US regulatory guide

FDA Cosmetic Registration: What It Is and What It Is Not

FDA listing is not FDA approval. The FDA does not approve cosmetics before sale.

What is FDA cosmetic registration?

FDA cosmetic registration is the statutory duty to file two separate records with the US Food and Drug Administration: facility registration and product listing. The legal basis is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which inserted sections 612 and 613 into the Federal Food, Drug, and Cosmetic Act. Section 612 covers registration of cosmetic product facilities; section 613 covers cosmetic product listings.

Facility registration identifies the establishment that manufactures or processes a cosmetic product. Product listing identifies the product itself — its name, ingredients, and the facility responsible for it. They are two filings, not one, and a facility can be registered while its products remain unlisted.

The deadlines were fixed. Facility registration and product listing opened on 27 Dec 2023 and were due by 1 Jul 2024 for existing businesses. New facilities must register within 60 days of first engaging in manufacturing or processing, and new products must be listed within 120 days of marketing. Registration renews every two years.

Registration is not approval. FDA does not review a cosmetic before it goes on sale, does not certify the product, and issues no cosmetic approval certificate. A registration number confirms a record was filed — nothing more. For the wider US framework, see our US MoCRA guide.

FDA registration vs FDA approval: what the difference means in practice

Registration and listing are records. They are not certificates, licences, or endorsements. When a facility registers under section 612 or a product is listed under section 613, FDA receives information. It does not assess safety, efficacy, or claims, and it does not issue a document a brand can point to as permission to sell.

FDA does not approve cosmetics or cosmetic ingredients before sale. The exception is colour additives: those require pre-market approval, and that requirement predates MoCRA. For everything else — creams, serums, shampoos, lipsticks — the product reaches the market on the brand's own responsibility, with the brand carrying the safety substantiation and labelling obligations.

This is where brands get into trouble. Writing "FDA approved" on a label, a website, or an Amazon listing is itself a labelling problem. It is a false or misleading claim about a product that has never been approved, and it invites exactly the regulatory attention the brand was trying to avoid. The same applies to implying FDA endorsement through a registration number, a badge, or a certificate graphic.

What registration actually buys you is standing. It puts your facility and products into FDA's records, which is what the statute requires and what a retailer or distributor may ask to see. It does not buy permission, and it does not transfer responsibility away from you.

If your labels or marketplace copy currently lean on approval language, that is a fixable problem — our label and claims review covers US claims alongside EU and UK requirements.

How to register a cosmetic facility with the FDA

Registration and listing are filed electronically through Cosmetics Direct, FDA's submission portal. Paper submissions on Form FDA 5066 (registration) and Form FDA 5067 (listing) remain available, but the portal is the intended route and the one FDA processes fastest.

Facility registration requires the facility's name, physical address, and contact details; the name and contact details of the owner or operator; all brand names under which the product is manufactured or processed; the product categories handled; and the parent company name where applicable. A single registration can cover multiple brand names and categories — you do not file once per product.

Product listing requires the product name and category, the list of ingredients including fragrance and flavour, the responsible person's name and contact details, the facility registration number for the site that manufactured or processed it, and the website where the label image can be viewed. Listing is filed by the responsible person, not by the facility.

Foreign facilities face one extra requirement: a US Agent. Any facility located outside the United States must designate a US-based agent who is physically present in the country, reachable during normal business hours, and able to receive FDA communications on the facility's behalf. The US Agent is a regulatory contact point, not a distributor and not an importer of record. Our US Agent and MoCRA service covers this appointment.

Both filings renew on a two-year cycle. FDA has stated that it will not enforce renewal deadlines against small businesses until further notice, but the underlying obligation stands and the exemption is narrow. Renewal timing and the small-business position are set out in our MoCRA deadline guide.

Does the FDA approve cosmetics before they go on sale?

FDA Basics for Industry states that cosmetic products and ingredients are not subject to premarket approval, except color additives. FDA-regulated is not FDA-approved. The agency can act after sale if a cosmetic is adulterated or misbranded. That is why an label and claims review matters before anyone writes “FDA approved” on a page.

What is FDA cosmetic registration under MoCRA?

The Modernization of Cosmetics Regulation Act created the federal registration regime. The working sequence is in our US MoCRA guide. Renewals run on each facility’s own date, not one shared deadline; the mechanics are in MoCRA facility-registration renewals. CIGREG files this through the US Agent and MoCRA service.

Is facility registration the same as product listing?

FDA registration and listing are two filings. Who lists, when, and what ingredients must appear is in our product listing guide. Combined CPNP, SCPN and FDA filing is also covered under notifications.

Does listing a product make it FDA approved?

If the listing is being used as a marketing line, stop and treat it as a claims problem first. The US market page states the same rule: listing records what is sold.

Who must register, and who must list?

The small-business threshold, the higher-risk categories that void it, and what still applies are in the small-business exemption guide. Exempt or not, a brand still needs safety substantiation; EU-style CPSR work can support that file, but it is not an FDA approval document.

Do I need a US Agent to register a foreign facility?

CIGREG can act as the named US Agent and file registration and listing through Cosmetics Direct. That is the US Agent and MoCRA mandate: one setup, then biennial renewals tracked so the facility date does not lapse.

How do you file registration and listing with the FDA?

Cosmetics Direct is the free portal. The SPL XML is where first-time filers stall. Our MoCRA setup is a fixed $900 and covers facility registration, product listing and the US Agent role for foreign facilities.

What still applies if you skip registration, or qualify as a small business?

Skipping a required registration or listing is non-compliance now, not a grace-period issue. The exemption never lifts labelling or adverse-event duties. Review claims on the label and the product page through label and claims review before anyone treats a listing number as a badge.

How does US listing differ from EU CPNP notification?

CPNP sits inside EU cosmetic regulations: Responsible Person, CPSR, PIF, then notification. The US model is post-market listing plus facility registration. The two systems are mapped in US vs EU. Filing one does not file the other.