What MoCRA Requires: Facility Registration, Safety Proof and New Labels Before Launch

The Modernization of Cosmetics Regulation Act, passed in December 2022, represents the first substantial update to U.S. cosmetics law in 84 years. The previous framework, the Federal Food, Drug, and Cosmetic Act, dates to 1938. For eight decades, the FDA’s authority over cosmetics remained largely unchanged: the agency could not mandate facility registration, issue recalls, or demand safety documentation before products reached shelves.

MoCRA fundamentally reshaped this landscape. Enforcement began July 1, 2024. For beauty founders, the law now requires four core compliance steps before launching: facility registration with the FDA, product listing, documented safety substantiation, and updated labeling that includes fragrance allergen disclosures and adverse event contact information. Understanding these requirements and their costs helps entrepreneurs plan launch timelines and budgets.

Facility Registration: Putting Products on the FDA’s Radar

Every cosmetics manufacturer and processor distributing in the U.S. must register with the FDA through an electronic portal called Cosmetics Direct. The registration puts facilities “on the FDA’s radar” for the first time, according to legal analysis of the law. Existing facilities had until July 1, 2024, to register; new facilities must register within 60 days of first manufacturing or processing. The registration requires accurate facility information and an FDA Establishment Identifier (FEI).

Registrations must be renewed every two years. The facility owner—distinct from the “responsible person” who manages product listings—is responsible for maintaining current registration information and updating the FDA within 60 days of any changes to ownership, location, or manufacturing operations. Foreign manufacturers must designate a U.S. agent who maintains a place of business and is physically present in the United States. A single facility can encompass multiple buildings within three miles of each other under one FDA Establishment Identifier, requiring only one registration.

Compliance deadline already passed
The FDA extended the original December 29, 2023 deadline for facility registration and product listing to July 1, 2024. Existing facilities that have not registered and products not yet listed are non-compliant and subject to FDA enforcement action.

Product Listing: Ingredient Transparency and Tracking

Once a facility is registered, the “responsible person”—defined as the manufacturer, packer, or distributor whose name appears on the product label—must list each marketed cosmetic with the FDA. The product listing requires product category data, an ingredient list, and the name and place of business of the manufacturer. Unlike facility registration, which identifies where products are made, product listing identifies what those products are and what they contain.

Existing products had until July 1, 2024, to be listed; new products must be listed within 120 days of first marketing. Product listings must be updated annually. Free samples and gifts intended for consumer use require listing, but research and development samples do not. As of January 6, 2026, the FDA’s system reflected 14,299 active facility registrations and 992,907 active product listings. Incomplete or inaccurate product listings risk FDA enforcement action.

Safety Substantiation: From Warning Labels to Scientific Evidence

MoCRA requires manufacturers to substantiate that each cosmetic product is safe under its intended or reasonably foreseeable conditions of use. This represents a major departure from prior practice. Manufacturers must now maintain what the FDA calls “adequate substantiation.” The law defines this as “tests, studies, research, analyses or other evidence considered by qualified scientific experts that support the reasonable certainty a cosmetic product is safe.”

Substantiation can take multiple forms: ingredient safety data sheets, published scientific literature, toxicological risk assessments, exposure evaluations, product testing, microbiological testing, stability testing, and other relevant scientific evidence. A qualified scientific expert—someone with education and experience in evaluating cosmetics safety—must review and approve the substantiation. Manufacturers must maintain these complete records for six years, or three years for small businesses with less than $1 million in average annual U.S. sales over three years. The FDA does not require a single standardized format; companies can organize substantiation as they see fit, but records must be maintained and available for FDA inspection.

Labeling and Adverse Event Reporting: Consumer Protection and Brand Liability

Product labels must now include a U.S. address, phone number, or electronic contact where the responsible person can receive adverse event reports from consumers. This gives the FDA a new surveillance mechanism: consumers can report problems directly to brands, and brands must forward serious incidents to the agency. Labels must also include the statement of identity (what the product is), net quantity of contents, name and address of manufacturer or distributor, and a complete ingredient declaration.

A significant new requirement affects many beauty brands: fragrance allergen disclosure. For cosmetics used by both consumers and professionals, manufacturers must list each fragrance allergen included in the product. Disclosed allergens include ingredients such as linalool and citronellol. As of January 2026, the FDA had not yet issued fragrance allergen labeling regulations.

Manufacturers must maintain records of all adverse events—serious and non-serious—for six years, or three years for qualifying small businesses. “Serious adverse events” include those resulting in death, life-threatening experiences, inpatient hospitalization, persistent or significant disability, congenital anomaly, birth defect, infection, or “significant disfigurement,” which the FDA defines to include severe rashes, deep burns, substantial hair loss, or lasting appearance changes. An event may also be serious if it requires medical intervention to prevent these outcomes. When a manufacturer learns of a serious adverse event, it must report the incident to the FDA within 15 business days, including patient information, event details and outcomes, suspect product details, and a copy of the product label. If new material information emerges within one year of the initial report, companies must submit updates within another 15 business days.

Manufacturers must now maintain what the FDA calls ‘adequate substantiation’—tests, studies, research, analyses or other evidence considered by qualified scientific experts that support the reasonable certainty a cosmetic product is safe.

Good Manufacturing Practice Rules: Framework Delayed but Coming

MoCRA required the FDA to establish Good Manufacturing Practice (GMP) regulations for cosmetics by December 29, 2025. However, this deadline has been delayed. An October 2025 target for a proposed rule, estimated in late 2024, passed without one being issued; as of January 2026, the FDA had not yet issued proposed or final GMP regulations. When finalized, the regulations will establish standards for manufacturing, processing, packing, and holding cosmetics.

While waiting for formal GMP regulations, manufacturers are expected to follow current industry standards to ensure cosmetics are not adulterated or unsafe. The FDA has not enforced specific GMP compliance during this interim period, but founders should plan for future compliance once the final rule is published.

Small Business Exemptions and Compliance Costs

Businesses with average gross U.S. sales under $1 million over three years are generally exempt from facility registration, product listing, and GMP requirements. This exemption significantly reduces compliance burden for emerging beauty brands. However, this exemption has substantial carve-outs. It does not apply to manufacturers or processors of products that regularly contact the eye’s mucous membrane, are injected, are intended for internal use, or alter appearance for more than 24 hours without consumer removal as part of normal use. Eye makeup remover, eye shadow, liquid or mucosal eyeliner, and false eyelash adhesive—products that contact the eye membrane—fall outside the small business exemption. Injectables, lip stains lasting more than 24 hours, and any internal-use products are also excluded. This means a small beauty startup developing a long-wearing lipstick or eyeshadow line still faces full compliance requirements regardless of revenue.

The FDA charges no government fees for facility registration or product listing. However, brands typically hire third-party compliance firms to prepare, submit, and manage registrations and listings. Costs rise with the number of products a brand must list. Many compliance firms also charge for updates, corrections, and ongoing regulatory monitoring as the FDA issues guidance and final rules on fragrance allergen labeling and GMP standards.

Related coverage: What Sephora, Ulta and Target buyers require before a brand gets shelf space; How Sarelly Raised $3 Million to Enter 600 Target Stores With Target Beauty Studio.

Photo: Missionedit · CC BY-SA 4.0 · via Wikimedia Commons