By Vincent Cruz
Under MoCRA, nearly every foreign facility that manufactures or processes cosmetics for the U.S. market must designate a U.S. agent (qualifying small businesses are exempt). Several providers offer the service, with bundled registration-plus-agent packages starting around $750 per year and enterprise firms pricing on request. Here is how the main options compare in 2026, and what to check before you hire one.
How we compared providers
We scored each provider on five things that matter to foreign brands:
- Transparent pricing – is the price public, with no quote wall?
- Scope – registration filing, FEI help, and ongoing representation, or agent-only?
- Contract terms – what happens when you cancel? Look for a formal resignation filing, not a silent drop.
- Billing model – monthly flexibility vs. annual upfront.
- Focus – a dedicated U.S.-agent service vs. one line item in a large consultancy.
The shortlist
| Provider | Starting price | Model | Best for |
|---|---|---|---|
| US MoCRA Agent | $450 one-time + $34.99/mo | Onboarding + monthly | Foreign brands that want transparent, month-to-month representation |
| FDA Registration Assistance | $849/year | Annual bundle | Brands that want registration and agent bundled yearly |
| United Safety Agents | $750 | Per 2-year coverage | Facilities that prefer multi-year coverage paid upfront |
| CE.way | $990/year | Annual | EU brands already using CE.way for other markets |
| Biorius | On request | Enterprise | Large groups needing full regulatory consultancy |
Prices as listed on provider websites in September 2026 and subject to change. Confirm current pricing before you decide.
Our pick for most foreign brands: US MoCRA Agent
We run this site, so take the ranking with the appropriate skepticism – but the reasons are concrete: public pricing ($450 one-time onboarding plus $34.99/month), no per-product surcharge, biennial renewal filing included while you are subscribed, and a formal resignation filed with FDA if you ever cancel, so your registration is never silently abandoned. Every filing is reviewed with you field by field, and nothing is submitted without your written approval.
The alternatives
FDA Registration Assistance ($849/year) bundles MoCRA facility registration with a year of U.S. agent service. A reasonable fit if you want one annual payment covering both.
United Safety Agents ($750) covers one facility for two years, including the registration, agent representation, FEI obtainment, and up to two amended registrations. Worth a look if you prefer paying for multi-year coverage upfront.
CE.way ($990/year) offers U.S. agent service for non-U.S. facilities as part of a broader EU/U.S. regulatory practice. Sensible if you already use them for EU compliance.
Biorius is an established cosmetics regulatory consultancy (15 years in the EU/UK) that acts as U.S. agent through its U.S. entity. Pricing is quote-based, which usually means enterprise budgets.
What to check before you hire any U.S. agent
- Is the pricing public, or do you have to request a quote to learn the cost?
- Does the fee cover just the agent designation, or also the registration filing and FEI?
- Are product listings billed per SKU? Per-product surcharges add up fast for brands with large catalogs.
- What happens when you cancel – is a formal resignation filed, or does representation just stop?
- Who actually answers if FDA writes to your facility?
- How quickly do they respond? Ask for a straight answer before you pay.
Red flags
- No public pricing anywhere on the site.
- Per-SKU fees buried in fine print.
- No written process for resignation on cancellation.
- The “agent” is only a mailbox with no one available during business hours.
- Pressure to pay a full year before you have seen a single draft filing.
For a deeper walkthrough of the criteria above, see our guide on how to choose a MoCRA U.S. agent.
Frequently asked questions
Do I need a U.S. agent if I already have a U.S. distributor?
A distributor does not automatically serve as your U.S. agent. The agent must be formally designated on your FDA facility registration and accept the role.
Can I switch agents later?
Yes. Switching is done by filing an amended facility registration naming the new agent. Your FEI number and registration history carry over. See our transfer guide for the full process.
Does the U.S. agent have to be a company?
No. It can be a person or a business, but it must be physically present in the U.S. and available during business hours. A mailbox or answering service alone does not qualify.
US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. This article is for informational purposes only and is not legal advice. Competitor pricing was checked in September 2026; verify current terms on each provider’s website.
See also: how much a MoCRA U.S. agent costs — a provider-by-provider price comparison.
