registration of the processing and storage facilities, in accordance with the AF/LACF regulations.

Therefore, it is not enough to look at the trade name or the container: the formulation, process, and characteristics of the product are decisive. Other sectors, such as juices and fish products, have specific requirements. Wine and spirits may also require TTB compliance; for products under USDA jurisdiction, it is necessary to check the relevant regulations.

Labels: compliance, not a generic FDA approval

For foods that the FDA does not pre-approve labels for. The responsibility of complying with applicable requirements remains with the operators.

The verification can concern the labeling, ingredients, allergens, net quantity, nutritional information, responsible party, and commercial claims. Translating the European label into English does not guarantee American compliance. Any nutritional exemptions must also be carefully evaluated: they do not automatically eliminate the other obligations.

Cosmetics: the MoCRA route

For cosmetics, the MoCRA provides specific requirements, including registration of establishments and product listing, with exemptions and responsibilities to be verified. The renewal of cosmetic establishments follows its own biennial deadline: it should not be confused with the October–December window for food registration.

Safety, labeling, management of adverse events, and the role of the Responsible Person must also be evaluated. On September 9, 2026, the FDA reiterated that it does not issue certificates to demonstrate compliance with the registration of cosmetic establishments or the product listing.

The classification comes before the practices: composition, intended use and claim can also classify a product under the discipline of medicines.

Frequently asked questions about “FDA certification”

Is there a mandatory FDA certificate for exporting food to the United States?

There is no universal FDA certificate for exporting food to the USA. It is necessary to verify the obligations applicable to the product and operators: establishment registration, US Agent, Prior Notice, label compliance, and, when required, specific practices. Registration does not equate to FDA approval of the product; any private certifications are not official FDA-certified.

Does the US FDA Agent coincide with the FSVP importer?

Not automatically. The US Agent listed in the food registration is the US representative of the facility for contact with the FDA. The FSVP importer has separate responsibilities for verifying the foreign supplier, when applicable. The same entity can perform both roles if the conditions are met, but merely being appointed as US Agent is not enough.

Does the FDA registration replace the Prior Notice and the label verification?

No. The registration concerns the establishment; the Prior Notice concerns food shipments subject to the relevant regulations; the verification of labels concerns the information required about the product. These are separate obligations. However, a registered establishment may still export non-compliant goods if labels, shipping details, or other applicable requirements are incorrect.

Do cosmetics require the same FDA registration as food products?

No. Cosmetics follow the MoCRA process, with registration of establishments and product listing when applicable, as well as safety obligations and other responsibilities. Any exemptions must be verified. The October–December feed window does not determine cosmetic renewal. Registration and listing do not equate to FDA approval and do not entitle you to an official certificate of compliance.

Do you want to understand which practices are necessary for your project? Fill out the questionnaire on the page Link2America's FDA compliance practices for a preliminary assessment. For cosmetics, also consult the service Registration of cosmetics USA MoCRA from the services section.

General informational content, updated as of September 30, 2026. The obligations depend on the product, activity, involved parties, and any exemptions; it does not constitute legal advice or an assessment of the compliance of each product.

Where to start

Before exporting, prepare product sheets, composition, labels, plant data, and information about the importer and the sales channel. These elements allow identifying the applicable obligations and the professionals to be involved.

Do you want to understand which practices are necessary for your project?

Fill out the questionnaire on the page Link2America's FDA compliance practices for a preliminary assessment.

For cosmetics, please also consult the service Registration of cosmetics USA MoCRA from the services section.