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Don’t be Surprised by the Modernization of Cosmetics Regulation Act of 2022

Posted 14 ene. 2025 by Nathan Schneider, Regulatory Manager

The outward glamor of beauty products covers a heart that is all business. Beauty and cosmetics are in sharp competition for attention and market share as standards of beauty and expectations increase yearly. Health-oriented, sustainable products are having a moment in the spotlight. However, the Modernization of Cosmetics Regulation Act of 2022 for beauty and cosmetic products production adds additional regulations to raise the stakes for sustainable ingredients and processes. Beauty product manufacturers must pay even closer attention to important parts of their process, like product safety, good manufacturing practices, and registered facilities.

In this article, we describe how the act applies to the beauty and cosmetic industries, the more extensive features of the act that may change how companies produce cosmetics and the challenges and opportunities that the act provides.

It’s the Law: Cosmetics Modernization Act of 2022

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) expanded the United States Food and Drug Administration’s (FDA) capacity to ensure the safety of the beauty and cosmetic industry. It has been one of the most significant expansions of cosmetic regulation since 1938. The new act follows the stricter language used in the medical device industry.

One place to start understanding MoCRA is through a few terms that are front and center in the act. For instance,

With MoCRA, the FDA will use these terms to pay closer attention to the production, distribution, and use of cosmetics. Plus, the FDA plans to monitor the outcomes associated with using the products. MoCRA will be enforced according to these deadlines:

  • For cosmetic products already marketed before August 22, 2022: not later than 1 year after the date of enactment (August 22, 2023).
  • For new cosmetic products first marketed after August 22, 2022: within 120 days of marketing such products in interstate commerce.
  • Registration requires an annual renewal.

MoCRA Provisions that May Change Your Manufacturing Practices

With the advent of MoCRA, more FDA scrutiny of the beauty and cosmetic industry production process is expected.

Mandatory Reporting of Adverse Events

Like the pharmaceutical and medical device industries, adverse events are a priority reporting task for the FDA, a task taken very seriously through MoCRA. Cosmetic manufacturers that have not had to prioritize adverse event reporting in the past will have to adapt to the strict requirements. Tracking adverse events will be the responsibility of everyone involved in the organization, so educational programs will be needed to train employees and other associates. Key points about this provision are:

  1. Responsible person(s) must report an adverse event to the FDA within 15 business days. That initial report must include a copy of the product label.
  2. If new information is received within one year of the initial report, that information must be reported to the FDA within 15 business days.

Mandatory Facility Registration

Facility registration is a mandatory requirement of MoCRA. Companies and organizations that sell beauty products and cosmetics in the United States will be required to have up-to-date registrations for their facilities. The facility will need to follow Good Manufacturing Practices (GMP) as outlined by the FDA. The FDA offers a Decision Tool and a draft guidance on Cosmetic Good Manufacturing Practices for those wondering if they need to register their facility. There will be exemptions for certain small businesses from Good Manufacturing Practices (GMP), registration, and product listing requirements.

If there is a "reasonable probability" that a product manufactured at a registered facility is causing a serious adverse event or death to a human, the FDA has the authority to suspend the facility registration. A company with a suspended facility registration is prohibited from distributing or selling its product in the U.S.

Safety Substantiation & Records Access

Ensuring the safety of beauty products includes producing and maintaining records that can substantiate or demonstrate the safety claims made. The expectation is that any data used for substantiation be derived from scientifically robust methods. If certain conditions of the act are not met, the FDA can access and copy records related to a cosmetic product.

MoCRA Opportunities and Challenges

The opportunities of the $49 billion beauty and cosmetic industry are balanced by the challenge of planning the manufacturing steps needed to produce beauty products and cosmetics. Gaining attention among markets and influencers tuned in to health and safety means taking the MoCRA health and safety requirements seriously. Having the capacity to demonstrate the science and rigor behind health claims is vitally important.

One challenge includes ensuring that each step of the beauty and cosmetic supply chain aligns with the MoCRA goals and parameters. Partnering with vendors who can source materials with the same goals in mind is critical.

[CTA] Wise Partnering to Meet Strict MoCRA Demands

H.B. Fuller has a history of paying careful attention to the rules and regulations behind FDA requirements. The Fuller beauty line meets rigorous safety and quality requirements. All beauty adhesives are certified to ISO 10993 regulations. As a global market leader in adhesives, H.B. Fuller has the breadth and depth to formulate and manufacture cosmetic and beauty products to address the broad needs and expectations of consumers.

Connect with an H.B. Fuller specialist today to explore MoCRA-ready adhesive solutions for your beauty product needs.

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