If you are planning to export products to the United States, it is essential to understand which type of FDA registration is required depending on the product you intend to ship. In this article, we explain the most common FDA registrations so you can identify which one applies to your business.
This registration applies to facilities that manufacture, process, pack, or hold food intended for human or animal consumption in the United States.
Products that require this registration include:
processed foods, dietary supplements, beverages (alcoholic and non-alcoholic), food ingredients, and pet food.
This registration is mandatory. Without it, your products may be refused entry, detained, or destroyed at U.S. customs.
Applicable to manufacturers, repackers, relabelers, and distributors of medical devices.
Examples include: thermometers, diagnostic tests, implantable devices, and medical equipment.
Cosmetics Registration under MoCRA (Modernization of Cosmetics Regulation Act of 2022)
As of December 2023, cosmetics registration with the FDA is mandatory for many companies. Under MoCRA, cosmetic manufacturers and importers must:
Products covered include: makeup, body creams, shampoos, conditioners, fragrances, cosmetic soaps, and similar products.
The purpose of MoCRA is to ensure that cosmetics marketed in the United States are safe and properly regulated. Failure to comply may result in penalties or product detention at customs.
This registration applies to manufacturers and importers of both over-the-counter (OTC) and prescription drugs.
Examples include: pain relievers, cough syrups, and pharmaceutical creams.
Biological Products Registration
Intended for companies that develop products such as vaccines, plasma derivatives, blood products, or biotechnology-based products.
This is one of the most stringent FDA registrations, requiring extensive technical documentation and strict regulatory compliance.
Tobacco and Vaping Products Registration
Manufacturers and importers of products such as cigars, cigarettes, electronic cigarettes, vapes, and vaping liquids must be registered with the FDA.
The products mentioned above are general examples. In practice, the required FDA registration depends on the productâs composition, intended use, and function.
In addition, you may need to meet other FDA requirements, such as:
Without the proper registration, products may be detained, refused entry, destroyed, or returned. Companies may also face penalties and lose credibility in the U.S. market. Many buyers, distributors, and e-commerce platforms require proof of FDA compliance before commercializing products.
If you are unsure which FDA registration applies to your product or how to comply with U.S. regulatory requirements, CORE Consulting can guide you step by step to ensure a smooth, compliant, and successful export process.
Contact us and enter the U.S. market with confidence.
If you are planning to export products to the United States, it is essential to understand which type of FDA registration is required depending on the product you intend to ship. In this article, we explain the most common FDA registrations so you can identify which one applies to your business.
This registration applies to facilities that manufacture, process, pack, or hold food intended for human or animal consumption in the United States.
Products that require this registration include:
processed foods, dietary supplements, beverages (alcoholic and non-alcoholic), food ingredients, and pet food.
This registration is mandatory. Without it, your products may be refused entry, detained, or destroyed at U.S. customs.
Applicable to manufacturers, repackers, relabelers, and distributors of medical devices.
Examples include: thermometers, diagnostic tests, implantable devices, and medical equipment.
Cosmetics Registration under MoCRA (Modernization of Cosmetics Regulation Act of 2022)
As of December 2023, cosmetics registration with the FDA is mandatory for many companies. Under MoCRA, cosmetic manufacturers and importers must:
Products covered include: makeup, body creams, shampoos, conditioners, fragrances, cosmetic soaps, and similar products.
The purpose of MoCRA is to ensure that cosmetics marketed in the United States are safe and properly regulated. Failure to comply may result in penalties or product detention at customs.
This registration applies to manufacturers and importers of both over-the-counter (OTC) and prescription drugs.
Examples include: pain relievers, cough syrups, and pharmaceutical creams.
Biological Products Registration
Intended for companies that develop products such as vaccines, plasma derivatives, blood products, or biotechnology-based products.
This is one of the most stringent FDA registrations, requiring extensive technical documentation and strict regulatory compliance.
Tobacco and Vaping Products Registration
Manufacturers and importers of products such as cigars, cigarettes, electronic cigarettes, vapes, and vaping liquids must be registered with the FDA.
The products mentioned above are general examples. In practice, the required FDA registration depends on the productâs composition, intended use, and function.
In addition, you may need to meet other FDA requirements, such as:
Without the proper registration, products may be detained, refused entry, destroyed, or returned. Companies may also face penalties and lose credibility in the U.S. market. Many buyers, distributors, and e-commerce platforms require proof of FDA compliance before commercializing products.
If you are unsure which FDA registration applies to your product or how to comply with U.S. regulatory requirements, CORE Consulting can guide you step by step to ensure a smooth, compliant, and successful export process.
Contact us and enter the U.S. market with confidence.
