U.S. Cosmetics Registration Guidelines

As a giant in the cosmetic industry, the U.S. is in the spotlight with every update to its cosmetic regulations. The FDA released final guidance on cosmetic facility and product listing and launched a new cosmetic portal, Cosmetic Direct. Additionally, the FDA announced that cosmetic facility registration and product listing requirements are officially mandatory starting July 1, 2024. In this article, we summarize the key points of registration of cosmetic products in the U.S. based on the FDA's final guidance.

U.S. Cosmetics Category

U.S. regulation defines a cosmetic as an article used on the human body by applying, spreading, spraying, or other means to cleanse, beautify, promote attractiveness, or alter appearance.

Specifically, U.S. cosmetics include skin moisturizers, perfumes, lipsticks, nail polishes, eye and face cosmetics, cleansing shampoos, perms, hair dyes, and deodorants, as well as any substance used as a cosmetic ingredient. Soap is not considered a cosmetic.

It is important to note that U.S. cosmetics, with the exception of color additives, do not require premarket approval from the FDA for cosmetic products and ingredients used as cosmetics, but are regulated by the FDA.

Introduction of MoCRA

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA's regulatory authority over cosmetics since the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act).

The FDA is allowed to do the following under MoCRA:

• Access to records (e.g., safety records) pertaining to specific cosmetic products.
• The FDA has the authority to mandate product recalls under certain conditions if a cosmetic product is believed to be adulterated or misbranded and could cause serious health problems or death.

MoCRA established a number of new requirements for the cosmetics industry, including:

• Serious adverse event reporting obligations.
• Manufacturers and processors must register their facilities with the FDA and update their registrations every two years.
• The principal must list each listed cosmetic product, including product ingredients, and update the information annually.
• Companies and individuals who manufacture or sell cosmetic products are legally responsible for ensuring the safety of cosmetic products and are required to maintain records that support an adequate demonstration of the safety of their cosmetic products. FDA recommends that manufacturers conduct any testing necessary to ensure the safety of their products and ingredients.

FDA will also establish good manufacturing practice (GMP) requirements for cosmetic manufacturing facilities, as well as regulations for fragrance allergen labeling and standardized test methods for detecting asbestos in talc.

Business Registration Number Application

The FDA Establishment Identifier (FEI) is an FDA system-generated number used to identify a business. To facilitate the registration process, the owner or operator of a business facility needs to obtain an FEI number prior to submitting the facility for registration.

Manufacturers applying for an FEI will need to provide the following information:

• Name of the law firm
• All aliases, former names of the company
• Physical address, all previous addresses
• Designated mailing address
• Name and contact information of the designated contact person
• Complete list of activities conducted at this specific location (e.g., drug manufacturing, food packaging, etc.)
• Any registration numbers associated with other FDA centers (if applicable)

Applicants should send the above information to feiportal@fda.hhs.gov. Requests for the issuance of FEI numbers will be processed within 7-10 business days, and we recommend that companies apply for FEI numbers in advance.

Determine FEI Number: FEI Search Portal

Business Registration

Manufacturers and processors of cosmetic products marketed in the U.S. are required by statute to register their businesses with the FDA, but small businesses are exempt from registration and listing requirements.

A small business, as defined in Section 612 of the FD&C Act, is a person who is a principal, owner, or operator of a business that has had average annual sales of less than $1,000,000 (adjusted for inflation) of cosmetic products sold in the U.S. during the past 3 years. And the business is not engaged in the manufacture or processing of certain cosmetic products described in section 612(b) of the FD&C Act, such as cosmetic products that routinely come into contact with the mucous membranes of the eye, cosmetic products for injection, and cosmetic products for internal use.

Businesses other than small businesses are required to provide the following information to conduct this phase, which includes:

• The name of the business owner and/or operator
• Name, physical address, e-mail address, and telephone number of the business
• Contact information (name and phone number) of the U.S. agent of the business enterprise outside the U.S., and electronic contact information (if available)
• Business registration number. If the business is exempt from registration, e.g., because it is a small business, the name/address of the facility may be provided
• Names of all brands of cosmetic products manufactured or processed at the facility for sale
• Product category and responsible person for each cosmetic product manufactured or processed at the facility
• Type of submission (initial, change, renewal)

Product Listing

After the enactment of the MoCRA Act, cosmetic products were changed from voluntary registration to mandatory registration. Manufacturers, packagers, or distributors of cosmetic products must list each listed cosmetic product, including product ingredients, with the FDA and update it annually.

Product listing may be waived in the following cases:

(1) Small businesses

(2) The listed cosmetic product is subject to drug or medical device regulations

Through this process, companies must provide detailed information about the product including:

• Business registration number
• Category of cosmetic product
• Name and contact number of the person in charge
• The name of the cosmetic product, as it appears on the label
• A list of the ingredients in the cosmetic product, including any fragrances, flavors or colors. Each ingredient is identified by name, as required by 21 CFR (or any successor regulation) § 701.3, or by the common or usual name of the ingredient.
• Product Listing Number (if previously assigned)
• Submission Type (Initial, Change, Renewal)

Cosmetics Direct Submission

Structured Product Labeling (SPL) is a Health Level Seven (HL7) approved document labeling standard adopted by the FDA as a mechanism for exchanging product and company information.

SPL is primarily used to submit labeling content to FDA as part of a marketing application and is formatted in Extensible Markup Language (XML). It is designed to help applicants submit product information in a structured electronic format and to assist FDA staff in reviewing and managing product information using electronic systems.

Cosmetics Direct is an FDA-provided SPL authoring tool for cosmetic company registrations and cosmetic product listings that creates and saves SPL submissions and submits SPLs to FDA for internal processing without the use of an Electronic Submission Gateway (ESG).

Proregulations specializes in the latest FDA regulatory requirements for cosmetics and is committed to helping customers complete cosmetics registration. If you are interested in our services or need more details, please contact us.

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US FDA Cosmetics Registration