Setting Up Your Cosmetics Direct Portal Account

The first time you go looking for where to actually file your MoCRA registration, it's easy to end up three tabs deep wondering whether you need a paper form, an account with a government-wide system, or something else entirely. The short answer: FDA built an electronic submission portal specifically for this, commonly referred to as Cosmetics Direct, and getting your account set up correctly the first time saves you a genuinely annoying amount of backtracking later.

What MoCRA actually asks of you

Before the portal itself, it helps to be clear on what you're setting the account up to do. MoCRA, the Modernization of Cosmetics Regulation Act passed in 2022, requires facility registration and product listing with the FDA, along with naming a responsible person, maintaining safety substantiation, and keeping adverse event records. Some small businesses are exempt from the registration and listing pieces specifically, so it's worth confirming your business's size and situation against the current exemption criteria before assuming you must register.

Two separate things get filed through the portal: facility registration (the physical place where your cosmetics are manufactured or processed) and product listing (each cosmetic product you're marketing). They're related but distinct submissions, and a lot of first-time users don't realize they need to complete both.

Creating the account

The portal sits behind an identity verification layer, since it's a government submission system handling business information. Practically, that means:

1. You'll need a working email address you check regularly, since account verification and any follow-up correspondence route through it.
2. You'll be asked to establish an identity-verified login, similar in spirit to other federal e-filing systems, rather than a simple username-and-password signup.
3. Once your identity is verified, you gain access to the actual registration and listing forms inside the portal, rather than downloading a PDF to fill out offline.

Give yourself more time than you'd expect for this first step. Identity verification steps on government systems are rarely instant, and starting this the week before you plan to launch is cutting it closer than it needs to be.

Portal versus paper forms

Historically, plenty of FDA-adjacent filings had a paper-form option sitting alongside the electronic one. For MoCRA facility registration and product listing, the expectation is electronic submission through the portal as the standard path. Paper alternatives, where they exist for specific circumstances, are the exception rather than a routine choice, and relying on outdated guidance about paper forms is a common way people end up submitting something that doesn't actually satisfy the requirement. If you've found instructions referencing a paper process, treat that as a signal to double check the current FDA guidance directly rather than assume it still applies.

What you'll need on hand before you start

Item	Why you need it
Facility physical address	Registration is tied to where manufacturing or processing happens
Responsible person's name and contact details	MoCRA requires a named responsible person on file
Full product list with formulas	Product listing requires ingredient information per product
Safety substantiation documentation	Required to support your listing, not submitted line by line but must exist

A note on named responsible person

The responsible person named in your MoCRA filing isn't a formality. That's the entity FDA holds accountable for the product meeting safety substantiation and recordkeeping obligations. If you're a small operation and you are the responsible person, make sure the contact information tied to that role in the portal is one you'll actually be checking, not an old business email you abandoned two rebrands ago.

Once you're in

After account setup, the actual registration and listing entries are where the detail work happens: correctly identifying your facility, correctly listing each product with the information the portal asks for, and keeping that listing current as your product line changes. Getting the account created is just the door opening, the substance of MoCRA compliance lives in what you submit once you're inside.

Cosmetic Comply's Canada notification tooling is live today, mapping ingredients to INCI and CAS and screening them before filing, and the same approach is being built out for the US, EU, and Australia pathways. If you're setting up your Cosmetics Direct account now, it's a good moment to also get your ingredient documentation, INCI names, CAS numbers, real concentrations, organized once so it's ready for whichever market's filing you tackle next.