FDA Registration for United States

The legal authority that regulates cosmetic products in the United States is the US Food and Drug Administration (FDA). In order to sell a cosmetic product in the US, federal cosmetic regulations that apply to all US States must be taken into account. The two main federal laws that apply to cosmetic products in the US are:

– Federal Food, Drug and Cosmetic Act (FD&C Act),
– Fair Packaging and Labelling Act (FPLA),

In addition to this, it is important to note that there are many state provisions to consider, such as California Proposition 65 (Prop 65).
On December 29, 2022, the U.S. President signed into law the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), a long-awaited reform of U.S. cosmetics regulation. MoCRA is the biggest change to the Food, Drug, and Cosmetic Act since 1938. This new legislation will affect all companies that manufacture, distribute, and import cosmetics in the U.S. Some of the key changes brought about by MoCRA include:

* FDA registration is mandatory for cosmetic facilities,
* Mandatory product listings for cosmetic products marketed in the US,
* Compliance with Good Manufacturing Practices (GMPs will be published by FDA),
* Declaration of fragrance allergens on labels,
* Labeling requirements for professional use products,
* Labeling of Responsible Person contact information,
* To keep records of security verifications and documentation,
* Notification of adverse events to FDA and recall authorization,
* Phasing out animal analysis.

As Omni Danışmanlık, we can provide services by supporting you with mandatory processes such as Responsible Person, product listing, facility registration, US Agent, product safety verification, labeling and ingredient evaluation for cosmetic products that you want to sell in the US.