Cosmetic Product Registration
MoCRA: This information is applicable to: All Cosmetic Manufacturers
Under the new MoCRA requirements, if your business is not exempt as a small business, you must register all the products you make with the FDA.1
Who is responsible for product registration?
The "responsible person"2 is the person or company named on the label.
If you are making and selling the product, then your business name and address should be listed on the label. You are the person responsible registering your products.
If you make cosmetic products for someone else to sell under their own label, then their business would be on the label. Even though the product label should say "Manufactured for ..." or "Distributed by ..." and it's clear that they didn't actually make the product, they would still be responsible the product registration. However, it all likelihood, if you are making the products for them, you would do the product registration.
The same holds true you if buy cosmetic products and then sell them under your own label. If your business name and address are on the label, then you would be responsible for the product registration if the manufacturer didn't do it for you.
Is there a fee to register?
What information is required in the product registration?
First, before registering the product, you need to register the facility in which the product is made.
Once you have the facility registered, you’ll need the following info for each product you are going to register:3
- The facility registration number. This will be the FEI number, which you need to get before registering the facility.
- Name and contact number for the responsible person (that’s the person or business listed on the product label)
- Name of the cosmetic product as it appears on the label.
- The applicable cosmetic category or categories (see FDA Cosmetic Product Categories) for the product.
- List of ingredients in the product, including fragrances, flavors, or colors, identified by the name as it is required in the ingredient declaration or by the common or usual name of the ingredient.
- Product listing number (if one was previously assigned)
- Type of submission (initial, update to content (annual), abbreviated renewal).
- Requested, but optional, information:
- Parent company name (if applicable)
- Type of business as listed on the label (manufacturer, packer or distributor)
- Image of the label
- Product webpage link
- If the product is for professional use only
- Responsible entity’s DUNS number4 (if any)
- Unique Ingredient Identifiers (UNIIs)
- Additional contact information
When your product is registered it will receive a product listing number.
Is the information in the listing public?
Some, but not all, of the information is public or available through a Freedom of Information Request. The FDA will not disclose the product listing number or information on the brands that are manufactured in a facility.
Can I combine listings for similar products?
You can submit one listing for multiple cosmetic products that have the same formulation but differ only in color, fragrance, flavor, or quantity of contents.
In other words, if you have a lotion that has the same formulation but comes in five different scents, three different colors, and two different sizes for each, they can all be included in the same product listing.
How do I submit a registration?
The FDA is in the process of creating the registration portal. When it is completed, you will be able to submit your registration on-line.
When does it go into effect?
If the product was on the market as of December 29, 2022, you will be able to register your facility by December 29, 2023. FDA will not be enforcing registration until July 1, 2024.
If you started making the product after December 29, 2022, you will be able to register your facility by December 29, 2023. FDA will not be enforcing registration until July 1, 2024.
If you start making a product after July 1, 2024, it must be registered within 120 days of when it enters interstate commerce.5,6
Does the registration have to be renewed?
Once registered, your product registration should be updated annually.7 If there aren’t any changes to the product registration, there will be a shorter process for renewing.8
Additional information may be found in the Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (Draft) and Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing published on the FDA website.
1 21 USC 364c(c)(1) and 21 USC 364h(a)
2 In legal terms, a “person” could be either a real person or a business entity such as an LLC, corporation or partnership.
3 21 USC 364c(c)(4)
4 Data Universal Numbering System (DUNS) number is a unique non-digit identification number provided by Dun & Bradstreet. See What is a DUNS Number?
5 21 CFR 364c(c)(2)
6 Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
7 21 USC 364c(c)(2)
8 21 USC 364c(c)(3)