MoCRA - FDA 2024
Modernization of the Cosmetics Regulation Law
MoCRA is the most significant expansion of the FDA's authority to regulate cosmetics to ensure the safety of the cosmetic products we consume every day.
Complying with MoCRA regulations is more complex than it seems, if you want us to do it for you in an easy and professional way, do not hesitate to contact us.
MoCRA: Modernization of the Cosmetics Regulation Act
What is MoCRA?
Last December 2022, the US Senate approved the MoCRA regulations (Modernization of the Cosmetic Regulatory Act), introducing significant changes to the requirements that cosmetics and the companies that manufacture them must meet in order to sell in the United States.
The main new features established by MoCRA are:
Strengthening the role of the FDA in market control, supervision of products and manufacturers.
The mandatory registration of products and companies.
The need to have a physical address in the US on the label.
Strengthening market surveillance through the US Responsible Person.
The obligation to prepare a product evaluation (CPSR).
Reinforcing the role of GMP.
Tightening claims control, transparency and veracity of the information shown to the consumer.
Requirements that affect cosmetic products
Responsible Person - US Market Surveillance Contact
Each cosmetic product must have a designated Responsible Person. The name and address of the responsible person must be clearly stated on the product label. This contact agent located in US territory will be in charge of market surveillance.
List of products
All cosmetic products must be compulsorily registered on the new MoCRA registration portal by the Responsible Person. At the time of registration, products whose manufacturer is not registered with the FDA cannot be registered.
CPSR Mandatory
The Cosmetic Product Safety Report (CPSR) prepared following the guidelines of the European Cosmetics Regulation EC No 1223/2009 is considered appropriate to convincingly and technically demonstrate the safety of a cosmetic product in the United States. However, those cosmetic products that are not marketed in the European Union or the United Kingdom will require a toxicological risk assessment that meets the same objective as the CPSR.
Requirements for manufacturers
Facility registration
Manufacturers and processors must register their facilities with the FDA through a US agent.
The FDA will have the authority to suspend the registration of a facility if it determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse consequences, prohibiting the entry or sale of its products in the United States. USA.
Registration with the FDA and obtaining the FEI number
At the end of the registration process, the facilities will obtain an FEI number, with which cosmetic products can be registered.
US agent as primary contact with FDA authorities
The US Agent is the contact agent between the FDA and cosmetic product manufacturers. The role of the US agent is to ensure:
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Compliance of facilities in accordance with Good Manufacturing Practices (GMP)
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Act as a channel between the manufacturer and the authority.
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Renew the authorization every two years.
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Coordinate action measures dictated by the FDA with the manufacturer.
Adverse Event Reporting and Record Keeping for MoCRA
Regarding the reporting of adverse events, according to the guidelines established by MoCRA, companies are required to maintain a comprehensive record of any health-related adverse events related to the use of cosmetic products marketed in the United States, during a period of six years. In the case of small businesses, they are required to keep these records for three years. In situations where a Serious Adverse Incident occurs, the responsible person must submit a report to the Food and Drug Administration (FDA) and be constantly updated with said agency regarding any new medical information. for one year after submitting the initial report.
FDA News in 2024: Regulatory Advances and Crucial Decisions
In the exciting world of regulation and approval of medical and pharmaceutical products, the year 2024 has brought with it a number of significant developments by the United States Food and Drug Administration.
1. Cosmetics Direct: A new electronic filing portal
FDA introduces "Cosmetics Direct," an electronic portal designed to expedite the submission of registration and listing applications. This platform promises efficiency and ease of use, ensuring that interested parties can seamlessly navigate the submission process.
2. Essential Registration Numbers: FDA Establishment Identifier (FEI)
A notable aspect of the guidance is the introduction of the FDA Establishment Identifier (FEI) as a mandatory facility registration number. Interested parties must obtain an FEI number before submitting their installation registration.
3. Detailed presentation criteria
The guidelines provide a structured breakdown of the information that must be included in submissions, submission deadlines and exemptions. For example, while small businesses may have exemptions, certain cosmetic products, such as those intended for internal use or injectables, remain under strict scrutiny.
4. Draft guidelines and feedback mechanisms
FDA invites industry professionals and interested parties to submit comments on the new draft guidance section, Appendix B. This section addresses frequently asked questions, providing clarity on various aspects of facility registration and listing. of products.
Understanding the magnitude of these regulatory changes, the FDA has shown flexibility by delaying the implementation of certain requirements.
With the original application date set for December 29, 2023, the FDA has extended this deadline until July 1, 2024.
The objective of this extension is to give the industry more time to adapt and comply with the updated regulations.
Additionally, facilities that began operating after December 29, 2022 will also benefit from this grace period.
They will not be subject to registration and listing requirements until the stipulated deadline of July 1, 2024.
It is imperative to familiarize yourself with the new guidelines, utilize available resources, and proactively engage with the FDA.
We will be happy to help you, do not hesitate to contact us.
MoCRA timeline
Dec, 29 2022
MoCRA goes into effect
Product Listing
Facility registration
Jun, 29 2024
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compliance with labeling requirements
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GMP proposal in cosmetics
Dec, 29 2025
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Promulgation by MoCRA
Dec, 29 2023
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proposal for a list of aromatic allergens
Dec, 29 2024
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cosmetic GMP final rule publication by FDA