S.S.S | Can Products Without Fda Registration Be Sold In The United States?

MoCRA (Modernization of Cosmetics Regulation Act): A New Era in U.S. Cosmetics Compliance

Enacted in 2022, the Modernization of Cosmetics Regulation Act (MoCRA) introduced significant changes to the sale and marketing of cosmetic products in the United States. Under this new regulation, cosmetic products that are not registered with the FDA (Food and Drug Administration) are no longer permitted for sale in the U.S. market.

This shift marks a critical regulatory compliance process, particularly for brands exporting cosmetic products to the United States. The legal requirements apply not only to the products themselves but also to the facilities where they are manufactured or processed, which must also be registered with the FDA.

Key Requirements Introduced by MoCRA

Companies intending to market cosmetics in the United States must comply with the following obligations:

1. Facility Registration

All facilities that manufacture or process cosmetic products intended for sale in the U.S. must be registered with the FDA.

This applies to both domestic and international manufacturers.
Facility registrations must be renewed annually.

2. Product Listing

Each cosmetic product must be registered in the FDA system along with the product name, ingredient details, label information, and responsible person’s contact.

If a product’s formulation or commercial name changes, the listing must be updated accordingly.
Product listings must be renewed and updated every year.

3. Serious Adverse Event Reporting

If a serious adverse event (e.g., hospitalization, permanent damage, risk of death) related to a cosmetic product occurs, it must be reported to the FDA within 15 business days.

This responsibility lies with the designated Responsible Person.

Who Is Required to Register with the FDA?

MoCRA regulations directly apply to the following entities:
Manufacturers (both U.S.-based and foreign exporters)
Companies involved in repackaging or relabeling
Private label owners
Distributors and importers designated as the responsible party

Can You Export Products to the U.S. Without FDA Registration?

No. Products that are not fully registered with the FDA cannot legally enter or be marketed in the U.S. Non-compliant shipments detected at customs may result in:
Rejection of shipment
Destruction or return of goods
Potential penalties or sanctions against the company

Why Is MoCRA and FDA Registration Important?

These regulations aim to ensure that cosmetic products in the U.S. market are safe, effective, and transparent. For companies, MoCRA provides:
Legal compliance
Elimination of market entry barriers
Increased brand credibility

► MoCRA has redefined the conditions for selling cosmetics in the U.S. market. Compliance with FDA registration and product listing is no longer optional, but a legal necessity.

All companies—whether manufacturers or brand owners—must fulfill these obligations before exporting products to the United States.

Let Cosming Handle Your FDA Compliance Process

At Cosming, our expert team manages your FDA registration procedures and ensures your products and facilities are listed in accordance with MoCRA requirements.

Cosming'de arayın.

S.S.S | Can Products Without Fda Registration Be Sold In The United States?

MoCRA (Modernization of Cosmetics Regulation Act): A New Era in U.S. Cosmetics Compliance

1. Facility Registration

2. Product Listing

3. Serious Adverse Event Reporting

Can You Export Products to the U.S. Without FDA Registration?

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