If you’ve searched for the “FDA registry for cosmetics,” you’re probably trying to answer a simple question: do I need to register my cosmetics with the FDA, and how? Here’s the first thing to know — there is no single “FDA cosmetics registry.” What people mean by that phrase is actually two separate filing requirements created by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): facility registration and product listing, both filed through FDA’s electronic portal, Cosmetics Direct.

You may also see it called the “FDA cosmetic registry” — that’s the same thing: there is no separate FDA cosmetic registry, just these two MoCRA filings.

This guide explains what each filing is, who must complete them, the step-by-step process, the U.S. agent requirement for foreign facilities, FEI numbers, the small-business exemption, renewal timelines, and the mistakes that get companies into trouble.

What “FDA registry for cosmetics” actually means

Before MoCRA, cosmetics registration with FDA was voluntary. The old Voluntary Cosmetic Registration Program (VCRP) let companies register if they wanted to — most didn’t. MoCRA replaced that with mandatory requirements under section 607 of the FD&C Act:

Facility registration (Form FDA 5066). Every facility that manufactures or processes a cosmetic product for distribution in the United States must register with FDA through Cosmetics Direct. This is the closest thing to a “registry” — it’s a database of every cosmetic facility in FDA’s system, and each registered facility is assigned an FDA Establishment Identifier (FEI) number.
Product listing (Form FDA 5067). For each cosmetic product marketed in the United States, the “responsible person” (the manufacturer, packer, or distributor whose name appears on the label) must file a listing with FDA that includes the product’s ingredients and other details.

These are two different filings with different timelines and different update rules — confusing them is one of the most common compliance mistakes.

Who must register

Facility registration applies to any person who owns or operates a facility that manufactures or processes a cosmetic product for distribution in the United States. That includes:

Foreign facilities. If your factory is outside the United States and your cosmetics are sold in the U.S., you must register. Foreign facilities must also designate a U.S. agent — a person or company in the United States who acts as FDA’s point of contact for your facility.
Contract manufacturers. If you manufacture cosmetics for other brands and those products are distributed in the U.S., your facility must register — even if your own name never appears on a label.
Private-label manufacturers. The facility that makes the product registers, regardless of whose brand is on the package.

Product listing is the responsibility of the responsible person — generally the manufacturer, packer, or distributor named on the product label. Each marketed cosmetic product gets its own listing, including its ingredient list.

The small-business exemption (and its limits)

MoCRA provides an exemption for certain small businesses under Section 612 of the FD&C Act (21 U.S.C. § 364h). A facility qualifies if its average gross annual sales in the United States over the preceding 3-year period were less than $1,000,000 (adjusted for inflation). Qualifying small businesses are exempt from facility registration, product listing, and certain other requirements.

But the exemption has hard limits. Under Section 612(b) of the FD&C Act (21 U.S.C. § 364h), it does not apply to facilities that manufacture or process — or to responsible persons for — cosmetic products that: regularly come into contact with the mucus membrane of the eye (think eyeliners, mascaras, eye shadows); are injected; are intended for internal use; or are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual (such as certain hair dyes or permanent makeup).

If any of your products fall into those categories, the small-business exemption doesn’t protect you — you must register and list like everyone else.

The U.S. agent requirement for foreign facilities

If your facility is outside the United States, MoCRA requires you to designate a U.S. agent in your facility registration. The agent is FDA’s domestic point of contact for your facility — inspection notices, information requests, and renewal reminders go to the agent first. The agent must be a person or company physically located in the United States, reachable and responsive, and named in your facility registration with their name, email, and phone number.

This is where many foreign brands get stuck: they complete the registration mechanics but name an agent who isn’t actually monitoring FDA correspondence. A proper U.S. agent also handles your biennial renewal filing and keeps your registration details current. That’s the core of what we do at US MoCRA Agent — continuous representation, not just a one-time filing. See our pricing for plan details.

How to register: step by step

All filings go through Cosmetics Direct, FDA’s online portal for cosmetics.

Step 1: Get access to Cosmetics Direct. Create an account in the Cosmetics Direct portal. You’ll need a working email address — for foreign facilities, use an email that your U.S. agent also monitors, since FDA correspondence will flow through the registration contact details.

Step 2: File your facility registration (Form FDA 5066). Submit your facility’s details: legal name, physical address, contact information, and — for foreign facilities — your designated U.S. agent’s name, email, and phone number. Human-review every field before submitting, and get written approval of the exact data from whoever is responsible for the facility.

Step 3: Receive your FEI number. Once FDA accepts your facility registration, your facility is issued an FDA Establishment Identifier (FEI) number — a 10-digit number tied to your physical facility. If you’re not sure whether your facility already has one, run our free FEI check before filing — duplicate registrations against the wrong record cause real headaches. For background, read our guide What Is an FDA FEI Number?

Step 4: File product listings (Form FDA 5067). For each cosmetic product marketed in the U.S., the responsible person files a listing with the product’s details and ingredient list. A single facility registration can support many product listings.

Step 5: Keep everything current. Facility registration changes: update within 60 days of any change. Product listings: updates are filed annually, including notification when a product is discontinued.

Step 6: Renew biennially. Facility registrations must be renewed every two years, with the renewal date based on each facility’s initial registration date. Cosmetics Direct displays the facility’s renewal date, and FDA sends email reminders ahead of it.

What it costs

FDA charges no fee for facility registration or product listing — the filings themselves are free. Anyone charging you an “FDA registration fee” is charging for their own service, not a government fee — and anyone promising an “FDA certificate” is misrepresenting the system, because FDA does not issue registration certificates. Your proof of registration is the accepted submission record (Submission ID).

Common mistakes to avoid

Treating the VCRP as still valid. The old voluntary program is gone — you need a Cosmetics Direct facility registration.
Naming a U.S. agent who doesn’t monitor correspondence.
Confusing the update timelines. Facility changes: 60 days. Product listing updates: annually.
Assuming the small-business exemption covers everything. Eye-area products, injectables, internal-use products, and >24-hour appearance-altering products are carved out under Section 612(b) of the FD&C Act (21 U.S.C. § 364h) regardless of sales.
Missing your biennial renewal date. The renewal date is based on your facility’s initial registration date — Cosmetics Direct shows it, and FDA sends email reminders ahead of it.
Filing against the wrong FEI. Always verify your facility’s FEI before filing — use our free FEI check if you’re unsure.

New to MoCRA? Start with our complete MoCRA Compliance Guide for Cosmetic Brands (2026).

Frequently asked questions

Is there really an “FDA registry” for cosmetics? Not as a single registry. The phrase usually refers to MoCRA’s two filing requirements: facility registration (Form FDA 5066) and product listing (Form FDA 5067), both submitted through FDA’s Cosmetics Direct portal.

Do foreign cosmetics brands need to register with FDA? Yes. Any facility that manufactures or processes cosmetics for distribution in the United States must register, wherever it’s located. Foreign facilities must additionally designate a U.S. agent in their registration.

How long does registration take? There’s no fixed FDA processing SLA published for Cosmetics Direct submissions. The timeline is mostly driven by preparation: gathering accurate facility and product data, human review, and approval of the filing contents before submission.

Does FDA charge a fee to register? No. FDA charges no fee for cosmetic facility registration or product listing. Costs come from professional services (like U.S. agent representation), not from the agency.

Will I get an FDA registration certificate? No. FDA does not issue registration certificates for cosmetics. Your proof of filing is the accepted submission record (Submission ID). Treat any “FDA certificate” offer as a red flag.

What happens if I don’t register? Operating an unregistered facility or marketing unlisted products exposes you to FDA enforcement, including import detention or refusal for foreign products. Read our overview of MoCRA non-compliance risks.

Do I need a U.S. agent if I only sell through Amazon or TikTok Shop? The U.S. agent requirement depends on where your facility is, not where you sell. If your manufacturing facility is outside the United States and your products are distributed in the U.S. — through any channel — you need a designated U.S. agent.

Is the FDA cosmetic registry different from facility registration? No. The “FDA cosmetic registry” is an informal name for the same MoCRA system described in this guide — mandatory facility registration (Form FDA 5066) and product listing (Form FDA 5067) filed through Cosmetics Direct. There is no separate registry beyond those two filings.

This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on FDA’s published guidance and are current as of September 2026; always verify requirements against FDA’s official sources before acting.

FDA Registry for Cosmetics: How to Register Under MoCRA (2026)