MoCRA Facility Obligations After the 2024 Deadline: Ensuring Full Regulatory Alignment

A Mandate for Manufacturers and Processors Entering the U.S. Market

The Modernization of Cosmetics Regulation Act (MoCRA) represents the most significant update to U.S. cosmetic law in decades, giving the FDA (Food and Drug Administration) enhanced authority to oversee cosmetic product safety and facility transparency. MoCRA shifts facility registration from a voluntary practice to a legally enforceable obligation, requiring manufacturers and processors who sell in the U.S. to meet defined registration and listing deadlines and provide a clear point of contact for the agency.

Introducing MoCRA: The New Era of Cosmetic Regulation

MoCRA was enacted to strengthen consumer protections and modernize oversight of cosmetics. The law’s primary goal is to ensure the FDA can rapidly identify where products are made, investigate safety issues, and coordinate recalls or other public-health actions when necessary. For manufacturers and processors, MoCRA implies new administrative duties, amplified reporting, and clearer accountability across domestic and foreign supply chains.

The Definition of a Cosmetic Facility

Under MoCRA, a “cosmetic facility” generally includes any location where cosmetics are manufactured or processed for distribution in the United States. Typical examples are formulation labs, contract manufacturers, and packaging sites. Entities that solely retail, re-label without processing, or simply store finished goods often fall outside the “facility” definition, but each business should confirm its status based on its specific operations and legal counsel.

The Obligation: Why Registration is Now Mandatory

Unlike the pre-MoCRA voluntary program, facility registration is now a statutory requirement. The FDA needs accurate facility data to support inspections, adverse-event investigations, and market surveillance. Manufacturers and processors must therefore treat registration and product listing as a compliance imperative rather than optional paperwork.

Strategy for Firms That Missed the Initial Deadline

The initial compliance deadline has passed (July 1, 2024), meaning most companies should have completed the required registration and listing. For those that haven't yet complied:

• Risk of Non-Compliance: Failure to meet the initial deadline results in an establishment being considered unregistered. Consequences may include increased regulatory scrutiny, the detention of shipments at U.S. ports, and potential enforcement actions that disrupt distribution and sales.
• Immediate Action Required: Although the initial milestone has passed, the legal obligation to register is continuous. The most critical action is to register and list immediately to minimize operational and administrative risk.

Deadlines for New Facilities and Biennial Renewal

MoCRA creates ongoing obligations for both new facilities and existing registrants.

New Facility Registration Requirement

Facilities that begin manufacturing or processing cosmetics for distribution in the U.S. after MoCRA’s effective date must register within a statutory timeframe: commonly within 60 days of commencing manufacturing operations. This requirement ensures the FDA obtains near real-time visibility into new supply chain participants.

The Biennial Renewal Requirement

Once registered, facilities must renew their registration every two years (biennially), as specified by the FDA. Registrants should calendar renewal reminders and verify contact details, product listings, and any changes in ownership or operations to maintain compliance.

Key Information Required for Registration and Listing

Gathering accurate data in advance simplifies both facility registration and mandatory product listing and reduces the likelihood of rework.

Required Facility and Operator Data

Typical registration fields include facility name and address, operator or owner details, and unique identifiers the FDA may use (such as FEI numbers). Accurate information supports inspection readiness and rapid follow-up should safety issues arise.

Mandatory Requirement for Foreign Facilities: The U.S. Agent

Foreign facilities must designate a U.S. Agent as part of the registration process. The U.S. Agent is the FDA’s official contact for regulatory correspondence and must be available to respond to inquiries, assist in coordinating inspections, and receive official notifications on behalf of the foreign establishment.

Exemption Status: When Registration is Not Required

MoCRA includes carve-outs for certain small businesses and specific activities. However, exemptions are narrowly defined and often based on gross cosmetic revenue thresholds. Even exempt firms should evaluate other MoCRA obligations—such as recordkeeping or adverse-event reporting—that may still apply despite a registration exemption.

The Small Business Exemption Threshold

Smaller manufacturers may qualify for exemption from facility registration if they fall below the statutory revenue threshold. Nonetheless, these entities should verify eligibility carefully, as other statutory duties under MoCRA can remain applicable regardless of registration status.

Supporting Continuous MoCRA Compliance

MoCRA has redefined cosmetic facility registration and product listing—from voluntary practices to mandatory, time-bound requirements. Both U.S. and international manufacturers must now maintain ongoing compliance through accurate data management, timely renewals, and structured update procedures.

At Techlink International LLC, we provide end-to-end MoCRA compliance support for cosmetic manufacturers and processors. Our team assists with data compilation, submission management, U.S. Agent coordination, and the creation of efficient renewal and update workflows.

Reach out today to discover how we can help your facility stay compliant and maintain uninterrupted access to the U.S. cosmetic market.