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Regulatory Compliance in the US and Canada

From our office in Europe, we help companies from all over the world export their products to the American market with agility and professionalism. If you want to export your cosmetic products to the USA or Canada to boost your business in this great market, we will accompany you in the process!

Export products to the American market

Export to the United States with guarantees

FDA and State Regulations

Cosmetic products in the United States are regulated under the regulations of the Federal and Drug Administration (FDA) and certain state and local laws.

In the US, many products that are cosmetics in other parts of the world, such as antiperspirants, toothpastes and sunscreens, are considered medications or Over the Counter (OTC) products, that is, medications without a medical prescription.

The first phase of the export process to the US is to receive good advice to classify the products and decide the correct registration route.

MoCRA. New Regulations in the US

Starting in 2024, cosmetic products must meet the following requirements in the United States:

  1. - Have a Responsible Person in the US

  2. - Mandatory product registration.

  3. - Have a complete Security Assessment (CPSR)

Additionally, manufacturers must list their facilities with the FDA through an Authorized Agent in the US.

Stay informed about the latest FDA updates

FDA releases final guidelines on registration and facility listing of cosmetic products.

Below we will leave you the main aspects of the FDA Final Guidance

FDA / MOCRA

Cosmetic Regulation and OTC Products

Cosmetic products

Under FDA regulations and other State regulations.

OTC PRODUCTS

Under FDA regulations and US State regulations

Export Services and International Regulation

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