Time Flies! Cosmetic Manufacturing Facilities are Due for FDA Registration Renewal

February 18, 2026

Manufacturers and processors of U.S.-distributed cosmetic products must renew their facility registration for the first time by July 1, 2026. To assist with the biennial registration requirement, the Food and Drug Administration (FDA) announced updates to its Cosmetics Direct electronic submission portal, a related user guide, and other instructions on February 11, 2026. Cosmetic manufacturers were required to initially register their facilities with FDA by July 1, 2024, and must renew their registration every two years. As a result, facilities that were registered by that initial deadline have a fast-approaching renewal date under Section 607(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Registrants and responsible persons should coordinate now, to ensure that facility renewals are submitted in a timely manner.

Registration and Renewal

The MoCRA registration requirement went into effect on December 29, 2023, but FDA delayed its implementation until July 1, 2024. Therefore, cosmetic facilities that registered in early 2024 are due for registration renewal this year. Renewal dates are based on the company’s initial registration date. For example, if FDA received the initial registration on February 20, 2024, then the renewal date would be February 20, 2026.

Cosmetic product facilities may submit registration renewals earlier than the two-year deadline if their products are also drugs subject to the Center for Drug Evaluation and Research’s annual establishment registration renewal.

Facility registration applies to entities that “manufacture or process” a cosmetic product. This term 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, as per 21 CFR § 700.3(k). Small businesses, as defined in FD&C Act Section 612, are exempt from facility registration.

More background on the initial facility registration under MoCRA can be found in Wiley’s June 17, 2024 client alert entitled “Time’s Up! Cosmetic Facilities Must Comply With FDA’s New Registration Requirements by July 1.”

Updates to Submission Portal

While paper renewal submission options are also available, FDA strongly encourages electronic submissions through its Cosmetics Direct portal. This portal is designed to help streamline the submission and receipt of registration information for account holders.

In preparation to receive the first biennial registration renewals, FDA updated Cosmetics Direct with several new features. For example, Cosmetics Direct now displays two new fields on the facility registration homepage: “REGISTRATION STATUS” and “RENEWAL DATE.”

Registration renewal reminders will be sent by FDA via email to registered facilities. The facility contact, the Cosmetics Direct account contact, the U.S. agent, any additional contact, and the paper submitter (as applicable) will receive these automated email reminders before the renewal date.

The Cosmetics Direct renewal submission options include: 

• Biennial Renewal (for facility registration renewals with changes); and
• Abbreviated Renewal (for facility registration renewals without changes).

According to Section 607(a)(4) of the FD&C Act, a cosmetic product facility that is required to register must notify FDA within 60 days of changes to any of the following information submitted in the registration:

• The facility’s name, physical address, email address, and telephone number;
• The contact information for the U.S. agent of a foreign facility;
• The facility registration number (if previously assigned);
• All brand names under which cosmetic products manufactured or processed in the facility are sold; and
• The product category and responsible person for each cosmetic product manufactured or processed at the facility.

If there are any of these changes, a facility would have to fill out a Biennial Renewal form, not the Abbreviated Renewal form.

Registration Guidance

For registration renewals, especially in cases where the abbreviated renewal is not available due to changes that occurred since registration, cosmetic product facilities can consult FDA’s Guidance to Industry. The guidance, released December 12, 2024, provides non-binding recommendations, instructions, and answers to frequently asked questions to assist persons submitting registrations, as detailed in Wiley’s January 8, 2025, client alert entitled “FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing.”

FDA has also provided explanatory notes on its pre-specified Cosmetic Product Categories and Codes which are submitted as part of the facility registration. Some categories have multiple components (i.e., primary, secondary, and tertiary product categories), as described in FDA’s diagram, below:

Source: FDA, “Cosmetic Product Categories and Codes” (Content current as of February 11, 2026).

Key Takeaways

Facility Registrants should check their renewal date and gather information on any changes to the facility identification details, product brands that are manufactured, and related product primary, secondary and tertiary categories. It is best to initiate the registration renewal process at least two weeks prior to the due date in order to manage for possible electronic submission delays and portal malfunctions.

Responsible Persons should confirm that their contract manufacturers are preparing to comply with the registration renewal process over the next few months, because the failure to register is a prohibited act under Section 301(hhh) of the FD&C Act and could lead to FDA enforcement action.

* * *

Wiley’s Food & Drug practice will continue to monitor developments as FDA refines its approach to regulating the cosmetics industry. For more information, please contact one of the authors of this alert if you have any questions about these or other requirements under MoCRA. Subscribe below to receive future updates on FDA activities in the areas of beauty and wellness or personal care products.