October 30, 2024

In today’s beauty-obsessed culture, many Americans rely on a variety of cosmetic products every day. On average, individuals use between 6 to 12 products, including makeup, nail polishes, shaving cream, fragrances, and skincare items. Given the prominence of these products in our daily routines, ensuring their safety has become paramount. Enter the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)—a pivotal law that enhances the FDA’s authority to oversee the safety of cosmetics. MoCRA was implemented on December 29, 2022, making compliance essential for all cosmetic manufacturers.

Understanding MOCRA

The passage of MoCRA marks the most significant update to cosmetic regulations since the Federal Food, Drug, and Cosmetic Act was enacted in 1938. This legislation empowers the FDA to implement crucial safety measures, helping to safeguard consumers from potential hazards associated with cosmetic products.

Key Terms to Know

  1. Adverse Event: Any health-related issue tied to the use of a cosmetic product that is deemed adverse.
  2. Facility: Any establishment that manufactures or processes cosmetic products distributed in the U.S.
  3. Responsible Person: The manufacturer, packer, or distributor whose name appears on the product label.

MoCRA introduces several new requirements and authorities, fundamentally changing how cosmetics are regulated in the United States.

New FDA Authorities Under MoCRA

  • Records Access: The FDA can now access and copy safety records related to cosmetic products.
  • Mandatory Recall Authority: If a cosmetic is found to be potentially harmful, the FDA can mandate a recall, ensuring swift action for consumer safety.

New Industry Requirements

  1. Adverse Event Reporting: Companies must report serious adverse events to the FDA within 15 business days, including a copy of the product label.
  2. Facility Registration: Manufacturers and processors are required to register their facilities with the FDA and renew this registration every two years.
  3. Product Listing: Each marketed cosmetic product must be listed with the FDA, including all ingredients, with annual updates required.

Safety Substantiation

Manufacturers now bear the responsibility for proving the safety of their products. While there are no specific testing mandates, companies must maintain adequate records to support the safety of their cosmetics. Notably, animal testing is not a requirement, but all safety data must come from scientifically valid methods.

How Maven Can Assist with MOCRA Registration

With these sweeping changes, navigating the regulatory landscape can be daunting for cosmetic manufacturers and marketers. This is where Maven steps in. We offer comprehensive services to ensure compliance with MoCRA and facilitate a smooth registration process. Here’s how we can help:

1. Expert Guidance on Compliance

Maven provides expert consultancy on the nuances of MoCRA, helping you understand the specific requirements that apply to your products. We ensure that you’re well-informed about adverse event reporting, facility registration, and product listing.

2. Facilitating Facility Registration

Our team assists in the registration of your manufacturing or processing facilities with the FDA, ensuring that all necessary information is accurately submitted and renewed as required.

3. Product Safety Documentation

We help compile and maintain the necessary safety substantiation records, ensuring you have scientifically sound data to support the safety of your products.

4. Adverse Event Management

Maven offers support in setting up systems for tracking and reporting adverse events, complying with the new 15-day reporting requirement, and ensuring that all necessary documentation is readily available.

5. Training and Resources

We provide training for your team on Good Manufacturing Practices (GMP) and other regulatory requirements, ensuring your operations align with MoCRA standards.

6. Staying Updated

The regulatory landscape is ever-changing. Maven ensures you stay updated on any new guidance or requirements from the FDA, helping you adapt your processes as needed.

Conclusion

The introduction of the Modernization of Cosmetics Regulation Act represents a significant shift in how cosmetic products are regulated in the U.S. Compliance is essential not only for legal reasons but also for the safety and trust of your consumers. Maven is here to assist you every step of the way, providing the tools and expertise needed for successful MOCRA registration and compliance. Together, we can ensure that your cosmetic products meet the highest safety standards, protecting both your business and your consumers.

For more information on how Maven can help you navigate the complexities of MOCRA, contact us today!