Are You Ready for MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new law empowering the Food and Drug Administration (FDA) to oversee cosmetics in the United States. This law is intended to improve the safety of cosmetic products that millions of people use daily.
This legislation introduces various changes impacting the creation and sale of cosmetic products. It mandates stricter adherence to regulations, with the FDA taking a closer look at cosmetic products and their ingredients. The majority of these regulations were originally intended to go into effect one year after the law was passed, December 29, 2023. However, on November 8, The U.S. FDA announced they have postponed enforcement of cosmetic product registration and listing requirements under the MoCRA until July 1, 2024. Additionally, facilities engaged in post-Dec. 29, 2022, cosmetic production and products marketed after this date have enforcement relief until the July 1, 2024, deadline.
MoCRA establishes significant rules, including:
Adverse Event Reporting: A representative of the company is required to promptly inform the FDA of any serious issues resulting from the use of a cosmetic product within the United States, within a 15-day timeframe. Additionally, they must provide a copy of the product's packaging label.
Mandatory Recall Authority: Should the FDA identify a cosmetic product as unsafe or improperly labeled, posing a risk of harm or fatality, the FDA can mandate the removal of the product from the market if the responsible party fails to take action independently.
Records Access: Under certain conditions, the FDA has the authority to review and obtain copies of specific records related to a cosmetic product, including safety records.
The implications of this new law are substantial for cosmetics companies. Compliance with the updated manufacturing and processing requirements, coupled with the expanded enforcement role of the FDA, will necessitate heightened scrutiny and more stringent compliance obligations on your business.
Please note that the details mentioned here do not cover all provisions of MoCRA. For further information, please refer to the sources at the end of this article.
Your third-party logistics (3PL) companies provide services that can help you comply with the new rules of the Modernization of Cosmetics Regulation Act of 2022.
Capacity can provide industry consultants for the following topics:
Good Manufacturing Practices (GMP): Guidance in using GMPs, as it relates to how products are packed, and kept in line with MoCRA proposed rules.
Labeling Compliance: Assurance that your product labels meet proposed MoCRA requirements.
Recall Management: Advisory on product recalls including help with recall planning, action, and paperwork as well as providing information needed as a part of adverse event reporting under proposed MoCra requirements.
We understand that these changes might pose challenges, and we are committed to assisting as the industry moves through this change.
It's important to remember that while 3PL companies can give important help to cosmetic brands, it's ultimately up to the brand to make sure they're following MoCRA rules.