FDA Registration and Listing for Cosmetic Companies

FDA registration of cosmetic companies was voluntary until the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As per the new regulation, cosmetic companies are required to register their establishment and list the cosmetic products with FDA. Cosmetic companies are also required to comply with GMP and adverse event requirements.

As of now, FDA requires the cosmetic facilities to complete their establishment registration and product listing by July 1, 2024.

The Modernization of Cosmetics Regulation Act - MoCRA - provides the following authorities to the FDA:

  • Records Access: If FDA has a reasonable belief that a cosmetic product, including an ingredient in a cosmetic product, is likely to be adulterated and the use or exposure to the product presents a threat of serious adverse health consequences or death to humans, the FDA can access and copy certain records related to the cosmetic product, including safety records.

  • Safety Substantiation: Before the product is released to the market, it is the legal responsibility of the manufacturer or distributor to make sure that the cosmetic products and the ingredients are safe to be used as per the directions on the label. FDA does not approve any cosmetic product or ingredient before they are marketed.

    Also, as per MoCRA FDA is going to make regulations for GMP requirements, fragrance allergen labeling requirements and testing methods for identifying Talc in the product. So, companies are expected to adhere to these regulations.

  • Serious Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to the FDA, accompanied by a copy of the label on or within the retail packaging, within 15 business days of receiving a report of such event and maintain records related to each report to a period of six years.

  • Cosmetic Facility Registration: Cosmetics manufacturers and processors must register their facilities with FDA and renew their registration every two years. If a cosmetic facility manufactures or processes cosmetic products on behalf of another facility, the FDA requires only a single registration for such a facility.

    FDA can suspend any facility’s registration if it finds that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a potential of causing serious adverse health conditions or death to humans. Once the facility’s registration is suspended, the facility is not allowed to distribute or sell commercially in the United States.

  • Product Listing: Each cosmetic manufacturing/processing facility must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.

  • Recall Authority: If FDA determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and use of or exposure to, the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the company/responsible person refuses to do so voluntarily.

  • Labels: The new MoCRA requires cosmetic labels must comply with FDA labeling requirements. In addition, a cosmetic product label must include specific contact information through which the responsible person can receive adverse event reports, and the label must disclose fragrance allergens.

FDA Cosmetic Registration and Listing - FAQ

Who is required to register with FDA?

(A) Existing facilities: Facilities that engage in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with FDA not later than 1 year after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

(B) New facilities:Facilities that first engage, after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, in the manufacturing or processing of a cosmetic product for distribution in the United States shall register with the FDA within 60 days of first engaging in manufacturing or processing activity or 60 days after the deadline for registration.

How many registrations does a Contract Manufacturer require?

If a contract manufacturing facility manufactures or processes cosmetic products for another company, FDA requires only a single registration for the facility, even if the facility is manufacturing or processing its own cosmetic products or cosmetic products for multiple companies.

How often be cosmetic facilities renewed?

Cosmetic facility registration renewal is required every two years.

Any change on the cosmetic FDA registration needs to notify before registration renewal?

Yes, any change in the cosmetic registration must be notified within 60 days to the FDA.

What is the format for submitting the registration?

FDA still needs to declare the cosmetic facility registration format.

What all information is to be provided during cosmetic registration with FDA?

The cosmetic registration shall contain:

  1. Facility's name, physical address, email address, and telephone number.

  2. US agent information for foreign cosmetic establishments.

  3. The cosmetic facility registration number, if any, previously assigned by the FDA

  4. All brand names of cosmetic products manufactured or processed in the facility

  5. Product category or categories and the responsible person for each cosmetic product manufactured or processed at the facility.

Who should list the Cosmetic Ingredients?

The responsible person for a cosmetic product shall submit a cosmetic product listing to the FDA not later than one year after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 or for a cosmetic product that is first marketed after the date of enactment of the Act, within 120 days of marketing the cosmetic product in the USA.

How often should the cosmetic listing be renewed?

Any updates to cosmetic listing shall be made annually.

What all information is to be provided in the listing?

The cosmetic listing shall contain:

  1. The facility registration number of each facility where the cosmetic product is manufactured or processed.

  2. The name and contact number of the responsible person and the name of the cosmetic product.

  3. Category or categories for the cosmetic product.

  4. List of ingredients in the cosmetic product, including any fragrances, flavors, or colors.

  5. Product listing number, if any, previously assigned by the FDA.

A responsible person may submit product listing information as part of a facility registration or separately.

Who are exempt from Cosmetic establishment registration and listing?

  1. Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.

  2. 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.

  3. Hospitals, physicians' offices, and health care clinics.

  4. Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.

  5. Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.

  6. Trade shows and other venues where cosmetic product samples are provided free of charge.

  7. 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.

  8. An establishment that solely performs one or more of the following with respect to cosmetic products: (I) Labeling, (II) Relabeling, (III) Packaging, (IV) Repackaging, (V) Holding, (VI) Distributing. Clarification: The terms `packaging' and `repackaging' do not include filling a product container with a cosmetic product.

  9. Small businesses - facilities whose average gross annual sales in the United States 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 cosmetic products described below (a-d) are exempted from registration and listing requirements.

    1. Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual.

    2. Cosmetic products that are injected.

    3. Cosmetic products that are intended for internal use.

    4. Cosmetic products that are intended to alter the 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.

Do I need a US Agent for foreign cosmetic facility registration?

Yes, a US Agent is a mandatory requirement for cosmetic facility registration.

Definition:

  1. Cosmetic product: The term 'cosmetic product' means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.

  2. Serious Adverse Events: The term 'serious adverse event' means any health-related event associated with the use of a cosmetic product which may result in death, hospitalization, infection, significant disability, significant undesired change in appearance or disfiguration, birth defect or any surgeries.

  3. Facility:- The term 'facility' includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

  4. Responsible person: The term 'responsible person' means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of this Act or section 4(a) of the Fair Packaging and Labeling Act.