​The Modernization of Cosmetics
Regulation Act of 2022 ​​
MoCRA
Facility Registration
Serious Adverse Reporting
& Records Maintenance
Product Listing Registration
Labeling Requirements
U.S. Agent
Good Manufacturing Practices
About Me.
On December 29, 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law adding section 607 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The intention of regulation is meant to protect the public's health and confirm consumer confidence and place safety measures on all cosmetics sold in the United States. MoCRA establishes the Food and Drug Administration's (FDA's) oversight over the cosmetic industry within the United States (U.S.) and aims to standardize its manufacturing practices to align with international standards.
Facility Registration
Every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product, must register such facility with the FDA within 60 days of first engaging in distribution in the U.S. and biennially thereafter.
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A facility includes any establishment (including an establishment of an importer) that manufactures, or process cosmetic products distributed in the U.S.
Product Listing Registration
For each cosmetic product distributed in the U.S., a cosmetic product listing must be registered with the FDA.
A cosmetic product listing must be registered within 120 days of marketing such product in interstate commerce and annually thereafter.
A cosmetic product means a preparation of cosmetic ingredients with a qualitatively and quantitively set composition for use in a finished product.
A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulation, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
U.S. Agent
The U.S. agent is the person, which includes an individual or business entity, that resides in the U.S. or maintains a U.S. place of business and is physically present in the U.S. A U.S. agent is not a mailbox, answering machine or service, or other place where an individual acting as the foreign facility’s agent is not physically present.
U.S. Agents are required for foreign facilities to submit registration. The FDA does not provide U.S. agents to foreign facilities.
Serious Adverse Event
A serious adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended or under conditions of use that are customary or usual.
The responsible person must submit any serious adverse event associated with the use, in the U.S. of a cosmetic product manufactured, packed, distributed by such person with the FDA.
A serious adverse event report must be submitted, accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.
The responsible person must submit any new material medical information related to a serious adverse event report submitted to the FDA, no later that 15 business days after such information is received by the responsible person.
Records Maintenance
The responsible person must maintain records relation to each report of an adverse event associated with the use, in the U.S, of a cosmetic product manufactured or distributed by such person, for a period of 6 years. For the responsible person considered a small business, such records must be maintained for a period of 3 years.
Responsible Person
The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic label.
The responsible person must ensure and maintain records there is adequate safety substantiation for their cosmetic products. This means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by specific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
Labeling Requirements
Domestic address, phone number or electronic information is included on the label. The FDA recommends when the responsible person is a foreign company, the label should include electronic contact information, such as an email or website.
Products meant for professional use only must state such on the label.
Each fragrance or allergen must be disclosed on the packaging. The FDA will release a final ruling of allergens.
Good Manufacturing Practices (GMPs)
On December 29, 2025, the FDA is required to issue a final rule establishing current Good Manufacturing Practices for cosmetic product manufacturing facilities. This ruling will establish GMPs that will closely align national standards with global standards, intending to protect the publics' health and ensure that cosmetic products are not adulterated. Such regulations will allow the FDA to inspect records to demonstrate compliance with the established GMPs.
United Safety Agents
MoCRA Services
United Safety Agents (USA) acts as the U.S. Registration Agent, submitting Facility Registrations, Product Listing Registrations, assists in Serious Adverse Event Reporting, serves as the point of contact between the involved parties and the FDA, and provides Certificates of Registration. USA helps guide clients through the U.S. cosmetic regulatory system and provides knowledge and insight on current FDA rulings and guidelines. USA also offers cosmetic Label Assessment, ensuring compliance with all U.S. standards.
BEGIN THE MoCRA PROCESS
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