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. 

Diaz Trade Law provides assistance with FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions. For assistance with cosmetics compliance requirements, required registration, reporting, or other FDA matters, contact us at 305-456-3830 or info@diaztradelaw.com.

Learn more:

• A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
• FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions
• Webinar: Getting MoCRA Compliant
• FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
• FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

• 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 at 305-456-3830 or info@diaztradelaw.com.

Learn more:

• A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
• FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions
• Webinar: Getting MoCRA Compliant
• FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
• FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

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 (309)
• Italy (273)
• France (245)

Are You MoCRA Compliant?

The MoCRA compliance deadline was July 1, 2024.

Companies behind on registration should immediately establish who is responsible for registering products and facilities, and also put in place processes for adverse event reporting, recall inquiries, and record keeping.

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
• Assign Diaz Trade Consulting as your U.S. Agent (it is mandatory for foreign facilities to have a U.S. Agent)
• List a cosmetics product
• Pay registration fees
• Complete annual renewal
• Request a UNII code

Visit the portal today or contact us to learn more about MoCRA requirements – info@diaztradelaw.com.

Learn more:

• Blog: A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
• Blog: MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal
• Webinar: Getting MoCRA Compliant

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 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. 

 Take Action Now to Ensure You are in Compliance! 

 Companies should immediately establish who is responsible for registering products and facilities, and also put in place processes for adverse event reporting, recall inquiries, and record keeping. 

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 
• Assign Diaz Trade Consulting as your U.S. Agent (it is mandatory for foreign facilities to have a U.S. Agent) 
• List a cosmetics product 
• Pay registration fees 
• Complete annual renewal 
• Request a UNII code 

 Visit the portal today or contact us to learn more about MoCRA requirements – info@diaztradelaw.com. 

 Learn more: 

• Blog: A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act 
• Webinar: Getting MoCRA Compliant 

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.

Read more about MoCRA:

• A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
• Webinar: Getting MoCRA Compliant
• MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal

Cosmetics Direct

The Cosmetics Direct portal is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA. The portal is an FDA Structured Product Labeling (SPL) authoring tool that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing.

Along with the launch of the portal, the agency also released a portal user guide. The guide provides helpful information on creating submissions through the portal including:

• Managing accounts and subaccounts
• How to check submission information and statuses
• Step-by-step instructions for new registrations
• Instructions for amending registrations

While the agency prefers electronic submissions, individuals and companies may also submit paper forms which will be offered soon.

Final MoCRA Guidance

The final guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. The guidance document explains several frequently asked questions including:

• The statutory requirement to submit cosmetic product facility registrations and product listings
• Definitions
• Who is responsible for making the submissions
• What information to include in the submissions
• How to make the submissions
• When to make the submissions

The guidance also details how the FDA will be utilizing the FDA Establishment Identifier (FEI) as the required facility registration number for product facility registrations. In order to complete both the facility registration and product listing, a company must first obtain an FEI by either searching FDA’s existing FEI database or by requesting a new FEI.

Individuals and companies may utilize the FEI Search Portal to confirm if a facility already has an FEI number.

Get MoCRA Compliant With the Help of a Customs Attorney

​​Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com for assistance submitting your product listing, facility registration, or for help assessing the impacts of MoCRA on your cosmetic products.

Read more about MoCRA requirements:

• A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
• FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

Background

The growth in the cosmetics industry over the last several years prompted Congress to pass the Modernization of Cosmetics Regulation Act (MoCRA). in 2022. MoCRA modernizes and strengthens cosmetics regulations in the United States and gives the FDA additional authority. Key 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. To assist companies in their MoCRA compliance efforts, the FDA has published new guidance answering key questions and providing recommendations.

Draft Guidance

The draft guidance for industry describes MoCRA requirements for facility registration and product listings, as well as the exemptions for certain small businesses. The guidance explains:

• The statutory requirement to submit cosmetic product facility registrations and product listings
• Definitions
• Who is responsible for making the submissions
• What information to include in the submissions
• How to make the submissions
• When to make the submissions

The document also answers key questions such as what to do if a product is both a drug and a cosmetic product and whether there are fees to submit a registration or product listing. The guidance does not establish legally enforceable responsibilities. Rather, it describes the agency’s thinking on a topic and should be viewed as recommendations.

What Should Cosmetics Companies Do?

The guidance that has been issued is not finalized. The FDA will be accepting comments from industry and the public until September 7. Once finalized, cosmetics companies should carefully review the guidance and use it to further inform their MoCRA compliance strategy.

Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com for assistance submitting comments on the guidance or for help assessing the impacts of MoCRA on your cosmetic products.

Read more about MoCRA requirements:

A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act

MoCRA was signed into law on January 1, 2022, and replaces the previous Cosmetic Act, which had not been updated since 1938. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA will impact the entire lifecycle of cosmetics products from manufacturing to marketing.

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.

Facility Registration and Product Listing 

Cosmetic facilities must register with the FDA (deadline has been extended to July 1, 2024) and renew their registration every two years thereafter . The term “facility” means any establishment that either manufactures or process cosmetic products distributed in the United States. New facilities must be registered within 60 days after they start manufacturing cosmetics.

The FDA may suspend a facility’s registration if the FDA determines that:

1. A product manufactured or processed by the facility has a reasonable probability of causing death or serious adverse health consequences to humans;
2. The agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated or the failure is sufficiently pervasive to raise concerns about other products in the facility.

If a facility’s registration is suspended, it is a prohibited from selling or distributing cosmetics products in the U.S. from the facility.

In addition to the registration requirement, “responsible persons” – defined as manufacturers, distributors, or packers of a cosmetic product whose name appears on the label must list their product with the FDA. This listing must include product ingredients and responsible persons must provide the FDA with any updates annually.

To complete a valid listing, companies should collect the following information:

• An FDA Establishment Identification Number (FEI)
• A list of all products
• A list of ingredients in all products
• The regulation name or common name of all ingredients

It is critical for cosmetics companies to sort out who is required to register (manufacturer, brand owner) and submit the listing in a timely manner.

 The Voluntary Cosmetic Regulations Program (VRCP) 

The VCRP was a voluntary program that allowed manufacturers, packers, and distributors of cosmetic products to submit product information to the FDA. However, as of March 27, 2023, the FDA has ceased accepting submissions to the VCRP and has now transitioned to the new registration portal: Cosmetics Direct.  

Safety and Disclosure Requirements

One of the most significant changes that the MoCRA introduces is the requirement for cosmetic manufacturers to submit safety information about their products to the Food and Drug Administration (FDA). This information includes any adverse reactions reported by consumers and information about any potentially harmful ingredients used in the products. The FDA will then use this information to evaluate the safety of the products and take any necessary actions to protect consumers.

Companies must report serious adverse events within 15 days after receiving the report. Companies must also report material updates about the event for one year following the initial submission. Businesses are also required to maintain records of any health-related adverse events associated with its product for six years.

MoCRA also requires cosmetic manufacturers to adhere to good manufacturing practices (GMPs), which are a set of guidelines that ensure the quality and safety of cosmetic products. This includes requirements for the use of clean equipment, the appropriate handling and storage of ingredients, and the implementation of quality control measures.

Another important aspect of MoCRA is the requirement for cosmetic manufacturers to disclose the full list of ingredients used in their products on the product label. This is a significant change from previous regulations, which allowed manufacturers to use vague terms such as “fragrance” to avoid disclosing specific ingredients. This change will provide consumers with more transparency and allow them to make more informed decisions about the products they use.

Safety Substantiation

While current FDA regulations do not require specific tests to demonstrate the safety of individual ingredients or products, companies and individuals who manufacture cosmetics have a responsibility to ensure the safety of their products. Under MoCRA, responsible persons must maintain records supporting adequate product safety substantiation. Manufacturers can use existing data to support the safety of their products, but the data must be derived from scientifically robust methods.

 MoCRA Exceptions 

MoCRA exempts cosmetic/drug and cosmetic/device combination products from some requirements such as GMPs, adverse event reporting, registration and listing, safety substantiating, and recordkeeping. However, these exemptions do not apply to facilities that manufacture both combination products and cosmetics.

Additionally, small businesses are exempt from the GMP and registration and listing requirements. A “small business” is defined a business with average gross annual sales in the U.S. for the previous 3-year period of less than 1,000,000 adjusted for inflation. The small business exemption does not apply if the business manufactures products that: come into contact with eyes, are injected, are intended for internal use, alter the appearance for more than 24 hours.

Enforcement & Mandatory Recall Authority

 MoCRA gives the FDA new powers to enforce the requirements of the law. The FDA may suspend a facility’s registration if the agency determines that a product has a reasonable probability of causing serious adverse health consequences or death. The agency also has new authority to inspect records of a cosmetics facility.

Perhaps the most significant new authority is the ability to issue mandatory recalls. If the FDA determines that there is a reasonable probability that a cosmetic is misbranded or adulterated, and the use of the cosmetic will cause serious adverse health consequences or death, the agency may issue a mandatory recall. The FDA must provide companies with an informal hearing as well as the opportunity to voluntarily recall the product.

 Conclusion 

Overall, MoCRA represents an important step towards modernizing the regulation of cosmetics in the US. MoCRA has been welcomed by many in the beauty industry, including consumer advocacy groups and cosmetic manufacturers. The increased transparency and regulation provided by the new law will help to build trust between consumers and the industry, while also ensuring that cosmetic products are safe for use.

Companies should establish who is responsible for registering products and facilities, and also put in place processes for adverse event reporting, recall inquiries, and record keeping.

Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com today to assess the impacts of MoCRA on your cosmetic products.

Learn more about MoCRA in our webinar: “Getting MoCRA Compliant.”

With the passage of the Omnibus bill recently, the Food Drug and Cosmetic Act is also amended to include significant changes to cosmetics regulation, including: 

• Cosmetic Registration & Ingredient Listing (becomes mandatory, it is currently voluntary) 
  • Required in 1-year from enactment (this will be signed very soon). 
  • For products developed after enactment, 120 days of first marketing. 

• Serious Adverse Events 
  • Cosmetics will have a Serious Adverse Events requirement (same as OTC drugs and dietary supplements). Thus, the labels will need a U.S. phone number or mailing address to receive reports and the company identified on the label will report to FDA, as needed. “Serious Adverse Events” are events where your customer ends up harmed or having to go to the doctor. We can develop a system for this reporting requirement. 
  • Required 2 years from enactment. 

• Fragrance Allergen Declarations 
  • Labels must declare fragrance allergens (a change from merely declaring “fragrance”). 
  • Required 18 months from enactment. 

• Substantiation of Safety 
  • The legal standard is “adequate substantiation of safety,” which means data (tests, studies, research, analysis) considered sufficient by qualified experts to support “a reasonable certainty that a cosmetic is safe.”  “Safe” does not require the cosmetic or ingredient to cause no minor or transient irritation. The new law codifies FDA’s approach. 
  • We do not expect this requirement to be enforced often, absent serious safety concerns, or as a stand-alone charge. Much like the dietary supplement New Dietary Ingredient Notification requirements that mostly get enforced with there is a public safety concern. FDA will likely produce guidance on this, but we don’t think we should expect much enforcement without a significant resource allocation to enforcement. 
  • Effective 1 year after enactment. 

• Good Manufacturing Practice (GMP)s for Cosmetics 
  • FDA will establish GMPs for cosmetics. 
  • Will take more 3 years to establish regulations. 
• Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Recommendations 
  • FDA will assess PFAS substances within 3 years. 
  • Various states have enacted laws regarding food and cosmetics packaging with intentionally-added PFAS. 
  • Expect PFAS to be banned widely. 
• FDA gains mandatory recall authority 
• Record keeping and records inspection rules 

Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com today to assist in assessing the impacts of the Omnibus bill and the Food Drug and Cosmetic Act amendments on the regulation of your cosmetic products.

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Why Should Industry Register for the Webinar?

Warning Letters in 2021:

• Just yesterday, FDA teamed up with the Federal Trade Commission (FTC) to publicly admonish 5 companies with warning letters for illegally selling dietary supplements claiming to treat infertility because FDA advised the products are unapproved drugs.
• Since the beginning of 2021, alone, the FDA has already issued 260 warning letters. 55 of those warning letters were issued against firms, including cosmetic firms, for selling unapproved drugs that are misbranded or adulterated or selling unapproved and misbranded products related to COVID-19.

Import Alerts in 2021:

• FDA has 208 active import alerts. Since the beginning of 2021, the FDA has already updated 74 import alerts to add new violators. 4 of the 74 import alerts are specifically for unapproved drug violations:

• FDA has updated Import Alert 66-41 a total of 274 times since the beginning of 2021, with the most recent update on May 6, 2021. This import alert lists 379 violative cosmetic products which are (because of their claims) unapproved drugs. This import alert will be discussed in detail at the webinar. The speedy increase in the number of firms subject to the this import alert indicates that manufacturers, importers, and distributors of cosmetic and over-the-counter drugs must review their labeling and pre-compliance protocols to avoid being targeted by the FDA.
• Important to note that on February 25, 2021, FDA published Import Alert 62-08, which allows for the “Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico.”

This one-hour webinar will provide an overview of FDA regulatory enforcement actions. Our international trade attorneys will discuss top labeling dos and don’ts to lower your risk of FDA enforcement, while offering best practices. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real case scenarios. The objective of the webinar is to teach manufacturers, importers, and the like, how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of Over the Counter (OTC) drugs or cosmetic products are encouraged to attend our one-hour webinar, “Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions” either live on June 9, 2021 at 12:00 PM, or on demand thereafter.

Diaz Trade Law’s president, Jennifer Diaz, accompanied by DTL’s Associate Attorney Denise Calle, will be our featured speakers. Importers, exporters, brokers, and others interested in trade policy are encouraged to attend. REGISTER HERE!