FDA Cosmetic Facility Registration & Product Listing - MoCRA
Cosmetic Facility Registration
- Under the newly approved Modernization of Cosmetics Regulation Act of 2022-MoCRA, most cosmetic facilities, including contract manufacturers of cosmetic products marketed in the U.S., must follow the FDA cosmetic registration requirements for cosmetic facility registration and product listing under MoCRA. Registered facilities must promptly update and renew any changes to their registration biennially. All facilities outside the U.S. must designate a U.S. Agent with the FDA to complete their facility registration.
- The FDA has created a Decision Tool to help companies determine whether they need to register as Cosmetic Product Facilities. To use the tool, users can follow the series of questions available on the FDA’s website. 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.
Cosmetic Product Listing
The MoCRA further requires cosmetic manufacturers, packers, and distributors whose names are on the product label to submit a cosmetic product listing to the FDA. The listing must include the list of ingredients, including color additives, fragrances, and flavors, the manufacturer facility name and location, the responsible party, and a product label.
Cosmetic product listings must be updated annually. A flexible listing option will enable a unified submission for multiple cosmetic products that share identical formulations or exhibit variances limited to packing size, color additives, fragrances, or flavors.
Cosmetic product listings must be updated annually. A flexible listing option will enable a unified submission for multiple cosmetic products that share identical formulations or exhibit variances limited to packing size, color additives, fragrances, or flavors.
Cosmetic Labeling Requirements
All cosmetic product labels are subject to the FDA cosmetic labeling regulations, which means the FDA law prohibits false or misleading claims and inaccurate information on a cosmetic label. The differences between a cosmetic claim, either direct or implied, and a drug claim can be very subtle, and failure to recognize the distinction can result in enforcement actions by the FDA. The MoCRA introduces additional labeling requirements, including adverse events contact, declaration of allergens, and a statement for use by an industry professional.
Cosmetics Facility Registration Process Cost: $994 (Includes MoCRA Facility Registration and 1 Product Listing)
Step 1
Complete the initial form below, and tell us about your company
Step 2
We will issue you a short and simple questionnaire to collect additional company and product listing details
Step 3
We prepare a draft for your review and approval, then submit it to the FDA
Step 4
We will work with the FDA to get your facility registered and products listed
Step 5
Your cosmetics facility will be FDA registered, and product listed