Cosmetics firms often have questions about FDA's Voluntary Cosmetic Registration Program (VCRP). Here some frequently asked questions and FDA's answers:
- Who can open an online VCRP account?
- Can I have a consultant enter cosmetic products into the VCRP for me?
- 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?
- 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)?
- Who should submit an original establishment registration (Form FDA 2511), and when?
- Who should submit amendments to an establishment registration (Form FDA 2511), and when?
- Who should cancel an establishment registration, and when?
- How will FDA acknowledge acceptance of my establishment registration (Form FDA 2511) submission and how do I get my establishment registration numbers?
- When can I begin entering my cosmetic formulations into the VCRP?
- Do I need to file my cosmetic formulations in the VCRP in order to import them into the United States?
- Can I file formulations in the VCRP for products that are considered drugs but also have a cosmetic function?
- Who should file cosmetic formulations in the VCRP (Form FDA 2512), and what if my products are made by a contract manufacturer?
- 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?
- Who should submit amendments to a cosmetic formulation (Form FDA 2512), and when?
- Who should discontinue a cosmetic formulation, and when?
- The cosmetic formulations that I previously filed in the VCRP using paper forms are not in my online account. How can I get them moved so I can manage them?
- Some of my cosmetic products don't fit into any of the Product Categories provided. What should I do?
- Can I include the Color Index (CI) number when entering color additives into the VCRP?
- 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?
- How will FDA acknowledge acceptance of my cosmetic formulation submission?
- How do I get my Cosmetic Products Ingredient Statement (CPIS) numbers for the cosmetic formulations I have entered into the VCRP? I have entered several cosmetic formulations into the VCRP and I still can't see them in my Active folder.
- Is information entered into the VCRP publicly available if requested under a Freedom of Information (FOI) request?
Any responsible employee from a cosmetic manufacturer, distributor, or contract manufacturer 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.
No, each company should have only one VCRP account because you can only view cosmetic formulations and establishment registrations using the account from which they were entered.. If your company has multiple VCRP accounts, you will not be able to manage all of your formulations and establishments from a single account. If several people in your company need access to your 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.
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). Submit a minor name change (such as changing "Co." to "Inc."), type of business (manufacturer or packer), trading name, email address, or a new phone number as an amendment
For a major name change or a new address, however, please inform FDA in writing on company letterhead, addressed to Voluntary Cosmetic Registration Program, HFS-125, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835.
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).
FDA will let you know whether your submission was accepted by e-mail, usually within seven business days. You then will be able to login to the system and view your establishments and registration numbers in your Active folder. You also will be able to print out your establishment information, including your establishment registration numbers.
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) Please do not enter them before they are available for sale in this country.
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.
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?)."
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.
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 discontinuance of commercial distribution of the product. Cosmetic formulations can be discontinued using the online VCRP system (21 CFR 720.6).
In order to see the formulations in the VCRP database that you previously filed using paper forms, select the "Transfer My Formulations" link after you log into the VCRP. You will be prompted to enter information that will verify that the cosmetic formulations belong to you. Once we are assured that they belong to you we will transfer them to your online account.
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).
Submit the formulation with the unrecognized ingredient 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.
FDA will send you an email once your submission has been accepted. You can then use the online system to activate your formulation and to generate an official receipt. You will need to activate each formulation in order to view, amend, or discontinue a formulation that you have filed.
How do I get my Cosmetic Products Ingredient Statement (CPIS) numbers for the cosmetic formulations I have entered into the VCRP? I have entered several cosmetic formulations into the VCRP and I still can't see them in my Active folder.
After we have processed a cosmetic formulation that you submitted, a link will appear above your folders to the page where you can activate the formulations we have accepted. Follow the link, open each of the formulations, and activate them by selecting the Activate button. A receipt will also appear that includes your CPIS number. You should print out and file this receipt for your records.
For the most part, yes. However, most of the information in the VCRP database is 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 FOI request.