MoCRA’s First Biennial Renewal Wave Is Here: What Foreign Brands Must Check Now

By Vincent Cruz

When FDA launched its Cosmetics Direct portal in December 2023, cosmetic facilities around the world rushed to register under MoCRA. Two years later, that first wave of registrations is coming due — and many foreign brands don’t realize the clock is already running.

In February 2026, FDA updated Cosmetics Direct specifically to prepare for this moment: the portal now shows a REGISTRATION STATUS and a RENEWAL DATE for every facility, and FDA sends automated email reminders before each renewal date. Those reminders go to the facility contact — and, importantly for foreign brands, to the facility’s U.S. agent.

Here’s what every foreign brand needs to know.

Renewal is biennial — and it’s tied to YOUR registration date

Under MoCRA, every person required to register a facility must renew that registration every two years (section 607(a)(2) of the FD&C Act). The renewal date is based on your initial registration date — a facility first registered in February 2024, for example, was due for renewal by February 2026. There is no single industry-wide deadline; your obligation runs on your own calendar.

Product listings work differently: the responsible person must keep every marketed product’s listing current, with annual updates.

Two renewal paths exist in Cosmetics Direct: a full Biennial Renewal (when registration details have changed) and an Abbreviated Renewal (when nothing has changed since the last submission).

What it means for foreign brands

Three things make this renewal wave especially risky for brands outside the US:

1. Your U.S. agent is your early-warning system — if their contact info is current. FDA’s automated renewal reminders go to the U.S. agent on record. If you changed agents, or your agent changed email addresses, the reminder goes nowhere and the renewal can slip past unnoticed.

2. A lapsed registration is not a paperwork footnote. FDA considers products from an unregistered facility to be unregistered products — and that classification carries real enforcement exposure, including import holds.

3. “We registered once” is not compliance. Registration was step one. The renewal cycle, the annual listing updates, and the 60-day update rule for facility changes are the ongoing obligations that actually keep you compliant.

What to do now

1. Check your renewal date. Log into Cosmetics Direct and look at the RENEWAL DATE field for each of your facilities. If you don’t know when you first registered, that field will tell you.
2. Confirm your U.S. agent’s contact details are current in the registration — and that the agent is actually responsive. A silent or unreachable agent is a liability during renewal season.
3. Decide which renewal path fits: changes since last submission → full Biennial Renewal; nothing changed → Abbreviated Renewal.
4. Don’t wait for the reminder. Automated emails are a backstop, not a plan — especially if your agent details have drifted.

Official sources

• FDA Cosmetics Direct portal (registration & listing, renewal fields): fda.gov — Cosmetics Direct
• FDA constituent update on biennial renewal preparation (February 11, 2026): fda.gov — Biennial renewal update

Next step

Not sure where your facility stands? Run through the free MoCRA checklist or check your eligibility in two minutes (MoCRA eligibility checker). And if your U.S. agent has gone quiet — or you never had one — that’s exactly what we do: facility registration, renewals, and ongoing FDA representation for $450 one-time + $34.99/month.

This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on published sources current as of October 2026; always verify requirements against FDA’s official sources before acting.