USA market access requirements for cosmetics

To sell your cosmetics on the American market, you need to comply with American market access requirements. These requirements can vary from national legislation to common buyer preferences.


Legal requirements

In the USA, cosmetic ingredients and products are regulated under the Federal Food, Drug and Cosmetic act (FD&C Act). It does not require cosmetic ingredients and products to be approved by the FDA before entering the market. However, any colour additives must be approved for intended use. In addition, there’s a list of ingredients that is either prohibited or restricted by FDA regulations. Aside from these regulations, you are allowed to use any ingredient in your cosmetic, as long as it does not cause the product to be adulterated in any way. Overall, FDA states that cosmetics must be safe for consumers under labelled or customary conditions of use, and it should be labelled properly. You, as a supplier or manufacturer, are responsible for the product to be safe and that packaging and labelling is not misleading.

If cosmetics are marketed to consumers on a retail basis, they have to follow the ingredient labelling requirements of the Fair Packaging and Labelling Act.

Not all personal care products are regulated as cosmetics in the USA, some products are regulated as drugs. Make sure to check if your product is defined as a cosmetic or drug. In case your product is a drug under the US law, it must meet the legal requirements for drugs, such as premarket approval.

The FDA encourages cosmetic firms to register their companies and file their product formulations with the Voluntary Cosmetic Registration Program (VCRP), but registration is not mandatory. The FDA uses this information to evaluate cosmetic products on the market. Participating in the VCRP does not indicate FDA approval, and no registration number is required to import cosmetics into the United States.


Want to know more?

Would you like to know more about American market access requirements for cosmetics? You can read all about them in FDA’s Cosmetics & U.S. Law, including tips and guidance documents!

Share This