Jaclyn Bellomo, Registrar Corp.

The passage of The Modernization of Cosmetics Regulation Act (MoCRA) in 2022 by the US Congress marks a pivotal moment for the cosmetics industry. The new oversight will continue to reshape the landscape for years to come. The $500 billion global industry faces the most significant shift in US cosmetics regulation in 85 years, setting unprecedented standards for every segment of the industry—from brands and manufacturers to packers and testing labs.

Echoing the US Food and Drug Administration’s approach to drug and medical device oversight, MoCRA grants the FDA enhanced enforcement authority, fundamentally altering how cosmetics companies navigate compliance. Its ramifications touch every business process; adding time, staff, money and additional restrictions to how products are handled in the US.

MoCRA regulations will impact all major distribution channels and points of the supply chain. Suppliers, retailers and even online marketplaces must reprioritize regulatory compliance to compete and continue to market in the industry.

MoCRA Regulations That Require Immediate Action

There are current and upcoming pivotal requirements that every brand and facility will need to comply with under MoCRA (see timeline below).

A Majority of MoCRA Regulations Are Already Enforced By FDA

Product & Ingredient Listings

Responsible Persons must list all cosmetic products marketed in the US. This will allow FDA to have full visibility of the products in the hands of US consumers and who is responsible for the safety of those products.

The Cosmetics Direct Portal allows companies to list their products through Structured Product Labeling (SPL) which is a standard approved by FDA to include all required information in a readable format. Those unfamiliar with SPL in the XML format have been provided training documentation and user manuals but it remains a complicated standard for those who do not have experience in this type of submission to FDA.

Facility Registration & US Agent

Facilities that manufacture and process cosmetic products must register with FDA and disclose the brands and types of products at the facility. This information enables FDA to know where products are made that are distributed in the US market and who is responsible for those products. Contract manufacturers and labs are not excluded from registration—they must also comply with this regulation.

Non-US facilities have an additional requirement to obtain a US agent. The US agent must be physically present in the US and be a liaison for FDA communications for the foreign facility. This will include any updates, audits, inspections or public health concerns that need immediate attention.

Product Labeling Requirements

Labeling regulations have been a long withstanding requirement with FDA as this is the first interaction a consumer has with a product. It is important that cosmetic product labels have all the necessary information to properly inform consumers what is in the product, its intended use and any warnings about using the product.

Additional requirements for cosmetic product labeling have been added to MoCRA and build upon existing regulations in the Code of Federal Regulations (CFR) and FDA guidance documents.

The most significant change will be that brands will be required to add the Responsible Person’s contact information to all product labels for consumers to contact if they experience an Adverse Event with the use of a product (see below). This is one of many new requirements for Adverse Events for cosmetics. This will be enforced by FDA beginning December 29, 2024.

Another update to make sure consumers remain protected for certain products, professional use products, such as those intended for salons and stylists, must include a clear and prominent statement on the product label stating they are for licensed professionals only.

Lastly, and behind even some US state labeling requirements, fragrance allergen disclosures will soon become mandatory on all cosmetics labels. Set to be proposed in late 2024, this rule represents a significant step toward greater consumer awareness and safety.

Safety Substantiation Requirements

Safety documentation has been a requirement for many other international markets, requiring testing, analysis and even safety assessments before allowing products to be sold in that market.

FDA now requires Safety Substantiation on cosmetic products. This requires brands to have sufficient documentation that their products, when used as intended, are safe. FDA has not called out specific tests, but “that tests or studies, research, analyses or other evidence…” to support that a cosmetic product is safe.

These safety records will be crucial to provide to FDA if there is a serious adverse event or public health concern. FDA’s new record access authority allows FDA to request these types of documentation to ensure that there is adequate substantiation of safety of products.

Adverse Event Management

Adverse events are not new to the cosmetic industry. They have become more frequent in recent years due to the increased use of multiple cosmetic products, products not being used correctly or products not undergoing proper safety testing.

In other industries, such as drugs and medical devices, FDA has strict control over the labeling, record keeping and reporting of non-serious and serious adverse events. Under MoCRA, cosmetics will now be held to the same standards.

Consumers can directly contact brands on adverse events that occur, so brands must have a process to receive, review, investigate, record and report (if necessary) to FDA. Receiving adverse events is the first step and it involves collecting detailed personal and medical information. This interaction with consumers should allow them to provide as much information as possible so that brands can properly review and investigate. Most reports and reviews involve collecting up to 43 data fields for a proper assessment, which is crucial for proper record keeping.

Once a report is received, the brand must review and if necessary, investigate further to determine the next steps. The investigation process can be both lengthy and complex, requiring the coordination of multiple business departments, supply chain points, external medical experts and more (see graphic). Most cosmetics companies struggle to manage these investigations within FDA’s deadline, due to a lack of prior experience or expertise.

If the adverse event falls under FDA’s updated definition of a serious adverse event, the brand will have 15 business days from the date of receiving the report to submit to FDA. Submitting reports to FDA can be a challenge since FDA is still building a form and portal specific for cosmetic adverse events. FDA recommends submitting reports using MedWatch Form 3500A, a detailed six-page document with more than 50 data fields. This form was built for drug and medical device adverse event reporting and will be new to most cosmetic companies.

Adverse Event Investigation Spans Departments and Locations

Lastly, brands must keep and maintain all records of every adverse event for up to six years (three years for small businesses). This should include all communication with the consumer, assessments from medical professionals, hospital or lab data, safety testing and clinical data, and more. These records should be kept on a secure, centralized platform that’s easily accessible when FDA requests them.

Limited FDA Exemptions

Companies with average annual gross sales of less than $1 million during the previous three-year period will be considered a small business and do not need to register their facility or list cosmetic products.

Regardless of the small business exemption, companies that manufacture products interacting with the eye’s mucus membrane, are injected, for internal use, or products that alter consumers’ appearance for over 24 hours must still adhere to the facility registration and product listing requirements.

Small businesses must still comply with adverse event management, product labeling, safety substantiation and any other pending MoCRA regulations unless explicitly stated otherwise.

Navigating these exemptions can be no small feat. FDA has no set process for identifying exempt small businesses during a port inspection, FDA has also stated that it will not provide small businesses validation or a certificate of exemption from MoCRA requirements, making the burden of proof even more complex.

Regulatory and Business Impact of MoCRA Non-Compliance

MoCRA grants FDA an unprecedented level of authority when it comes to regulatory action, from Warning Letters to Mandatory Recalls. The graphic below demonstrates the true scope of FDA’s authority over the industry.

FDA’s New Authority Over Cosmetics

In addition to FDA’s regulatory consequences for non-compliance, companies face equally serious business impacts spanning retailer actions, supply chain disruptions and legal ramifications.

Retailer Actions

US retailers have tremendous power over cosmetics brands and the beauty industry. They’re also keen to avoid the fallout of selling noncompliant products: customer complaints and returns, inventory issues, negative media coverage and potential lawsuits.

As a result, many top retailers now insist that their suppliers provide product listings numbers, adverse event contact information and other proof of compliance with MoCRA’s rigorous requirements. Failure to comply can lead to serious business consequences, such as penalties for lost sales, jeopardized contracts and returned or destroyed products. At worst, brands risk reduced shelf space or having their product removed from retailers’ shelves entirely.

Complying with MoCRA ensures that brands meet their retail partner’s expectations and keep their products on shelves.

Supply Chain Disruption

For brands that use co-manufacturers or packagers, MoCRA compliance is crucial across the entire supply chain. FDA detentions, whether at the factory or in transit, can become a logistical and financial disaster during peak sales periods like seasonal or holiday resets.

Legal Ramifications

FDA violations can be the basis for class-action lawsuits on multiple fronts. For example, not reporting a serious adverse event (or following all the investigation and recordkeeping requirements) can leave the brand owner and manufacturer liable and open to legal action.

Navigating MoCRA Requirements with Registrar Corp

For over 20 years, Registrar Corp has been at the forefront of regulatory compliance. Now, we turn our attention to guiding companies through the complexities of MoCRA.

“In the past year, we have helped thousands of cosmetics companies get MoCRA ready,” says Raj Shah, CEO of Registrar Corp, “And this is just the beginning.”

As the world’s largest FDA compliance company with over 30,000 clients, we have the solutions, expertise and security to support all of your MoCRA compliance needs, including:

• Product Listings
• Facility Registration & U.S. Agent
• Label Compliance Review
• Product Lifecycle Management (PLM) software
• Custom Consulting

For those in need of adverse event support, Registrar’s new software offering, Adverse Event Management (AEM), acts as a bridge for clients, their customers, and FDA.

Our solution supports customers through the entire adverse event process, from intake to investigation and report submission. As an ISO27001-certified platform, we also offer secure storage for sensitive data and adverse event reports, all on one convenient dashboard.

How Registrar’s Adverse Event Management Solution Works

“Our AEM solution assists cosmetics companies in gathering the exact data as required by FDA to report adverse events. Should FDA change what is required, our solution will adjust accordingly to be sure they remain in compliance,” said Registrar Corp Co-Founder and President David Lennarz.

About the Author
Jaclyn Bellomo is senior director of cosmetic science and regulatory affairs, Registrar Corp.