Cosmetics Registration Program FAQs
Who can open an online VCRP account?
Any responsible employee from a cosmetic manufacturer, packer, or distributor can open a VCRP account. Consultants or agents cannot open accounts.
Yes. 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. However, the consultant or agent cannot enter information on behalf of a company without the company’s express permission.
There are several people in my organization that will be entering cosmetic formulations into the VCRP at the same time. Should each person have their own VCRP account?
No, each company should have only one VCRP account because you can only view and manage cosmetic formulations and establishment registrations using the account from which they were entered. If several people in your company need access to your VCRP account, they should share one account user name and password.
If I wish to participate in the VCRP, do I need to file both a Form FDA 2511 (Establishment Registration) and a Form FDA 2512 (Cosmetic Product Ingredient Statement)?
No. Although FDA encourages cosmetic firms to participate in both parts of the VCRP, participation in either is completely voluntary. If you choose to participate in the VCRP, you may choose whether to register your establishment (Form FDA 2511), file Cosmetic Product Ingredient Statements (Form FDA 2512), or both.
Any firm that manufactures or packages cosmetics may submit an establishment registration. This includes contract manufacturers or packers of a cosmetic, as well as foreign cosmetic product establishments whose products are exported for sale in the United States (21 CFR 710.1). A firm should submit an establishment registration within 30 days of beginning operations (21 CFR 710.2).
Any firm, once having registered with the VCRP, is responsible for maintaining an accurate filing with FDA. Please make changes to information submitted in your Form FDA 2511 within 30 days after the change occurs (21 CFR 710.5).
Any firm that has registered its establishment with the VCRP should discontinue the registration when an establishment has changed its name and no longer conducts business under the original name. Minor name changes or a new phone number can be made to an establishment registration by filing an amendment (21 CFR 710.5).
How will FDA acknowledge receipt of my establishment registration (Form FDA 2511) and how do I get my establishment registration numbers?
FDA will email you an acknowledgment that we have received your Form FDA 2511. You will also receive an email to let you know whether we needed clarification on any of the information you have submitted. You will be able to log into the system and view your establishment’s information, including any assigned registration numbers in the main menu.
The VCRP is intended for cosmetic products after they are in commercial distribution to consumers in the United States (21 CFR 720.1 and 720.2). Commercial distribution of a cosmetic product means annual gross sales in excess of $1,000 for that product (21 CFR 700.3(i)). Please do not enter cosmetic formulations into VCRP before they are available for sale in this country.
Do I need to file my cosmetic formulations in the VCRP in order to import them into the United States?
No. The VCRP is a voluntary program. Cosmetic registration is not required, even for imported products. However, some products that are considered cosmetics by some countries, such as sunscreens, are considered drugs in the United States, and these products must comply with the U.S. drug regulations before they can be imported into this country. You can find more information on the registration of drug products online.
Can I file formulations in the VCRP for products that are considered drugs but also have a cosmetic function?
Yes, products that are considered drugs in the United States, such as sunscreens, but also make cosmetic type claims, such as moisturizing, can be filed in the VCRP.
However, it is important to remember that if your product is either solely a drug or a drug/cosmetic combination, it is subject by law to different requirements than those for products that are solely cosmetics. These include special requirements for product listing and establishment registration (Federal Food, Drug, and Cosmetic Act, section 510), among others. Filing your formulations or registering your establishment with the VCRP does not fulfill any of your legal responsibilities for marketing drugs.
For more information, see Drug Registration and Listing and "Is it Cosmetic, a Drug, or Both? (Or is it a Soap?)."
Who should file cosmetic formulations in the VCRP (Form FDA 2512), and what if my products are made by a contract manufacturer?
Any firm, whether domestic or foreign, that manufactures, packs, or distributes cosmetics in the United States may submit a separate Form FDA 2512 in the online VCRP system for each cosmetic formulation (21 CFR 720.1).
When a product is made by a contract manufacturer and distributed by a different firm, either the contract manufacturer or the distributor can enter the formulation into the VCRP, but not both. The two companies need to decide who will enter the formulation.
My products are made by a contract manufacturer, but I don't want to enter that information into the VCRP. Can I omit the contractor information?
Yes, entering contract manufacturer information into the VCRP is optional.
Any firm, once having filed an original cosmetic formulation, is responsible for maintaining an accurate filing with FDA for that formulation. You can amend your formulation using the online VCRP system. Please submit changes to a brand name or ingredients within 60 days after beginning commercial distribution of the changed cosmetic product in the United States. Please submit other changes within one year after such changes occur (21 CFR 720.6).
Any firm, once having filed a cosmetic formulation (Form FDA 2512), should discontinue it within 180 days after the product is no longer in commercial distribution. Cosmetic formulations can be discontinued using the online VCRP system (21 CFR 720.6).
The cosmetic formulations that I previously filed in the VCRP using paper forms are not in my online account. How can I retrieve them so I can manage them?
Send an email to VCRP@fda.gov with your Cosmetic Product Ingredient Statement number(s), brand/ specific product name(s), and the name of the new online VCRP account so that we can process your request.
Some of my cosmetic products don't fit into any of the Product Categories provided. What should I do?
Select the closest Product Category available and we will review your selection. Keep in mind that products intended for use in the eye area must be entered into an eye area product category.
No, the database does not recognize CI numbers. Colors must be entered as they appear in the online dictionary in order for them to be recognized (for example, FDC Yellow #5).
What should I do if an ingredient I enter is not recognized ("Unresolved") by the VCRP, but I have entered the name I found in the International Cosmetic Ingredient Dictionary?
Submit the formulation with the unrecognized ingredient name and the VCRP editors will make any necessary corrections. However, please make every effort to look up the name of each unrecognized ingredient in the online dictionary. Searching for partial ingredient names often provides several choices for you to select from. Cosmetic formulations submitted with numerous unrecognized ingredients that are in the online dictionary will be returned to you for correction.
How will FDA acknowledge receipt of my cosmetic formulation submission and how do I get my Cosmetic Product Ingredient Statement (CPIS) numbers for the cosmetic formulations I have entered into the VCRP?
FDA will email you an acknowledgement that we have received your Form FDA 2512. You will also receive an email to let you know whether your Form FDA 2512 was filed or whether we needed clarification on any of the information you have submitted. Once you have received this information, log into the online system to view your cosmetic product information, including any assigned CPIS numbers in the main menu.
Is information entered into the VCRP publicly available if requested under a Freedom of Information Act (FOIA) request?
Most of the information in the VCRP database is currently found on your product label and is available to the public. The only time information that might not be on your product label might be entered into the VCRP database would be if your product is made by a contract manufacturer. Entering contract manufacturing information is optional, and even if it is entered, it would not be released under an FOIA request.
Please note, in late 2018, certain registration information from the VCRP, that is currently available to the public through FOIA, will be posted on the VCRP "Registration Reports" website. This will include:
- Current Form FDA 2511 registrations - cosmetic establishment name, type of establishment, and address (only city, state, zip/postal code, and country will be made public)
- Current Form FDA 2512 filings - cosmetic product name, labeler name, type of business, address (only city, state, zip/postal code, and country will be made public), product category, and ingredients
Proprietary business information and contract manufacturer information, which is not releasable under FOIA, will not be published on the VCRP "Registration Reports" website. Filers may choose to de-register or cancel their Form FDA 2511 establishments or discontinue their Form FDA 2512 formulations.