Why this isn't FSVP
If you've worked with FDA-regulated food, you'll be looking for something like FSVP — the Foreign Supplier Verification Program that puts the burden of supplier verification on a food's U.S. importer. Cosmetics don't have that program. FSVP is written into the FD&C Act specifically for food, and MoCRA didn't extend it to cosmetics. Instead, MoCRA created a role unique to cosmetics: the Responsible Person.
The distinction matters because the two roles do different work. FSVP is about verifying a foreign supplier's food safety practices before import. The Responsible Person's job is about the product itself, on an ongoing basis, regardless of where it's manufactured — safety substantiation and handling adverse events.
Who is the Responsible Person
Under MoCRA, the Responsible Person is the manufacturer, packer, or distributor whose name appears on the cosmetic's label. If more than one name could apply, the Responsible Person is whichever of those parties actually controls or directs the product's manufacturing, packaging, or distribution — it isn't automatically the first name printed on the box. A brand that has a contract manufacturer produce its products under the brand's own name is typically the Responsible Person, not the manufacturer.
Core duty: safety substantiation
The Responsible Person must ensure there's adequate substantiation that the cosmetic is safe for its intended use, based on data or information reasonably available before the product enters the market. This is a meaningful shift from pre-MoCRA practice, where a "safety not determined" warning on the label was a legally acceptable substitute for actually doing the safety work. MoCRA closes that door: the warning statement no longer satisfies the requirement, and substantiation has to be a real, defensible file — the kind of documentation FDA can request and review.
In practice, this usually means toxicological review of the finished formula and its individual ingredients, referencing existing safety data where it exists (industry panels, published literature, prior clinical or consumer-use data) rather than commissioning new testing on every ingredient from scratch.
Core duty: adverse event reporting
The Responsible Person is also who receives and must act on adverse event reports. A serious adverse event — one resulting in death, a life-threatening experience, hospitalization, significant disfigurement, or other serious outcome — must be reported to FDA within 15 business days of the Responsible Person becoming aware of it, along with a copy of the product's label. Follow-up information discovered within one year must also be submitted. Records of all adverse events, serious and non-serious, must be kept for six years (a shorter period applies to small businesses under FDA's implementing rule).
This is why the product label has to carry a working domestic address, phone number, or electronic contact for adverse event reports — a requirement that took effect December 29, 2024. Consumers, retailers, and healthcare providers need a real channel back to the Responsible Person.
When a U.S. Agent is also required
If the Responsible Person is located outside the United States — or if the manufacturing facility itself is foreign — a separate U.S. Agent designation is required as part of facility registration. The U.S. Agent is FDA's domestic point of contact for that facility; it doesn't replace the Responsible Person's substantive safety and reporting duties, which travel with the Responsible Person regardless of where they're based.
What FDA can do if this breaks down
A cosmetic can be deemed misbranded or adulterated if the Responsible Person fails to maintain adequate safety substantiation, and FDA has mandatory recall authority under MoCRA for cosmetics that present a reasonable probability of serious adverse health consequences — a new power the agency didn't have over cosmetics before this law. Getting the Responsible Person role right isn't paperwork; it's the thing that determines who's accountable when something goes wrong with a product already on shelves.