Americans have a long-standing love affair with cosmetics, making it a multi-billion-dollar industry. On average, Americans spend over $49.2 billion annually on cosmetic products, with people buying monthly cosmetics between $244 and $313. However, the quest for beauty often comes at a price, particularly when cheap, unqualified substances are involved, and the products are being produced in non GMP compliant and unsafe facilities that are not taking steps to prevent contamination to the products.
The FDA has upped its efforts to protect consumer health by enforcing The Modernization of Cosmetics Regulation Act of 2022. (MoCRA). This Act intends to increase cosmetic product oversight and regulation, ensuring their safety and reducing the dangers connected with dangerous substances and contaminants.
What Is The Modernization of Cosmetics Regulation Act?
The Cosmetics Regulatory Reform Act of 2022, commonly known as the Modernization of Cosmetics Regulation Act (MoCRA), marks a significant milestone in the FDA's regulatory approach towards cosmetics.
Enacted on December 29, 2022, as a component of the broader 2023 Consolidation Act, MoCRA aims to guarantee the safety of cosmetic products. This groundbreaking legislation compels manufacturers to offer reliable assurances regarding the safety of their offerings. By establishing a robust framework for cosmetics regulation, MoCRA addresses the need for transparency and consumer protection in an ever-evolving industry.
With this reform, the FDA is better equipped to tackle the challenges posed by cosmetics containing potentially harmful substances. The Act's stringent standards for product listings and recalls demonstrate its commitment to ensuring consumer wellbeing and maintaining high levels of safety within the cosmetics market.
The Modernization of Cosmetics Regulation Act Requirements
Primarily, the MoCRA amendment affects a wide range of stakeholders within the cosmetics industry, including manufacturers, importers, packers, and distributors of finished cosmetic products. While certain small business entities may be exempt from some of the requirements, the majority of medium to large organizations are required to comply with or partake in various aspects of MoCRA.
Adhering To Best Manufacturing Practices
A crucial component of the MoCRA is the emphasis on Good Manufacturing Practices (GMP). These practices serve as a comprehensive set of guidelines designed to ensure the consistent and safe production of high-quality products across various industries. GMP guidelines, widely employed in sectors such as pharmaceuticals, food and beverage, and more, play a critical role in establishing the necessary standards for manufacturing processes, equipment, and facilities.
By incorporating GMP into MoCRA, the Act aims to elevate the cosmetics industry's commitment to safety and quality, while minimizing the risks associated with potentially harmful substances.
Mandatory Product and Ingredient Listing
One of the significant implications of MoCRA pertains to the stipulations for product and ingredient labeling. Entities involved in manufacturing, packing, or distributing cosmetic products are mandated to provide the FDA with detailed information on the ingredients and manufacturing processes of their products.
For cosmetic products introduced to the market prior to MoCRA's implementation, companies are obligated to submit product listings by December 29, 2023. Meanwhile, products introduced after the Act's approval must be included within 120 days of their launch. Furthermore, these listings must be reviewed and updated on an annual basis to ensure that they remain in accordance with MoCRA's criteria.
Adverse Event Reporting
The new regulation requires a responsible party to notify to the FDA any major adverse events associated with the use of cosmetic goods in the United States. This reporting must be completed within 15 business days after receiving the adverse event report.
Also, any further pertinent medical information obtained must be presented within one year following the initial report. During inspections, the FDA will retain the power to access and assess these adverse event reports, ensuring that the required steps are taken to mitigate any risks and prioritize consumer safety.
Safety Substantiation
Under the new legislation, a responsible must ensure and preserve records that demonstrate sufficient safety validation for their cosmetic products. This entails maintaining documentation that confirms the product's safety through various methods, such as research analysis, tests, or other evidence deemed adequate by qualified experts in the field.
A thorough safety validation process involves gathering evidence that supports the claim that a cosmetic or beauty product is safe for use, based on expert consensus. These records must be accessible to authorized FDA personnel for inspection in cases where a product is suspected of contamination, posing health risks, or containing potentially harmful ingredients.
Note: MoCRA mandates that cosmetic companies adhere to regulations set forth by the FDA in the following areas:
- Compliance with labeling requirements for fragrance allergens present in cosmetics.
- Implementation of standardized testing procedures for the detection and identification of asbestos in cosmetic products containing talc.
The Highly Important “Mandatory Facility Registration” Requirement
As stipulated by MoCRA, both domestic and international facilities involved in the production or processing of cosmetic products intended for distribution in the U.S. are required to register with the FDA. Facilities that were already in operation before MoCRA's enactment must complete their registration within one year from the date the legislation was enacted. Newly established facilities, on the other hand, must register within 60 days of commencing the production of cosmetic products.
This mandatory registration process ensures that all facilities engaged in the cosmetics industry comply with the regulatory standards set forth by MoCRA, thereby maintaining the safety and quality of products available to consumers in the U.S. market.
Navigating MoCRA with Ease: BioSerene Leads the Way in Compliance
At BioSerene, our commitment to safety and quality has been unwavering since our inception. Even before the introduction of the Modernization of Cosmetics Regulation Act, we have been diligently adhering to the highest standards, ensuring that our consumers receive only the finest cosmetic products. This steadfast dedication to excellence has placed us at the forefront of the industry in terms of compliance.
Our product range reflects our dedication to ethical and responsible practices. BioSerene's offerings are manufactured in a GMP Certified and FDA registered facility with lab-tested ingredients and products, demonstrating our commitment to compassionate manufacturing.
Moreover, BioSerene is dedicated to supporting smaller businesses in navigating the complexities of MoCRA compliance. We believe that by sharing our expertise and resources, we can help create a safer and more affordable pathway for these businesses to offer their products to consumers. By fostering a collaborative approach, BioSerene aims to contribute to a cosmetics industry that prioritizes the wellbeing of its customers, while ensuring that businesses of all sizes can thrive in a responsible and sustainable manner.