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FDA REGISTRATION REQUIREMENTS AND TIMELINE
• Initial Registration of Cosmetic Facility The cosmetic facility that manufactures or processes a cosmetic product for distribution in the United States on December 29, 2022, must register each facility before July 1, 2024.
Cosmetic facilities that first engage in the manufacturing or processing of a cosmetic product for distribution in the United States after December 29, 2022, must register within 60 days of first engaging in such activity or by July 1, 2024, whichever is later.
• Amended Registration Each cosmetic facility required to register must update its registration within 60 days of any changes to the registration information. This includes any changes that result in the cancellation of the registration.
• Renewal of Registration Cosmetic facilities registered with the FDA must renew the registration biennially.
COSMETIC PRODUCT LISTING WITH FDA
• Initial Cosmetic Product Listing The person responsible for a cosmetic product marketed on December 29, 2022, must submit a cosmetic product listing before July 1, 2024. For a cosmetic product first marketed after December 29, 2022, the listing must be submitted within 120 days of marketing the product or July 1, 2024, whichever is later.
• Update and Renewal of Cosmetic Product Listing The cosmetic facility must update the listing annually. This includes an update that the product was discontinued.
WHO IS EXEMPT FROM COSMETIC ESTABLISHMENT REGISTRATION AND LISTING?
1. Beauty shops and salons, unless such establishments manufacture or process 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.Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
4. 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.
5.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.
6.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.
a. Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual.
b.Cosmetic products that are injected. c.Cosmetic products that are intended for internal use.
d. 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.
FDA Cosmetic Registration and Listing Assistacne LMG assists with FDA MoCRA regulations, FDA cosmetic facility registration, cosmetic product listing, and US FDA agent service to cosmetic facilities. Please contact us for more information
