MoCRA reaches foreign facilities directly
Before MoCRA, a foreign cosmetics manufacturer's obligations when entering the U.S. market were comparatively thin: get the label right, don't run afoul of misbranding or adulteration rules, and let your U.S. distributor handle the rest. MoCRA changes that by attaching obligations directly to the foreign manufacturing facility and to whichever party is named as Responsible Person — regardless of where either one is physically located.
What a foreign manufacturer now has to do directly
- Register the manufacturing facility with FDA via Cosmetics Direct and obtain an FEI, the same as a domestic facility — there's no exemption for being located outside the U.S.
- Designate a U.S. Agent as part of that registration — a U.S.-based point of contact FDA can reach directly, separate from any commercial importer relationship you may have.
- Ensure a Responsible Person is named for every product, whether that's the foreign manufacturer itself, its U.S. distributor, or a third party — and that whoever holds that role actually does the safety substantiation and adverse-event-reporting work it requires.
- Put domestic contact information on the label — an address, phone number, or electronic contact within the U.S. where adverse events can be reported, independent of whatever contact info appears for the brand itself.
Importer vs. Responsible Person: not the same role
These two roles get conflated often enough that it's worth stating plainly: your U.S. importer of record for customs purposes and your MoCRA Responsible Person do not have to be the same party, and often aren't. A foreign brand can retain the Responsible Person role itself, appoint a specialized U.S. compliance firm to hold it, or let its distributor take it on — the choice is commercial, but whoever accepts it takes on real legal exposure for safety substantiation and adverse event handling, so it shouldn't be assigned by default to whichever party happens to touch the shipment last.
| Role | What it covers | Can be foreign? |
|---|---|---|
| Facility (manufacturer) | Where the product is made or processed | Yes, with a U.S. Agent |
| U.S. Agent | FDA's domestic contact for a foreign facility | No — must be U.S.-based |
| Responsible Person | Safety substantiation & adverse event handling | Yes, if the label names them |
| Importer of record | Customs entry & duties | No — U.S. entity required by CBP |
Records access
MoCRA also expanded FDA's authority to access certain records relevant to a cosmetic's safety on request, including safety substantiation records held by the Responsible Person. For a foreign manufacturer, this means the safety file needs to actually exist somewhere reachable and produced on request — not just referenced as "on file with the manufacturer" without a clear custodian able to respond to FDA in a reasonable timeframe.
For foreign brands entering the U.S. for the first time, the practical sequence is: register the facility and designate a U.S. Agent, decide who holds the Responsible Person role and confirm they can actually do the substantiation and reporting work, list your products, and only then finalize label artwork with the correct domestic contact information built in from the start.