MoCRA: Navigating the New Regulatory Landscape for Private Label Cosmetic Brands

For private label cosmetic brand owners, staying informed about regulatory changes is crucial for business success. The Modernization of Cosmetics Regulation Act (MoCRA) brings significant updates to the cosmetic industry's regulatory framework. This blog post provides a brief overview of MoCRA, focusing on the key responsibilities it places on brand owners.

What Is MoCRA?

MoCRA was enacted at the end of 2022 by the US Congress. It is aimed at modernizing the regulation of cosmetics in the United States. It introduces new standards for safety, transparency, and accountability in the cosmetics industry, significantly impacting the FDA’s regulatory authority over cosmetics.

3 Key Responsibilities for Brand Owners Under MoCRA

1. Product Listing:

Brands must list their products with the FDA, including product ingredients, and provide any updates annually. The original deadline for product listings was December 29, 2023, but due to FDA’s delays in releasing the new cosmetics listing portal, it is excercising its enforcement discretion to delay enforcement until July 1, 2024. New cosmetics must be listed with the FDA 120 days after introduction to commerce.

EXEMPTION: The FDA does allow a small business exemption. If your average gross annual sales of cosmetics in the United States are less than $1 million USD over the past three years, the requirement for product listing is waived.

If you are a UCo Private Label customer and your business does not qualify as a small business, please reach out to our MoCRA project lead Lisa Sykes at lsykes@universalcompanies.com. She will provide you with some information that will be required for product listing.

2. Safety Substantiation:

MoCRA requires brand owners to maintain thorough records substantiating the safety of their cosmetic products and their ingredients.

For our Private Label Customers, we have gathered safety substantiation documents from the manufacturer for your Private Label products. These documents are available for download if ever requested by the FDA. You can find them located in the Private Label Education Hub in the “MoCRA Information & Resources” folder.

3. Adverse Event Recordkeeping & Reporting:

Brand owners are required to maintain for 6 years (3 years for small businesses) records of any complaints of adverse events associated with the use of their cosmetic products. In addition, brand owners are required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days. Please visit the FDA’s website for more information about what qualifies as a serious adverse event and Adverse Event Reporting.

By understanding and fulfilling your responsibilities under this new act, you can ensure compliance, build consumer trust, and position your brand as a leader in safety and transparency. And as always, your team at UCo is here to support you.

Please note that the information provided in this blog is not intended to be legal advice or a comprehensive interpretation of the Modernization of Cosmetics Regulation Act (MoCRA) or any other regulations. As a cosmetic brand owner, you should consult a qualified legal professional for specific advice tailored to your business.

Universal Companies is proud to have a team of experienced spa advisors on staff and welcomes you to consult with our professionals about spa products and supplies, including ingredients, equipment, and retail. Dedicated to the success of spa professionals everywhere, we're grateful to be recognized with the American Spa Magazine Professional's Choice Award, Favorite Distributor of the Year for many consecutive years. (Thank you!)

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