Unpacking MoCRA, Impacting Beauty Brands

Beauty Industry Enthusiasts,

Today, let’s talk about MoCRA or the Modernization of Cosmetics Regulation Act of 2022. This significant legislation has redefined the narrative of cosmetic regulation in the United States, marking a new chapter of enhanced safety, transparency, and responsibility. As we navigate these changes, it is a moment to reflect on the progressive strides we are making in the field of cosmetics regulation.?

Disclaimer: Please note that we are not regulatory specialists. The following information is intended for general informational purposes only.??

What is MoCRA?

At its core, MoCRA is a law that brings major changes to how cosmetic products are regulated in the U.S. It gives the Food and Drug Administration (FDA) more power to ensure that cosmetics sold in the country provide consumer safety.

Six Key Points of MoCRA:

1. Elevated Safety Standards: MoCRA introduces rigorous safety substantiation requirements for cosmetic products. This means companies must demonstrate their products' safety with solid scientific evidence. For more details, visit the FDA's overview of MoCRA's Background and Key Terms.

2. Increased Transparency: The act mandates clear labeling, including the disclosure of fragrance allergens. This is to enhance ingredient transparency for consumers.The FDA provides information on labeling requirements under MoCRA, accessible here.

3. Empowered FDA Authority: MoCRA boosts the FDA's regulatory power, including the authority to enforce mandatory recalls of harmful products. You can read more about the FDA’s expanded authority under MoCRA on their official page.

4. Product Listing: This involves the requirement for companies to register their cosmetic products with the FDA. This includes providing detailed information such as the product's ingredients, manufacturing locations, and contact information for responsible individuals. By maintaining an updated product list, the FDA can better monitor the market for compliance and swiftly address any safety concerns that may arise. Find more about it here

5. Adverse Event Reporting: Companies are obligated to report serious adverse events, a step towards improved accountability and consumer safety. Details about adverse event reporting can be found in the FDA’s guidance on Mandatory Reporting for Cosmetics.

6. Focus on Small Businesses: MoCRA takes into account the unique challenges small businesses face and includes specific provisions to address them. For specific information on how MoCRA affects small businesses, refer to the FDA’s Final Guidance and the insights provided by Loeb & Loeb LLP here.

With MoCRA, the FDA's regulatory scope is broadened. However, the full implications, especially for small businesses, might still need clarification. To delve deeper into this topic, check out our recent podcast episode, "MoCRA, Misconceptions and Regulatory Risk" with Ariana Farina, a Regulatory Consultant. Listen to the episode here?

As we turn the pages of this new chapter, it's essential for everyone in the beauty industry – from budding entrepreneurs to established brands – to understand and adapt to these changes. MoCRA isn't just legislation; it's a promise of a safer, more responsible future in cosmetics.

Warm Regards,?

Megan

P.S…At GLC, Packaging & Project Execution Team, we are big about compliance and regulations. MoCRA impacts Packaging, and I have regulatory on my team from Steinberg & Associates and Ariana Farina Consulting. Contact us today to conduct an initial audit and update your packaging per MoCRA regulations.?