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MoCRA: New Cosmetic Regulation in the United States
- Daniel Jiménez
- 2 days ago
- 4 min read
Updated as of December 2025
The implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has completely changed the regulatory landscape for cosmetics in the United States. MoCRA expands the obligations of manufacturers, importers, and distributors, and strengthens the FDA's role in safety, oversight, and market control.
Table of contents
This guide summarizes the essential elements that companies wanting to market cosmetics in the U.S. should know—and also consumers seeking greater transparency.
1. Who is affected by MoCRA?
MoCRA applies to any company that manufactures, processes, packages, distributes, or places its name on a cosmetic product marketed in the U.S. The law formally introduces two key figures:
Facility : establishment that manufactures or processes cosmetics for distribution in the U.S.
Responsible Person : manufacturer, packer or distributor whose name appears on the product label.
Both figures are subject to new obligations that were not previously enforceable at the federal level.
2. Registration of facilities and product list
MoCRA incorporates into section 607 of the FD&C Act the requirement to:
Registration of facilities
All facilities—including foreign manufacturers exporting to the U.S.—must register with the FDA through a U.S. Agent. The registered information must be updated every two years.
Product list
Each cosmetic product must be listed, providing:
Trade name
Category
Ingredients
Facility where manufacturing or processing
Responsible Person Details
This must be updated annually. MoCRA provides a partial exemption for small businesses, but it does not apply to higher-risk products (e.g., cosmetics requiring sterile hygiene, certain children's products, etc.).
3. Product safety and technical documentation
MoCRA requires that the Responsible Person have adequate safety substantiation . The FDA does not impose a specific methodology, but it does require evidence supporting the product's safety under normal or foreseeable conditions of use. This evidence may include:
Toxicological evaluation of the ingredients
Review of historical data
Compatibility tests, stability tests, and other relevant studies
Expert review according to accepted scientific standards
Not having this documentation now constitutes a legal breach.
4. Obligation to report serious adverse events
One of the pillars of MoCRA is the strengthening of post-market surveillance.
The Responsible Person must notify the FDA of any serious adverse event within 15 business days of becoming aware of it. In addition, if they receive additional medical information during the following year, they must resubmit that data in a new report.
This requirement allows the FDA to react more quickly to emerging safety issues.
5. New labeling requirements
MoCRA incorporates several changes to the information that must appear on the label:
Contact details of the Responsible Person (address, telephone number or email) to allow the consumer to report adverse events.
Future obligation to declare fragrance allergens , once the FDA publishes the corresponding rule.
Additional requirements for talc-containing products, related to the new asbestos analysis standards.
Ongoing review of the use of PFAS in cosmetics, which may involve new restrictions or labeling.
6. Good Manufacturing Practices (GMP)
MoCRA requires the FDA to publish a specific Good Manufacturing Practices (GMP) standard for cosmetics.
Until the final regulation is published, the agency has already stated that it expects the facilities to operate under adequate controls of quality, hygiene, traceability and risk management.
For many companies, especially small and medium-sized ones, this involves reviewing internal procedures, batch documentation, and supplier controls.
7. Key deadlines according to the FDA
According to the FDA itself, the main milestones are:
Registration of facilities: mandatory for facilities active from December 29, 2023.
Product list: mandatory for products marketed from that same date.
Updates:
Registration of facilities: every 2 years
Product list: annual
Talc: implementation of standardized testing methods to detect asbestos.
PFAS: Assessment report by December 29, 2025.
The FDA issued a transition policy announcing that it would not enforce strict registration/listing enforcement measures before July 1, 2024, to allow the industry time to adapt.
10. Practical checklist for companies
Before marketing in the US:
Confirm if your facility needs to be registered (includes foreign manufacturers).
Review labels and add contact information.
Prepare the security documentation.
Create a list of each product.
Establish a procedure for managing adverse events.
Ensure that your manufacturing processes meet standards equivalent to GMP.
Prepare for future changes (allergens, PFAS, talc).
The entry into force of MoCRA has led to a culture of greater control, scientific evidence and monitoring.
For brands that operate internationally, MoCRA requires adapting internal processes, documenting the safety of their products, and maintaining an active relationship with the FDA.
At Belab Services, we assist companies worldwide in accessing the US market, managing everything from facility and product registration to label review, safety substantiation preparation, and communication with the FDA.
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