MoCRA: Understanding the New Facility Registration Requirements

The enactment of the Modernization of Cosmetics Regulation Act (MoCRA) on December 29, 2022, signaled a seismic shift in the regulatory landscape for the cosmetic and personal care industry. For nearly a century, the Federal Food, Drug, and Cosmetic Act (FDCA) provided the Food and Drug Administration (FDA) with limited oversight authority over cosmetics. MoCRA has effectively dismantled this era of self-regulation, imposing rigorous federal mandates that align the industry more closely with the stringent requirements long faced by the pharmaceutical and food sectors.

For executives, brand founders, and legal counsel at Anthony Girand Law’s clients, the transition from voluntary compliance to mandatory federal registration and listing is not merely an administrative hurdle—it is a fundamental change to the risk profile of your business.

The Paradigm Shift: Why MoCRA Matters

Prior to MoCRA, the FDA’s Voluntary Cosmetic Registration Program (VCRP) functioned as an elective database. MoCRA transforms this into a compulsory system of oversight. The intent of Congress was clear: to empower the FDA with a comprehensive view of the domestic and global supply chain. By requiring the registration of facilities and the listing of products, the agency has secured the tools necessary to perform targeted inspections, issue mandatory recalls, and respond rapidly to safety signals.

Failure to treat these requirements with the gravity of a material business obligation can lead to severe operational disruptions, including the potential for "misbranded" status under the FDCA, which may authorize the FDA to seize products, issue warning letters, or trigger administrative detention at the border.

Deciphering Facility Registration Requirements

Under MoCRA, the "owner or operator" of a facility that manufactures or processes cosmetic products for distribution in the United States must register that facility with the FDA. This is an expansive definition that captures a vast segment of the industry.

Who is Captured Under the Mandate?

The registration requirement is not limited to primary manufacturers. It encompasses:

• Domestic and Contract Manufacturers (CMOs): Any entity engaged in the formulation, mixing, or packaging of cosmetic products.
• Foreign Facilities: Any international facility whose products are destined for the U.S. market must register, regardless of geography.
• Repackagers and Relabelers: Facilities that do not formulate the base product but engage in secondary operations that alter the final presentation of the product.

The Small Business Exemption: A Narrow Safe Harbor

There is an exemption for "small businesses," defined as those with average annual gross sales in the U.S. of cosmetic products for the previous three-year period of less than $1,000,000. However, counsel must approach this exemption with caution. It is inapplicable to businesses that manufacture or process cosmetic products that regularly come into contact with the eye area, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours. Furthermore, even if you qualify today, rapid scaling or private equity investment can quickly push a firm past this threshold, necessitating an immediate pivot to compliance.

Navigating Product Listing Obligations

Registration of the facility is only half of the equation. MoCRA also necessitates a detailed product listing for every cosmetic product marketed in the U.S. This process is distinct from registration and is managed through the FDA’s Cosmetics Direct electronic portal.

Key elements of a product listing include:

• Responsible Person Identity: You must designate the "Responsible Person," typically the brand owner, manufacturer, or packer whose name appears on the label.
• Ingredient Disclosure: This must include the full ingredient list, including fragrances and colors, which has historically been a closely guarded trade secret for many brands.
• Product Categories: Precise classification of each product is required to facilitate FDA categorization and risk assessment.

The mandate requires that these listings be submitted within 120 days of a product first entering the market, with annual updates required to ensure the agency maintains an accurate ledger of the products circulating in the U.S. consumer economy.

Strategic Operational Considerations

For businesses, especially those utilizing contract manufacturing (CMO) models, the division of labor between the brand and the manufacturer is often the source of significant regulatory friction.

Clarifying Roles in Manufacturing Agreements

Many brands erroneously believe that if their contract manufacturer registers their facility, the brand’s own obligations are satisfied. This is incorrect. The facility owner registers the physical site; the Responsible Person (the brand) must list the products. These are distinct, independent duties under MoCRA. We strongly advise our clients to review their CMO agreements to clearly delineate:

1. Which party holds the FEI (FDA Establishment Identifier) number: Ensure your CMO is proactive in maintaining its registration.
2. Reporting Obligations: Establish a contractual "duty to inform" wherein the manufacturer must notify the brand immediately if their registration status changes or lapses.
3. Liability Shifting: Indemnification clauses should be updated to account for losses incurred due to a partner’s failure to maintain regulatory compliance.

The Risk of Non-Compliance

The FDA has explicitly stated that facilities that fail to register are in violation of the FDCA. The consequences are not theoretical. Non-compliant facilities face:

• Import Refusals: Products manufactured in unregistered facilities or listed by non-compliant Responsible Persons may be detained or refused entry at the border, leading to significant inventory losses.
• Public Scrutiny: The FDA’s commitment to transparency means that compliance records are increasingly part of a brand’s public-facing risk profile.
• Operational Stagnation: Redirecting executive bandwidth to rectify registration errors during an audit or a supply chain crisis is a preventable expense that distracts from core business growth.

Moving Forward

The transition to a MoCRA-compliant framework requires a sophisticated approach that integrates regulatory awareness into the company’s operational lifecycle. Compliance is not a "set-it-and-forget-it" task; it is an ongoing state of alertness that requires biennial renewal of registrations and consistent updates to product listings.

If your organization is navigating the complexities of the Cosmetics Direct portal, or if you require an audit of your existing supply chain agreements to ensure your brand is protected, our office at Anthony Girand Law is prepared to assist. We specialize in aligning your legal infrastructure with the realities of the modern regulatory environment, ensuring that your growth is both sustainable and secure.