Last December 2022, the US Congress passed the Modernization of the Cosmetic Act, known as MoCRA, which changes the regulatory landscape for cosmetic products in the US.
In March 2023, the FDA rescinded all previous registrations of cosmetic products made in the Cosmetic Voluntary Registration Program, making new registrations of all cosmetic products required and mandatory in the new MoCRA portal, available in October 2023.
In order to register cosmetic products, companies must indicate the manufacturers FEI number in the registration process.
FEI, or FDA Establishment Identifier, is the registration number that a manufacturer obtains when it is registered with the FDA. Until now, FEI registration number was only required for drug, medical device and food manufacturers. From now on, the FEI number is also required for cosmetics manufacturers.
To register with the FDA and obtain the FEI number cosmetic manufacturers must have an US Agent I means, a natural or legal person established in the USA who will be in charge of submitting the documentation and will act as a main contact between the FDA and the companies.
Each facility where manufacturers carry out manufacturing activities (manufacturing, packaging, storage) must have a different EIF number, in case activities are carried out in different production centers.
Products that do not have a registered manufacturer with a valid EIF number cannot be registered in the U.S. market and therefore cannot be sold in the country as of December 29, 2023.
Therefore, all cosmetic manufacturing companies have to legalize their status in the U.S. before this date.
Belab Services LLC, based in Miami (Florida) provides manufacturers the service of US Agent for registration and obtention of the FEI number of their facilities.
For more information, do not hesitate to contact us.
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