Do You Have to Register Your Cosmetic Facility With FDA?

Facility registration is the piece of MoCRA that generates the most confused questions, mostly because "facility" doesn't map cleanly onto what a lot of makers picture when they hear the word. You don't need a warehouse or an industrial building for this to apply to you. Let's work through it as an actual decision, not a definition.

Start here: are you manufacturing or processing a cosmetic?

MoCRA's facility registration duty attaches to the place where a cosmetic product is manufactured or processed for distribution in U.S. commerce. If you mix, cook, mold, fill, or otherwise physically make the product yourself, wherever that happens is a candidate for registration. This is true whether that's a rented commercial kitchen, a dedicated production space, or your own home if that's genuinely where the product is made.

If a contract manufacturer makes the product for you and you never touch the physical production process, the facility registration duty generally sits with that manufacturer, not with you as the brand owner. You as the brand are still very much on the hook for other MoCRA duties, particularly the responsible person role and product listing, but the specific facility registration is tied to wherever the physical manufacturing happens.

The small business exemption, and why it's not automatic

MoCRA does exempt some small businesses from the facility registration and product listing requirements based on defined size criteria. This matters a lot for solo makers and small operations, but two things trip people up:

1. The exemption is based on specific criteria (generally tied to the business's size), and those thresholds are exactly the kind of detail that changes and should be confirmed against current FDA guidance rather than assumed from something read secondhand.
2. Certain product categories are excluded from the small business exemption regardless of business size. If your product falls into one of those excluded categories, being small doesn't get you out of registration.

So the honest answer to "do I have to register" usually runs through two questions in sequence: are you below the size threshold that qualifies for the exemption, and even if you are, does your product category fall into one of the categories excluded from that exemption. Both need checking, not just one.

A decision walkthrough

Your situation	Likely registration status
You physically manufacture the product yourself, business is above the small business size threshold	Facility registration likely required
You physically manufacture the product yourself, business qualifies as small, product is not in an excluded category	May be exempt from facility registration and product listing
You physically manufacture the product yourself, business qualifies as small, but product falls in an excluded category	Registration likely still required despite small size
A contract manufacturer makes your product for you	Facility registration duty generally sits with the manufacturer, not you
You're the named responsible person for the brand regardless of who manufactures	Responsible person duties (safety substantiation, adverse event recordkeeping) apply to you regardless of facility registration status

Don't confuse "exempt from registration" with "exempt from everything"

This is the part that causes real problems. Even a business that's genuinely exempt from facility registration and product listing under the small business provision still has responsibilities as the responsible person for its products, including maintaining safety substantiation for the formula and keeping records of adverse events reported by consumers, with serious adverse events reported to FDA. The exemption is narrow. It doesn't erase the responsible person role.

What to actually do next

If you're not sure whether you fall under the small business exemption, or whether your product category is one of the ones excluded from it, that's worth confirming directly against current FDA MoCRA guidance rather than guessing, since getting registration wrong in either direction, registering when exempt or skipping registration when required, creates its own cleanup work later.

If you're past that question and know registration applies to you, or you're preparing your product listing information regardless of your registration status, getting your ingredient list into clean, correctly named form is a good use of time either way. Cosmetic Comply's ingredient screening already covers Canadian notification filings, with U.S. support in development, so the underlying ingredient-to-INCI mapping work is something you can get ahead of now rather than scrambling for it later.

The registration question really comes down to two things: who physically makes the product, and whether your specific size and product category land you in the exemption. Answer those honestly before assuming either way.