What Is the MoCRA Law and What Does It Require?

The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, is the federal law that for the first time requires cosmetics companies to register their facilities with the FDA, list every product and its ingredients, substantiate that each product is safe, report serious adverse events within 15 business days, and comply with FDA recall orders. The core MoCRA law requirements fall on the “responsible person” named on the product label, with limited exemptions for very small businesses. Several pieces of the framework, including good manufacturing practice regulations and fragrance allergen disclosure rules, are still awaiting FDA rulemaking.¹

Who Has to Comply

MoCRA’s obligations run to the “responsible person,” defined as the manufacturer, packer, or distributor whose name appears on the product label.¹ If your brand is on the package, you are responsible for compliance even if a contract manufacturer actually makes the product. Facility owners and operators who manufacture or process cosmetics for U.S. distribution carry a separate registration obligation of their own.

Small Business Carve-Out

A business whose average gross annual U.S. cosmetic sales over the prior three years fall below $1,000,000 (adjusted for inflation) qualifies as a small business and is exempt from facility registration, product listing, and good manufacturing practice requirements.² The exemption disappears entirely if the business manufactures or processes any of these higher-risk products:

Cosmetics that regularly touch the mucous membrane of the eye, such as mascara or eyeliner
Any cosmetic that is injected
Cosmetics intended for internal use
Cosmetics intended to alter appearance for more than 24 hours when the consumer is not expected to remove them

Making even one product in these categories means full MoCRA compliance. And the small business exemption never reaches adverse event reporting or safety substantiation. Those apply to every responsible person, regardless of revenue.²

Facility Registration

Every person who owns or operates a facility that manufactures or processes cosmetics for U.S. distribution must register that facility with the FDA. Facilities already operating when MoCRA was enacted on December 29, 2022, had until December 29, 2023, to complete initial registration. A facility that begins cosmetic manufacturing after that date must register within 60 days of starting operations.³

Registration requires the facility’s name, physical address, email, and phone number. Foreign facilities must additionally provide contact information for a U.S. agent. Each registration lists the product categories manufactured at the facility and identifies the responsible person for each product.³ Registrations must be renewed every two years from the date of initial registration.⁴

Product Listing

Separately from facility registration, the responsible person must submit a product listing for every cosmetic product on the market. Each listing includes the product’s ingredients, including any fragrances, flavors, or colors, with each ingredient identified by its common or regulatory name. After the initial submission, listings must be updated annually to reflect any formulation changes or discontinued products.⁵

Both facility registrations and product listings are submitted electronically through the FDA’s Cosmetics Direct portal, a free tool that walks users through structured data-entry forms and submits directly to the agency.⁶ Imported cosmetics that lack proper product listing data face potential delays or rejection at the border, since the FDA and Customs and Border Protection increasingly rely on this data during import screening.

Safety Substantiation

Every responsible person must ensure, and keep records supporting, that each cosmetic product has adequate safety substantiation before it reaches consumers. The law defines “adequate substantiation” as tests, studies, research, or other evidence that qualified scientific experts would consider sufficient to support a reasonable certainty that the product is not harmful under its intended or customary conditions of use.⁷

MoCRA does not prescribe a specific type of test. Clinical trials, in-vitro studies, published literature reviews, computational toxicology, or a combination all qualify if a qualified expert would find them persuasive. Congress included a statement that animal testing should not be used for cosmetic safety purposes and should be phased out, with exceptions where no validated alternative method exists.¹ The FDA has stated that animal testing is not a requirement for marketing a cosmetic product.

A product lacking adequate safety substantiation is considered adulterated under the FD&C Act, which can trigger seizure or injunction. This is the practical shift: before MoCRA, the FDA had to prove a product was unsafe; now the manufacturer must be able to show it is safe.

Labeling

Every cosmetic product must include on its label a domestic address, phone number, or electronic contact (which can be a website) so consumers have a way to report adverse events to the responsible person.⁸ This requirement took effect when MoCRA was enacted.

MoCRA also requires responsible persons to list individual fragrance allergens on the product label, rather than grouping them under the generic term “fragrance.” The FDA was directed to issue a proposed rule identifying which specific allergens must be disclosed within 18 months of enactment.⁸ As of mid-2026, the FDA has not published the proposed fragrance allergen regulation, so the specific substances and concentration thresholds that will trigger disclosure remain undefined. The statute directs the agency to consider international standards, including European Union allergen disclosure rules, when writing the regulation.

Serious Adverse Event Reporting

When a responsible person receives a report of a serious adverse event linked to one of their cosmetic products, they must submit that report to the FDA within 15 business days.⁹ The report must include a copy of the product’s retail label. A “serious adverse event” is one that results in:

Death
A life-threatening experience
Inpatient hospitalization
Persistent or significant disability or incapacity
Significant disfigurement, including serious rashes, second- or third-degree burns, significant hair loss, or persistent alteration of appearance not intended by the product
A condition requiring medical or surgical intervention to prevent any of the outcomes listed above

The responsible person must also keep records of all adverse event reports, not only the serious ones, for six years. Small businesses that do not manufacture or process any of the higher-risk product categories may keep these records for three years instead.⁹ The obligation to report serious events applies to every responsible person regardless of company size.

Good Manufacturing Practices

MoCRA directs the FDA to establish good manufacturing practice regulations for cosmetic facilities. The statute requires those rules to be consistent with national and international standards while accounting for the size and scope of different businesses, and it specifically mandates simplified GMP requirements and longer compliance timelines for smaller companies.¹⁰

The statutory deadline for a proposed GMP rule was December 2024, and the final rule was due by December 2025. Neither deadline was met. As of mid-2026, the GMP rulemaking has been classified as a long-term action, and no proposed rule has been published.¹⁰ Even without a final rule, the FDA has signaled through warning letters to dual drug-and-cosmetic facilities that it expects manufacturers to maintain structured manufacturing controls and product safety practices. The regulatory delay is not permission to ignore quality controls.

FDA Recall and Records Access

Before MoCRA, the FDA could not order a cosmetic recall. Now, if the agency determines there is a reasonable probability that a cosmetic is adulterated or misbranded and will cause serious health consequences or death, it must first give the responsible person a chance to voluntarily stop distribution and recall the product.¹¹ If the company refuses or fails to act within the FDA’s timeframe, the agency can order a mandatory recall.¹²

The FDA also gained expanded authority to access cosmetic company records. If the agency has a reasonable belief that a cosmetic product is likely adulterated in a way that presents a threat of serious health consequences or death, the responsible person and facility must allow FDA officers to access and copy all records related to that product. The statute carves out specific categories from this access, including recipes and formulas, financial data, pricing data, most personnel records, non-safety research data, and sales data other than shipment records.¹³ During routine facility inspections, FDA inspectors can also review adverse event records and GMP-related documentation maintained under other sections of the law.¹⁴

What MoCRA Does Not Cover

MoCRA preempts state and local laws that differ from the federal requirements in seven specific areas: registration, product listing, good manufacturing practice, records, recalls, adverse event reporting, and safety substantiation. States cannot impose requirements in these areas that go beyond or differ from the federal framework.¹⁵

The preemption has real limits. States retain the ability to ban specific cosmetic ingredients or restrict the amount of an ingredient used in a product, and any state ingredient reporting requirement already in effect when MoCRA was enacted in December 2022 also remains valid.¹⁵ MoCRA also explicitly preserves state product liability laws. Nothing in the act limits a consumer’s ability to bring a state-law damages claim against a cosmetic company, whether based on statute or common law.

1
U.S. Food and Drug Administration. Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
2
Office of the Law Revision Counsel. 21 USC 364h – Small Businesses
3
Office of the Law Revision Counsel. 21 USC 364c – Registration and Product Listing
4
U.S. Food and Drug Administration. Registration and Listing of Cosmetic Product Facilities and Products
5
U.S. Government Publishing Office. 21 USC 364c – Registration and Product Listing
6
U.S. Food and Drug Administration. Cosmetics Direct
7
Office of the Law Revision Counsel. 21 USC 364d – Safety Substantiation
8
Office of the Law Revision Counsel. 21 USC 364e – Labeling
9
Office of the Law Revision Counsel. 21 USC 364a – Adverse Events
10
Office of the Law Revision Counsel. 21 USC 364b – Good Manufacturing Practice
11
Office of the Law Revision Counsel. 21 US Code 364g – Mandatory Recall Authority
12
U.S. Food and Drug Administration. FDA Recall Policy for Cosmetics
13
Office of the Law Revision Counsel. 21 USC 364f – Records
14
Office of the Law Revision Counsel. 21 USC 374 – Inspection
15
Office of the Law Revision Counsel. 21 USC 364j – Preemption