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FDA Updates Cosmetics Direct Portal for Biennial Registration Renewal Under MoCRA
On 11 February 2026, the U.S. Food and Drug Administration (FDA) announced significant updates to its Cosmetics Direct electronic submission portal, along with revised user guides and instructional materials. These updates are designed to support cosmetic product facilities through their first biennial registration renewal under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
For manufacturers, processors, and responsible persons distributing cosmetics in the United States, understanding the renewal process and meeting the deadline is critical. Failure to comply is a prohibited act under federal law and could lead to FDA enforcement action.
What Is MoCRA and Why Does Biennial Renewal Matter?
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, fundamentally changed how cosmetics are regulated in the United States. For the first time, MoCRA made facility registration and product listing mandatory for cosmetic manufacturers and processors.
Under Section 607(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), every registered cosmetic product facility must renew its registration every two years from the date of initial registration. Since facilities were initially required to register by 1 July 2024, the first wave of biennial renewals is now due.
This means that facilities registered in early 2024 already have renewal dates approaching. For example, a facility whose initial registration was received by FDA on 20 February 2024 has a renewal date of 20 February 2026.
What’s New in Cosmetics Direct?
The FDA has updated the Cosmetics Direct portal with several new features specifically designed for the renewal process:
- Registration Status field: The facility registration homepage now displays the current registration status, making it easy to see whether your facility is active, expired, or pending renewal.
- Renewal Date field: A dedicated field now shows the exact date by which each facility must complete its renewal.
- Automated email reminders: FDA will send renewal reminders before the due date to the facility contact, the Cosmetics Direct account contact, the U.S. agent, and any additional contacts on file.
Two Renewal Options
The updated Cosmetics Direct portal offers two electronic renewal paths:
Biennial Renewal (With Changes)
Use this option if there have been changes to your facility information since the most recent registration submission. This includes changes to the facility name, address, contact details, product brands manufactured, or product categories.
Abbreviated Renewal (Without Changes)
As provided under Section 607(a)(5) of the FD&C Act, FDA allows an abbreviated renewal when there have been no updates to the registration information since the most recent submission. This streamlined option is faster and requires less documentation.
Paper submission options are also available for facilities that cannot use the electronic system.
Who Must Renew?
Facility registration applies to entities that “manufacture or process” a cosmetic product. Under 21 CFR § 700.3(k), this is defined as engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.
This means that if your facility performs any step in the production or processing of a cosmetic product distributed in the United States, you are required to maintain an active registration and renew it biennially.
Key Dates for 2026
| Date | Event |
|---|---|
| 11 February 2026 | FDA announces Cosmetics Direct portal updates with renewal features |
| Individual renewal dates | Based on each facility’s initial registration date (two years from registration) |
| By 1 July 2026 | Latest deadline for facilities registered by 1 July 2024 |
Important: Renewal dates are individual to each facility. Check your specific date in Cosmetics Direct.
Consequences of Non-Compliance
Failure to register or renew a cosmetic product facility is a prohibited act under Section 301(hhh) of the FD&C Act. This can lead to:
- FDA enforcement action, including warning letters
- Products being classified as misbranded or adulterated
- Facility suspension, which would prevent all products from entering U.S. commerce
- Border holds and import refusals for internationally manufactured products
The stakes are significant, particularly for international manufacturers and contract manufacturing organizations (CMOs) that serve multiple brands.
Recommended Actions for Facilities and Responsible Persons
- Check your renewal date: Log into Cosmetics Direct and review the new Registration Status and Renewal Date fields for each registered facility.
- Start early: Initiate the renewal process at least two weeks before your due date to account for potential electronic submission delays or portal issues.
- Gather updated information: Before submitting, confirm all facility identification details, product brands manufactured, and product primary, secondary, and tertiary categories.
- Choose the right renewal path: Use Abbreviated Renewal if nothing has changed since initial registration. Use Biennial Renewal if any facility or product information has been updated.
- Notify within 60 days of changes: Under Section 607(a)(4), facilities must notify FDA within 60 days of changes to facility name, address, contact information, product brands, or product categories.
- Coordinate with contract manufacturers: Responsible persons should confirm that all contract manufacturing facilities are aware of their renewal dates and are prepared to comply.
- Verify U.S. agent information: For international facilities, ensure your U.S. agent details are current, as they will receive renewal reminders from FDA.
How CosmeReg Can Help
CosmeReg assists cosmetic brands and manufacturers with MoCRA compliance, including facility registration, biennial renewal preparation, product listing, and ongoing regulatory monitoring for the U.S. market.
Contact our team to ensure your facility registrations are up to date and your renewal submissions are completed on time.
Published: February 2026 | Last updated: February 2026
Source: FDA — Updates Web Portal and Informational Materials to Help Cosmetic Facilities Prepare for Biennial Registration Renewal (11 February 2026).
Pasquale Carvelli is a Regulatory Strategy & International Compliance Advisor for Cosmereg, an international regulatory affairs company supporting manufacturers, distributors, and brand owners navigating complex compliance frameworks across multiple jurisdictions.
Through a multidisciplinary network of certified safety assessors and regulatory experts, he oversees strategic compliance pathways for cosmetic, food, and supplement products entering regulated markets.
