Recurring mandate
MoCRA US Agent and facility registration services.
Facility registration, annual product listing and a US Agent for foreign facilities, with biennial renewals handled for you.
What is a MoCRA US Agent?
A US Agent is the person or entity a foreign cosmetic facility designates to act as its point of contact with the FDA in the United States. The requirement comes from MoCRA — the Modernization of Cosmetics Regulation Act — which extended FDA oversight of cosmetics and created obligations that did not previously exist for foreign manufacturers. The agent is not a distributor, not a consultant on retainer, and not a mailbox. It is a named, reachable US presence that the FDA can contact directly.
For a foreign facility, the practical effect is simple. Without a designated US Agent, the facility cannot complete its MoCRA registration. The agent’s details are part of the registration record, and the FDA uses them as the channel for correspondence, questions, and any follow-up on the facility’s filings. If the FDA cannot reach a US contact, the facility has no one to receive the message.
The US Agent is the FDA's point of contact in the United States
The agent receives FDA communications on behalf of the foreign facility and relays them onward. That includes routine correspondence and any request for information tied to registration or listing. The agent must be physically located in the United States and reachable during US business hours — the role exists precisely because the FDA needs a domestic party to contact.
This is the function that defines the role. Everything else the agent does flows from being the reachable US endpoint for a foreign facility’s regulatory correspondence.
Who must designate a US Agent
Foreign facilities that manufacture or process cosmetic products for US distribution must designate a US Agent. The obligation attaches to the facility, not to the brand name on the label, and it applies whether the facility is a contract manufacturer, a fill-and-finish operation, or a brand’s own overseas production site.
If your product is made outside the United States and sold into the US market, the facility that made it needs a US Agent. CIGREG acts as that agent for foreign cosmetic facilities, and holds the designation so the facility can register and stay reachable.
US Agent vs. Responsible Person
The Responsible Person and the US Agent are distinct roles under MoCRA, and conflating them is one of the most common errors in US market entry. The Responsible Person owns product-level obligations — safety substantiation, adverse event records, labelling. The US Agent owns the communication channel between the foreign facility and the FDA.
A single organisation can hold both roles, and CIGREG does. But the obligations do not merge. A brand that appoints a US Agent has not thereby appointed a Responsible Person, and vice versa. Both must be in place, and both must be named.
What the law requires
Federal registration, listing and a US Agent.
Deadlines and who does what
The dates that matter, and the split most brands miss.
MoCRA’s registration and listing deadlines have already passed for products marketed at the effective date. If you sell in the US now and have not filed, you are non-compliant now, not still inside a grace period.
Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 26 July 2026
Foreign cosmetic facilities selling into the US must register with the FDA, name a US Agent, and keep a product listing current under MoCRA. CIGREG acts as your named US Agent, files registrations and listings in SPL through Cosmetics Direct, and tracks your biennial renewal date.
Legal basis: FDA: MoCRA, FDA Cosmetics Direct.
How CIGREG covers it
What is included.
A mandate that registers your facilities, maintains your listing, acts as your US Agent and keeps your renewals on track.
There is no FDA fee to register a facility or list a product under section 607 of the FD&C Act. The cost is in preparing the submissions correctly and keeping them current, which is what our fixed setup fee covers. Cosmetics Direct is the FDA’s free SPL authoring tool; the required XML format is where first-time filers most often get stuck, so we handle the formatting for you rather than leave you with the portal.
What we need from you
The inputs that let us file.
Registration and listing move quickly once we have the facts. Most of what we need already exists in your production and label records. What the listing duty involves, and why it belongs to the Responsible Person rather than the factory, is explained in our product listing guide. The product listing has to name the products you market and their ingredients, so an accurate ingredient list per product is the piece we cannot proceed without.
If you already hold an FDA Establishment Identifier for a facility, we use it. If you do not, we obtain it as part of the work. Where you sell through a contract manufacturer, we confirm which party is registering the facility and which is doing the product listing, so the two filings line up.
Edge cases and scope
Where MoCRA gets more specific.
A few situations change what applies to you. We flag these at the start so the scope is right before anything is filed.
How it fits the other markets
US coverage alongside the EU, UK and Switzerland.
The US regime is separate from the EU, UK and Swiss ones, and a US filing does nothing for the others. A brand selling across all four markets needs an EU Responsible Person with CPNP notification under Reg. 1223/2009, a UK Responsible Person with SCPN notification through OPSS, a responsible person with a Swiss address, and MoCRA registration with a US Agent. These are four legal regimes, four sets of obligations, and portals that do not talk to each other.
We hold all four in one relationship. The same team that runs your US MoCRA mandate handles your EU, UK and Swiss obligations, so renewal dates across every market are tracked in one place instead of scattered across separate vendors. Where a product is going to more than one market, we reuse the same ingredient and label data rather than asking for it four times.
Who it is for
Brands selling cosmetics into the United States.
If your cosmetics are manufactured or processed at a facility selling into the US, and particularly at a facility outside the United States, MoCRA requires facility registration, an annual product listing and, for foreign facilities, a designated US Agent. This mandate suits brands that want US coverage handled correctly, with renewal dates tracked for them. It fits indie and direct-to-consumer brands that have deferred MoCRA and need to catch up, and portfolio accounts running several facilities with staggered renewal dates.
Pricing
Fixed, transparent pricing.
MoCRA facility registration and product listing setup is a fixed fee. Ongoing monitoring and renewals are covered under Compliance Care.
Prices in USD.
See full pricing →Where this service fits
The US Agent in your compliance path.
FAQ
Common questions.
Related
Pairs well with.
In practice
Compliance, in the real world.
