FAQ: Cosmetic Product Facility Registration & Product Listing
WHAT IS THE FDA COSMETIC PRODUCT FACILITY REGISTRATION REQUIREMENT?
Beginning in 2024, the FDA requires every person that owns or operates a facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States” to register each facility with the FDA.
WHAT IS THE FDA COSMETIC PRODUCT LISTING REQUIREMENT?
Also beginning in 2024, FDA requires a cosmetic product listing for each cosmetic product.
WHEN MUST FACILITIES REGISTER?
For facilities operating on December 29, 2022, facility registrations must be registered no later than December 29, 2023.
For facilities that first operate after December 29, 2022, facility registrations must be submitted within 60 days of first engaging in activity or by February 27, 2023, whichever is later.
WHEN MUST PRODUCT LISTINGS BE MADE?
For products marketed on December 29, 2022, cosmetic product listings must be submitted no later than December 29, 2023.
For products first marketed after December 29, 2022, cosmetic product listings must be submitted 120 days of marketing the product, or within 120 days of December 29, 2023, whichever is later.
Product Listing must be updated annually. This includes notification that the product was discontinued.
WHAT BUSINESSES ARE SUBJECT TO THE REGISTRATION & PRODUCT LISTING REQUIREMENTS?
Every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States is subject to the registration and listing requirements.
WHAT BUSINESSES ARE EXCLUDED FROM THE REGISTRATION AND PRODUCT LISTING REQUIREMENTS?
- “Small Businesses” as defined in section 612 of the FD&C Ac: responsible persons, and owners and operators of facilities, whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the following cosmetic products:
- Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual;
- Cosmetic products that are injected;
- Cosmetic products that are intended for internal use; or
- Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
Contact us if you need assistance determining if your business falls under the FDA’s definition of “Small Business.”
- A facility or cosmetic product that is also subject to the requirements in chapter V of the FD&C Act (for drugs and devices) unless the facility also manufactures or processes cosmetic products that are not subject to the requirements of chapter V of the FD&C Act (see section 613 of the FD&C Act).
- Facilities that solely manufacture cosmetic products that are also drugs are not subject to these requirements. Likewise, products that are also drugs are not subject to these requirements.
- Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location;
- Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of the Internal Revenue Code of 1986), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location; (iii) Hospitals, physicians’ offices, and health care clinics;
- Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer;
- Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services;
- Trade shows and other venues where cosmetic product samples are provided free of charge;
- An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale;
- An establishment that solely performs one or more of the following with respect to cosmetic products:
HOW SHOULD CONTRACT MANUFACTURERS FULFILL THE REGISTRATION REQUIREMENT?
If a facility manufactures or processes cosmetic products on behalf of a responsible person (i.e., a contract manufacturer), only a single registration is required for such facility even if the facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Under this approach, an owner or operator of a contract manufacturing facility would not register such facility if the responsible person submitted the facility registration.
IS THIS REQUIRED FOR COMPANIES WHO PARTICIPATED IN FDA’S VOLUNTARY COSMETIC REGISTRATION PROGRAM?
Information from the voluntary registration program will not be transferred, and so participation in the voluntary registration program will not be sufficient to meet the new requirement. All affected businesses will need to submit a new product facility registration and cosmetic product listing.
WHAT INFORMATION IS NEEDED FOR A FACILITY REGISTRATION?
Information on the initial registration includes:
- the name of the owner and/or operator of the facility
- the facility’s name, physical address, email address, and telephone number
- with respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact information (email);
- the facility registration number, if any, previously assigned
- all brand names under which cosmetic products manufactured or processed in the facility are sold;
- the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility;
- type of submission (initial, amended, biennial renewal, or abbreviated renewal, for further information see discussion in section III.F.1).
- parent company name (if applicable)
- facility DUNS Number (optional)
- additional contact information for individuals associated with the registration. (Optional)
WHAT INFORMATION IS NEEDED FOR A PRODUCT LISTING?
A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents. Information to be submitted in a cosmetic product listing includes:
- the facility registration number of each facility where the cosmetic product is manufactured or processed;
- the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
- the applicable cosmetic category or categories for the cosmetic product
- a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient;
- the product listing number, if any previously assigned
- type of submission (initial, update to content (annual), abbreviated renewal).
- parent company name (if applicable)
- type of business (as listed on the label), i.e., manufacturer, packer, or distributor;
- image of the label
- product webpage link
- whether the cosmetic product is for professional use only;
- responsible person DUNS Number for address listed on product label
- Unique Ingredient Identifiers (UNIIs)
- additional contact information for individuals associated with the listing.
WHAT IS A US AGENT?
Foreign cosmetic facilities must designate a U.S. agent for communication with the FDA. This must be a person, partnership, corporation or association who has a place of business or residence and is physically present in the United States. The U.S. Agent serves as a communication link between the FDA and the foreign facility.
WHAT IF A FACILITY FAILS TO REGISTER OR RENEW?
If a foreign facility is required to register but fails to do so, cosmetics from the facility will be subject to refusal by the FDA or CBP.