Information on the new cosmetics law in the USA

In the USA, President Biden passed a new law for cosmetic products at the end of 2022: MoCRA (Modernisation of Cosmetics Regulation Act). Read here what this means for us and our customers.

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Modernisation of Cosmetics Regulation Act

The requirements for cosmetic products on the US market are now similar to EU cosmetics legislation:

  • Registration of products and manufacturing facilities with the FDA (Product Listing, Facility Registration),
  • Appointment of a person responsible to the authorities (Responsible Person),
  • Preparation of a safety report for the products (safety substantiation),
  • Production under GMP conditions,
  • Recording and reporting of adverse effects (Adverse Event Reporting).

Whether there will be mutual recognition, e.g. for European product safety reports or GMP certification in accordance with ISO 22716, remains to be seen.

This does not affect the previous regulation that certain products (e.g. sun protection products) are categorised as OTC pharmaceuticals in the USA and therefore require a significantly higher regulatory effort.

The following FRIKE Group sites fulfil these high requirements: Glaropharm is FDA-Pharma certified, FRIKE Pharma AG in Mönchaltdorf is working on finalising certification as soon as possible.

All "normal" cosmetic products under MoCRA must be registered in the USA from 1 July 2024 and fulfil the above requirements. Registration of the associated production facility is also important for product registration. Our cosmetics plant FRIKE Cosmetic AG in Ebnat-Kappel has the necessary facility registration with the FEI number (FDA Establishment Identifier).

For representation in the USA, the FRIKE Group works with Michael Pfeiffer (Pfeiffer Consulting) and Claire Bing (Confiance Cosmetic). We will be happy to put you in touch with them.

The FRIKE Group is the right partner if you want to distribute cosmetic products in the USA.

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