The US Food and Drug Administration (FDA) regulates cosmetic products under the Federal Food, Drug, and Cosmetic Act. While the law does not require that cosmetic products or ingredients (with the exception of colour additives) have FDA approval prior to entering the market, the FDA highly recommends registration through the Voluntary Cosmetic Registration Program (VCRP).  Some products on the cosmetic/drug industry may actually be Over-the-Counter drugs. EcoMundo can help you classify your product as a drug or cosmetic. 

Enregistrer des cosmétiques aux USA : Voluntary Cosmetic Registration Program (VCRP)

How are cosmetics registered?

In the United States, cosmetic products are not subject to Food and Drug Administration (FDA) premarket approval. Instead, the Voluntary Cosmetic Registration Program (VCRP) allows for registration of cosmetic products. The VCRP is not a cosmetic approval program or a promotional tool. It is the firm's responsibility to ensure that its cosmetic products and ingredients are safe, properly labelled, and in full compliance with the law.

VCRP registration is only applicable for cosmetics being sold to consumers. Products that are for professional use only, or products that are not for sale (such as hotel samples) need not be registered.

How do I register my product under VCRP?

In order to register a cosmetic product, a company must first open a VCRP account with the FDA. Once a VCRP account is activated registration can be divided into two steps:

  1. The online VCRP system is used to file an establishment registration (FDA Form 2511)

  2. The online VCRP system is used to file a Cosmetic Product Ingredient Statements (CPIS) for each product formulation (FDA Form 2512)

EcoMundo can assist you in registering your establishment, and can prepare and file the CPIS for your products.

The VCRP account

Who can open a VCRP account?

Any owner or operator from a cosmetic manufacturer, packer, or distributor can open a VCRP account. This can be done through a request on the FDA website.

Please note that consultants or agents cannot open accounts on behalf of their clients.

If a company chooses to have a consultant or agent enter data into the VCRP on its behalf, the company can open an account and provide the consultant or agent with the username and password. The consultant can then enter cosmetic formulations and establishments into the VCRP database.

How many VCRP accounts should be initiated?

Each company should have only one VCRP account. Cosmetic formulations and establishment registrations can only be viewed using the account from which they were entered. If several people need access to a VCRP account, they should share one account user name and password. There is no limit to the number of people who can work in the database at the same time from the same account.

If a product is made by a contract manufacturer, but distributed by a different firm, either the contract manufacturer or the distributor can register the product, but not both. The two establishments need to decide who will register the formulation.

Who should submit an establishment registration?

Any firm that manufactures or packages cosmetics may submit a VCRP establishment registration. This includes contract manufacturers or packers, as well as foreign establishments whose products are exported to be sold in the United States (21 CFR 710). An establishment registration should be submitted within 30 days of beginning operations.

When should a cosmetic product be registered?

Cosmetic products should be registered after they are in commercial distribution in the United States. Commercial distribution of a cosmetic product means that annual gross sales are in excess of $1,000 for that product. Cosmetic formulations should not be entered into VCRP before they are available for sale in the United States (21 CFR 720).

Want to know more about the cosmetic regulation in the United States?

For more information on EcoMundo's services and software for your compliance in North America, do not hesitate to contact our expert, Mr. Michaël Sommeil by phone at : +1 (514) 575-6085 or even send him an email at [email protected]

Related articles

vignette blog

OTC drug registration in the US

An Over-the-Counter (OTC) drug is a product that is generally safe and effective for use without seeking help from... Read more

vignette blog

OTC drug, cosmetic, or both?

There can be a fine line between when a product is considered a Cosmetic, an Over-the-Counter drug, or both. It is... Read more

vignette blog

How to substantiate your cosmetic claims?

Claims are usually considered as the most powerful tool of the marketing process of your cosmetic product. It... Read more

  Post a comment

Post a comment

Our teams are available to answer any and all enquiries you might have.

Filtered HTML

The comment language code.

We use cookies to ensure that you have the best possible browsing experience on our website. Learn more