FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

On September 12, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. The system is an interactive tool designed to facilitate the public’s ability to search and find real-time adverse event data on cosmetic products. Through the tool, users can search and view reports using search terms, including the product name. Users can also download data sets and report listings. The FDA will update the tool daily to ensure it includes the most recent submissions.

The dashboard includes serious adverse event reports submitted by responsible persons for cosmetic products under requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as well as voluntary adverse event reports submitted to the FDA by healthcare professionals, consumers, salon professionals, cosmetologists, and others. 

This announcement follows a recent launch of real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics. 

In the announcement, the FDA stated these real-time reporting tools are part of the agency’s commitment to transparency and providing greater insight into the safety and regulation of the products consumers use every day.

Note: Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event. 

ICYMI: FDA Launches Nationalized Entry Review Program (NER)

FDA recently implemented the Nationalized Entry Review Program (NER), which centralizes how the agency reviews imports nationwide. The program is effective as of August 4, 2025. Key changes include: 

  • Coordinated National Response: Rather than each port conducting manual reviews of certain entries on its own, specialized teams now coordinate their efforts across the country to more quickly identify and stop dangerous products.

  • Harmonized Real-Time Alert System: If the FDA detects a high-risk product at one port, such as contaminated infant formula or counterfeit drugs, alerts are immediately shared across all ports so they can watch for the same threats.

  • Improved Efficiency: Built on a successful 2022 pilot, the NER program has sped up processing by 70% and increased detection of high-risk products by 36%.

  • Expanded Reviewer Capacity: The program allows for more FDA reviewer availability and collaboration across the national network. 

The FDA’s current evaluative standards, regulatory requirements, and admissibility thresholds remain the same. 

The FDA has also published a communications guide that includes general contact protocols, hot shipments handling, email formatting requirements, and FAQs.

Diaz Trade Law provides assistance with FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions. For assistance with NER requirements or other FDA matters, contact us […]

MoCRA Update: FDA Provides Summary Data on Facility Registrations and Product Listings

The U.S. Food and Drug Administration (FDA) has released summary data from mandatory registration of cosmetic product facilities and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA Background & Requirements

MoCRA was passed in 2022 in an effort to modernize and strengthen cosmetic regulations in the United States. MoCRA replaced the previous Cosmetic Act, which had not been updated since 1938.

Subsequent to the bill’s passage, the FDA issued regulations implementing the law. In issuing MoCRA regulations, FDA’s aim was to help ensure the overall safety of cosmetic products, and expand the Agency’s ability to trace and track non-compliant products and facilities.

MoCRA Requirements:

  • FDA registration for cosmetics facilities
  • Product listings for each cosmetic product
  • Adverse event reporting
  • Safety substantiation
  • Compliance with Good Manufacturing Practices (GMPs)
  • Fragrance allergen labeling

MoCRA also gives the FDA new records access and mandatory recall authority.

The FDA has issued guidance providing recommendations to assist companies in complying with the law. In addition, the agency developed a new online tool – Cosmetics Direct – dedicated exclusively to product facility registration and cosmetic product listing submissions.

New Data

As of January 1, 2025, the number of unique, active facility registrations is 9,528 and the number of unique, active product listings is 589,762.

The top five states for number of domestic registered facilities are:

  • California (373)
  • Florida (201)
  • New Jersey (144)
  • Texas (120)
  • New York (118)

The top five countries for foreign registered facilities are:

  • China (4,260)
  • South Korea (617)
  • India […]

MoCRA Enforcement is Right Around the Corner! Are You Ready? 

The Food and Drug Administration (FDA) is set to start enforcing the requirements of the Modernization of Cosmetics Regulation Act (MoCRA) on July 1, 2024. Manufacturers, distributors, or packers of cosmetic products must comply with the requirements to avoid an enforcement action. 

MoCRA Background 

In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety. 

MoCRA was passed in 2022 and aims to modernize and strengthen cosmetic regulations in the United States. MoCRA replaced the previous Cosmetic Act, which had not been updated since 1938.  

Subsequent to the bill’s passage, the FDA issued regulations implementing the law. In issuing MoCRA regulations, FDA’s aim was to help ensure the overall safety of cosmetic products, and expand the Agency’s ability to trace and track non-compliant products and facilities. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA impact the entire lifecycle of cosmetics products from manufacturing to marketing. 

MoCRA Requirements 

New MoCRA requirements include:

  • FDA registration for cosmetics facilities 
  • Product listings for each cosmetic product 
  • Adverse event reporting 
  • Safety […]

MoCRA Facility and Product Registration Portal Now Open! 

Essential deadlines under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) come into effect July 1, 2024. MoCRA brings significant changes to the cosmetic industry and will impact your company if you manufacture, distribute, or pack a cosmetic product in the United States.

What is Required Under MoCRA

MoCRA replaces the previous Cosmetic Act, which had not been updated since 1938.

New MoCRA requirements include:

  • FDA registration for cosmetics facilities
  • Product listings for each cosmetic product
  • Adverse event reporting
  • Safety substantiation
  • Compliance with Good Manufacturing Practices (GMPs)
  • Fragrance allergen labeling

MoCRA also gives the FDA new records access and mandatory recall authority. In issuing MoCRA regulations, FDA’s aim is to help ensure the overall safety of cosmetic products, and significantly expand the Agency’s ability to trace and track non-compliant products and facilities.

Registration and Listing Made Easy Through Our Online Portal

Not sure what is required to register a facility or list a cosmetic product? Our online portal will take you through the process step-by-step to ensure you are in compliance.

On our website you can:

  • Register a facility
  • Enlist Diaz Trade Consulting as your U.S. Agent
  • List a cosmetics product
  • Pay registration fees
  • Complete annual renewal
  • Request a UNII code

Get started here. Have questions? Reach out to us at info@diaztradeconsulting.com or call us at 305-400-8458.

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