What You Need to Know About MoCRA

If you are in the cosmetics industry, chances are you’ve heard of MoCRA (the Modernization of Cosmetics Regulation Act of 2022) and know that you need to be compliant, but how does it affect you and your company?

In the United States the FDA is the regulatory agency that oversees cosmetic compliance. Until MoCRA was introduced, the guidelines may have been less strict than other countries and regions like Canada and the European Union where products need to be registered in order to be sold there. The US had compulsory registration only for OTC (over the counter) products that are also classified as drugs. We will go over the change in registration requirements as well as the other new requirements for cosmetic products sold in the US.

What is MoCRA?

MoCRA was signed into law as part of the 2023 Omnibus Bill. The FDA describes it as “the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.”

It is important to note that there are some exemptions for small businesses with average gross annual sales in the United States below one million USD over the past three years, but not necessarily for manufacturers or facilities that manufacture certain types of products. The exemptions only affect Facility Registration, Product Listing, and GMP.

What changed?

This is a brief explanation of the changes that MoCRA have brought to the U.S. market.

Mandatory Facility Registration

Cosmetic product manufacturing facilities are now required to register with the FDA. This includes providing information about the facility and a list of products manufactured there. Certain small businesses may be exempt, but the exemptions do not apply to facilities that handle higher-risk products like those used near the eyes or that are injected​ (FDA)​. Facilities will be given a unique FEI number that is required in the product listing for businesses that don’t have the small business exemption.

Deadline: July 1, 2024 or within 60 days after engaging in manufacturing or processing of cosmetic products for U.S. distribution. Updated registration every two years.

Product Listing Requirements

Manufacturers, packers, or distributors of cosmetic products must list each marketed product with the FDA, including its ingredients. This listing needs to be updated annually. This is a shift towards greater transparency in the cosmetic products available on the market​ (FDA)​.

Deadline: December 29, 2024 or within 120 days of initial sale or change. Updated product listing every year.

Good Manufacturing Practices (GMPs)

MoCRA mandates that the FDA establish Good Manufacturing Practices (GMPs) for cosmetics, which are aimed at ensuring product safety and quality. The FDA has been consulting with industry stakeholders to develop these standards and currently there is draft guidance​ (FDA)​.

This is already in effect since December 29, 2023.

Adverse Event Reporting

Companies are now required to report any serious adverse events associated with a cosmetic product to the FDA within 15 business days of receiving the information. This requirement enhances the FDA's ability to monitor product safety and take action when necessary​ (FDA)​.

This is already in effect since December 29, 2023.

Fragrance Allergen Labeling Requirements

MoCRA will require the disclosure of certain fragrance allergens on product labels, similar to those seen in the EU. This change aims to help consumers make informed decisions, especially those with sensitivities to certain ingredients​ (FDA)​.

Projected to be enacted in 2025.

Cosmetic Labeling for Professional-Use Products

New labeling requirements for products intended for professional use also take effect. Professional product labels must state that only licensed professionals may use the product. 

This is already in effect since December 29, 2023.

Mandatory Recall Authority

The FDA now has more authority to conduct product recalls if a cosmetic product is found to pose a health risk. This power gives the agency a more active role in protecting public health in the cosmetics industry​ (FDA)​.

This is already in effect since the enactment of the law on December 29, 2022.

Safety Substantiation

Manufacturers must ensure and document that their products are safe for use, based on sufficient evidence. This means that each company must appoint a “Responsible Person” who will maintain these records. The FDA can request proof of safety substantiation from companies.

This is already in effect since December 29, 2023.

What does this mean for you?

Evaluate. Does your company fall under the small business exemptions? Are you in compliance with each requirement, and if not, where are the gaps? What substantiates safety for each product? Who is your responsible person?

Substantiate. Make sure there is evidence of product safety, claims, testing, and compliance. 

Document. Confirm that all documents are easily accessible if needed for safety substantiation, adverse event reporting, GMPs, registrations, and listings. 

The evaluations, substantiations, deadlines, and documentation for MoCRA can be a full-time job. At LDR Consulting, we are ready to take this on for you and ensure that your company is in full compliance with MoCRA. We can provide:

• Initial Evaluation 

• Responsible Person

• Facility Registration

• Product Listings 

• GMP Audits

• Label Reviews

• Record Keeping 

• Product Retains Management

If you are unsure of your current compliance level, we would love to hear from you. Schedule a free 30-minute consultation for a compliance roadmap.