The cosmetics industry is experiencing a significant transformation with the introduction of the Modernization of Cosmetics Regulation Act (MoCRA). As of December 29, 2023, there are four essential compliance requirements that businesses in the cosmetic and personal care product sector must meet to align with the new regulatory landscape. Let's delve into these key requirements and what they mean for the industry.

1. Cosmetic Safety Substantiation:

One of the central pillars of MoCRA is ensuring the safety of cosmetic products. Businesses must substantiate the safety of each cosmetic product through rigorous testing, research, or other substantiated evidence. While the law and FDA regulations do not mandate specific tests, it is the responsibility of the "Responsible Person" to maintain records supporting adequate safety substantiation for their cosmetic products.

The "Responsible Person" is a critical concept introduced by MoCRA. This term refers to the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label. Responsible persons must ensure that all safety data is derived from scientifically robust methods.

 Importantly, MoCRA does not require animal testing for cosmetic products. The key is to demonstrate that a cosmetic product is safe for users under the conditions of use prescribed in the labeling or under customary or usual conditions.

It is recommended that businesses consult experts, such as toxicologists, to conduct Toxicological Risk Assessments on their products, assess risks, and establish a safety substantiation policy to meet these requirements. Compliance with this requirement is mandatory by December 29, 2023.

2. Adverse Event Recordkeeping & Serious Adverse Event Reporting:

For the first time, cosmetic companies are required to report serious adverse events associated with the use of their cosmetic products. MoCRA defines "serious adverse events" as those that result in death, life-threatening experiences, inpatient hospitalization, significant disability or incapacity, congenital anomalies or birth defects, infections, significant disfigurement, or events requiring medical or surgical intervention.

Businesses must report these serious adverse events to the FDA within 15 business days of receipt of the report. Regular updates to the FDA are also required as new information is reported.

MoCRA extends the requirement for cosmetic companies to maintain records of health-related adverse events for at least 6 years post-receipt of the report. Compliance with these reporting and record-keeping requirements is crucial for businesses.

3. Mandatory Facility Registration & Product Listing:

All cosmetic facilities involved in manufacturing or processing cosmetic products for distribution in the United States must be registered with the FDA. The deadline for initial registration was December 29, 2023, for facilities engaged in manufacturing or processing cosmetic products before December 29, 2022.

Facilities must also renew their registrations biennially, regardless of whether there have been any changes to the facility's information. Additionally, responsible persons must submit a comprehensive cosmetic product listing. The initial listing deadline was December 29, 2023, for products marketed on or before December 29, 2022.

These requirements ensure that the FDA has access to crucial information about cosmetic facilities and products, promoting transparency and accountability.

4. Cosmetic Labeling (for Professional Use Products):

By December 29, 2023, products intended solely for professional use must be clearly labeled, indicating that they can only be administered or used by a licensed professional. This requirement aims to enhance safety and transparency, ensuring that professionals are aware of the products they use in their work.

It closes a previous loophole where "for professional use only" cosmetic products did not require ingredient listings. The development of this requirement was influenced by the need for salon workers to access ingredient information on product labels, promoting awareness of substances they are exposed to while working.

Meeting these four key requirements under the Modernization of Cosmetics Regulation Act (MoCRA) is essential for businesses operating in the cosmetics and personal care product industry. Compliance ensures not only the adherence to the law but, more importantly, the safety and well-being of consumers. As we navigate the evolving regulatory landscape, businesses should prioritize transparency, safety, and accountability to thrive in this new era of cosmetic regulation.

Comprehensive Support from EWC:

For businesses seeking a seamless journey to compliance, the Equity and Wellness Collaborative (EWC) is the ideal partner. EWC offers an all-encompassing solution, acting as the "Responsible Person" to register facilities and ingredients, ensuring compliance at every step of the process. They collaborate with accredited labs to verify safety, allowing businesses to access safety substantiation from reputable sources. Moreover, EWC can assist in the intricate process of labeling, ensuring that products are clearly and accurately marked for consumer transparency.

For further insights, personalized guidance, and comprehensive support with MoCRA compliance, connect with our experts at EWC. Together, we're shaping the future of cosmetics regulation for the well-being of all. EWC can help with ALL four key requirements, simplifying the compliance process and guaranteeing that your products meet the highest standards of safety and adherence.