How to Register with the FDA?

22/09/2025 By Luana Oliveira 4 Minutos

Contents

Registration with the Food and Drug Administration (FDA) is essential for exporting various types of products to the United States. Establishments must register and identify the type of products or list the products, as well as comply with other obligations, such as prior notice of shipment.

The U.S. is one of the largest importers of products in the world and imports of food, beverages, supplements, medical devices and drugs are regulated by the FDA. This agency is responsible for ensuring that these items are safe, effective, and properly labeled. Each segment has its own particularities for registration. Understanding them is essential so that products exported to the country are not rejected at the time of shipment.

In addition to FDA registration, foreign exporters must also meet other requirements, such as sending a prior notice, and, in all cases, designating an agent in the U.S.

How is the U.S. Market for Foreign Products?

In several segments, there are huge sales opportunities for foreign companies that comply with regulatory requirements:

Food and beverages represent an important portion of U.S. imports.
Dietary supplements have been gaining ground with the demand for health and wellness.
Medical devices and drugs are more regulated sectors, but they hold potential for companies that offer technology, quality, and safety certifications.

FDA Registration by Segment

FDA Registration for Food

Registration of manufacturers, processors, packers, and storers in the FDA Industry Systems (FIS), renewed every two years.
Mandatory designation of a U.S. agent by foreign establishment.
Mandatory prior notice of shipment.
Labeling in English, with nutritional information and compliance with ingredient and production requirements.

Specific cases:

LACF/AF: low-acid canned foods and acidified foods need an FCE number and scheduled processes.
HACCP: required for seafood and juice.

FDA Registration for Beverages

Non-alcoholic: follow the same rules as food.
Alcoholic beverages: must follow Alcohol and Tobacco Tax and Trade Bureau (TTB) rules and FDA requirements, including labeling standards and permitted ingredients.
Mandatory designation of a U.S. agent by foreign establishment.

FDA Registration for Dietary Supplements

Classified as food but with specific requirements.
Labeling in the Supplement Facts format.
Ingredients must be safe and, where applicable, listed as GRAS.
Restricted health claims; only structure/function claims are allowed, with a disclaimer.
Compliance with Good Manufacturing Practices (GMP) is mandatory.
Mandatory designation of a U.S. agent by foreign establishment.

FDA Registration for Cosmetics

Under MoCRA, mandatory requirements include facility registration, product listing, and designation of a Responsible Person in the U.S. for all companies not defined as small businesses.
Mandatory English labeling, with ingredient list in descending order.
Prohibition of restricted or banned ingredients.
Claims cannot suggest a therapeutic effect, or the product risks reclassification as a drug.
Mandatory designation of a U.S. agent by foreign establishment.

FDA Registration for Medical Devices

Company registration (Establishment Registration) and device listing.
Classification (Class I, II, or III) defines regulatory requirements.
Some devices require 510(k) clearance or PMA approval before marketing.
Mandatory designation of a U.S. agent by foreign establishment.

FDA Registration for Drugs

Company registration (Drug Establishment Registration) and listing of all products.
Prescription products require a New Drug Application (NDA) or an Abbreviated NDA (ANDA) for generics.
Over-the-counter (OTC) products must follow specific monographs.
Labeling in the Drug Facts Panel format.
Mandatory designation of a U.S. agent by foreign establishment.

Oversight and Compliance

The FDA conducts inspections, collects samples, and verifies compliance with labeling and safety standards. Actions include:

Field exams: at ports, warehouses, transport, and borders.
Laboratory analysis: to verify safety, composition, and labeling.
Document review: to confirm registration, licenses, and production processes.

Reasons for oversight include a history of violations, product risks, and routine inspections.

Consequences of Non-Compliance

Failure to register or comply may result in:

Refusal of admission at the port of entry.
Seizure and destruction of goods.
Fines and legal actions.

Conclusion

Exporting to the U.S. requires more than just a quality product. It is necessary to meet all FDA requirements and have a U.S. agent to ensure entry into the American market.

The B2B TradeCenter is a company specializing in compliance with FDA regulations, assisting with all types of products imported into the U.S. This includes food, beverages, supplements, cosmetics, medical devices, and drugs.