Understanding the Modernization of Cosmetics Regulation Act (MoCRA)

Signed into law in December 2022, the Modernization of Cosmetics Regulation Act (MoCRA) represents the most significant update to US cosmetics regulation since 1938.

Mike Picchioni, Associate Director of Regulatory Affairs at G&L Scientific, examines the sweeping changes that manufacturers, importers, and brand owners selling cosmetic products in the United States must now navigate.

What is MoCRA?

MoCRA amends Chapter VI of the Federal Food, Drug and Cosmetic Act (FDCA) and introduces a structured regulatory framework for the cosmetics industry.

Its goal is to enhance product safety and increase transparency.

Key requirements under MoCRA

Facility registration - Any establishment that manufactures or processes cosmetic products for distribution in the US must be registered with the FDA. This includes importers.

However, exemptions apply to certain entities such as:

• Beauty salons and retail establishments (under specific conditions).
• Public health agencies and hospitals.
• Trade shows and research facilities.
• Sites performing only labelling, packaging, holding, or distributing.

Facilities must renew their registration every two years.

Facility inspections and records access - The FDA now has authority to inspect cosmetic manufacturing facilities and access records, particularly in cases where there is concern over adulteration or potential harm to consumers.

If a facility presents a risk of Serious Adverse Events and the issue cannot be isolated, the FDA may suspend the registration altogether.

The Responsible Person (RP) - Each cosmetic product must have a designated Responsible Person. Non-US companies must appoint a local US agent.

The RP acts as the main FDA contact and must be experienced in:

• Managing adverse event reporting.
• Communicating with the FDA.
• Overseeing confidential business information.

The RP’s name and contact details must appear on the product label.

Adverse event reporting - MoCRA defines two types of adverse events:

• Adverse event: Any health-related issue associated with the use of a cosmetic product.
• Serious adverse event: Includes death, life-threatening experiences, hospitalization, significant disfigurement (e.g. severe rashes, second/third-degree burns, substantial hair loss), congenital anomalies, or any event requiring medical intervention to prevent such outcomes.

The RP must report serious adverse events to the FDA within fifteen business days of learning about the issue and must provide any follow-up medical information within a year.

Safety substantiation - The RP is responsible for ensuring that each marketed cosmetic product has adequate safety substantiation and for the ongoing maintenance of supporting records.

Product Listing and Labeling - Cosmetic products must be listed with the FDA, including details of ingredients. This information must be updated annually.

Labels must include:

• The domestic address and contact details of the Responsible Person.
• A phone number and website.
• A complete list of ingredients (with upcoming changes for allergen disclosure).

FDA is expected to publish regulations requiring certain fragrance allergens to be disclosed on labels, with the implementation timeline still under review.

Introduction of Cosmetics Direct - The previous voluntary registration system has been replaced with Cosmetics Direct, a structured product labelling (SPL) portal designed to streamline submissions for both facility registration and product listings.

Looking ahead

MoCRA signals a significant shift toward stricter oversight and a more harmonized regulatory model for cosmetics in the US.

While the current focus is on safety, transparency, and reporting, many in the industry believe this is only the beginning.

For example FDA is to develop regulations to identify fragrance allergens to be disclosed on label in a similar way to allergen labelling in the EU Cosmetic Regulation. The allergen labelling rules were expected in October 2024 but haven’t been published yet.

With the shifting political landscape, further developments in regulatory enforcement and product standards may follow.

At G&L Scientific, we are closely tracking the evolution of MoCRA and supporting clients in navigating these new requirements with confidence. Whether you are updating labeling, registering products, or managing cross-border compliance, our regulatory experts can guide you through the process.

Visit www.gandlscientific.com to learn more.

Mike Picchioni is Associate Director of Regulatory Affairs at G&L Scientific.