What MoCRA Actually Changed for Cosmetic Makers

If you've never had to deal with federal cosmetic law before, "MoCRA" probably sounds like alphabet soup someone mentioned in a Facebook group. Here's what it actually is and what it actually asks of you, without assuming you already know the pre-2022 rules.

Before MoCRA, the bar was low

For decades, US federal cosmetic regulation was thin. There was no federal requirement to register your facility with the FDA, no requirement to list your products, and no formal mechanism for the FDA to track adverse events tied to a specific product line at the federal level. States filled some gaps, and reputable makers still did safety testing because it was the responsible thing to do, but there wasn't a standing federal paper trail the way there is for drugs.

MoCRA, the Modernization of Cosmetics Regulation Act, passed in 2022, changed that baseline. It's the first major expansion of FDA authority over cosmetics in a long time, and it added several concrete, checkable obligations.

The four things MoCRA actually requires

1. Facility registration

If you manufacture or process cosmetics for the US market, your facility generally needs to be registered with the FDA. This is a registration of the facility itself, separate from any individual product.

2. Product listing

Each cosmetic product you sell generally needs to be listed with the FDA, tying it back to the registered facility and giving the FDA a record of what's on the market and where it's made.

3. A named responsible person

MoCRA requires a designated responsible person for each product, someone accountable for maintaining safety substantiation and for receiving and acting on adverse event reports. This isn't just a company name on a label, it's a specific accountable role.

4. Safety substantiation and adverse event recordkeeping

You need to be able to show that you have adequate substantiation that your product is safe, and you need a system for recording adverse events reported by consumers, with certain serious events reportable to the FDA within set timeframes.

Who's exempt, and why that's not a free pass

Some small businesses are exempt from the facility registration and product listing requirements. That exemption exists because MoCRA's drafters recognized that a one-person soap maker selling at farmers markets doesn't have the same infrastructure as a national brand, and a blanket registration requirement could be disproportionate.

That said, "exempt from registration and listing" doesn't mean exempt from every part of MoCRA. Safety expectations and general adulteration and misbranding rules still apply broadly. If you're a small operation, it's worth checking the current FDA guidance on which specific exemptions apply to your size and situation rather than assuming the whole law doesn't touch you.

What this looks like day to day

Before MoCRA, a lot of small and mid-size makers operated on the honor system: keep good notes, source clean ingredients, respond if a customer complains. MoCRA turns some of that into a documented obligation. Concretely, that can mean:

• Keeping a real file of safety substantiation for each product, not just "we've never had a complaint."
• Having an actual process for logging when a customer reports a reaction, including what you did in response.
• Knowing exactly who inside your business (or which outside party) is the designated responsible person, and making sure that's not just an assumption.

One thing MoCRA didn't change

Sunscreen is still regulated as an OTC drug, not a cosmetic, and that didn't shift under MoCRA. If your product line includes an SPF item alongside your cosmetics, that item lives under a different, older regulatory pathway entirely, with its own testing and monograph requirements. Don't fold it into your MoCRA compliance thinking as if it's the same track.

Where this leaves a small maker

If you've been selling cosmetics in the US without ever thinking about federal registration, MoCRA is the reason to check where you actually stand now, specifically whether your size qualifies for the small business exemptions and what your safety documentation currently looks like versus what MoCRA expects. Cosmetic Comply is Canada-first today, with US MoCRA support on the roadmap, and part of the reason is that this kind of "what's actually new" confusion is common enough that a lot of makers could use a clearer map of what changed under their feet.