Home
Since the Federal Food, Drug, and Cosmetic Act was passed in 1938, the Modernization of Cosmetics Regulation Act of 2022, MoCRA, is a significant improvement to the FDA cosmetics regulations. This new regulation helps consumers by ensuring the safety and transparency of Cosmetics products used by many every day.
What is the New FDA Cosmetic Regulations
According to section 607 of the MoCRA Act of 2022, manufacturers’ facilities must be registered with the FDA with renewal after every two years. Also, manufacturers, packers, or distributors of cosmetic products must list each cosmetic product with the FDA including the active ingredients regardless of whether they are located in the US or internationally.
FDA Cosmetic Facility Registration
From December 29th, 2023, MoCRA requires all cosmetics Manufacturing facilities located inside the U.S. or abroad to register with the FDA. They must also provide necessary information such as the brand names, product categories, and the identity of the responsible person, which is the cosmetic manufacturer or distributor of a product and whose name will also appear on the product.
Furthermore, MoCRA also states that cosmetic facilities that had existed before Dec. 29, 2022, will need to be registered with the FDA by Dec. 29, 2023, as a result of information from the formal official voluntary cosmetic registration program not transmitted to the new MoCRA. Also, facilities created thereafter will need to register within 60 days after the first cosmetic product manufacturing or 60 days after Dec. 29, 2023.
FDA Cosmetic Product Listing
MoCRA Act of 2022 also states that all facilities are to list all cosmetics products they market in the U.S. The FDA Cosmetics product listing must include information like the name and phone number of the responsible person for the product, the FDA cosmetic facility registration number of each location where the cosmetic is made or processed, the category or categories of the cosmetics product, a list of the active ingredients including flavors, colors, and fragrances, and the FDA cosmetic product listing number, if any.
FDA Exemptions
MoCRA exempted small businesses from FDA cosmetic Facility Registration and FDA Cosmetic Product listing requirements. However, the FDA welcomes voluntary listing and registration for the exempted facilities.
These exemptions may not be applied for facilities that process high-risk products, or responsible persons for high-risk products.
These high-risk products are products that frequently come in contact with the eye’s mucous membrane regularly, products that are administered via injection, products designed to be taken internally, and products that can change appearance for more than 24 hours under customary or usual conditions ns do not fall under this category.
FDA Cosmetic Labeling requirements
By Dec 29, 23, all cosmetics products that are intended for professional use would all have product labels indicating that they are intended for use only by licensed professionals. Also, all cosmetic product labels must have a contact number by December 29, 2024, so that reports of adverse events can be sent to the responsible person. Also, regulation mandating the identification of fragrance allergens on product labels would be developed and published by the FDA By June 29, 2024
How to Apply for FDA Cosmetic Product Listing
Pre-submission and document preparation
Prior to submission of document, you need to check your eligibility by evaluating if your product is compliant with FDA Good Manufacturing Practices (GMP).
FDA account registration
You Need to create an account on the FDA’s electronic registration system, also known as FURLS.
Obtain a Facility Establishment Identifier (FEI)
You will be issued a unique Facility Establishment Identifier by the FDA.
Submit Registration Application
Start the Registration Application by visiting the FURLS system. You will also need to provide necessary information about the FDA Cosmetic Facility registration and products where necessary.
FDA Product Review
Before FDA cosmetic product listing, they will review the product to ensure it meets safety standards. You will have to wait for approval from the FDA. Approval time may depend on several factors such as the completeness and clarity of the submitted information or the type of products.
FDA Registration Certificate and Number
After successful verification and the FDA user fee, you will be issued an FDA Registration Certificate and a unique registration number.
Annual Reporting Requirements
Every year, the responsible person must provide an annual report including product sales, product quality, safety, etc. to the FDA before the 1st of January.
Are you looking for the right FDA Cosmetic Regulations consulting company?
FDA Listing Inc. is an industry-leading company that provides FDA registration and product listing such as FDA Cosmetic Product listing, OTC drug Listing, and FDA Medical Device Registration.
