Trade implications of MOCRA regulation for exporting and selling cosmetic products to the U.S.

From 2024, the export of cosmetic products to the U.S. can only be through a local importer registered with the FDA.

In fact, on December 29, 2023, MOCRA [Modernization of Cosmetics Regulation Act], the new regulation governing the import and marketing of cosmetics in the U.S. market, came into effect.

One of the requirements imposed by MOCRA concerns the requirement to register with the FDA of companies producing cosmetic products for the U.S. market. In addition to the manufacturer, U.S. importers must also register with the FDA, and the products to be imported [name, ingredients, company name of manufacturer] must also be included in the FDA registration.

What are the commercial implications of this new registration requirement under MOCRA/FDA? In fact, the export of cosmetic products to the U.S. is no longer free but can only be done through a U.S. importer registered with the FDA and who, within his corporate registration, has also included our cosmetic products to be imported to the U.S.

This is similar to what has already occurred for food products when, starting in 2026, the FDA required to import through importers who also agree to act as FSVP Agents. The business implications for cosmetics companies are not insignificant because replacing or adding an importer for the U.S., if necessary, could be not so obvious or fast.

What is the best solution to this? The opening of a U.S. company. At that point, your U.S. subsidiary will register with the FDA as the importer of cosmetic products for the U.S. market, and you will no longer need to depend on an outside importer to sell your cosmetic products in the U.S.