FDA details how to register facilities and list cosmetic products — Cosmetics Direct portal, FEI and deadlines explained
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Summary
FDA officials explained who must register facilities, product‑listing obligations, exemptions for small businesses, required data fields, and the Cosmetics Direct submission portal; as of July 6, 2026 the agency reported over 14,000 registered facilities and about 992,000 listed products.
Megumi Yamamoto, project manager for Registration and Listing in FDA’s Office of Cosmetics and Colors, walked attendees through MOCRA requirements for facility registration and product listing and the tools available for submissions.
Yamamoto said MOCRA requires "owners and operators of facilities engaging in manufacturing or processing of cosmetic products for distribution in the United States" to register each facility and renew registration every two years. She said a "responsible person" — the manufacturer, packer or distributor whose name appears on the label — must list each marketed cosmetic product with FDA and update listings annually.
Yamamoto explained key exemptions: businesses with average U.S. gross annual cosmetic sales under $1,000,000 (three‑year average, inflation‑adjusted) may be exempt from registration and listing, but exemptions do not apply to products that regularly contact the eye, are injected, intended for internal use, or intended to alter appearance for more than 24 hours.
On how to submit, Yamamoto described the Cosmetics Direct portal (part of FDA Direct) which supports SPL/XML formatted submissions and validation checks; alternatives include the electronic submission gateway or paper forms (5066 and 5067), though FDA "strongly encourages electronic submissions" to improve timeliness and accuracy. She said facilities must obtain an FDA Establishment Identifier (FEI) before registering and that FDA provides a portal to lookup or request FEIs.
Yamamoto reiterated deadlines and enforcement guidance: facilities first engaged after 12/29/2022 had to register within 60 days of first engaging or by Feb. 27, 2024, whichever was later, and FDA said it did not intend to enforce until July 1, 2024 to provide industry time to comply. She reported that, "as of 07/06/2026, we have over 14,000 unique active facilities registered and about 992,000 unique active cosmetic product listed." FDA said it is working to make registration and listing information available to the public as permitted by law.
